When to insert the Nuvaring ring after a break. Nuvaring: instructions for use of the hormonal ring

Ring NuvaRing — hormonal drug, which has a high contraceptive effect and does not cause negative consequences for the body. Instructions for use characterize it as reliable method protection.

It is not fussy to use, since it does not require the daily participation of a woman, acting independently. How exactly is this level of protection against unwanted conception achieved, and in what situations should it be preferred?

Nuvaring ring, the instructions for use of which describe in detail the rules of use, is highly effective birth control contraceptive new generation. Artificial material, from which the ring is made, is also used for breast enlargement and in the manufacture of implants.

This is a translucent, almost colorless rim, 6 cm in diameter, which reliably protects the egg from fertilization by sperm and the onset of conception. The material from which the drug is made is hypoallergenic, therefore negative reaction it occurs extremely rarely.

Composition and principle of action

The instructions for the NuvaRing ring describe in detail active substance and mechanism of action. Inside the ring are ethinyl estradiol and etonogestrel, which are released from their shell every day in strictly limited doses. Due to the fact that there are many vessels in the vagina, active substance quickly penetrates the blood and begins to act.

They work exactly the same birth control pills, when taken, the substance is absorbed through the stomach, and not through the walls of the vagina.

On female body NuvaRing has the following effects:

  1. Suppresses the onset of ovulation.
  2. Does not allow the hormonal system to function.
  3. Promotes education thick mucus in the cervix, preventing sperm from penetrating and fertilizing the egg.

These processes can be reversed if you stop removing the ring from the body and wait for the cycle to normalize.

Advantages of the method

In addition to the reliability of this type of contraception, the NuvaRing ring has other positive aspects:

  1. Low doses of hormones that a woman receives daily while using the ring. According to researchers, it releases almost a third less ethinyl estradiol than oral contraceptives.
  2. A woman does not need to think about taking contraceptives every day, since the drug works independently of her, releasing the required amount of the active substance.
  3. It makes it easy to adjust your monthly cycle, namely, delaying or prolonging the onset of menstrual bleeding.
  4. Like any hormonal agent, NuvaRing has a beneficial effect on appearance - improves skin, hair and nails, allows you to reduce discomfort during menstruation and pain.

Disadvantages of the method

Main disadvantages of use contraceptive ring consist in the presence of an impressive list of contraindications and side effects, as well as the need to strictly adhere to the regimen of using the drug.

But the disadvantages do not end there:

  1. The NuvaRing cannot protect a woman from sexually transmitted diseases, such as AIDS and syphilis. The same can be said about everything hormonal contraceptives.
  2. Additionally, if a woman is susceptible to infection, the presence of a foreign object in the vagina can increase inflammation and increase the amount of discharge.
  3. Due to the fact that the ring can move and even be removed from the vagina on its own, there is a need to periodically check its presence in order to prevent sperm from fertilizing the egg.
  4. This method of contraception is psychologically unusual for women, and therefore often causes mistrust in its contraceptive properties.

Technique of use

You can use the NuvaRing ring only after fully reading the instructions and consulting with a gynecologist. You should not prescribe the use of this contraceptive yourself, as it is difficult to take into account all the nuances known only to a professional.

When the first period occurs, you can inject the drug into the vagina, and the procedure should be as follows:

  1. Wash your hands.
  2. Take a comfortable position that allows access to the vagina and allows you to completely relax, for example, lie on the sofa.
  3. Open the package and remove the ring from the aluminum wrapper.
  4. Flatten it with two fingers and insert the ring deeply into the vagina, adhering to the back wall.

The whole process does not take much time and is very similar to inserting a tampon when menstruation occurs. None pain there should not be, therefore, if you feel discomfort, you must immediately remove the drug and consult a doctor. Elastic ring NuvaRing, in case correct application, should stick to the walls of the vagina and be fixed on them.

After three weeks of use, the contraceptive should be removed. This needs to be done correctly, although there is nothing complicated in the process.

You need to again take a comfortable position and pick up the ring with your finger to carefully remove it from the body. This item can no longer be reused, so it can be disposed of. Next, the girl can expect bleeding, which should begin within the next 7 days. A new ring should be inserted 8 days after the previous one is removed.

Use if hormonal contraceptives were not used in the previous cycle

The NuvaRing ring can be administered already on the first day of the cycle when initial signs bleeding to protect yourself as much as possible from conception. If necessary, you can delay using the ring for 2-5 days if you turn to alternative methods of protection.

Switching from combined hormonal contraceptives

If desired, a woman can change the method of contraception and choose the NuvaRing ring instead of combined hormonal drugs. The instructions for use do not exclude this possibility if the woman followed the gynecologist’s instructions and did not miss taking pills.

Switching from drugs containing only progestogen

Mini-pills can also be easily replaced with NuvaRing. Moreover, the transition can be made on any day of the cycle by instantly replacing the implant or IUD with a ring. When using injections to prevent conception, you should not take breaks, but replace them after the final injection.

After this, it is better to resort to using condoms for a week due to possible reduction protective action rings.

After an abortion in the first trimester

Using after abortion early stages NuvaRing ring, the instructions of which clearly describe this situation, does not require resorting to alternative methods of protection against conception. An exception may be medical indications, in which a woman is allowed to delay the insertion of the ring for up to 5 days.

After childbirth or after an abortion in the second trimester

More serious abortion performed surgical method By medical indications, or childbirth requires a more delicate approach in further protection. NuvaRing should be used only after a month if the woman is not breastfeeding her newborn.

In case of delaying contraception and using the ring for more late dates, you should use condoms to protect yourself as much as possible from conception. In addition, you need to make sure that you are not pregnant. It is necessary to continue using barrier methods of protection for 7 days after inserting the ring.

Use during pregnancy and breastfeeding

Due to the fact that the NuvaRing ring is a hormonal drug intended to prevent pregnancy, its use during this period is strictly prohibited. Although studies of the drug have not been conducted among women expecting to give birth, there is no need to risk the health of the baby.

In addition, once pregnancy has already occurred, there is no need for contraception. The same cannot be said about the lactation period, which is also not recommended to be combined with the use of hormonal contraceptives. This is due to the fact that the active substance contained in the ring can change the composition of breast milk or reduce its volume.

Break in use

Violation of the contraceptive regimen prescribed by the gynecologist can lead to conception. Before using the NuvaRing ring after a break, the instructions provided by the manufacturer advise you to make sure there is no pregnancy.

If fertilization of the egg has not occurred, the drug should be installed in the most as soon as possible, while simultaneously using alternative ways contraception. But a break does not always happen due to the fault of a woman who simply got lost in the dates.

The NuvaRing ring tends to involuntarily move into the vagina and even be removed from it. Then it is urgent to return it to its place. If the contraceptive was absent from the vagina for no more than 3 hours, then there is no need to be afraid of conception. Otherwise, it is better to play it safe and resort to condoms or other barrier methods.

Extended use

If NuvaRing was used longer due date, but not longer than a month, Then contraceptive effect will remain sufficient to prevent conception. The woman needs to take the prescribed week break and use the following drug.


Scheme for using the NovaRing contraceptive ring.

After 4 weeks of use, the contraceptive effect of NuvaRing decreases, therefore, before inserting a new ring, you need to do a pregnancy test or consult a doctor to establish the fact of absence of pregnancy.

Menstruation and bleeding during use

Bleeding during contraception with this hormonal drug is considered normal occurrence. Most often, menstruation begins immediately after the ring is removed and stops with the introduction of a new contraceptive. Less often, bleeding does not start at all, and this is also not a deviation, provided that all recommendations are followed.

Repeated absence of menstruation requires the intervention of a gynecologist, as this may mean pregnancy. However, when using the NuvaRing ring, the instructions require strict monitoring of the body’s condition, since heavy bleeding should be observed by the attending gynecologist.

Cancellation of NuvaRing

A woman can refuse contraception with NuvaRing at any time, since this process does not require special preparation. If necessary, the drug can be safely removed without waiting for 21 days of use.

Pregnancy after stopping the contraceptive ring

Refusal hormonal contraception leads to the cessation of effects on the woman’s body, and NuvaRing is no exception. Conception can occur as early as 4-5 weeks after the contraceptive ring is removed.

Drug interactions

Parallel use of the NuvaRing ring with others medications, may lead to a decrease in contraceptive effect, as the instructions warn about.

Medicines that should not be combined with hormonal contraception:

  1. Drugs, in large quantities excreted by the liver, leading to hepatic metabolism. This refers to medications such as barbitures, carbamazepine, phenytoin, rifampicin, and some other medications containing St. John's wort. When undergoing therapy with these drugs, it is better to resort to alternative methods of contraception without removing the ring from the vagina.
  2. Antibiotics also lead to a decrease in the contraceptive effect, as they have a great effect on the active substance of NuvaRing. When taking these drugs, with the exception of doxycycline and amoxicillin, you should use barrier contraceptives during treatment and for a week after the end of the course.

Birth control with a hormonal ring may also affect biochemical parameters some organs and change the composition of the blood. If during contraception a woman needs to undergo medical commission, the attending physician should be aware of the use of the NuvaRing ring.

Side effects

A negative reaction to the drug is extremely rare, but not completely excluded. Side effects associated with the use of NuvaRing rings usually do not require immediate attention. medical care because they pass on their own.

TO side effects include:

  1. Intoxication – nausea, diarrhea, and sometimes vomiting.
  2. dizziness, constant anxiety, changeable mood, pain in the head, as a result of the effect on the nervous system.
  3. Weight gain, breast hardening, decreased libido.
  4. Cystitis.
  5. Minor discharge, vaginitis.

In addition, a woman may be bothered by the sensation of a foreign object in the vagina, as well as spontaneous removal of the ring.

Contraindications for use and use with caution

Not everyone is recommended to use the NuvaRing ring, as it has many prohibitions and contraindications.

  • Hormone-dependent malignant tumors.
  • Vaginal bleeding that occurs for unknown reasons.
  • Blood disorders such as thrombosis or bleeding disorders.
  • Pregnancy and lactation.
  • Severe liver pathologies, including tumors.
  • Inflammatory processes in the vagina - vaginitis, colpitis.
  • Allergies to contraceptive components.

Careful use of the product is possible for:

  • varicose veins;
  • heart disease;
  • autoimmune diseases;
  • when the walls of the female genital organ droop or fall out;
  • cholelithiasis;
  • smoking.

It is necessary to stop using NuvaRing before the proposed surgery.

Conditions and shelf life

To prevent the drug from losing its contraceptive properties, it must be kept at 2-8 °C, then the NuvaRing ring will not lose its properties for 3 years from the date of release. The best place for this there will be a regular refrigerator compartment, where the required temperature is maintained.

In addition, the contraceptive ring should be protected from children's attention, since if it enters the body of a minor child, it can negatively affect the development of the baby. After the expiration date, it is strictly forbidden to use the drug for its intended purpose.

Where to buy and price

The NuvaRing ring is sold in free access, so you can find it at any pharmacy. Large selection The drug is offered by online portals for the sale of medicines. This makes it possible to resort to the use of NuvaRing in the most remote corners of the country, thanks to well-established logistics and courier delivery. On average, the price of one ring ranges from 600 to 1000 rubles.

Packages of the NuvaRing ring containing 3 contraceptives will cost from 1300 to 1800 rubles.

Each the woman will find its positive aspects of this method of contraception, because the convenience and effectiveness of the NuvaRing ring are obvious. Before deciding to use a hormonal drug, you should study the instructions and also consult a gynecologist.

Video about the NuvaRing ring, its effectiveness and rules of use

Instructions for use of the NuvaRing ring:

Expert opinion about the Nuvaring ring:

Content

To protect against unplanned pregnancy, it is recommended to use various contraception. One such drug is the birth control ring. Instructions for use Nuvaring describes how, when and under what circumstances the device is used. Initially, before use, you should find out the advantages and disadvantages of the contraceptive method, as well as reviews of women who have tried the drug before.

Advantages and disadvantages of the Nuvaring contraceptive ring

The NuvaRing device, due to its flexibility and elasticity, does not cause discomfort. A woman does not need to limit her physical activity. At intimacy The Nuvaring vaginal ring does not reveal itself, so the partner does not realize that there is a foreign object inside the vagina.

The NuvaRing device is inserted deeply into the vagina. Inside the cavity, the shape of the ring undergoes individual changes, taking on the contours of the female genital organ and occupying a convenient location.

The advantages of the device are:

  1. Low dosage of hormones contained in the contraceptive: only 20 mcg of the active substance is released into the bloodstream during the day, while other oral tablets have up to 30 mcg of the active substance.
  2. The effects of hormones do not extend to the entire body; the substances act only locally.
  3. The patient's weight does not increase during therapy.
  4. Correct use of the NuvaRing ring can reduce the risk of developing uterine and ovarian cancer.
  5. There is no need to control the intake - the ring is placed once every 21 days, and the tablets should be taken systematically.
  6. Has a beneficial effect on a woman’s appearance – improves her condition skin, hair, blocks painful discomfort when menstruation occurs, reduces their duration.
  7. It has the ability to delay or shorten the onset of menstruation thanks to modes of non-standard use of the device. But such use must be agreed upon with a gynecologist and strictly followed according to the instructions.

The disadvantages of using the device are the following points:

  • a careful regimen of use should be followed;
  • there are many contraindications that provoke side effects;
  • if the NuvaRing ring is not properly inserted, it may periodically fall out;
  • in the presence of diseases of the genital organs, when inserting the device, it develops inflammatory process, the volume of discharge increases.

Warning! The NuvaRing ring, like other contraceptives in this group, does not protect against contracting diseases transmitted by partners through intimate intimacy.

Composition of Nuvaring

NuvaRing is a contraceptive that is a ring. According to the instructions, made of transparent, flexible, elastic material, with a completely smooth surface.

The substance from which the ring is made contains two active components: etonogestrel and ethinyl estradiol. To enhance the effect, the following are contained as excipients:

  • magnesium stearate;
  • vinyl acetate copolymer;
  • ethylene.

Mechanism of action

When a hormonal ring is inserted, the process of egg maturation is blocked. The process occurs thanks to estrogen and progesterone, which are binding substances with the natural receptors of the female body.

After installing the Nuvaring ring, the sheath in the vagina is heated to degrees female body, resulting in the release of hormones contained within. The substances, when released, act specifically on the ovaries and uterus.

The available dose in the Nuvaring hormonal ring is sufficient to suppress ovulation. Due to this, conception does not occur.

Indications and contraindications for Nuvaring

The ring is specially designed for contraception. Thanks to its simple protection system, the device is popular among women different ages, including both young ladies and slightly older ladies:

  1. Young girls leading sex life and having one verified sexual partner, who have not previously given birth.
  2. Those who have recently given birth, as well as after the end of the period of natural feeding of the baby.
  3. Representatives of the fair sex in the premenopausal period, but in the absence of chronic pathologies.

But before use, you should find out what contraindications there are. There are situations when it is prohibited to use the NuvaRing contraceptive ring:

  • varicose veins in the legs, thrombosis;
  • frequent headaches with the presence of symptoms of neurological disorders;
  • liver pathologies acute type leakage;
  • vascular lesions during the development of autoimmune diseases;
  • vaginal discharge mixed with blood in the middle of the menstrual cycle;
  • tumors of a malignant and benign nature;
  • hypersensitivity and drug intolerance;
  • the period of gestation and then natural feeding of the baby.

The NuvaRing device is allowed to be used when identifying excess weight, at increased rates blood pressure. The following do not become an obstacle:

  • epilepsy;
  • myocardial defects;
  • cervical prolapse;
  • intestinal obstruction.

Comment! For these diseases, the patient should be constantly monitored by a gynecologist.

Side effects of Nuvaring

At correct use Side effects of the NuvaRing device are extremely rare. But when the patient inserts the ring, if there are contraindications for use, the following negative phenomena develop:

  • the occurrence of cystitis or cervicitis;
  • manifestation of vomiting, painful discomfort in the stomach, diarrhea;
  • growth of body fat, as well as increased appetite due to metabolic problems;
  • increase in blood pressure;
  • hypoesthesia;
  • decreased libido levels;
  • significant headaches;
  • skin rashes;
  • manifestation of muscle spasmodic pain in the back;
  • malaise, increased irritability.

Attention! Typically, such signs develop when the Nuvaring ring is administered simultaneously with the use of other hormonal contraceptives, which, according to the instructions for use, is unacceptable.

How to insert Nuvaring

Algorithm:

  1. The procedure is carried out with your own hands in a comfortable home environment.
  2. It is necessary to choose a comfortable position: squat down or raise one leg so that it is comfortable for administering the drug.
  3. Remove the packaging from the device.
  4. Lightly squeeze the ring in your hands, carefully, slowly, without unnecessary movements, insert it into the vaginal cavity, pushing it further away.

The elastic structure of the ring allows the device to be securely fixed in the folded walls of the vagina.

Instructions for using Nuvaring for the first time

The duration of the ring's stay in the vagina is 21 days. Afterwards, you need to take a break of 1 week. On day 2-3, discharge appears, with blood streaks turning into bleeding. This process is formed due to the cessation of the action of the contraceptive drug.

If the Nuvaring ring is being installed for the first time, it is inserted on the first day of your period. Installation of the device is allowed over the next 5 days, but in such a situation it is necessary to additionally use condoms during intimate intimacy for the next 7 days.

If the patient decides to switch from other oral contraceptives to the Nova Ring contraceptive ring, then the instructions advise inserting the device into the vagina on the last day after hormonal protection of another type.

Pregnancy and lactation

The Nuvaring device is being developed specifically to prevent unwanted pregnancy, therefore, the use of the ring is strictly prohibited during pregnancy. If the patient is absolutely sure that she is pregnant, the device is immediately removed.

After discontinuing use of the device desired pregnancy may occur immediately after restoration of normal egg maturation and the onset of a natural cycle.

Important! Using the Nuvaring contraceptive ring while breastfeeding naturally is strictly prohibited.

If a woman uses the device, the active components released will have a negative effect on breast milk, reducing the volume of lactation.

Price of the birth control ring Nuvaring

The contraceptive Nuvaring can be purchased at a hospital pharmacy or ordered online. In Moscow, the price of the drug is 1097 rubles. for 3 pieces, and in St. Petersburg – 1135-1351 rubles.

Analogs

Nuvaring, shown in the photo, has no analogues today that can completely replace the device in composition and effect.

There are other substitutes belonging to the same pharmacological group:

  • "Cliogest";
  • "Janine";
  • "Klimadinon";
  • "Klimonorm";
  • "Silest";
  • "Median";
  • "Novinet."

Warning! It is strictly forbidden to select the drug yourself. Only the attending physician correctly selects the remedy and prescribes the duration of therapy.

Conclusion

Thus, the instructions for use of Nuvaring recommend using the device various categories women who have no contraindications. The device allows you to block the possibility of conceiving a child, and also improves appearance women. The main thing is to follow the doctors’ recommendations and act according to the plan.

vaginal ring 2.7 mg+11.7 mg: pack. 1 or 3 pcs. Reg. No.: P N015411/01

Clinical and pharmacological group:

Hormonal contraceptive for intravaginal administration

Release form, composition and packaging

Vaginal ring smooth, transparent, colorless or almost colorless, without large visible damage, with a transparent or almost transparent area at the junction.

Excipients: ethylene and vinyl acetate copolymer (28% vinyl acetate) - 1677 mg, ethylene and vinyl acetate copolymer (9% vinyl acetate) - 197 mg, magnesium stearate - 1.7 mg.

1 piece - waterproof bags made of aluminum foil (1) - cardboard packs.
1 piece - waterproof bags made of aluminum foil (3) - cardboard packs.

Description of the active components of the drug " Nuvaring®»

Pharmacological action

Combined hormonal contraceptive drug, containing etonogestrel and ethinyl estradiol.

Etonogestrel is a progestogen (19-nortestosterone derivative) that binds with high affinity to progesterone receptors in target organs. Ethinyl estradiol is an estrogen and is widely used to produce contraceptives.

The contraceptive effect of the drug NuvaRing ® is due to the combination various factors, the most important of which is the suppression of ovulation.

Efficiency

IN clinical studies it was found that the Pearl index (an indicator reflecting the frequency of pregnancy in 100 women during 1 year of contraception) in women aged 18 to 40 years for the drug NuvaRing ® was 0.96 (95% CI: 0.64-1.39) and 0.64 (95 % CI: 0.35-1.07) at statistical analysis all randomized participants (ITT analysis) and analysis of study participants who completed them according to the protocol (PP analysis), respectively. These values ​​were similar to the values ​​of the Pearl indices obtained with comparative studies combined oral contraceptives (COCs) containing levonorgestrel/ethinyl estradiol (0.150/0.030 mg) or drospirenone/ethinyl estradiol (3/0.30 mg).

With the use of the drug NuvaRing ®, the cycle becomes more regular, the pain and intensity of menstrual-like bleeding decreases, which helps reduce the incidence of iron deficiency conditions. There is evidence of a reduction in the risk of endometrial and ovarian cancer with the use of the drug. In addition, high-dose COCs (0.05 mg ethinyl estradiol) reduce the risk of developing ovarian cysts, inflammatory diseases pelvic organs, benign changes in the mammary glands and ectopic pregnancy. It is not entirely clear whether low-dose hormonal contraceptives offer similar benefits.

Nature of bleeding

A comparison of bleeding patterns over a one-year period in 1000 women using NovaRing ® and COCs containing levonorgestrel/ethinyl estradiol (0.150/0.030 mg) showed a significant reduction in the incidence of breakthrough bleeding or spotting when using NovaRing ® compared to COCs. . In addition, the frequency of cases where bleeding occurred only during a break in the use of the drug was significantly higher among women using the drug NuvaRing ® .

Effect on bone mineral density

A comparative two-year study of the effect of the drug NuvaRing (n=76) and non-hormonal intrauterine device(n=31) showed no effect on mineral density bone tissue in women.

Children

Indications

- contraception.

Dosage regimen

NuvaRing ® is inserted into the vagina once every 4 weeks. The ring is in the vagina for 3 weeks and then removed on the same day of the week on which it was placed in the vagina; after a week's break, a new ring is inserted. For example: if the NuvaRing ® ring was installed on Wednesday at approximately 10:00 pm, then it should be removed on Wednesday 3 weeks later at approximately 10:00 pm; on the following Wednesday a new ring is inserted.

Bleeding associated with discontinuation of the drug usually begins 2-3 days after removal of NuvaRing ® and may not completely stop until a new ring is installed.

Hormonal contraceptives were not used in the previous menstrual cycle

NuvaRing ® should be administered on the first day of the cycle (i.e., the first day of menstruation). It is possible to install a ring on days 2-5 of the cycle, however, in the first cycle in the first 7 days of using the drug NuvaRing ®, additional use of barrier methods of contraception is recommended.

Switching from taking combined oral contraceptives

NuvaRing ® should be administered on the last day of the free interval in taking combined hormonal contraceptives (tablets or patches). If a woman has been taking a combined hormonal contraceptive correctly and regularly and is confident that she is not pregnant, she can switch to using vaginal ring on any day of the cycle.

The duration of the interval in taking hormonal contraceptives should not exceed the recommended period.

Switching from progestin-only contraception (mini-pill, implant, or injectable contraception) or progestogen-releasing intrauterine device (IUD)

A woman taking the mini-pill can switch to using NuvaRing ® on any day (the ring is inserted on the day the implant or IUD is removed or on the day of the next injection). In all these cases, the woman should use a barrier method of contraception for the first 7 days after insertion of the ring.

After an abortion performed in the first trimester of pregnancy

You can start using NuvaRing ® immediately after an abortion. In this case there is no need for additional use other contraceptives. If the use of NuvaRing ® immediately after an abortion is undesirable, the ring should be used in the same way as if hormonal contraceptives were not used in the previous cycle. In the interval, a woman is recommended alternative method contraception.

After childbirth or abortion performed in the second trimester of pregnancy

The use of NuvaRing ® should begin within the 4th week after childbirth (if the woman is not breastfeeding) or abortion in the second trimester. If the use of NuvaRing ® is started at a later date, then additional use of barrier methods of contraception is necessary in the first 7 days of using NuvaRing ® . However, if sexual intercourse has already taken place during this period, then it is necessary to first exclude pregnancy or wait until the first menstruation before starting to use the drug NuvaRing ® .

The contraceptive effect and cycle control may be impaired if the patient does not comply with the recommended regimen. To avoid loss of contraceptive effect in case of deviation from the regimen, you must follow the following recommendations.

Extending the break from using the ring

If you had sexual intercourse during a break from using the ring, pregnancy should be ruled out. How longer break, the higher the likelihood of pregnancy. If pregnancy is ruled out, a new ring should be inserted into the vagina as quickly as possible. Over the next 7 days, an additional barrier method of contraception, such as a condom, can be used.

If the ring has been temporarily removed from the vagina

If the ring remained outside the vagina less than 3 hours, the contraceptive effect will not decrease. The ring should be reinserted into the vagina as soon as possible.

If the ring was left outside the vagina for more than 3 hours during the first or second week of use, then the contraceptive effect may be reduced. You should place the ring in your vagina as soon as possible. Over the next 7 days, you must use a barrier method of contraception, such as a condom. The longer the ring was outside the vagina and the closer this period is to the 7-day break in using the ring, the higher the likelihood of pregnancy.

If the ring was outside the vagina for more than 3 hours during the third week of use, then the contraceptive effect may be reduced. The woman should throw away this ring and choose one of two methods:

1. Immediately install a new ring. Please note that the new ring can be used for the next 3 weeks. In this case, there may be no bleeding associated with the cessation of the drug's effect. However, spotting or bleeding in the middle of the cycle is possible.

2. Wait for bleeding associated with the cessation of the drug’s effect, and insert a new ring no later than 7 days after removing the previous ring. This option should only be chosen if the ring use regimen has not previously been violated during the first 2 weeks.

Extended use of the ring

If the drug NuvaRing ® was used no more maximum term at 4 weeks, then the contraceptive effect remains sufficient. You can take a week's break from using the ring and then insert a new ring. If NuvaRing ® remained in the vagina more than 4 weeks, then the contraceptive effect may worsen, so pregnancy must be ruled out before inserting a new ring.

To change the time of onset of menstrual bleeding

To postpone (prevent) menstrual-like withdrawal bleeding, you can insert a new ring without a week's break. The next ring must be used within 3 weeks. This may cause bleeding or spotting. Then, after the usual one-week break, you should return to regular use of NuvaRing ®.

To postpone the onset of bleeding on another day of the week, it can be recommended to take a shorter break from using the ring (for as many days as necessary). The shorter the interval between ring use, the higher the likelihood that there will be no bleeding after ring removal, and no bleeding or spotting will occur when the next ring is used.

Ring damage

IN in rare cases When using NuvaRing ®, ring rupture was observed. The core of the NuvaRing ® ring is solid, so its contents remain intact, and the release of hormones does not change significantly. If the ring ruptures, it usually falls out of the vagina. If the ring ruptures, a new ring must be inserted.

Ring falling out

NuvaRing ® has sometimes been reported to fall out of the vagina, for example, when it is inserted incorrectly, when a tampon is removed, during sexual intercourse, or due to severe or chronic constipation. In this regard, it is advisable for a woman to regularly check the presence of the NuvaRing ® ring in the vagina.

Incorrect insertion of the ring

In very rare cases, women have unintentionally inserted NuvaRing ® into the urethra. When symptoms of cystitis appear, it is necessary to consider the possibility of incorrect insertion of the ring.

Safety and effectiveness of the drug NuvaRing for teenagers under 18 years of age have not been studied.

Rules for using NuvaRing ®

A woman can independently insert NuvaRing ® into the vagina. To insert the ring, a woman should choose the position that is most comfortable for her, for example, standing, raising one leg, squatting, or lying down. NuvaRing ® must be squeezed and inserted into the vagina until the ring is in a comfortable position. The exact position of NuvaRing ® in the vagina is not decisive for the contraceptive effect.

After insertion, the ring must remain in the vagina continuously for 3 weeks. If the ring was accidentally removed, it should be washed with warm (not hot) water and immediately inserted into the vagina.

To remove the ring, you can pick it up with your index finger or squeeze it between your index and middle fingers and pull it out of the vagina. The used ring should be placed in a bag (keep out of the reach of children and pets) and discarded.

Side effect

When using the drug, side effects may occur, occurring with varying frequencies: often (≥1/100), infrequently (<1/100, ≥1/1 000), редко (<1/1000, ≥1/10 000).

Often Uncommon Rarely Post-marketing data 1
Infections and infestations
Vaginal infection Cervicitis, cystitis, urinary tract infections
From the immune system
Hypersensitivity
Metabolism
Weight gain Increased appetite
Mental disorders
Depression, decreased libido Mood changes
From the nervous system
Headache, migraine Dizziness, hypoesthesia
From the side of the organ of vision
Visual impairment
From the cardiovascular system
"Hot flashes", increased blood pressure Venous thromboembolism 3
From the digestive system
Abdominal pain, nausea Bloating, diarrhea, vomiting, constipation
From the skin
Acne Alopecia, eczema,
skin itching, rash
Hives
From the musculoskeletal system
Back pain, muscle spasms, pain in limbs
From the urinary system
Dysuria, urinary urgency, pollakiuria
From the genital organs and breast
Engorgement and tenderness of the mammary glands, genital itching in women, dysmenorrhea, pain in the pelvic area, vaginal discharge Amenorrhea, discomfort in the mammary glands, enlarged mammary glands, lumps in the mammary glands, cervical polyps, contact (during sexual intercourse) spotting (bleeding), dyspareunia, ectropion of the uterus, fibrocystic mastopathy, menorrhagia, metrorrhagia, discomfort in the pelvic area, premenstrual syndrome, uterine spasm, burning sensation in the vagina, vaginal odor, painful sensations in the vagina, discomfort and dryness of the vulva and vaginal mucosa Local reactions in partner 2
From the body as a whole
Fatigue, irritability, malaise, swelling
Others
Discomfort when using the vaginal ring, loss of the vaginal ring Difficulty using a contraceptive, rupture (damage) of the ring, sensation of a foreign body in the vagina

1 The list of side effects is based on data obtained from spontaneous reports. It is not possible to accurately determine the frequency.

2 Local reactions in a partner include reports of local reactions on the penis.

3 Observational cohort study data: ≥1/10,000 -<1/1000 женщин-лет.

Contraindications

- venous thrombosis (including a history), including thromboembolism;

- arterial thrombosis (including a history), including cerebrovascular accidents, myocardial infarction and/or precursors of thrombosis, including angina pectoris, transient ischemic attack;

— heart defects with thrombogenic complications;

- predisposition to the development of venous or arterial thrombosis, including hereditary diseases: resistance to activated protein C, antithrombin III deficiency, protein C deficiency, protein S deficiency, hyperhomocysteinemia and antiphospholipid antibodies (anticardiolipin antibodies, lupus anticoagulant);

— migraine with focal neurological symptoms in the anamnesis;

- diabetes mellitus with vascular damage;

- pronounced or multiple risk factors for venous or arterial thrombosis;

- pancreatitis (including a history), in combination with severe hypertriglyceridemia;

- severe liver diseases, until normalization of liver function indicators;

- liver tumors, malignant or benign (including in history);

- established or suspected hormone-dependent malignant tumors (for example, genital organs or breast);

- vaginal bleeding of unknown etiology;

— pregnancy (including suspected);

- hypersensitivity to any of the active or excipients of the drug NuvaRing ®.

If any of the above conditions occur, you should immediately stop using the drug.

WITH caution the drug should be prescribed if any of the following diseases, conditions or risk factors are present; in such cases, the doctor must carefully weigh the benefit-risk ratio of using the drug NuvaRing ®:

- presence of diseases in the family history (venous thrombosis and embolism and/or arterial thrombosis in brothers/sisters at any age or in parents at a relatively early age;

- prolonged immobilization, major surgical interventions, any surgical interventions on the lower extremities or serious trauma;

— obesity (body mass index more than 30 kg/m2);

— thrombophlebitis of superficial veins;

- smoking (especially in women over 35 years old);

- dislipoproteinemia;

- heart valve disease;

- atrial fibrillation;

- arterial hypertension;

- diabetes mellitus;

- acute or chronic liver dysfunction;

- jaundice and/or itching caused by cholestasis;

- cholelithiasis;

- porphyria;

- systemic lupus erythematosus;

- hemolytic-uremic syndrome;

- Sydenham's chorea (minor chorea);

- hearing loss due to otosclerosis;

- (hereditary) angioedema;

- chronic inflammatory bowel diseases (Crohn's disease and ulcerative colitis);

- sickle cell anemia;

- chloasma;

- conditions that make it difficult to use a vaginal ring: cervical prolapse, bladder hernia, rectal hernia, severe chronic constipation.

In case of exacerbation of diseases, deterioration of the condition, or the occurrence of any of the listed conditions, you should consult a doctor for the first time to decide on the possibility of further use of the drug NuvaRing ® .

Pregnancy and lactation

The drug NuvaRing ® is intended to prevent pregnancy. If a woman wants to stop using the drug in order to become pregnant, it is recommended to wait for the restoration of the natural cycle to conceive, as this will help to correctly calculate the date of conception and birth.

Pregnancy

The use of NuvaRing ® during pregnancy is contraindicated. If pregnancy occurs, the ring should be removed. Extensive epidemiological studies have not revealed an increased risk of congenital malformations in children born to women who took COCs before pregnancy, as well as teratogenic effects in cases where women took COCs in early pregnancy without knowing about it. Although this applies to all COCs, it is not known whether this also applies to NuvaRing ® . A clinical study in a small group of women showed that, despite the fact that the drug NuvaRing ® is inserted into the vagina, the concentrations of contraceptive hormones inside the uterus when using the drug NuvaRing ® are similar to those when using COCs. Pregnancy outcomes in women who used NuvaRing ® during a clinical trial have not been described.

Breastfeeding period

The use of NuvaRing ® during breastfeeding is not indicated. The composition of the drug can affect lactation, reduce the amount and change the composition of breast milk. Small amounts of contraceptive steroids and/or their metabolites may be excreted in milk, but there is no evidence of their negative effects on the health of children.

Use for liver dysfunction

Contraindicated in severe liver diseases (until normalization of function indicators).

Application for children

The safety and effectiveness of NuvaRing ® for adolescents under 18 years of age has not been studied.

Special instructions

If any of the diseases, conditions or risk factors listed below are present, the benefits of using the drug NuvaRing ® and the possible risks for each individual woman should be assessed before she starts using the drug NuvaRing ® . In case of exacerbation of diseases, deterioration of the condition, or the occurrence of any of the conditions listed below for the first time, a woman should consult a doctor to decide on the possibility of further use of the drug NuvaRing ®.

Circulatory disorders

The use of hormonal contraceptives may be associated with the development of venous thrombosis (deep vein thrombosis and pulmonary embolism) and arterial thrombosis, as well as associated complications, sometimes fatal.

The use of any COC increases the risk of developing venous thromboembolism (VTE) compared to the risk of VTE in patients not using COCs. The greatest risk of developing VTE is observed in the first year of COC use. Data from a large prospective cohort study of the safety of various COCs suggest that the greatest increase in risk, compared with the risk in women not using COCs, is observed in the first 6 months after starting COC use or resuming their use after a break (4 weeks or more). . In nonpregnant women not using oral contraceptives, the risk of developing VTE is 1 to 5 per 10,000 woman-years (WY). In women using oral contraceptives, the risk of developing VTE ranges from 3 to 9 cases per 10,000 women. The increase in risk occurs to a lesser extent than in pregnancy, where the risk is 5-20 per 10,000 YL (pregnancy data are based on the actual duration of pregnancy in standard studies; based on the assumption that pregnancy lasts 9 months, the risk is 7 to 27 cases per 10,000 YL). In postpartum women, the risk of developing VTE ranges from 40 to 65 cases per 10,000 women. VTE is fatal in 1-2% of cases.

According to research results, women using the drug NuvaRing ® are at greater risk of developing VTE, similar to that of women using COCs (adjusted risk ratio is presented in the table below). A large prospective observational study, TASC (Transatlantic Active Study of the Safety of Cardiovascular Safety of NuvaRing ®), assessed the risk of VTE in women who started using NuvaRing ® or COCs, switched to NuvaRing ® or COCs from other contraceptives, or resumed use the drug NuvaRing ® or COCs, in the population of typical users. The women were observed for 24-48 months. The results showed a similar level of risk of developing VTE in women using the drug NuvaRing ® (incidence of 8.3 cases per 10,000 YL) and in women using COCs (incidence of 9.2 cases per 10,000 YL). For women using COCs, excluding desogestrel, gestodene and drospirenone, the incidence of VTE was 8.9 cases per 10,000 women.

A retrospective cohort study initiated by the FDA (US Food and Drug Administration) showed that the incidence of VTE in women who started using the drug NuvaRing ® was 11.4 cases per 10,000 YL, while in women of those who started using COCs containing levonorgestrel, the incidence of VTE is 9.2 cases per 10,000 YL.

Assessment of the risk (risk ratio) of developing VTE in women using the drug NuvaRing ® compared with the risk of developing VTE in women using COCs

Epidemiological study, population Comparator(s) Risk ratio (RR) (95% CI)
TAS (Dinger, 2012)
Women who started using the drug (including again, after a break) and switched from other means of contraception.
All available COCs during Study 1 OR 2: 0.8 (0.5-1.5)
Available COCs, except those containing desogestrel, gestodene, drospirenone OR 2: 0.9 (0.4-2.0)
"FDA Initiated Study" (Sydney, 2011)
Women who started using combined hormonal contraceptives (CHCs) for the first time during the study period.
COCs available during study period 3 OR 4: 1.09 (0.55-2.16)
Levonorgestrel /0.03 mg ethinyl estradiol OR 4: 0.96 (0.47-1.95)

1 Incl. low-dose COCs containing the following progestins: chlormadinone acetate, cyproterone acetate, desogestrel, dienogest, drospirenone, ethynodiol diacetate, gestodene, levonorgestrel, norethindrone, norgestimate or norgestrel.

2 Taking into account age, BMI, duration of use, history of VTE.

3 Incl. low-dose COCs containing the following progestins: norgestimate, norethindrone or levonorgestrel.

4 Taking into account age, place and year of inclusion in the study.

There are extremely rare cases of thrombosis of other blood vessels (for example, arteries and veins of the liver, mesenteric vessels, kidneys, brain and retina) with the use of COCs. It is unknown whether these cases are related to the use of COCs.

Possible symptoms of venous or arterial thrombosis may include pain in one leg and/or swelling; sudden severe chest pain, possibly radiating to the left arm; attack of shortness of breath, cough; any unusual, severe, prolonged headaches; sudden partial or complete loss of vision; double vision; slurred speech or aphasia; dizziness; collapse, accompanied or not accompanied by a focal epileptic seizure; sudden weakness or severe numbness on one side of the body or any part of the body; movement disorders; "sharp" stomach.

Risk factors for the development of venous thrombosis and embolism:

- age;

- presence of diseases in the family history (venous thrombosis and embolism in brothers/sisters at any age or in parents at a relatively early age). If a hereditary predisposition is suspected, before starting any hormonal contraceptives, the woman should be referred to a specialist for consultation;

- prolonged immobilization, major surgical interventions, any surgical interventions on the lower extremities or serious trauma. In such situations, it is recommended to stop using the drug (in the case of planned surgery at least 4 weeks in advance) with subsequent resumption of use no earlier than 2 weeks after complete restoration of motor activity;

- for obesity (body mass index more than 30 kg/m2);

possibly thrombophlebitis of the superficial veins and varicose veins.

There is no consensus on the possible role of these conditions in the etiology of venous thrombosis.

Risk factors for the development of complications of arterial thromboembolism:

age;

smoking (with heavy smoking and with age, the risk increases even more significantly, especially in women over 35 years of age);

dyslipoproteinemia;

obesity (body mass index more than 30 kg/m2);

hypertension;

migraine;

heart valve disease;

atrial fibrillation;

presence of diseases in the family history (arterial thrombosis in brothers/sisters at any age or in parents at a relatively early age). If a hereditary predisposition is suspected, the woman should be referred to a specialist for consultation before starting any hormonal contraceptives.

Biochemical factors that may indicate hereditary or acquired predisposition to venous or arterial thrombosis include activated protein C resistance, hyperhomocysteinemia, antithrombin III deficiency, protein C deficiency, protein S deficiency, antiphospholipid antibodies (anticardiolipin antibodies, lupus anticoagulant).

Other conditions that can lead to unwanted circulatory problems include diabetes mellitus, systemic lupus erythematosus, hemolytic uremic syndrome and chronic inflammatory bowel disease (such as Crohn's disease or ulcerative colitis), as well as sickle cell anemia.

It is necessary to take into account the increased risk of thromboembolism in the postpartum period.

An increase in the frequency or severity of migraines (which may be a prodromal symptom of cerebrovascular accidents) while using hormonal contraceptives may be a reason to immediately discontinue use of hormonal contraceptives.

Women using CHCs should be advised to consult a doctor if possible symptoms of thrombosis occur. If thrombosis is suspected or confirmed, CHC use should be discontinued. In this case, it is necessary to use effective contraception, since anticoagulants (coumarins) have a teratogenic effect.

Risk of developing tumors

The most important risk factor for developing cervical cancer is infection with the human papillomavirus (HPV). Epidemiological studies have shown that long-term use of COCs leads to an additional increase in this risk, but it remains unclear to what extent this is due to other factors such as more frequent cervical smear examinations and differences in sexual behavior, including. use of barrier contraceptives. It remains unclear how this effect is related to the use of the drug NuvaRing ®.

A meta-analysis of 54 epidemiological studies found a small increase (1.24) in the relative risk of breast cancer in women taking combined hormonal oral contraceptives. The risk gradually decreases over 10 years after stopping the drugs. Breast cancer rarely develops in women under 40 years of age, so the additional incidence of breast cancer in women who take or have taken COCs is small compared to the overall risk of developing breast cancer. Breast cancer diagnosed in women who use COCs is clinically less severe than cancer diagnosed in women who have never used COCs. An increased risk of developing breast cancer may be
due to both the fact that women taking COCs are diagnosed with breast cancer earlier and the biological effects of COCs, or a combination of both of these factors.

In rare cases, cases of development of benign, and even more rarely, malignant liver tumors have been observed in women taking COCs. In some cases, these tumors led to the development of life-threatening bleeding into the abdominal cavity. The doctor should consider the possibility of a liver tumor in the differential diagnosis of diseases in a woman taking NuvaRing ® if symptoms include acute pain in the upper abdomen, liver enlargement, or signs of intra-abdominal bleeding.

Other states

Women with hypertriglyceridemia or a corresponding family history have an increased risk of developing pancreatitis when taking hormonal contraceptives.

Many women taking hormonal contraceptives experience a slight increase in blood pressure, but clinically significant increases in blood pressure are rare. A direct connection between the use of hormonal contraceptives and the development of arterial hypertension has not been established. If a constant increase in blood pressure is observed when using the drug NuvaRing ®, it is necessary to contact your doctor to decide whether it is necessary to remove the vaginal ring and prescribe antihypertensive therapy. With adequate blood pressure control using antihypertensive drugs, it is possible to resume use of the drug NuvaRing ®.

During pregnancy and during the use of combined oral contraceptives, the development or worsening of the following conditions was noted, although their relationship with the use of contraceptives has not been definitively established: jaundice and/or itching caused by cholestasis, formation of gallstones, porphyria, systemic lupus erythematosus, hemolytic -uremic syndrome, Sydenham's chorea (minor chorea), herpes of pregnancy, hearing loss due to otosclerosis, (hereditary) angioedema.

Acute or chronic liver dysfunction may serve as a reason to discontinue the drug NuvaRing ® until liver function indicators normalize. Recurrence of cholestatic jaundice, previously observed during pregnancy or during the use of sex steroids, requires discontinuation of the drug NuvaRing ® .

Although estrogens and progestogens may influence peripheral insulin resistance and tissue glucose tolerance, there is no evidence to support the need to change hypoglycemic therapy during the use of hormonal contraceptives. However, women with diabetes should be under constant medical supervision when using the drug NuvaRing ® , especially in the first months of contraception.

There is evidence of a worsening of Crohn's disease and ulcerative colitis with the use of hormonal contraceptives.

In rare cases, pigmentation of the facial skin (chloasma) may occur, especially if it occurred earlier during pregnancy. Women predisposed to the development of chloasma should avoid exposure to sunlight and ultraviolet radiation while using NuvaRing ®.

The following conditions may prevent the ring from being inserted correctly or may cause it to fall out: cervical prolapse, bladder and/or rectal hernia, severe chronic constipation.

In very rare cases, women have unintentionally inserted the NuvaRing ® vaginal ring into the urethra and possibly into the bladder. When symptoms of cystitis appear, it is necessary to consider the possibility of incorrect insertion of the ring.

Cases of vaginitis have been described during use of the drug NuvaRing ® . There is no evidence that treatment of vaginitis affects the effectiveness of the use of the drug NuvaRing ® , as well as evidence of the influence of the use of the drug NuvaRing ® on the effectiveness of treatment of vaginitis.

Very rare cases of difficulty in removing the ring have been described, requiring its removal by a medical professional.

Medical examination/consultation

Before prescribing the drug NuvaRing ® or resuming its use, you should carefully review the woman’s medical history (including family history) and conduct a gynecological examination to exclude pregnancy. It is necessary to measure blood pressure, conduct an examination of the mammary glands, pelvic organs, including a cytological examination of cervical smears and some laboratory tests, to exclude contraindications and reduce the risk of possible side effects of the drug. The frequency and nature of medical examinations depend on the individual characteristics of each patient, but medical examinations are carried out at least once every 6 months. A woman should read the instructions and follow all recommendations. The woman should be informed that NuvaRing ® does not protect against HIV infection (AIDS) and other sexually transmitted diseases.

Reduced efficiency

The effectiveness of the drug NuvaRing ® may decrease if the regimen is not followed or concomitant therapy is carried out.

Reduced cycle control

During use of the drug NuvaRing ®, acyclic bleeding (spotting or sudden bleeding) may occur. If such bleeding is observed after regular cycles while using the drug NuvaRing ® correctly, you should contact your gynecologist to conduct the necessary diagnostic tests, incl. to exclude organic pathology or pregnancy. A diagnostic curettage may be required.

Some women do not bleed after the ring is removed. If the drug NuvaRing ® was used according to the instructions, it is unlikely that the woman is pregnant. If the recommendations of the instructions are not followed and there is no bleeding after removing the ring, as well as if there is no bleeding for two cycles in a row, pregnancy must be excluded.

Effects of ethinyl estradiol and etonogestrel on a sexual partner

The extent of exposure and possible pharmacological effects of ethinyl estradiol and etonogestrel on male sexual partners due to absorption through penile tissue have not been studied.

Laboratory research

The use of contraceptive steroids may affect the results of certain laboratory tests, including biochemical parameters of liver, thyroid, adrenal and kidney function, plasma levels of transport proteins (for example, corticosteroid binding globulin and sex hormone binding globulin), lipid/lipoprotein fractions, carbohydrate metabolism parameters and indicators of coagulation and fibrinolysis. Indicators, as a rule, vary within normal values.

Impact on the ability to drive vehicles and operate machinery

Based on information about the pharmacodynamic properties of the drug NovaRing ®, it can be expected that it does not affect the ability to drive vehicles and operate machinery.

Considering the pharmacodynamic properties of the drug NuvaRing ®, its effect on the ability to drive a car and use complex equipment is not expected.

Overdose

Serious consequences of an overdose of hormonal contraceptives have not been described.

Alleged symptoms: nausea, vomiting, slight vaginal bleeding in young girls.

Treatment: carry out symptomatic therapy. There are no antidotes.

Drug interactions

Conditions for dispensing from pharmacies

The drug is available with a prescription.

Storage conditions and periods

The drug should be stored out of the reach of children at a temperature of 2° to 8°C. Shelf life - 3 years.

Drug interactions

Interactions between hormonal contraceptives and other drugs may lead to the development of acyclic bleeding and/or contraceptive failure.

The literature describes the following interactions with combined oral contraceptives in general.

There may be an interaction with drugs that induce microsomal enzymes, which can lead to increased clearance of sex hormones. Interactions have been established with the following drugs: phenytoin, barbiturates, primidone, carbamazepine, rifampicin, and possibly also oxcarbazepine, topiramate, felbamate, ritonavir, griseofulvin and preparations containing St. John's wort.

When treating any of the listed drugs, you should temporarily use a barrier method of contraception (condom) in combination with the drug NuvaRing ® or choose another method of contraception. During concomitant use of drugs that cause the induction of microsomal liver enzymes, and for 28 days after their discontinuation, barrier methods of contraception should be used.

If concomitant therapy is to be continued after 3 weeks of ring use, the next ring should be administered immediately without the usual interval.

A decrease in the effectiveness of oral contraceptives containing ethinyl estradiol has been observed with concomitant use of antibiotics such as ampicillin and tetracyclines. The mechanism of this effect has not been studied. In a pharmacokinetic interaction study, oral administration of amoxicillin (875 mg 2 times / day) or doxycycline (200 mg / day, and then 100 mg / day) for 10 days while using the drug NuvaRing ® had little effect on the pharmacokinetics of etonogestrel and ethinyl estradiol. When using antibiotics (except amoxicillin and doxycycline) you should use a barrier method of contraception (condom) during treatment and for 7 days after stopping antibiotics. If concomitant therapy is to be continued after 3 weeks of ring use, the next ring should be administered immediately without the usual interval.

Pharmacokinetic studies did not reveal the effect of the simultaneous use of antifungal agents and spermicides on the contraceptive effectiveness and safety of the drug NuvaRing ®. When combined with suppositories and antifungal drugs, the risk of ring rupture slightly increases.

Hormonal contraceptives can cause disruption of the metabolism of other drugs. Accordingly, their concentrations in plasma and tissues may increase (for example, cyclosporine) or decrease (for example, lamotrigine).

To exclude possible interactions, it is necessary to study the instructions for use of other drugs.

Pharmacokinetic data show that the use of tampons does not affect the absorption of hormones released from the NovaRing ® vaginal ring. In rare cases, the ring may be accidentally removed when removing the tampon.

A combined hormonal contraceptive drug containing etonogestrel and ethinyl estradiol.

Etonogestrel is a progestogen (19-nortestosterone derivative) that binds with high affinity to progesterone receptors in target organs. Ethinyl estradiol is an estrogen and is widely used in the production of contraceptives.

The contraceptive effect of the drug NuvaRing ® is due to a combination of various factors, the most important of which is the suppression of ovulation.

Efficiency

In clinical studies, it was found that the Pearl index (an indicator reflecting the frequency of pregnancy in 100 women during 1 year of contraception) in women aged 18 to 40 years for the drug NuvaRing ® was 0.96 (95% CI: 0.64-1.39) and 0.64 (95% CI: 0.35-1.07) in the statistical analysis of all randomized participants (ITT analysis) and the analysis of study participants who completed them according to the protocol (PP analysis), respectively. These values ​​were similar to the Pearl index values ​​obtained in comparative studies of combined oral contraceptives (COCs) containing levonorgestrel/ethinyl estradiol (0.150/0.030 mg) or drospirenone/ethinyl estradiol (3/0.30 mg).

With the use of the drug NuvaRing ®, the cycle becomes more regular, the pain and intensity of menstrual-like bleeding decreases, which helps reduce the incidence of iron deficiency conditions. There is evidence of a reduction in the risk of endometrial and ovarian cancer with the use of the drug.

Nature of bleeding

A comparison of bleeding patterns over a one-year period in 1000 women using NovaRing ® and COCs containing levonorgestrel/ethinyl estradiol (0.150/0.030 mg) showed a significant reduction in the incidence of breakthrough bleeding or spotting when using NovaRing ® compared to COCs. . In addition, the frequency of cases where bleeding occurred only during a break in the use of the drug was significantly higher among women using the drug NuvaRing ® .

Effect on bone mineral density

A comparative two-year study of the effect of the drug NuvaRing (n=76) and a non-hormonal intrauterine device (n=31) did not reveal any effect on bone mineral density in women.

The safety and effectiveness of NuvaRing ® in adolescent girls under 18 years of age has not been studied.

Pharmacokinetics

Etonogestrel

Suction

Etonogestrel, released from the NuvaRing ® vaginal ring, is rapidly absorbed through the vaginal mucosa. The plasma etonogestrel Cmax of approximately 1700 pg/ml is achieved approximately 1 week after ring administration. Plasma concentrations vary within a small range and decrease slowly to approximately 1600 pg/mL after 1 week, 1500 pg/mL after 2 weeks, and 1400 pg/mL after 3 weeks of use. Absolute bioavailability is about 100%, which exceeds the bioavailability of etonogestrel when taken orally. Based on the results of measurements of etonogestrel concentrations in the cervix and inside the uterus in women using the drug NuvaRing ® and women using oral contraceptives containing 0.150 mg of desogestrel and 0.020 mg of ethinyl estradiol, the observed values ​​of etonogestrel concentrations were comparable.

Distribution

Etonogestrel binds to serum albumin and sex hormone binding globulin (SHBG). The apparent V d of etonogestrel is 2.3 l/kg.

Metabolism

Biotransformation of etonogestrel occurs through known pathways of sex hormone metabolism. Apparent plasma clearance is about 3.5 l/h. No direct interaction with ethinyl estradiol taken concomitantly has been identified.

Removal

The concentration of etonogestrel in the blood plasma decreases in two phases. In the terminal phase, T1/2 is about 29 hours. Etonogestrel and its metabolites are excreted by the kidneys and through the intestines with bile in a ratio of 1.7:1. Half life of metabolites is approximately 6 days.

Ethinyl estradiol

Suction

Ethinyl estradiol, released from the NuvaRing ® vaginal ring, is rapidly absorbed through the vaginal mucosa. Plasma Cmax of approximately 35 pg/ml is achieved 3 days after ring administration and decreases to 19 pg/ml after 1 week, to 18 pg/ml after 2 weeks and 18 pg/ml after 3 weeks of use. Absolute bioavailability is approximately 56% and is comparable to that of oral ethinyl estradiol. Based on the results of measurements of ethinyl estradiol concentrations in the cervix and inside the uterus in women using NuvaRing ® and women using oral contraceptives containing 0.150 mg of desogestrel and 0.020 mg of ethinyl estradiol, the observed values ​​of ethinyl estradiol concentrations were comparable.

Ethinyl estradiol concentrations were studied in a comparative randomized study of NovaRing ® (daily vaginal release of ethinyl estradiol 0.015 mg), transdermal patch (norelgestromin/ethinyl estradiol; daily release of ethinyl estradiol 0.020 mg) and COC (levonorgestrel/ethinyl estradiol; daily release of ethinyl estradiol 0.030 mg) during one cycle in healthy women. Systemic exposure to ethinyl estradiol over a month (AUC 0-∞) for the drug NuvaRing ® was statistically significantly lower than for the patch and COC, and amounted to 10.9, 37.4 and 22.5 ngch/ml, respectively.

Distribution

Ethinyl estradiol binds to serum albumin. The apparent Vd is about 15 l/kg.

Metabolism

Ethinyl estradiol is metabolized by aromatic hydroxylation. During its biotransformation, a large number of hydroxylated and methylated metabolites are formed, which circulate both in the free state and in the form of glucuronide and sulfate conjugates. The apparent clearance is approximately 3.5 l/h.

Removal

The concentration of ethinyl estradiol in blood plasma decreases in two phases. T 1/2 in the terminal phase varies widely; the median is about 34 hours. Ethinyl estradiol is not excreted unchanged; its metabolites are excreted by the kidneys and through the intestines in a ratio of 1.3:1. Half life of metabolites is about 1.5 days.

Special patient groups

The pharmacokinetics of NovaRing ® in healthy adolescent girls under 18 years of age who have already menstruated have not been studied.

Renal dysfunction

The effect of kidney disease on the pharmacokinetics of NovaRing ® has not been studied.

Liver dysfunction

The effect of liver diseases on the pharmacokinetics of NovaRing ® has not been studied.

However, in patients with impaired liver function, the metabolism of sex hormones may deteriorate.

Ethnic groups

The pharmacokinetics of the drug in representatives of ethnic groups has not been specifically studied.

Release form

The vaginal ring is smooth, transparent, colorless or almost colorless, without major visible damage, with a transparent or almost transparent area at the junction.

Excipients: ethylene and vinyl acetate copolymer (28% vinyl acetate) - 1677 mg, ethylene and vinyl acetate copolymer (9% vinyl acetate) - 197 mg, magnesium stearate - 1.7 mg.

1 piece - waterproof bags made of aluminum foil (1) - cardboard packs.
1 piece - waterproof bags made of aluminum foil (3) - cardboard packs.

Dosage

NuvaRing ® is inserted into the vagina once every 4 weeks. The ring is in the vagina for 3 weeks and then removed on the same day of the week on which it was placed in the vagina; after a week's break, a new ring is inserted. For example: if the NuvaRing ® ring was installed on Wednesday at approximately 10:00 pm, then it should be removed on Wednesday 3 weeks later at approximately 10:00 pm; on the following Wednesday a new ring is inserted.

Bleeding associated with discontinuation of the drug usually begins 2-3 days after removal of NuvaRing ® and may not completely stop until a new ring is installed.

Hormonal contraceptives were not used in the previous menstrual cycle

NuvaRing ® should be administered on the first day of the cycle (i.e., the first day of menstruation). It is possible to install a ring on days 2-5 of the cycle, however, in the first cycle in the first 7 days of using the drug NuvaRing ®, additional use of barrier methods of contraception is recommended.

Switching from taking combined oral contraceptives

NuvaRing ® should be administered on the last day of the usual interval between cycles of combined hormonal contraceptives (pills or patches). If a woman has been taking the combined hormonal contraceptive correctly and regularly and is confident that she is not pregnant, she can switch to using a vaginal ring on any day of her cycle.

Switching from progestogen-only medications (mini-pills, progestin-only oral contraceptives, implants, injectables, or hormone-containing intrauterine systems (IUDs))

A woman taking the mini-pill can switch to using NuvaRing ® on any day. The ring is inserted on the day of removal of the implant or IUD. If a woman received injections, then use of the drug NuvaRing ® begins on the day when the next injection should have been given. In all these cases, the woman should use a barrier method of contraception for the first 7 days after insertion of the ring.

After an abortion performed in the first trimester of pregnancy

You can start using NuvaRing ® immediately after an abortion. In this case, there is no need for additional use of other contraceptives. If the use of NuvaRing ® immediately after an abortion is undesirable, the ring should be used in the same way as if hormonal contraceptives were not used in the previous cycle. In the interval, the woman is recommended an alternative method of contraception.

After childbirth or abortion performed in the second trimester of pregnancy

The use of NuvaRing ® should begin within the 4th week after childbirth (if the woman is not breastfeeding) or abortion in the second trimester. If the use of NuvaRing ® is started at a later date, then additional use of barrier methods of contraception is necessary in the first 7 days of using NuvaRing ® . However, if sexual intercourse has already taken place during this period, then before using the drug NuvaRing ® it is necessary to exclude pregnancy or wait until the first menstruation.

The contraceptive effect and cycle control may be impaired if the patient does not comply with the recommended regimen. To avoid loss of contraceptive effect in case of deviation from the regimen, the following recommendations must be followed.

Extending the break from using the ring

If you had sexual intercourse during a break from using the ring, pregnancy should be ruled out. The longer the break, the higher the likelihood of pregnancy. If pregnancy is ruled out, a new ring should be inserted into the vagina as quickly as possible. Over the next 7 days, an additional barrier method of contraception, such as a condom, can be used.

If the ring has been temporarily removed from the vagina

If the ring remains outside the vagina for less than 3 hours, the contraceptive effect will not decrease. The ring should be reinserted into the vagina as soon as possible (no later than after 3 hours).

If the ring was left outside the vagina for more than 3 hours during the first or second week of use, the contraceptive effect may be reduced. You should place the ring in your vagina as soon as possible. Over the next 7 days, you must use a barrier method of contraception, such as a condom. The longer the ring was outside the vagina and the closer this period is to the 7-day break in using the ring, the higher the likelihood of pregnancy.

If the ring was left outside the vagina for more than 3 hours during the third week of use, the contraceptive effect may be reduced. The woman should throw away the ring and choose one of the following two methods.

1. Immediately install a new ring. Please note that the new ring can be used for the next 3 weeks. In this case, there may be no bleeding associated with the cessation of the drug's effect. However, spotting or bleeding in the middle of the cycle is possible.

2. Wait for bleeding associated with the cessation of the drug’s effect, and insert a new ring no later than 7 days after removing the previous ring. This option should only be chosen if the ring use regimen has not previously been violated during the first 2 weeks.

Extended use of the ring

If the drug NuvaRing ® was used for no more than a maximum period of 4 weeks, then the contraceptive effect remains sufficient. You can take a week's break from using the ring and then insert a new ring. If NuvaRing ® remains in the vagina for more than 4 weeks, the contraceptive effect may deteriorate, so pregnancy must be excluded before inserting a new ring.

How to shift or delay the onset of menstrual bleeding

To delay menstrual-like withdrawal bleeding, you can insert a new ring without a week's break. The next ring must be used within 3 weeks. This may cause bleeding or spotting. Then, after the usual one-week break, you should return to regular use of NuvaRing ®.

To postpone the onset of bleeding to another day of the week, it may be recommended to take a shorter break from using the ring (for as many days as necessary). The shorter the interval between ring use, the higher the likelihood that there will be no bleeding after ring removal, and no bleeding or spotting will occur when the next ring is used.

Ring damage

In rare cases, when using NuvaRing ®, ring rupture has been observed. The core of the NuvaRing ® ring is solid, so its contents remain intact, and the release of hormones does not change significantly. If the ring ruptures, it usually falls out of the vagina. If the ring ruptures, a new ring must be inserted (following the recommendations above "If the ring has been temporarily removed from the vagina").

Ring falling out

NuvaRing ® has sometimes been reported to fall out of the vagina, for example, when it is inserted incorrectly, when a tampon is removed, during sexual intercourse, or due to severe or chronic constipation. In this regard, it is advisable for a woman to regularly check the presence of the NuvaRing ® ring in the vagina. If the ring falls out of the vagina, you should follow the recommendations above "If the ring has been temporarily removed from the vagina."

Rules for using NuvaRing ®

A woman can independently insert NuvaRing ® into the vagina. To insert the ring, a woman should choose the position that is most comfortable for her, for example, standing, raising one leg, squatting, or lying down. NuvaRing ® must be squeezed and inserted into the vagina until the ring is in a comfortable position. The exact position of NuvaRing ® in the vagina is not decisive for the contraceptive effect.

After insertion, the ring must remain in the vagina continuously for 3 weeks. If the ring was accidentally removed, it should be washed with warm (not hot) water and immediately inserted into the vagina.

To remove the ring, you can pick it up with your index finger or squeeze it between your index and middle fingers and pull it out of the vagina. The used ring should be placed in a bag (keep out of the reach of children and pets) and discarded.

Overdose

Serious consequences of an overdose of hormonal contraceptives have not been described.

Suggested symptoms: nausea, vomiting, slight vaginal bleeding in young girls.

Treatment: carry out symptomatic therapy. There are no antidotes.

Interaction

Interactions between hormonal contraceptives and other drugs may lead to the development of acyclic bleeding and/or contraceptive failure.

The literature describes the following interactions with combined oral contraceptives in general.

There is a possibility of interaction with drugs that induce microsomal liver enzymes, which can lead to an increase in the clearance of sex hormones. Interactions have been established with the following drugs: phenytoin, barbiturates, primidone, carbamazepine, rifampicin, and possibly also oxcarbazepine, topiramate, felbamate, ritonavir, griseofulvin and preparations containing St. John's wort.

When treating any of the listed drugs, you should temporarily use a barrier method of contraception (condom) in combination with the drug NuvaRing ® or choose another method of contraception. During concomitant use of drugs that cause the induction of microsomal liver enzymes, and for 28 days after their discontinuation, barrier methods of contraception should be used.

If concomitant therapy is to be continued after 3 weeks of ring use, the next ring should be administered immediately without the usual interval.

A decrease in the effectiveness of oral contraceptives containing ethinyl estradiol has been observed with concomitant use of antibiotics such as ampicillin and tetracyclines. The mechanism of this effect has not been studied. In a pharmacokinetic interaction study, oral administration of amoxicillin (875 mg 2 times / day) or doxycycline (200 mg / day, and then 100 mg / day) for 10 days while using the drug NuvaRing ® had little effect on the pharmacokinetics of etonogestrel and ethinyl estradiol. When using antibiotics (excluding amoxicillin and doxycycline), you should use a barrier method of contraception (condom) during treatment and for 7 days after stopping antibiotics. If concomitant therapy is to be continued after 3 weeks of ring use, the next ring should be administered immediately without the usual interval.

Pharmacokinetic studies did not reveal the effect of the simultaneous use of antifungal agents and spermicides on the contraceptive effectiveness and safety of the drug NuvaRing ®. When combined with suppositories and antifungal drugs, the risk of ring rupture slightly increases.

Hormonal contraceptives can cause disruption of the metabolism of other drugs. Accordingly, their concentrations in plasma and tissues may increase (for example, cyclosporine) or decrease (for example, lamotrigine).

To exclude possible interactions, it is necessary to study the instructions for use of other drugs.

Pharmacokinetic data show that the use of tampons does not affect the absorption of hormones released from the NovaRing ® vaginal ring. In rare cases, the ring may be accidentally removed when removing the tampon.

Side effects

Determination of the frequency of side effects: often (≥1/100), infrequently (<1/100, ≥1/1000), редко (<1/1000, ≥1/10 000).

OftenUncommonRarelyPost-marketing data 1
Infections and infestations
Vaginal infectionCervicitis, cystitis, urinary tract infections
From the immune system
Hypersensitivity
Metabolism
Weight gainIncreased appetite
Mental disorders
Depression, decreased libidoMood changes
From the nervous system
Headache, migraineDizziness, hypoesthesia
From the side of the organ of vision
Visual impairment
From the cardiovascular system
"Hot flashes", increased blood pressureVenous thromboembolism 2
From the digestive system
Abdominal pain, nauseaBloating, diarrhea, vomiting, constipation
From the skin
AcneAlopecia, eczema,
skin itching, rash
Hives
From the musculoskeletal system
Back pain, muscle spasms, pain in limbs
From the urinary system
Dysuria, urinary urgency, pollakiuria
From the genital organs and breast
engorgement and tenderness of the mammary glands, genital itching in women, painful menstrual-like bleeding, pain in the pelvic area, vaginal dischargeAbsence of menstrual-like bleeding, discomfort in the mammary glands, enlarged mammary glands, lumps in the mammary glands, cervical polyps, contact (during sexual intercourse) spotting (bleeding), pain during intercourse, ectropion of the cervix, fibrocystic mastopathy , heavy menstrual-like bleeding, acyclic bleeding, discomfort in the pelvic area, premenstrual-like syndrome, burning sensation in the vagina, vaginal odor, pain in the vagina, discomfort and dryness of the vulva and vaginal mucosa Local reactions in partner 3
galactorrhea
From the body as a whole
Fatigue, irritability, malaise, swelling
Others
Discomfort when using the vaginal ring, loss of the vaginal ringDifficulty using a contraceptive, rupture (damage) of the ring, sensation of a foreign body in the vagina

1 The list of side effects is based on data obtained from spontaneous reports. It is not possible to accurately determine the frequency.

2 Observational cohort study data: ≥1/10,000 -<1/1000 женщин-лет.

3 Local reactions in the partner include reports of local reactions in the penis (eg, pain, flushing, bruising and abrasions).

Side effects that occurred when taking combined hormonal contraceptives: pancreatitis, cholecystitis, cerebrovascular disorders, benign and malignant liver tumors, chloasma, changes in insulin resistance.

In women with hereditary forms of angioedema, exogenous estrogens may cause or worsen symptoms of angioedema.

Indications

Contraception.

Contraindications

  • thrombosis (arterial or venous) and thromboembolism currently or in history (including deep vein thrombosis, pulmonary embolism, myocardial infarction, cerebrovascular disorders);
  • conditions preceding thrombosis (including transient ischemic attacks, angina) currently or in history;
  • predisposition to the development of venous or arterial thrombosis, including hereditary diseases: resistance to activated protein C, antithrombin III deficiency, protein C deficiency, protein S deficiency, hyperhomocysteinemia and antiphospholipid antibodies (anticardiolipin antibodies, lupus anticoagulant);
  • migraine with focal neurological symptoms currently or in history;
  • diabetes mellitus with vascular damage;
  • pronounced or multiple risk factors for venous or arterial thrombosis: hereditary predisposition to thrombosis (thrombosis, myocardial infarction or cerebrovascular accident at a young age in one of the immediate family), arterial hypertension, lesions of the valvular apparatus of the heart, atrial fibrillation, extensive surgery, prolonged immobilization, extensive trauma, obesity (BMI>30 kg/m2), smoking in women over 35 years of age;
  • pancreatitis (including a history) in combination with severe hypertriglyceridemia;
  • severe liver disease;
  • liver tumors, malignant or benign (including history);
  • established or suspected hormone-dependent malignant tumors (for example, genital organs or breast);
  • vaginal bleeding of unknown etiology;
  • pregnancy (including suspected);
  • breastfeeding period;
  • hypersensitivity to any of the active or excipients of the drug NuvaRing ®.

The safety and effectiveness of NuvaRing ® in adolescent girls under 18 years of age have not been studied.

If any of the above conditions occur, you should immediately stop using the drug.

The drug should be prescribed with caution if any of the following diseases, conditions or risk factors are present; in such cases, the doctor must carefully weigh the benefit-risk ratio of using the drug NuvaRing ®:

  • the presence of risk factors for the development of thrombosis and thromboembolism: hereditary predisposition to thrombosis (thrombosis, myocardial infarction or cerebrovascular accident at a young age in one of the immediate relatives), smoking, obesity, dyslipoproteinemia, arterial hypertension, migraine without focal neurological symptoms, valve diseases heart, heart rhythm disturbances, prolonged immobilization, serious surgical interventions;
  • thrombophlebitis of superficial veins;
  • dyslipoproteinemia;
  • heart valve disease;
  • adequately controlled arterial hypertension;
  • diabetes mellitus without vascular complications;
  • acute or chronic liver dysfunction;
  • jaundice and/or itching caused by cholestasis;
  • cholelithiasis;
  • porphyria;
  • systemic lupus erythematosus;
  • hemolytic-uremic syndrome;
  • Sydenham's chorea (minor chorea);
  • hearing loss due to otosclerosis;
  • angioedema (hereditary) edema;
  • chronic inflammatory bowel diseases (Crohn's disease and ulcerative colitis);
  • sickle cell anemia;
  • chloasma;
  • conditions that make it difficult to use a vaginal ring: cervical prolapse, bladder hernia, rectal hernia, severe chronic constipation.

In case of exacerbation of diseases, deterioration of the condition, or the occurrence of any of the listed conditions, you should consult a doctor for the first time to decide on the possibility of further use of the drug NuvaRing ® .

Features of application

Use during pregnancy and breastfeeding

The drug NuvaRing ® is intended to prevent pregnancy. If a woman wants to stop using the drug in order to become pregnant, it is recommended to wait for the restoration of the natural cycle to conceive, because this will help to correctly calculate the date of conception and birth.

The use of NuvaRing ® during pregnancy is contraindicated. If pregnancy occurs, the ring should be removed. Extensive epidemiological studies have not found an increased risk of birth defects in children born to women who took COCs before pregnancy, nor have there been teratogenic effects in cases where women took COCs in early pregnancy without knowing about it. Although this applies to all COCs, it is unknown whether this also applies to NuvaRing ® . A clinical study in a small group of women showed that, despite the fact that the drug NuvaRing ® is administered into the vagina, the concentrations of contraceptive hormones inside the uterus when using the drug NuvaRing ® are similar to those when using the COC. Pregnancy outcomes in women who used NuvaRing ® during a clinical trial have not been described.

The use of NuvaRing ® during breastfeeding is contraindicated. The composition of the drug can affect lactation, reduce the amount and change the composition of breast milk. Small amounts of contraceptive steroids and/or their metabolites may be excreted in breast milk, but there is no evidence of their negative effects on the health of children.

Use for liver dysfunction

Contraindicated in severe liver diseases (until normalization of function indicators).

Use in children

The safety and effectiveness of NuvaRing ® for adolescents under 18 years of age has not been studied.

Special instructions

If any of the diseases, conditions or risk factors listed below are present, the benefits of using the drug NuvaRing ® and the possible risks for each individual woman should be assessed before she starts using the drug NuvaRing ® . In case of exacerbation of diseases, deterioration of the condition, or the occurrence of any of the conditions listed below for the first time, a woman should consult a doctor to decide on the possibility of further use of the drug NuvaRing ®.

Circulatory disorders

The use of hormonal contraceptives may be associated with the development of venous thrombosis (deep vein thrombosis and pulmonary embolism) and arterial thrombosis, as well as associated complications, sometimes fatal.

The use of any COC increases the risk of developing venous thromboembolism (VTE) compared to the risk of VTE in patients not using COCs. The greatest risk of developing VTE is observed in the first year of using COCs. Data from a large prospective cohort study of the safety of various COCs suggest that the greatest increase in risk, compared with the risk in women not using COCs, is observed in the first 6 months after starting COC use or resuming their use after a break (4 weeks or more). . In nonpregnant women not using oral contraceptives, the risk of developing VTE is 1 to 5 per 10,000 woman-years (WY). In women using oral contraceptives, the risk of developing VTE ranges from 3 to 9 cases per 10,000 women. However, the risk increases to a lesser extent than during pregnancy, when it is 5-20 cases per 10,000 YL (pregnancy data are based on the actual duration of pregnancy in standard studies; when converted to a pregnancy duration of 9 months, the risk ranges from 7 to 27 cases per 10,000 JL). In postpartum women, the risk of developing VTE ranges from 40 to 65 cases per 10,000 women. VTE is fatal in 1-2% of cases.

According to research results, the increased risk of developing VTE in women using NuvaRing ® is similar to that in women using COCs (the adjusted risk ratio is presented in the table below). A large prospective observational study, TASC (Transatlantic Active Study of the Cardiovascular Safety of NuvaRing ®), assessed the risk of VTE in women who started using NuvaRing ® or COCs, switched to NuvaRing ® or COCs from other contraceptives, or resumed use of the drug NuvaRing ® or PDA, in a population of typical users. The women were observed for 24-48 months. The results showed a similar level of risk of developing VTE in women using NuvaRing ® (incidence 8.3 cases per 10,000 YL) and in women using COCs (incidence 9.2 cases per 10,000 YL). For women using COCs other than those containing desogestrel, gestodene and drospirenone, the incidence of VTE was 8.5 cases per 10,000 women.

A retrospective cohort study initiated by the FDA showed that the incidence of VTE in women who started using NuvaRing ® was 11.4 cases per 10,000 YL, while in women who started using COCs containing levonorgestrel, the incidence of VTE was 9.2 cases per 10,000 women. 10,000 JL.

Assessment of the risk (risk ratio) of developing VTE in women using NuvaRing ® compared with the risk of developing VTE in women using COCs

Epidemiological study, populationComparator(s)Risk ratio (RR) (95% CI)
TAS (Dinger, 2012)
Women who started using the drug (including again, after a break) and switched from other means of contraception.
All available PDAs during Study 1OR 2: 0.8 (0.5-1.5)
Available COCs, except those containing desogestrel, gestodene, drospirenoneOR 2: 0.9 (0.4-2.0)
"FDA Initiated Study" (Sydney, 2011)
Women who started using combined hormonal contraceptives (CHCs) for the first time during the study period.
PDAs available during Study Period 3OR 4: 1.09 (0.55-2.16)
Levonorgestrel /0.03 mg ethinyl estradiolOR 4: 0.96 (0.47-1.95)

1 Incl. low-dose COCs containing the following gestagens: chlormadinone acetate, cyproterone acetate, desogestrel, dienogest, drospirenone, ethynodiol diacetate, gestodene, levonorgestrel, norethindrone, norgestimate or norgestrel.

2 Taking into account age, BMI, duration of use, history of VTE.

3 Incl. low-dose COCs containing the following gestagens: norgestimate, norethindrone or levonorgestrel.

4 Taking into account age, place and year of inclusion in the study.

There are extremely rare cases of thrombosis of other blood vessels (for example, arteries and veins of the liver, mesenteric vessels, kidneys, brain and retina) with the use of COCs. It is unknown whether these cases are related to the use of COCs.

Possible symptoms of venous or arterial thrombosis may be unilateral swelling and/or pain in the lower extremity, local increase in temperature in the lower extremity, hyperemia or discoloration of the skin of the lower extremity; sudden severe chest pain, possibly radiating to the left arm; attack of shortness of breath, cough; any unusual, severe, prolonged headaches; sudden partial or complete loss of vision; double vision; slurred speech or aphasia; dizziness; collapse, accompanied or not accompanied by a focal epileptic seizure; sudden weakness or severe numbness on one side of the body or any part of the body; movement disorders; "sharp" stomach.

Risk factors for the development of venous thrombosis and embolism:

  • age;
  • presence of diseases in the family history (venous thrombosis and embolism in brothers/sisters at any age or in parents at a relatively early age). If a hereditary predisposition is suspected, before starting any hormonal contraceptives, the woman should be referred to a specialist for consultation;
  • prolonged immobilization, major surgery, any surgery on the lower extremities or serious trauma. In such situations, it is recommended to stop using the drug (in the case of planned surgery at least 4 weeks in advance) with subsequent resumption of use no earlier than 2 weeks after complete restoration of motor activity;
  • for obesity (BMI more than 30 kg/m2);
  • possibly thrombophlebitis of the superficial veins and varicose veins.

There is no consensus on the possible role of these conditions in the etiology of venous thrombosis.

Risk factors for the development of complications of arterial thromboembolism:

  • age;
  • smoking (with heavy smoking and with age, the risk increases even more significantly, especially in women over 35 years of age);
  • dyslipoproteinemia;
  • obesity (BMI more than 30 kg/m2);
  • arterial hypertension;
  • migraine;
  • heart valve disease;
  • atrial fibrillation;
  • presence of diseases in the family history (arterial thrombosis in brothers/sisters at any age or in parents at a relatively early age). If a hereditary predisposition is suspected, the woman should be referred to a specialist for consultation before starting any hormonal contraceptives.

Biochemical factors that may indicate hereditary or acquired predisposition to venous or arterial thrombosis include activated protein C resistance, hyperhomocysteinemia, antithrombin III deficiency, protein C deficiency, protein S deficiency, antiphospholipid antibodies (anticardiolipin antibodies, lupus anticoagulant).

Other conditions that can lead to unwanted circulatory problems include diabetes mellitus, systemic lupus erythematosus, hemolytic uremic syndrome and chronic inflammatory bowel disease (such as Crohn's disease or ulcerative colitis), as well as sickle cell anemia.

It is necessary to take into account the increased risk of thromboembolism in the postpartum period.

An increase in the frequency or severity of migraines (which may be a prodromal symptom of cerebrovascular accidents) while using hormonal contraceptives may be a reason to immediately discontinue use of hormonal contraceptives.

Women using COCs should be advised to consult a doctor if possible symptoms of thrombosis appear. If thrombosis is suspected or confirmed, use of the COC should be discontinued. In this case, it is necessary to use effective contraception, since anticoagulants (coumarins) have a teratogenic effect.

Risk of developing tumors

The most important risk factor for developing cervical cancer is infection with the human papillomavirus (HPV). Epidemiological studies have shown that long-term use of COCs leads to an additional increase in this risk, but it remains unclear to what extent this is due to other factors such as more frequent cervical smear examinations and differences in sexual behavior, including. use of barrier contraceptives. It remains unclear how this effect is related to the use of the drug NuvaRing ®.

A meta-analysis of the results of 54 epidemiological studies found a small increase (1.24) in the relative risk of developing breast cancer in women taking COCs. The risk gradually decreases over 10 years after stopping the drugs. Breast cancer rarely develops in women under 40 years of age, so the additional incidence of breast cancer in women who take or have taken COCs is small compared to the overall risk of developing breast cancer. Breast cancer diagnosed in women who use COCs is clinically less severe than cancer diagnosed in women who have never used COCs. The increased risk of developing breast cancer may be due to the earlier diagnosis of breast cancer in women taking COCs, the biological effects of COCs, or a combination of both.

In rare cases, cases of development of benign, and even more rarely, malignant liver tumors have been observed in women taking COCs. In some cases, these tumors led to the development of life-threatening bleeding into the abdominal cavity. A physician should consider the possibility of a liver tumor in the differential diagnosis of diseases in a woman taking NuvaRing ® if symptoms include acute pain in the upper abdomen, liver enlargement, or signs of intra-abdominal bleeding.

Other states

Women with hypertriglyceridemia or a corresponding family history have an increased risk of developing pancreatitis when taking hormonal contraceptives.

Many women taking hormonal contraceptives experience a slight increase in blood pressure, but clinically significant increases in blood pressure are rare. A direct connection between the use of hormonal contraceptives and the development of arterial hypertension has not been established. If a constant increase in blood pressure is observed when using the drug NuvaRing ®, it is necessary to contact your doctor to decide whether it is necessary to remove the vaginal ring and prescribe antihypertensive therapy. With adequate blood pressure control using antihypertensive drugs, it is possible to resume use of the drug NuvaRing ®.

During pregnancy and during the use of COCs, the development or worsening of the following conditions was noted, although their relationship with the use of contraceptives has not been definitively established: jaundice and/or itching caused by cholestasis, formation of gallstones, porphyria, systemic lupus erythematosus, hemolytic-uremic syndrome, Sydenham's chorea (minor chorea), herpes of pregnancy, hearing loss due to otosclerosis, angioedema (hereditary) edema.

Acute or chronic liver dysfunction may serve as a reason to discontinue the drug NuvaRing ® until liver function indicators normalize. Recurrence of cholestatic jaundice, previously observed during pregnancy or during the use of sex steroids, requires discontinuation of the drug NuvaRing ® .

Although estrogens and progestogens may influence peripheral insulin resistance and tissue glucose tolerance, there is no evidence to support the need to change hypoglycemic therapy during the use of hormonal contraceptives. However, women with diabetes should be under constant medical supervision when using the drug NuvaRing ® , especially in the first months of contraception.

There is evidence of a worsening of Crohn's disease and ulcerative colitis with the use of hormonal contraceptives.

In rare cases, pigmentation of the facial skin (chloasma) may occur, especially if it occurred earlier during pregnancy. Women predisposed to the development of chloasma should avoid exposure to sunlight and ultraviolet radiation while using NuvaRing ®.

The following conditions may prevent the ring from being inserted correctly or may cause it to fall out: cervical prolapse, bladder and/or rectal hernia, severe chronic constipation.

In very rare cases, women have unintentionally inserted the NuvaRing ® vaginal ring into the urethra and possibly into the bladder. When symptoms of cystitis appear, it is necessary to consider the possibility of incorrect insertion of the ring.

Cases of vaginitis have been described during use of the drug NuvaRing ® . There is no evidence that treatment of vaginitis affects the effectiveness of the use of the drug NuvaRing ® , as well as evidence of the influence of the use of the drug NuvaRing ® on the effectiveness of treatment of vaginitis.

Very rare cases of difficulty in removing the ring have been described, requiring its removal by a medical professional.

Medical examination/consultation

Before prescribing the drug NuvaRing ® or resuming its use, you should carefully review the woman’s medical history (including family history) and conduct a gynecological examination to exclude pregnancy. It is necessary to measure blood pressure, conduct an examination of the mammary glands, pelvic organs, including a cytological examination of cervical smears and some laboratory tests, to exclude contraindications and reduce the risk of possible side effects of the drug. The frequency and nature of medical examinations depend on the individual characteristics of each patient, but medical examinations are carried out at least once every 6 months. A woman should read the instructions and follow all recommendations. The woman should be informed that NuvaRing ® does not protect against HIV infection (AIDS) and other sexually transmitted diseases.

Reduced efficiency

The effectiveness of the drug NuvaRing ® may decrease if the regimen is not followed or concomitant therapy is carried out.

Changes in the nature of menstruation

During use of the drug NuvaRing ®, acyclic bleeding (spotting or sudden bleeding) may occur. If such bleeding is observed after regular cycles while using the drug NuvaRing ® correctly, you should contact your gynecologist to conduct the necessary diagnostic tests, incl. to exclude organic pathology or pregnancy. A diagnostic curettage may be required.

Some women do not bleed after the ring is removed. If the drug NuvaRing ® was used according to the instructions, it is unlikely that the woman is pregnant. If the recommendations of the instructions are not followed and there is no bleeding after removing the ring, as well as if there is no bleeding for two cycles in a row, pregnancy must be excluded.

Effects of ethinyl estradiol and etonogestrel on a sexual partner

The possible pharmacological effects and extent of exposure of ethinyl estradiol and etonogestrel to male sexual partners due to absorption through penile tissue have not been studied.

Laboratory research

The use of contraceptive hormonal drugs may affect the results of certain laboratory tests, including biochemical indicators of liver, thyroid, adrenal and kidney function, plasma concentrations of transport proteins (for example, corticosteroid binding globulin and sex hormone binding globulin), lipid/lipoprotein fractions, carbohydrate metabolism and indicators of coagulation and fibrinolysis. Indicators, as a rule, vary within normal values.

Impact on the ability to drive vehicles and operate machinery

Based on information about the pharmacodynamic properties of the drug NovaRing ®, it can be expected that it does not affect the ability to drive vehicles and operate machinery.

The Nuvaring vaginal ring allows women to protect themselves from unwanted pregnancy without the additional use of barrier contraceptive methods and pills.

The device has a large list of contraindications and sometimes causes adverse reactions.

Therefore, before use, you must carefully study the instructions, and it is better to consult a specialist.

The structure of the Nuvaring contraceptive ring is simple. Externally, it appears to be a silicone translucent rim that can be easily reshaped. The diameter of the protective agent is 5-6 cm.

Synthetic elastic material is used in pharmacology for the manufacture of various implants, therefore it is considered safe and proven.

Observations and studies show that the product is hypoallergenic. An allergic reaction to elastic material is a rare occurrence.

Inside the silicone rim contains a combination of drugs: etonogestrel.

Every day, a certain dose of active substances is released from the Nuvaring hormonal ring. They are absorbed into the vascular network of the vagina and penetrate into the bloodstream.

The effect of the drug begins immediately after installation and ends after removal. Using the ring has the following effect:

  • prevents their opening and release of the egg;
  • disrupts the process of endometrial proliferation, which creates unfavorable conditions for implantation;
  • organizes a special one that allows not only to protect against pregnancy, but also to obtain a therapeutic effect;
  • affects the secretory activity of the cervix, as a result of which the mucus thickens and reduces the activity of the sperm that enter it.

The mechanism of action of the ring is a reversible process.

Is it possible to get pregnant with a birth control ring?

The Nuvaring gynecological ring is intended to prevent unwanted pregnancy when maintaining an active sexual life without the use of others.

The mechanism of action of the silicone rim provides reliable protection against conception. When asked whether it is possible to get pregnant with a ring, gynecologists answer negatively.

However, there are exceptions to every rule. Medicine knows of cases where women became pregnant while using the hormonal system.

The reliability of the product is determined by the Pearl index, an indicator of the effectiveness of the contraceptive method. It is believed that the higher the value, the more dangerous the method.

The Pearl Index is determined from the number of random pregnancies involving 100 women of childbearing age during one year of use of the hormonal system.

For the Nuvaring ring, the rate is less than 1. This means that out of 100 representatives of the fairer sex who used the silicone device, only 1 became pregnant.

Nuvaring: instructions for use

The drug Nuvaring is recommended for use in the instructions for use for contraception. The hormonal agent is injected into.

It is permissible to start using Nuvaring on the 3rd or even 5th day. But only in this case will it be necessary to use additional means of protection against pregnancy throughout the entire month.

The product is approved for use after oral contraceptives, abortion, miscarriage and even childbirth (subject to refusal of breastfeeding).

For each case, an individual application scheme is provided.

How to insert the ring correctly?

The vaginal ring should only be inserted with clean hands. You must first open the package and remove the silicone rim.

To insert the system, you need to take a comfortable position: lying down, squatting, raising your leg on a chair. The ring is inserted in a similar way to sanitary tampons.

Use your thumb and index finger to flatten the elastic circle, insert it into the vagina and push it further away.

Over the next three weeks, the protective agent will remain in place. Its presence should be checked periodically, and in case of premature removal, the following measures should be taken:

  • take a break for a week, then use a new ring;
  • if the ring is not lost, then rinse it with water and reinsert it;
  • if the system is lost, introduce a new remedy immediately.

The effectiveness of the product after loss is not reduced if it is replaced no later than after 3 hours. If the gap is longer, then barrier protection must be used over the next few days.

How to take out Nuvaring?

Removal of the contraceptive ring is done with clean hands. You need to take a comfortable position, insert your finger into the vagina, pick up the system and pull it out.

Over the next week, menstrual-like withdrawal bleeding will begin.

The new device should be inserted exactly 7 days later at the same time as removal. During this period, bleeding may not yet be completed, but this does not affect the effectiveness of the hormonal ring.

If the break was more than 7 days, then the reliability of the protective agent decreases, which requires additional contraceptive measures.

Instructions for use after abortion

When used for the first time, Nuvaring is administered directly on the day of curettage.

If the use of vaginal products on the first day is undesirable, then you can start using the ring in the period from 2 to 5 days. This regimen requires additional contraception in the first week.

How to delay menstruation

To delay the onset of vaginal bleeding, you must remove the ring after 21 days and immediately insert a new one.

With this bleeding pattern, there will be no withdrawal, but some women experience spotting in the middle of the cycle.

Nuvaring should be removed after another 21 days or at the appropriate period for menstruation.

Using a ring for fibroids

The results of clinical studies show that the use of the Nuvaring ring for uterine fibroids has unexpected results.

In most patients, the tumor stopped growing under the influence of the new hormonal levels.

There are clinical cases showing the ineffectiveness of the silicone system for benign myometrial tumors. It is believed that today there are more effective ones than the Nuvaring ring.

Treatment of endometriosis

With endometriosis, focal spread of the functional layer of the uterus occurs. Under the influence of hormonal levels, they bleed, causing heavy menstruation.

The Nuvaring ring helps manage this condition by suppressing ovarian activity. The use of the hormonal system shows good results. Treatment is carried out in two ways:

  1. The standard method is to use the ring with regular 7-day breaks;
  2. Continuous use of the system for 3-6 months.

Use during pregnancy and pregnancy

The use of the Nuvaring ring is contraindicated during pregnancy. If conception occurs while using the device, the system should be removed immediately and consult a doctor.

The drug is intended to prevent unplanned pregnancy, so it is not advisable to use it while pregnant.

Nuvaring is not prescribed for breastfeeding. The medication is able to change a woman’s hormonal levels, reducing the amount of milk produced. Also, the substances that make up the ring are excreted in breast milk.

Modern pharmacology offers more effective and safe hormonal agents for preventing pregnancy during breastfeeding.

Contraindications to the use of Nuvaring

  • Thrombosis and varicose veins of the lower extremities. Any conditions accompanied by blood thickening.
  • Migraine accompanied by additional neurological symptoms. Including in the anamnesis.
  • Vascular lesions in diabetes mellitus.
  • Severe hypertriglyceridemia accompanied by pancreatitis.
  • Acute liver pathologies.
  • Malignant organ lesions with hormonal dependence.
  • Bloody vaginal discharge not associated with the menstrual cycle.
  • Hypersensitivity and high probability of an allergic reaction to the components.

If the described cases occur while using the ring, you should remove it immediately. The medication should be used with caution by women over 35 years of age and by smoking patients.

Advantages and disadvantages of the Nuvaring ring

The main advantage is the ability to realize reproductive function even after long-term use. Pregnancy after Nuvaring occurs in healthy women within 1-3 cycles.

The advantage of the drug can be called the method of its use. Vaginal administration eliminates problems with the digestive tract, as well as missed hormonal doses.

It is convenient to insert the ring and forget about contraceptive methods for 3 weeks. The advantages of the device are:

  • ease of use;
  • the ability to regulate the cycle;
  • reducing the intensity of bleeding.

The disadvantages include the price of Nuvaring. The cost of one ring is about 25 dollars. The triple system costs $55.

Like any medicine, Nuvaring can cause side effects.

They often manifest themselves in the form of spotting in the middle of the cycle, headaches, and decreased libido.

The drug affects the thickness of the blood, and therefore increases the risk of heart and vascular pathologies. Also, the disadvantages are listed:

  • Some patients find it difficult to insert and remove the system;
  • you can lose a ring and not notice it;
  • there may be increased secretion of vaginal mucus.