Study of interferon status. Instructions for interferon gamma, alpha, reviews, contraindications Interferon gamma human recombinant

To protect the human body from the damaging effects of pathogenic agents - viruses, the immune system has a mechanism that ensures the fight against infectious diseases. It represents the production by cells, for example, T-lymphocytes, of special substances, one of which is interferon gamma. Formed in the immune system, the compound plays the role of cellular defense. Why it is so important, how it is formed, and by what principle it ensures the integrity of our body - we will get answers to these questions in this article.

and receiving

The basis of the substance is a glycoprotein - a peptide associated with carbohydrate. Biochemists have identified two of its forms, differing in the amino acid composition of the first and 139th monomer in the polypeptide chain. They are called interferon gamma 1a and 2a. The average molecular weight is about 20 - 25 kDa. They are formed in response to the penetration of pathogenic agents represented by viral particles into tissues and cells. Under artificial conditions, the substance is obtained by biotechnology and genetic engineering using strains of Escherichia coli bacteria, the plasmid of which contains the human interferon gene. This gamma interferon is called recombinant, it is part of the drugs: “Immuneron”, “Ingaron”, “Immunnomax”.

Mechanism of immune reactions

The appearance of foreign virulent pathogens in the body is always accompanied by a system of protective processes, one of which is inflammation. It serves as a marker signaling the onset of both the disease itself and the cell response to pathogen antigens. A complex of interactions arises between the elements of the infected tissue or organ. It is based on substances produced by cells of lymphoid tissue: cytokines (lymphokines). For example, human interferon gamma and interleukin 2, through membrane interactions, force uninfected cells to begin the synthesis of antibodies, and, in fact, are signaling proteins. Let's take a closer look at them.

Properties of lymphokines

In the 6th pair of human chromosomes there is a locus containing a set of genes that carry information about the antigenic properties of the cytoplasmic membrane and other cellular organelles: nucleus, mitochondria, etc. Lymphokines themselves are not able to directly influence viral antigens, but they quickly transmit information about the presence of foreign substances from one cell to another. For example, the helper cell and T-lymphocyte antigen receptor TOR induces an intracellular signal by activating two special proteins. Subsequently, the process of mitotic division - proliferation intensifies, and cellular immunity increases significantly. Like other lymphokines, gamma interferon interferes with the processes of transcription of viral nucleic acid, and also inhibits the assembly mechanism of protein molecules of the pathogen. We can say that the protein compounds we are considering are the basis of humoral immunity.

How the immune system works

The thymus gland, lymph nodes, tonsils, appendix are the places where lymphocytes are formed. Protective cells produce antibodies that inhibit the development of infectious disease in the body. In the early stages of their development, cells of the immune system, called naïve cells, cannot track foreign antigens, bacteria and viruses. They must mature and become immunocompetent - this happens in the thymus. The body's system, which produces both the protective cells themselves: macrophages, T-lymphocytes, killer cells, and various types of gamma interferon, is controlled by the higher cortical centers of the brain.

Its activity is also regulated by the adrenal glands, pituitary gland and hypothalamus. Psycho-emotional disorders, poor nutrition and bad habits reduce the body’s immune responses, especially often against the background of chronic stress. Since the body’s response is the result of the action of all its systems, any disturbance of homeostasis is fraught with immune failures and deterioration of health.

Antibodies to human interferon gamma

In medical practice, substances containing protective proteins obtained by immunizing animals with recombinant interferon are used as a preventive and therapeutic agent. Antibody molecules are precipitated from blood serum, purified and used as an antiviral drug. It is able to enhance the activity of the body's own protective compounds, for example, gamma globulins, and also reduce the symptoms of respiratory infections: runny nose and nasal congestion, cough.

Therapeutic effect of interferon

The protective glycoprotein inhibits and stimulates cell enzymes, for example, adenylate synthetase and protein kinase, which suppress the synthesis of nucleic acid and viral envelope proteins. The substance has the ability to influence the sensitivity of membrane cellular proteins to lymphokines, i.e. it is an immunomodulator. Interferon gamma for children and adults is used for the prevention and treatment of influenza and respiratory infections, with a positive test for the presence of Koch bacillus in the body. The remedy is available in the form of tablets, ointments, suppositories and injections.

The use of a drug prescribed by a doctor in children can begin at 6 months, taking into account the child’s absence of allergic reactions and serious pathologies of the cardiovascular system. Contraindications to treatment in women are allergies and pregnancy. Modern drugs, especially those used in pediatrics, contain recombinant protective protein with a high degree of purification and the complete absence of polypeptide fragments.

ingARON®

Interferon-gamma human recombinant.

Trade name: inGARON®

International nonproprietary name: Interferon gamma.

INGARON- recombinant human interferon gamma. The drug is a product of microbiological synthesis produced using Russian technology, patented as an invention (Patent No. 000 registered in the State Register of Inventions of the Russian Federation on October 27, 2003). The author of the invention is Doctor of Medical Sciences, Deputy Director for Science of the Pharmaclon production enterprise, the only manufacturer of the drug Ingaron in Russia. Instructions for the medical use of the drug "INGARON" were approved by Order of Roszdravnadzor of the Russian Federation -reg/05 dated November 18, 2005. The following INF-gamma are registered abroad: Immukin (Germany) and its analogue Actimmune (Actimmune) USA, which have a less perfect biochemical structure (140 amino acid residues) and a higher cost ($175-190 per dose) than Ingaron ( 144 amino acid residues, 1060 rubles per dose, which is better quality and 5 times cheaper than Western analogues)

ANTI-INFECTIVE (antiviral, antibacterial, etc.);

· Stimulation of antigen recognition by cells of the immune system,

· Suppression of the replication of viral RNA and DNA and liberation of the cell from the virus, changing the surface of cell membranes, which blocks the attachment and introduction of the virus into cells;

ANTI-TUMOR;

The drug "INGARON" is responsible for antitumor immunity and has direct antitumor activity on a number of different tumor cells.

due to:

· Activation of antitumor immunity;

· Increased cytotoxic activity of chemotherapy drugs and antitumor cytokines;

· Strengthening the antitumor effect of cytotoxic lymphocytes, which leads to suppression of the growth of malignant cells;

· Increasing the cytotoxic potential and activity of natural killers (phagocytes and macrophages) that destroy cancer (a-typical) cells;

· Induction of apoptosis (death) of cancer cells;

Slowing tumor growth by suppressing angiogenesis

(tumor vasculature);

· Increased recognition of malignant cells by T-killer cells, which enhances their response to the tumor;

In oncological practice, to increase the effectiveness of treatment, interferons are used in combination with other antitumor chemotherapy drugs. When used together with chemotherapy, Ingaron improves its tolerability, significantly reduces toxic effects, including inhibition of hematopoiesis, while normalizing the activity of natural killer cells and increasing the antitumor effect.

3. IMMUNOMODULATING:

Activation of phagocytes, not noted with other types of interferons that destroy intracellular microorganisms:

Increased oxidative metabolism of macrophages; Antibody-dependent cytotoxicity; Activation of NK cells; Expression of Fc receptors and major histocompatibility complex antigens; Stimulation of the production of a number of cytokines; Activation of mediator production by mononuclear phagocytes;

Regulation of proliferation and differentiation of the lymphocyte population

INDICATIONS FOR USE OF INGARON

Prevention and treatment of infectious complications in patients with chronic granulomatous disease; Treatment and prevention of influenza, c. incl. “avian” and “porcine” origin, with the intranasal route of administration in combination with Alfarona (IFN-alpha2b). Treatment of chronic viral hepatitis C, chronic viral hepatitis B, HIV/AIDS infection and tuberculosis in complex therapy.

Treatment of lymphoproliferative oncological diseases in combination with chemotherapy and Refnot.

Treatment of genital herpesvirus infection and herpes zoster in monotherapy. Treatment of urogenital chlamydia in complex therapy (with azithromycin).

§ IFN-gamma is included in recommendations for the treatment of various forms of tuberculosis infection. When treating tuberculosis of various localizations together with chemotherapy, a short course of a month for pulmonary tuberculosis usually leads to BC-minus in the sputum and bronchial lavages; a resorption phase is observed radiographically.

§ Treatment of infections caused by various viruses: vesicular stomatitis, cytomegalovirus, etc.

§ Treatment together with antibiotics of diseases caused by intracellular pathogens: bacteria, mycoplasmas, fungi.

§ Use in a short course (3-5 injections) for surgical wound infections reduces infectious complications and accelerates suture healing by primary intention. Prevents the development of keloid scars.

§ Prevents the development and treats fibrosis (and its advanced stage - cirrhosis) of the liver and lungs.

§ Treatment of acute and chronic nonspecific diseases of the respiratory tract (acute respiratory infections, ARVI, bronchitis, pneumonia), genitourinary system (cystitis, prostatitis).

Efficiency The effectiveness of the innovative domestic drug INGARON for a wide range of diseases has been proven by research by the most authoritative specialists in the field of infectious pathology and oncology.

Scope of application of INF-gamma extensive. INGARON has found the widest application in oncology, hepatology, dermatovenerology, and the clinic of infectious diseases. The clinical use of INF-gamma has been proven to be effective in a number of diseases (chronic granulomatosis, malignant osterpetrosis), as well as in the treatment of acute and chronic viral hepatitis B, C, D and their combinations, acute viral meningoencephalitis, influenza, including avian and swine" origin, adenovirus infection, measles, herpetic keratitis, genital herpes, herpes zoster, HIV infection and many other diseases. Ingaron is indispensable in protecting the human body from dangerous viral infections, including: smallpox, plague, SARS, hemorrhagic fever, influenza, including those of “bird” and “pork” origin. Ingaron has good clinical and biological tolerability. No serious side effects were noted.

Contraindications. Individual intolerance to interferon gamma or any other component of the drug. Pregnancy. Autoimmune diseases. Diabetes mellitus.

Side effect.

The use of high doses over 1,000,000 IU can lead to the development of a flu-like syndrome: headache, weakness, fever. Mild symptoms do not require pharmacological correction. In case of severe symptoms, relief with aspirin or paracetamol.

Release form.

Lyophilisate for preparing a solution for intramuscular and subcutaneous administration in bottles of 100,000 IU, 500,000 IU, 1,000,000 IU per bottle. Bottles of 1, 5 or 10 pieces are packed in cardboard packs.

Storage conditions.

In a dry place, protected from light and out of reach of children, at a temperature not exceeding 10°C.

Store the dissolved drug for no more than a day in the refrigerator (do not freeze).

Best before date. 2 years

Manufacturer.

″Pharmaclon″, Russia.

Doctor of Medical Sciences Shmelev V. A.

Included in the preparations

Included in the list (Order of the Government of the Russian Federation No. 2782-r dated December 30, 2014):

VED

ATX:

L.03.A.B.03 Interferon gamma

Pharmacodynamics:

Unlike other interferons, it increases the expression of major histocompatibility complex antigens of both classes 1 and 2 on different cells, and induces the expression of these molecules even on those cells that do not constitutively express them. This increases the efficiency of antigen presentation and the ability of T lymphocytes to recognize them.

Interferon gamma blocks the replication of viral DNA and RNA, the synthesis of viral proteins and the assembly of mature viral particles. has a cytotoxic effect on virus-infected cells.

Interferon gamma blocks the synthesis of β-TGF, which is responsible for the development of fibrosis of the lungs and liver.

Pharmacokinetics:

Not adsorbed through the gastrointestinal tract. Peak plasma concentration is 4 hours after intramuscular administration; 7 hours later - after subcutaneous injection. The half-life is 38 minutes when administered intravenously, 2.9 hours when administered intramuscularly and 5.9 hours when administered subcutaneously.

Indications:

Lyophilisate for preparing a solution for intramuscular and subcutaneous administration

Complex therapy:

Chronic viral hepatitis C;

Chronic viral hepatitis B;

HIV/AIDS infection;

Pulmonary tuberculosis;

Mycobacterial infection in HIV-negative patients with ineffective conservative therapy;

Oncological diseases (as an immunomodulator - including in combination with chemotherapy);

Urogenital chlamydia;

Chronic prostatitis;

Genital herpesvirus infection and herpes zoster (Herpes zoster)- in monotherapy;

Psoriasis;

Rheumatoid arthritis;

L imfogranulomatosis;

Visceral leishmaniasis;

Leprosy;

Eczema and atopic dermatitis;

Anogenital warts (human papillomavirus) - treatment and prevention of relapse of the disease.

Prevention infectious complications in patients with chronic granulomatous disease.

Lyophilisate for the preparation of solution for intranasal administration

Complex therapy for the prevention and treatment of influenza and avian influenza (H 5 N 1 and H 1 N 1).

I.A15-A19.A16 Respiratory tuberculosis, not confirmed bacteriologically or histologically

I.A30-A49.A30 Leprosy [Hansen's disease]

I.A30-A49.A31.0 Pulmonary infection caused by Mycobacterium

I.A50-A64.A56 Other chlamydial sexually transmitted diseases

I.A50-A64.A60 Anogenital herpetic viral infection

I.A50-A64.A63.0 Anogenital (venereal) warts

I.B00-B09.B02 Shingles

I.B15-B19.B18.0 Chronic viral hepatitis B with delta agent

I.B15-B19.B18.1 Chronic viral hepatitis B without delta agent

I.B15-B19.B18.2 Chronic viral hepatitis C

I.B20-B24 Human immunodeficiency virus disease [HIV]

I.B50-B64.B55 Leishmaniasis

II.C76-C80.C80 Malignant neoplasm without specification of localization

II.C81-C96.C81 Hodgkin's disease [lymphogranulomatosis]

XII.L20-L30.L20.8 Other atopic dermatitis

XII.L40-L45.L40 Psoriasis

XII.L80-L99.L92 Granulomatous changes in the skin and subcutaneous tissue

XIII.M05-M14.M05 Seropositive rheumatoid arthritis

XIV.N40-N51.N41.1 Chronic prostatitis

XIV.N70-N77.N74.4* Inflammatory diseases of the female pelvic organs caused by chlamydia (A56.1+)

Contraindications:

Common to both dosage forms:

Individual intolerance to interferon gamma or any other component of the drug;

Pregnancy.

Lyophilisate for preparing a solution for intramuscular and subcutaneous administration:

Autoimmune diseases;

Diabetes mellitus;

Cardiovascular system disorders (ischemia, cardiovascular failure, arrhythmias);

Central nervous system disorders (epileptic seizures);

Multiple sclerosis;

Systemic syphilis;

Simultaneous use with cytotoxic drugs and radiation therapy.

Lyophilisate for preparing a solution for intranasal administration: children under 7 years of age.

With caution:

No data available.

Pregnancy and lactation: Directions for use and dosage:

The dosage regimen is set individually.

Intramuscularly , subcutaneously. The contents of the bottle are dissolved in 2 ml of water for injection. The dose of the drug is determined individually.

For the treatment of patients with chronic viral hepatitis B, chronic viral hepatitis C, as well as HIV infection/AIDS and pulmonary tuberculosis the average daily dose for adults is 500,000 IU. It is administered once a day, daily or every other day. The course of treatment ranges from 1 to 3 months, if necessary, the course of treatment is repeated after 1-2 months.

For the prevention of infectious complications in patients with chronic granulomatous disease usually the average daily dose for adults is 500,000 IU. It is administered once a day, daily or every other day. The course consists of 5-15 injections; if necessary, the course is extended or repeated after 10-14 days.

For the treatment of cancer the average daily dose for adults is 500,000 IU. It is administered once a day, every other day.

For the treatment of genital herpes virus infection, herpes zoster and urogenital chlamydia the average daily dose for adults is 500,000 IU. It is administered once a day subcutaneously, every other day. The course of treatment is 5 injections.

For the treatment of chronic prostatitis the daily dose is 100,000 IU. It is administered subcutaneously once a day, every other day. The course of treatment is 10 injections.

For the treatment of anogenital warts the daily dose is 100,000 IU. It is administered subcutaneously once a day, after cryodestruction, every other day. The course of treatment is 5 injections.

Intranasally. The contents of the bottle are dissolved in 5 ml of water for injection.

At the first signs of influenza, ARVI- 2 drops in each nasal passage, after toileting the nasal passages, 5 times a day for 5-7 days.

For the prevention of acute respiratory viral infections and influenza in case of contact with a patient and/or hypothermia- 2-3 drops in each nasal passage every other day, 30 minutes before breakfast for 10 days. If necessary, preventive courses are repeated. For single contact, one instillation is sufficient.

Side effects:

Flu-like syndrome chills, fatigue, drowsiness, nausea, p increased transaminase activity, skin itching, in severe fever myalgia, weakness, weight loss, n neutropenia and thrombocytopenia, alopecia, p olimorphic rash.

Overdose:

Not described. Treatment is symptomatic.

Interaction:

Not described.

Special instructions:

In case of severe side effects, you should stop taking the drug.

Impact on the ability to drive vehicles and other technical devices

Not identified.

Instructions

Indications

For intramuscular and subcutaneous administration: as part of complex treatment of chronic viral hepatitis B; as part of complex treatment of chronic viral hepatitis C; as part of complex treatment of human immunodeficiency virus; as part of complex treatment of acquired immunodeficiency syndrome; as part of complex treatment of pulmonary tuberculosis; as an immunomodulator as part of complex treatment of cancer, including in combination with chemotherapy; as part of complex treatment of chronic prostatitis; as part of complex treatment of urogenital chlamydia; prevention of infectious complications in patients with chronic granulomatous disease; monotherapy for genital herpesvirus infection; monotherapy for herpes zoster; treatment of anogenital warts (human papillomavirus) and prevention of relapse of the disease; supportive treatment of cutaneous and visceral leishmaniasis; psoriasis; leprosy; alternative treatment for rheumatoid arthritis; mycobacterial infection in patients without human immunodeficiency virus when conservative treatment is ineffective; eczema and atopic dermatitis, especially with high levels of immunoglobulin E.
For intranasal administration: prevention and therapy (as part of complex treatment) of influenza; prevention and therapy (as part of complex treatment) of H1N1 and H5N1 influenza.

Method of administration of interferon gamma and dose

Interferon gamma is administered intramuscularly, subcutaneously, or intranasally. After intranasal administration of interferon gamma, it is recommended to massage the wings of the nose with your fingers for several minutes so that the drug is evenly distributed in the nasal cavity. The dose of the drug is set individually depending on the indications and tolerability of treatment.
Chronic viral hepatitis B, chronic viral hepatitis C, human immunodeficiency virus, acquired immunodeficiency syndrome, pulmonary tuberculosis: for adults, the average daily dose is 500,000 IU; the drug is administered intramuscularly or subcutaneously once a day, every day or every other day; the course of therapy is 1 - 3 months, if necessary, after 1 - 2 months the course of therapy can be repeated.
Prevention of infectious complications in patients with chronic granulomatous disease: for adults, the average daily dose is 500,000 IU; the drug is administered intramuscularly or subcutaneously once a day, every day or every other day; the course of treatment is 5 - 15 injections; if necessary, the course is repeated after 10 - 14 days or extended.
Oncological diseases: for adults, the average daily dose is 500,000 IU; the drug is administered intramuscularly or subcutaneously once a day every other day.
Genital herpes virus infection, herpes zoster, urogenital chlamydia: for adults, the average daily dose is 500,000 IU; the drug is administered subcutaneously once a day every other day; The course of treatment is 5 injections.
Chronic prostatitis: for adults, the daily dose is 100,000 IU; the drug is administered subcutaneously once a day every other day; the course of treatment is 10 injections.
Anogenital warts: for adults, the daily dose is 100,000 IU; the drug is administered subcutaneously once a day, after cryodestruction, every other day; The course of treatment is 5 injections.
Influenza, acute respiratory viral infections: at the first signs of illness, the drug is administered intranasally after toileting the nasal passages, 2 drops into each nasal passage 5 times a day for 5 - 7 days.
Prevention of acute respiratory viral infections and influenza upon contact with a patient and/or hypothermia: 2 - 3 drops of the drug are administered into each nasal passage every other day, half an hour before breakfast for 10 days; if necessary, preventive courses are repeated; In the case of a single contact, one instillation of the drug is sufficient.
When using interferon gamma in the form of a lyophilisate to prepare a solution, the contents of the bottle are dissolved in 2 ml (for intramuscular and subcutaneous administration) or 5 ml (for intranasal administration) of water for injection.
When using interferon gamma in doses of more than 1,000,000 IU, a flu-like syndrome may develop, which is manifested by weakness, headache, joint pain, and increased body temperature. For mild symptoms, there is no need for pharmacological correction. In case of severe symptoms, it is necessary to relieve symptoms with paracetamol and glucocorticosteroids. In case of pronounced local and general reactions, the use of interferon gamma should be discontinued.
There is no data on the effect of interferon gamma on the ability to perform potentially hazardous activities that require increased concentration and speed of psychomotor reactions (including driving vehicles and machinery).

Contraindications for use

Hypersensitivity (including to the auxiliary components of the drug), autoimmune diseases, diabetes mellitus, breastfeeding, pregnancy, childhood (depending on the dosage form used).

Restrictions on use

No data available.

Use during pregnancy and breastfeeding

There are no data on the use of interferon gamma during pregnancy. The use of interferon gamma is contraindicated in women during pregnancy. There are no data on the use of interferon gamma during breastfeeding. While using interferon gamma, you must stop breastfeeding.

Side effects of interferon gamma

Reactions at the injection site: hyperemia at the injection site, local pain at the injection site (in the form of a weak aching pain (like an overtrained muscle)).
Others: especially when using doses above 1,000,000 IU, the development of a flu-like syndrome (weakness, headache, joint pain, increased body temperature) is possible; severe fever, myalgia, chills, fatigue, weakness, nausea, drowsiness, weight loss, increased transaminase activity, neutropenia, thrombocytopenia, alopecia, polymorphic rash, itching.