Ingaron^® (Lyophilisate) Instructions for Use

ATC Code

L03AB03 (Interferon gamma)

Active Substance

Interferon gamma (Rec.INN registered by WHO)

Clinical-Pharmacological Group

Interferon. An immunomodulatory drug with antiviral action

Pharmacotherapeutic Group

MIBP-cytokine

Pharmacological Action

Recombinant human Interferon gamma consists of 144 amino acid residues, lacks the first three amino acid residues Cys-Tyr-Cys, which are replaced by Met. Molecular weight is 16.9 kDa. It is obtained by microbiological synthesis in a recombinant strain of Escherichia coli and purified by column chromatography. Specific antiviral activity on cells (human fibroblasts) infected with vesicular stomatitis virus is 2 × 10⁷ IU/mg of protein.

Interferon gamma (immune interferon) is a key proinflammatory cytokine, produced in the human body by natural killer cells, CD4 Th1 cells, and CD8 cytotoxic suppressor cells. Receptors for interferon gamma are present on macrophages, neutrophils, natural killer cells, and cytotoxic T-lymphocytes. Interferon gamma activates the effector functions of these cells, particularly their microbiocidal activity, cytotoxicity, cytokine production, superoxide and nitrooxide radicals, thereby causing the death of intracellular parasites. Interferon gamma inhibits the B-cell response, interleukin-4, suppresses IgE production and CD23 antigen expression. It is an inducer of apoptosis of differentiated B-cells that give rise to autoreactive clones. It abolishes the suppressive effect of interleukin-4 on interleukin-2-dependent proliferation and generation of lymphokine-activated killers.

It activates the production of acute-phase inflammatory proteins and enhances the expression of genes for the C₂ and C₄ components of the complement system.

Unlike other interferons, it increases the expression of MHC antigens of both class I and II on various cells, and induces the expression of these molecules even on cells that do not constitutively express them. Thereby, it increases the efficiency of antigen presentation and their recognition by T-lymphocytes. Interferon gamma blocks the replication of viral DNA and RNA, the synthesis of viral proteins, and the assembly of mature viral particles. Interferon gamma has a cytotoxic effect on virus-infected cells.

Interferon gamma blocks the synthesis of β-TGF, responsible for the development of pulmonary and hepatic fibrosis.

Indications

• Treatment of chronic viral hepatitis C, chronic viral hepatitis B, HIV/AIDS infection, and pulmonary tuberculosis as part of complex therapy;
• Prevention of infectious complications in patients with chronic granulomatous disease;
• Treatment of oncological diseases as part of complex therapy as an immunomodulator, including in combination with chemotherapy;
• Treatment of genital herpesvirus infection and shingles (Herpes zoster) in monotherapy;
• Treatment of urogenital chlamydia as part of complex therapy;
• Treatment of chronic prostatitis as part of complex therapy;
• Treatment of anogenital warts (human papillomavirus) and prevention of disease recurrence.

ICD codes

Dosage Regimen

Lyophilisate

The drug is administered intramuscularly or subcutaneously. The contents of the vial are dissolved in 2 ml of water for injection. The dose of the drug is set individually.

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

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

For the treatment of oncological diseases, the average daily dose for adults is 500,000 IU. The drug is administered once a day, every other day.

For the treatment of genital herpesvirus infection, shingles (Herpes zoster), and urogenital chlamydia, the average daily dose for adults is 500,000 IU. The drug 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. The drug is administered once a day, subcutaneously, every other day. The course of treatment is 10 injections.

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

Adverse Reactions

Local reactions local soreness at the site of subcutaneous injection in the form of mild aching pain (similar to an overworked muscle) and hyperemia.

The use of high doses exceeding 1,000,000 IU may be accompanied by the development of a flu-like syndrome: headache, weakness, increased body temperature, joint pain. Mild symptoms do not require pharmacological correction. For severe symptoms – relief with paracetamol.

Contraindications

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

Use in Pregnancy and Lactation

The drug is contraindicated during pregnancy.

Overdose

Data on overdose are not provided.

Drug Interactions

Data on drug interactions are not provided.

Storage Conditions

The drug should be stored in a dry, light-protected place, out of the reach of children, at a temperature from 2°C (35.6°F) to 10°C (50°F). Do not freeze.

Shelf Life

Shelf life – 2 years.

Dispensing Status

The drug is dispensed by prescription.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.