Instruction for use: Wellferon

Dosage form: Solution for injection

Active substance: Interferonum alpha

ATX

L03AB06 Interferon alfa-n1

Pharmacological groups:

Antiviral drugs (excluding HIV)

Interferons

The nosological classification (ICD-10)

A63.0 Anogenital (venereal) warts: Anogenital warts; Venereal warts; Condylomata genital; Condyloma pointed; Externally pointed genital warts; Externally pointed condyloma; Pointed Condyloma; Flat condyloma

B15-B19 Viral hepatitis

C64 Malignant neoplasm of kidney, other than renal pelvis: Wilms tumor; Kidney Cancer; Metastatic Renal Cell Carcinoma; Renal carcinoma; Inoperable kidney carcinomas; Metastatic kidney carcinoma; Metastatic Renal Cell Carcinoma; Wilms tumor; Wilms swelling; Adenomyosarcoma; Adenomyocystosarcoma; Adenosarcoma of the kidney; Kidney Cancer; Common renal cell carcinoma; Nephroblastoma; Nephroma; Embryonal nephroma; Recurrent carcinoma of the kidney; Birch-Hirschfeld Tumor; Common renal cell carcinoma; Tumors of the kidney

C91.4 Hairy-cell leucosis

C92 Myeloid leukemia [myeloid leukemia]: Ph-positive chronic myelogenous leukemia; Granulocytic leukemia; Myeloid leukemia; Myeloid leukemia; Myeloma disease; Neuroleukemia; Acute myeloblastic leukemia; Acute non-lymphoblastic leukemia; Acute non-lymphoblastic leukemia in adults; Refractory acute non-lymphoblastic leukemia; Induction of remission in PMLL; Transformation of preleukemias; Subleukemic myelosis; Myeloblastic leukemia; Myeloid leukemia

Composition and release form

1 bottle with 1 ml solution for injection contains purified interferon alpha-n1 3 million IU, stabilized by human albumin in a solution of Trisglycine buffer to a final protein concentration of 1.5 mg / ml.

Pharmachologic effect

Mode of action - Antiviral, immunomodulating, antitumor.

Increases the resistance of uninfected cells to the virus, binds to specific receptors on the cell surface, stimulates the corresponding enzymes, acts on the RNA of the virus and prevents its replication.

Pharmacokinetics

After IM or SC administration of Cmax in the serum - after 4-8 hours T1 / 2 - 4-12 hours. It is not found in the urine (except in cases of severe kidney disease). The mean Cl value of the preparation (without correction for bioavailability) was 57 ml / min / m2 and approximately 2 ml / min / kg.

Clinical Pharmacology

Stimulates the activity of macrophages and NK (Natural killer) cells involved in the immune response of the body to tumor aggression. It directly affects tumor cells (with hairy cell leukemia), inhibits the reproduction of hepatitis B and C viruses.

Indication of the Wellferon

Hairy cell leukemia, chronic hepatitis B or C, kidney cancer (with metastases), myeloleukemia (chronic phase), refractory form of genital warts.

Contraindications

Hypersensitivity, a significant decrease in liver reserves (for the treatment of chronic hepatitis C), blast crisis or extramedullary granulocyte sarcoma (for administration in chronic myelogenous leukemia).

Application in pregnancy and breastfeeding

It is necessary to commensurate the expected clinical effect with a possible risk to the fetus. It is not recommended to carry out therapy for pregnant women with chronic hepatitis B.

Side effects

Fever, chills, tremors, headache, myalgia, symptoms resembling flu, inhibition, weakness, fatigue, decreased number of leukocytes (granulocytes), platelets, hemoglobin level; Severe depression, apathy, confusion, coma, convulsions, extrapyramidal disorders; Hypo- or hypertension, arrhythmia, myocardial infarction, stroke, nausea, vomiting, diarrhea, renal insufficiency, alopecia, arthralgia, Reynaud phenomenon, urticaria, nodal erythema, pruritus, psoriasis, mucositis, peripheral nerve damage; Exacerbation of autoimmune disorders; Local reactions at the injection site; With repeated intravenous infusions of very high doses (100-200 IU) - hypocalcemia, hyperkalemia.

Interaction

Reduces the activity of P450 cytochromes and slows the metabolism of cimetidine, phenytoin, curantyl, theophylline, diazepam, propranolol, and some cytostatics. Possible violation of mental status in the appointment with funds that affect the central nervous system. Increases the risk of severe myelosuppression with vinblastine.

Dosing and Administration

SC, IM. Adults: hairy cell leukemia - 3 million IU daily, after 12-16 weeks - 3 million IU 3 times a week (6 months or more).

Chronic hepatitis B - 10-15 million IU (maximum 7.5 million IU / m2) 3 times a week for 12 weeks.

Chronic hepatitis C - 5 million IU 3 times a week for 48 weeks.

Kidney cancer - 3 million IU daily, increasing to 30-60 million IU per week.

Chronic myelogenous leukemia - the first 3 weeks (after stabilizing the number of leukocytes at a level of 20 x 109 / L for 4 weeks on standard chemotherapy) - 3 million IU daily, then the dose is selected to maintain the number of leukocytes at a level of 2-5 x 109 / L , The course - 6 months.

Pointed condyloma - 5 million IU (3 IU / m2) every day for 14 days, then 3 times a week (6-8 weeks).

Children: chronic hepatitis B - up to 10 million IU / m2.

Precautionary measures

Regular monitoring of peripheral blood parameters is mandatory. With care appoint to patients with kidney pathology, cardiovascular system, decompensated liver disease, CNS diseases, mental disorders (in the anamnesis). It should not be combined with immunosuppressive drugs (including corticosteroids), which accelerate the replication of the virus.

Storage conditions of the drug Wellferon

In the dark place at a temperature of 2-8 ° C.

Keep out of the reach of children.

Shelf life of the drug Wellferon

3 years.

Do not use after the expiry date printed on the package.