Instruction for use: Alfaferone

Dosage form: Solution for injection

Active substance: Interferonum alpha

ATX

L03AB01 Interferon alfa

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

B20-B24 Disease caused by human immunodeficiency virus [HIV]: Deployed stage of HIV infection; AIDS in children; HIV / AIDS infection; Infections with HIV; AIDS; Human Immunodeficiency Virus HIV-1; HIV-1 infection HIV infection; HIV

C43 Malignant melanoma of skin: Malignant melanoma; Localized malignant melanoma; Localized form of malignant melanoma; Melanoma; Melanoma after surgical resection; Metastatic melanoma; Common metastatic malignant melanoma; Metastasizing form of malignant melanoma; Disseminated malignant melanoma

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

C83 Diffuse non-Hodgkin's lymphoma: Diffuse B-large-cell non-Hodgkin's lymphoma; Malignant lymphoma; Malignant lymphoma, especially of the histiocytic type; Lymphoblastic non-Hodgkin's lymphoma; Lymphoma non-Hodgkin's diffuse; Hepatic Lymphoma; Recurrence of lymphoma; Recurrent non-Hodgkin's lymphoma; Lymphoma of the liver

C84.0 Mushroom mycosis: Mycosis mushroom; Fungoid granuloma

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 ampoule with 1 ml solution for injection contains interferon alfa (prepared from donor human leukocytes) 1, 3 or 6 million IU.

Pharmachologic effect

Mode of action - Antiviral, immunostimulating, antitumor, antiproliferative.

It induces the expression of some oncogenes (myc, sys, ras), thereby inhibiting tumor growth. Affects the unaffected cells and increases their ability to withstand the penetration of the virus, regulates metabolism and cellular differentiation, stimulates the macrophagal system and NK cells.

Indication of the Alfaferone

Hairy cell leukemia, multiple myeloma (remission stage), non-Hodgkin's lymphoma (in combination with doxorubicin, cyclophosphamide, teniposide, prednisolone), fungal mycosis, chronic myelogenous leukemia; Kaposi's sarcoma on AIDS, renal carcinoma, malignant melanoma; Viral hepatitis B, C and D; Genital warts.

Contraindications

Hypersensitivity, thyroid disease (hypo- or hyperthyroidism), previous severe heart disease, severe liver and / or kidney dysfunction, chronic hepatitis with manifestations of liver failure, in patients receiving or recently received immunosuppressants, autoimmune hepatitis, cirrhosis, epilepsy and / Or a violation of the central nervous system.

Application in pregnancy and breastfeeding

During pregnancy, Alfaferon is prescribed only if the expected effect for the mother exceeds the risk to the fetus. Contraindicated in breastfeeding (should be abandoned breastfeeding).

Side effects

On the part of the gastrointestinal tract: loss of appetite, nausea, vomiting, diarrhea, impaired liver function.

On the part of the organs of hematopoiesis: myelodepression.

From the cardiovascular system: arterial hypotension, arrhythmia (in patients with pathology of the cardiovascular system).

From the side of the central nervous system: somnopelia, impaired consciousness, ataxia.

On the part of the skin: insignificant alopecia, dryness, erythema, rash, local reactions.

Other: influenza-like symptoms: fever, chills, headache, muscle pain, etc. (decrease on subsequent days of admission).

Interaction

Reduces Cl and the half-life of theophylline.

Dosing and Administration

IM and SC. Enter (depending on the disease) from 3 to 12 million IU, appoint every day or 3 times a week (the duration of treatment depends on the pathology). The maximum doses should be injected / drip slowly (within 30-60 minutes), the required dose of the drug is diluted in 50 ml of saline. With genital warts, additional local application of the solution is possible.

Precautionary measures

Before starting treatment, you need to determine the level of thyroid-stimulating hormone. With care appoint to patients with cardiovascular diseases (myocardial infarction, arrhythmia, etc.). In all patients it is recommended to control the composition of peripheral blood, liver function, electrolyte balance parameters, ECG (in patients with cardiovascular pathology). Women and men of reproductive age should use reliable contraception. The safety and effectiveness of Alfaferon in children and adolescents under the age of 18 years has not been proven.

Special instructions

The severity of adverse reactions is removed when taking the drug just before bedtime.

Storage conditions of the drug Alfaferone

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

Keep out of the reach of children.

Shelf life of the drug Alfaferone

2 years.

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