Instruction for use: Realdiron

Dosage form: Lyophilizate for the preparation of solution for intramuscular and subcutaneous administration; Powder lyophilized for the preparation of solution for injection

Active substance: Interferonum alpha-2b

ATX

L03AB05 Interferon alfa-2b

Pharmacological groups:

Antiviral drugs (excluding HIV)

Interferons

The nosological classification (ICD-10)

A84 Tick-borne viral encephalitis: Tick-borne encephalitis; Tick-borne encephalitis

B16 Acute hepatitis B: Viral hepatitis B; Hepatitis B; Acute hepatitis; Vaccination against hepatitis B; Subacute hepatitis; Acute viral hepatitis B; Acute lingering hepatitis B

B18.1 Chronic viral hepatitis B without delta-agent: Chronic viral hepatitis B; Chronic active hepatitis B; Chronic viral hepatitis B; Chronic hepatitis B; Chronic hepatitis B HBeAg-negative

B18.2 Chronic viral hepatitis C: Hepatitis C; Recurrence of chronic hepatitis C; Chronic active hepatitis C; Chronic viral hepatitis C; Chronic hepatitis C without cirrhosis; Chronic hepatitis C

B21.0 HIV disease, with manifestations of Kaposi's sarcoma: Kaposi angioreticulosis; Endotheliosarcoma; Kaposi angiosarcomatosis; Kaposi hemangiosarcoma; Kaposi hemorrhagic sarcoma; Kaposi multiple hemorrhagic sarcoma; Kaposi telangiectatic pseudo-sarcoma; Kaposi's Sarcoma in AIDS; Kaposi's sarcoma on AIDS; Kaposi's sarcoma on the background of AIDS

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

C84 Peripheral and cutaneous T-cell lymphomas: Malignant lymphoma; Cutaneous lymphoma; Cutaneous T-cell lymphoma; Lymphoma T-cell; T-cell lymphoma

C84.0 Mushroom mycosis: Mycosis mushroom; Fungoid granuloma

C84.1 Cesary's disease: Cesary's syndrome; Cesari Syndrome

C91.4 Hairy-cell leucosis

C92.1 Chronic myeloid leukemia: Myeloleukemia chronic; Myeloid leukemia chronic Ph-negative; Exacerbation of chronic myelogenous leukemia; The subleukemic form of chronic myelogenous leukemia; Chronic leukemia myeloid leukemia; Chronic myeloblastic leukemia; Chronic myelogenous leukemia; Chronic myelomonocytic leukemia; Idiopathic hypereosinophilic syndrome

Composition and release form

Powder lyophilized for the preparation of solution for injection 1 amp., fl.

Interferon alpha-2b human recombinant 1 million IU; 3 million IU; 6 million IU; 9 million IU; 18 million IU

Auxiliary substances: sodium chloride; Disodium hydrogen phosphate dodecahydrate; Sodium dihydrogen phosphate dihydrate

Stabilizer: dextran 60

In ampoules or vials; In a pack of cardboard 5 pcs.

Description of dosage form

Solution for the IM m and SC to the introduction: colorless transparent or slightly opalescent liquid.

Characteristic

Isolated from the cells Pseudomonas putida, in the genetic apparatus of which the human leukocyte interferon alpha-2b gene is built. According to the polypeptide structure of the molecule, biological activity and pharmacological properties is identical to human leukocyte interferon alpha-2b.

Pharmachologic effect

Mode of action - antiviral, immunomodulating, antitumor, antiproliferative.

Interferon alfa, interacting with receptors on the cell surface, initiates a complex chain of intracellular changes. It is assumed that these processes are associated with the prevention of viral replication in the cell, inhibition of cell proliferation, and immunomodulating action. Stimulates the phagocytic activity of macrophages, as well as the cytotoxic activity of T cells and "natural killers". These properties of interferon alfa and caused the therapeutic effect of Realdiron.

Indication of the Realdiron

Viral diseases (including acute and chronic active hepatitis B, chronic hepatitis C, tick-borne encephalitis); Oncological diseases (including hairy cell leukemia, chronic myelogenous leukemia, renal cell carcinoma, Kaposi's sarcoma against AIDS, cutaneous T-cell lymphoma (mushroom mycosis and Cesari syndrome), malignant melanoma).

Contraindications

Allergic reactions to interferon-alpha or other components of the drug.

Application in pregnancy and breastfeeding

Perhaps, if the expected effect of therapy exceeds the potential risk for the fetus (especially in the first trimester) or the child.

Side effects

Most often - chills, fever, fatigue, lethargy, headache, myalgia, joint pain, loss of appetite (partially suppressed by paracetamol); Possible - minor leukopenia, thrombocytopenia, some deviations in liver function indicators (disappear when the drug is withdrawn or its dose is reduced).

Dosing and Administration

IM, SC, dissolving immediately before use the contents of the ampule or vial in 1 ml of water for injection.

In acute hepatitis B (light, medium-heavy and severe forms) - 1 million IU 2 times a day for 5-6 days, then the dose is reduced to 1 million IU per day and injected for another 5 days. If necessary (after controlling biochemical blood tests to assess the functional state of the liver), treatment can continue for another 2 weeks, during which the drug is administered 1 million IU twice a week.

The most effective at the beginning of icteric period before 5 days of jaundice, in later terms, the administration of the drug is less effective. Ineffective in developing hepatic coma and cholestatic course of the disease.

With chronic active hepatitis B - 3-6 million IU 3 times a week for 24 weeks. If no clinical, biochemical improvement and / or disappearance of HBeAg is observed after 12 weeks of administration, treatment with the drug is canceled.

With chronic hepatitis C - 3 million IU 3 times a week for 24 weeks. If after administration of the drug for 4 weeks, 50% decrease in ALT activity in the blood plasma is not observed, the dose of the drug is increased to 6 million IU 3 times a week. If after 12 weeks of the drug is not observed clinical, biochemical improvement, treatment is discontinued.

In tick-borne encephalitis (meningeal forms) - 1-3 million IU 2 times a day for 10 days. Then support maintenance is prescribed - 5 times for 1-3 million IU every 2 days.

Oncological diseases.

The general principle of the use of interferon in cancer is to prescribe the maximum dose that the patient can tolerate for a sufficiently long period of time (months, years). Because Interferon alfa has a cytostatic effect, supporting treatment with Realdironum should continue after reaching an objective effect - hematological remission, regression of solid tumor sites.

With hairy cell leukemia, 3 million IU daily. After reaching hematologic remission go to supportive therapy for 3 million IU 3 times a week.

In chronic myelogenous leukemia - 9 million IU daily. After achieving hematological remission, supportive treatment for 9 million IU is prescribed 3 times a week.

With renal cell carcinoma - 18 million IU 3 times a week. Objective effect (complete or partial regression of metastases) is manifested after 8-12 weeks of treatment by Realdiron or later. When the therapeutic effect or stabilization of the disease is achieved, maintenance therapy is continued for 18 million IU three times a week.

With Kaposi's sarcoma on the background of AIDS - 36 million IU each. The drug is used for a long time, except for cases of rapid progression or severe intolerance. After the manifestation of the effect, maintenance therapy is prescribed for 18 million IU three times a week.

With cutaneous T-cell lymphoma (mushroom mycosis and Cesari syndrome), 18 million IU daily.

With malignant melanoma - 18 million IU daily. After achieving an objective effect (complete or partial regression of metastases), maintenance therapy is prescribed for 18 million IU three times a week. Adjuvant therapy Remeddiron for 18 million IU 3 times a week, prescribed after surgical removal of the primary tumor of melanoma I-II stage or metastases in the regional lymph nodes, contributes to an increase in the duration of remission and the survival of patients.

Precautionary measures

Patients with severe heart disease should be administered with caution. Patients who had previously suffered from cardiovascular disease, as an adverse reaction, may experience arrhythmia.

If the side effect of the drug is not weakened or aggravated, the dose is reduced to 50% or the treatment is stopped.

Depending on the individual sensitivity and the prescribed dose, patients may experience a delayed reaction due to side effects of the drug in the form of drowsiness, weakness, increased fatigue.

When treating Realdiron, alcohol should be excluded.

Special instructions

Use only freshly prepared solution.

Manufacturer

CJSC "Sikor Biotech", Lithuania.

Storage conditions of the drug Realdiron

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

Keep out of the reach of children.

Shelf life of the drug Realdiron

3 years.

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