Altevir ampoules 5 million IU 1 ml, 5 pcs. (interferon alfa-2b)

Release form

Injection

Packing

5 ampoules 1 ml each

Pharmacological action of

Altevir has antiviral, immunomodulating, antiproliferative and antitumor effects. Interferon alpha-2b, interacting with specific receptors on the cell surface, initiates a complex chain of changes within the cell, including the induction of the synthesis of a number of specific cytokines and enzymes, disrupts the synthesis of viral RNA and virus proteins in the cell. The result of these changes is nonspecific antiviral and antiproliferative activity associated with the prevention of virus replication in the cell, inhibition of cell proliferation and the immunomodulatory effect of interferon. Interferon alpha-2b stimulates the process of antigen presentation to immunocompetent cells, has the ability to stimulate the phagocytic activity of macrophages, as well as the cytotoxic activity of T cells and “natural killers” involved in antiviral immunity. It prevents the proliferation of cells, especially tumor cells. It has a depressing effect on the synthesis of certain oncogenes, leading to inhibition of tumor growth.

Indications

Altevir is used in combination therapy in adults:

for chronic viral hepatitis B without signs of liver cirrhosis,

for chronic viral hepatitis C in the absence of signs of liver failure (monotherapy or combination therapy with ribavirin), papilloma srlomatosis, genital warts,

for hairy cell leukemia, chronic myelogenous leukemia, non-Hodgkin’s lymphoma, melanoma, multiple myeloma, Kaposi’s sarcoma with AIDS, progressive kidney cancer.

Contraindications

hypersensitivity to recombinant interferon alfa-2b or any of the components of the

drug history of severe cardiovascular disease (uncontrolled chronic heart failure, recent myocardial infarction, severe cardiac arrhythmias or heart disease) including metastases)

epilepsy and / or other severe disorders of the central nervous system, especially manifested by depression, suicidal thoughts and attempts (including a history) of

chronic hepatitis with decompensated cirrhosis of the liver and in patients with or after previous immunosuppressive therapy (except for the condition after completion of short-term therapy with corticosteroids)

autoimmune hepatitis and other autoimmons diseases, as well as the administration of immunosuppressive drugs after

transplantation, thyroid disease that cannot be controlled by conventional therapeutic methods

decompensated for lung disease (including COPD)

diabetes mellitus, prone to ketoacidosis

hypercoagulation (including thrombophlebitis, pulmonary embolism)

severe myelosuppression

pregnancy

breastfeeding.

Use during pregnancy and lactation

Contraindicated in pregnancy. At the time of treatment should stop breastfeeding.

Special instructions

Before treatment with chronic viral hepatitis B and C by Altevir, a liver biopsy is recommended to assess the degree of liver damage (signs of an active inflammatory process and / or fibrosis). The effectiveness of treatment for chronic hepatitis C increases with combination therapy with Altevir and ribavirin. The use of Altevir is not effective in the development of decompensated cirrhosis of the liver or hepatic coma.

In case of side effects during treatment with Altevir, the dose should be reduced by 50% or the drug should be temporarily discontinued until they disappear. If side effects persist or occur again after a dose reduction, or disease progression is observed, then treatment with Altevir should be discontinued.

With a decrease in platelet count below 50x109 / L or granulocyte level below 0.75x109 / L, a 2-fold reduction in the dose of Altevir is recommended with a blood test after 1 week. If these changes are saved, Altevir should be discarded.

With a decrease in platelet count below 25x109 / L or granulocyte level below 0.5x109 / L, it is recommended that Altevir be withdrawn with a blood test after 1 week.

In patients receiving interferon alfa-2b preparations, antibodies can be detected in the blood serum, antiviral activity neutralizing it. In almost all cases, antibody titers are low, their appearance does not lead to a decrease in the effectiveness of treatment or the occurrence of other autoimmune disorders.

Preparation of the solution for iv administration: the volume of the Altevir solution needed to prepare the required dose is collected, added to 100 ml of a sterile 0.9% NaCl solution and administered for 20 minutes.

Composition

Active ingredient: 1 million IU interferon alpha-2b human recombinant

Excipients: sodium acetate, chloride, ethylenediaminetetraacetic acid disodium salt, tween 80, dextra H 40, water for injection.

Dosage and administration

Subcutaneous, intramuscular, intravenous.

Treatment should be initiated by a physician. Further, with the permission of the doctor, the patient can administer a maintenance dose on his own (in the case of subcutaneous or intramuscular injection).

In chronic viral hepatitis B - subcutaneous or intramuscularly in a dose of 5-10 million ME 3 times a week for 16-24 weeks. Treatment is stopped after 3-4 months of use in the absence of positive dynamics (according to a study of hepatitis B virus DNA).

In chronic viral hepatitis C - subcutaneous or IM at a dose of 3 million IU 3 times a week for 6-12 months. In patients with a recurring course of the disease and patients who have not previously received treatment with interferon alfa-2b, the effectiveness is increased when Altevir® is used in combination with ribavirin. The duration of combination therapy is at least 6 months. Patients with chronic hepatitis C with 1 genotype of the virus and high viral load, in whom at the end of the first 6 months of treatment serum RNA of hepatitis C virus is not detected, Altevir® therapy should be performed 12 months.

Laryngeal papillomatosis - sc in a dose of 3 million IU / m2 3 times a week. Treatment begins after surgical (laser) removal of the tumor tissue. The dose is selected taking into account the tolerance of the drug. To achieve a therapeutic effect, therapy may be required for 6 months.

Hairy cell leukemia - sc in a dose of 2 million IU / m2 3 times a week (for patients after splenectomy and without it). In most cases, the normalization of one or more hematological parameters occurs after 1-2 months of treatment, it is possible to increase the duration of treatment to 6 months. This dosing regimen should be adhered to constantly, unless there is a rapid progression of the disease or the occurrence of symptoms of severe intolerance to the drug.

Chronic myelogenous leukemia - the recommended dose of Altevir® as a monotherapy is from 4-5 million IU / m2 per day sc daily. To maintain the number of leukocytes, it may be necessary to use a dose of 0.5-10 million IU / m2. If treatment allows you to control the number of white blood cells, then to maintain hematological remission, the drug should be used in the maximum tolerated dose (4-10 million IU / m2), daily. The drug should be discontinued after 8-12 weeks of treatment, if therapy has not led to partial hematological remission or a clinically significant decrease in the number of leukocytes.

For non-Hodgkin's lymphoma, Altevir® is used as adjuvant therapy in combination with standard chemotherapy regimens. The drug is administered sc in a dose of 5 million IU / m2 for 2-3 months. The dose must be adjusted depending on the tolerance of the drug.

In case of melanoma - Altevir® is used as adjuvant therapy with a high risk of relapse in adults after removal of the tumor. Altevir® is administered iv in a dose of 15 million IU / m2 5 times a week for 4 weeks, and then sc in a dose of 10 million IU / m2 3 times a week for 48 weeks. The dose must be adjusted depending on the tolerance of the drug.

In case of multiple myeloma - sc in a dose of 3 million IU / m2 3 times a week. Altevir® is prescribed during the period of achieving stable remission.

With Kaposi's sarcoma against AIDS - the optimal dose has not been established. The drug is used s / c or / m at a dose of 10-12 million IU / m2 per day. In the case of stabilization of the disease or response to treatment, therapy is continued until the tumor regresses or drug withdrawal is required.

Kidney cancer - optimal dose and dosage regimen not established. It is recommended to use sc in doses of 3 to 10 million IU / m2 3 times a week.

Side effects are very slight, most frequent and very slight treatment or its cessation), headache, myalgia, chills, loss of appetite, nausea.

Less often - vomiting, diarrhea, arthralgia, asthenia, drowsiness, dizziness, dry mouth, alopecia, depression, suicidal thoughts and attempts, malaise, increased sweating, taste change, irritability, insomnia, decreased blood pressure.

Rarely - abdominal pain, skin rash, nervousness, itchy skin, anxiety, weight loss, dyspepsia, tachycardia, autoimmune thyroiditis. Changes (reversible) in laboratory parameters: leukopenia, granulocytopenia, decreased hemoglobin, thrombocytopenia, increased activity of liver enzymes.

Drug Interactions

The drug interaction between Altevir® and other drugs has not been fully studied. With caution, Altevir® should be used simultaneously with hypnotics and sedatives, narcotic analgesics and drugs that potentially have a myelosuppressive effect.

With the simultaneous administration of Altevir® and theophylline, it is necessary to control the concentration of the latter in the blood serum and, if necessary, change the dosage regimen.

When Altevir® is used in combination with chemotherapeutic antitumor drugs (cytarabine, cyclophosphamide, doxorubicin, teniposide), the risk of toxic effects increases.

Storage conditions

Store at 2 to 8 ° C, out of the reach of children. Do not freeze.

Deystvuyuschee substances

interferon alfa-2b

Dosage form

solution for injection

Appointment

Adult appointment enyyu doctor

Indications

Immunodeficiency states

Possible product names

Altevir ampoules 5 million IU 1 ml, 5 pcs.

Pharmstandard-Ufavita, Russia



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