Altevir, ampoules 5ml 1ml, 5pcs

Composition

Active ingredient:

1 million rubles. IU of human recombinant Interferon alfa-2b;

Auxiliary substances:

sodium acetate,

sodium chloride,

ethylenediaminetetraacetic acid disodium salt,

Twin 80,

dextran 40,

water for injection.

Pharmacological action

It has antiviral, antiproliferative, immunomodulatory and antitumor properties.

Pharmacodynamics and pharmacokinetics

The Active ingredient of the drug interacts with receptors on the cell surface, initiating a complex chain of transformations (for example, induction of cytokine and enzyme synthesis), and also interferes with the synthesis of viral RNA and viral proteins. This causes the antiviral and antiproliferative effect of the drug.

In addition, the Active ingredient of Altevir activates the presentation of antigen to immunocompetent cells. It also stimulates the cytotoxic effect T-cells and phagocytic activity of macrophages, inhibits the synthesis of certain oncogenes and prevents the proliferation of cells, including tumor cells.

Indications

As part of complex therapy in adults:

— in chronic viral hepatitis b without cirrhosis of the liver;

— with chronic viral hepatitis C in the absence of symptoms of liver failure (monotherapy or combination therapy with ribavirin);

— if laryngeal papillomatosis;

— at genital warts;

— when hairy cell leukemia, chronic myeloid leukemia, non-Hodgkin’s lymphoma, melanoma, multiple myeloma, Kaposi’s sarcoma on the background of AIDS, progressive kidney cancer.

Contraindications

— severe cardiovascular disease in history (uncontrolled congestive heart failure, recent myocardial infarction, severe heart rhythm disorders);

— severe renal and/or hepatic failure (including that caused by the presence of metastases);

— epilepsy and severe disorders of the Central nervous system, especially in terms of the depression, suicidal thoughts and attempts (including in the anamnesis);

— chronic hepatitis with decompensated liver cirrhosis and in patients receiving or recently received immunosuppressive therapy (with the exception of completed short course of treatment with glucocorticoids);

— autoimmune hepatitis or other autoimmune disease;

— immunosuppressive therapy after transplantation;

disease of the thyroid gland beyond the control of the conventional therapeutic methods;

— decompensated lung disease (including COPD);

— decompensated diabetes mellitus;

— hypercoagulability (including thrombophlebitis, pulmonary embolism);

— severe mielodeprescia;

— pregnancy;

— lactation (breastfeeding);

— hypersensitivity to the components of the drug.

Side effects

Most often — fever, weakness (are dose-dependent and reversible reactions, disappear within 72 hours after a break in treatment or its termination), headache, myalgia, chills, decreased appetite, nausea.

Less frequently — vomiting, diarrhea, arthralgia, asthenia, drowsiness, dizziness, dry mouth, alopecia, depression, suicidal thoughts and attempts, malaise, increased sweating, taste changes, 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 level, thrombocytopenia, increased activity of liver enzymes.

Interaction

The drug interaction between Altevir® and other medicinal products 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 simultaneous use of Altevir® and theophylline, it is necessary to monitor the concentration of the latter in the blood serum and, if necessary, change its dosage regimen.

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

How to take, course of use and dosage

Subcutaneously, intramuscularly, intravenously.

Treatment should be initiated by a doctor. Further, with the permission of the doctor, the patient can administer the maintenance dose independently (in the case of subcutaneous or intramuscular use).

In chronic viral hepatitis B — subcutaneous or intravenous injection at a dose of 5-10 million IU 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 the hepatitis B virus DNA study).

In chronic viral hepatitis C — subcutaneous or intramuscular injection at a dose of 3 million IU 3 times a week for 6-12 months. In patients with recurrent disease and patients who have not previously received treatment with Interferon alfa-2b, the effectiveness increases when using Altevir® in combination with ribavirin. The duration of combined therapy is at least 6 months. Patients with chronic hepatitis C with 1 genotype of the virus and a high viral load, who by the end of the first 6 months of treatment in the blood serum is not determined Hepatitis C virus RNA, Altevir® therapy should be performed for 12 months.

Laryngeal papillomatosis-subcutaneous injection at 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 tolerability of the drug. To achieve a therapeutic effect, it may be necessary to conduct therapy for 6 months.

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

Chronic myeloid leukemia — the recommended dose of Altevir® as monotherapy is from 4-5 million IU/m2 per day subcutaneously daily. To maintain the number of white blood cells, 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 the therapy did not lead to partial hematological remission or a clinically significant decrease in the number of white blood cells.

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

In melanoma, Altevir® is used as adjuvant therapy for patients with a high risk of relapse in adults after tumor removal. Altevir® is administered intravenously at a dose of 15 million IU / m2 5 times a week for 4 weeks, and then subcutaneously at a dose of 10 million IU / m2 3 times a week for 48 weeks. The dose should be adjusted depending on the tolerability of the drug.

For multiple myeloma-subcutaneous injection at a dose of 3 million IU / m2 3 times a week. Altevir® is prescribed during the period of achieving stable remission.

In Kaposi’s sarcoma on the background of AIDS, the optimal dose has not been established. The drug is used subcutaneously or intramuscularly at a dose of 10-12 million IU / m2 per day. If the disease stabilizes or responds to treatment, therapy is continued until the tumor regresses or the drug is discontinued.

Kidney cancer-the optimal dose and dosage regimen have not been established. It is recommended to use subcutaneous injection in doses from 3 to 10 million IU/m2 3 times a week.

Special instructions

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

If side effects occur during treatment with Altevir, the dose of the drug should be reduced by 50% or temporarily discontinued until they disappear. If side effects persist or recur after dose reduction, or if the disease progresses, treatment with Altevir should be discontinued.

If the platelet count is lower than 50×109 / l or the granulocyte count is lower than 0.75 x 109/L, it is recommended to reduce the dose of Altevir by 2 times with blood test monitoring after 1 week. If these changes persist, Altevir should be canceled.

If the platelet count drops below 25×109/l or the granulocyte count drops below 0.5 x 109/L, it is recommended to cancel Altevir with blood test monitoring after 1 week.

In patients receiving Interferon alfa-2b preparations, antibodies that neutralize its antiviral activity can be detected in the blood serum. In almost all cases, antibody titers are low, and 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 intravenous use: collect the volume of Altevir solution required to prepare the required dose, add to 100 ml of sterile 0.9% NaCl solution and inject for 20 minutes.

Active ingredient

Interferon alfa-2b

Conditions of release from pharmacies

By prescription

Dosage form

solution for injection

Purpose

For adults as directed by your doctor

Indications

Immunodeficiency states