Altevir, 3 ml/ml 1 ml 5 pcs

Indications

As part of the complex therapy in adults:

In chronic viral hepatitis B without signs of liver cirrhosis;
In chronic viral hepatitis C in the absence of symptoms of liver failure (monotherapy or combined therapy with ribavirin);
In laryngeal papillomatosis;
In acute condyloma;
In hairy cell leukemia, chronic myeloleukemia, non-Hodgkin’s lymphoma, melanoma, multiple myeloma, Kaposi sarcoma with AIDS, advanced kidney cancer.

Active ingredient

Composition

1 ml of the solution contains:

3 ml. IU of human recombinant interferon alfa-2b;

auxiliary substances:

sodium acetate,

sodium chloride,

ethylenediaminetetetraacetic acid diatriic acid salt,

Tween 80,

Dextran 40,

water for injection.

How to take, the dosage

I/m, p/c, IV, intrathecal, intraperitoneal, into the lesion. Adults – single dose – 3-6 million IU, higher doses may be used if necessary. Children – 500-100 thousand IU/kg.

Papillomatosis of the larynx (different regimens): children – 50-100,000 IU 3 times a week for 4 weeks; 50,000 IU twice a week for 12 weeks; 50,000 IU once a week for 28 weeks. Adults: 6 million IU 5 times a week for 4 weeks; 3-6 million IU 3 times a week for 4 weeks; 3 million IU twice a week for 12 weeks; 3 million IU once a week for 28 weeks. If progression of the underlying disease is seen during treatment, the higher dose should be continued.

Acute condylomas: adults – 6 million IU/day for 6 weeks in combination with local administration of interferon alfa2b (ointment) 3 times a day. Children – 50-100 thousand IU/kg. Viral hepatitis: subacute – 12-15 million IU daily for 3-5 days in intraperitoneal or IU/m, then 6 million IU/m every other day until negative results for viral markers of the disease are obtained. Acute liver failure in infants: 3-6 million IU/sq.m./day intraperitoneally for 1 week. During the 2nd week in the same dose in m/m.

Depending on the therapeutic effect, the frequency of administration can be reduced to 3 times a week from the 3rd week. Treatment is continued until negative results for viral markers of the disease are obtained. Subacute viral hepatitis in children over 1 year of age: 3-6 million IU/sq.m. for 1-2 weeks (intraperitoneal for the 1st week and then intramuscularly).

Treatment can be continued with the same dose, but at a frequency of 3 times a week, depending on the presence of viral markers and the condition of the patient. Chronic hepatitis B: adults – 6 million IU daily w/v for 2 weeks, then 3 times a week for 4 weeks and 2 times a week for 16 weeks. Children: 3-6 million IU/sq.m. IU/m 3 times a week for 16 weeks. Children over 12 years of age: a single dose of 6 million IU. Chronic hepatitis C: adults – 3 million IU/m or p/c 3 times a week for 9 months.

Children – 3 million IU/sq.m (maximum dose – 3 million IU) 3 times a week for 9 months. Herpes zoster: 6 million IU daily for 1 week, then (if necessary) 6 million IU every other day for 2 weeks. The drug should be combined with topical administration of interferon alfa2b ointment every 6 hours. HIV infection: 3 million IU 3 times a week during asymptomatic period of disease with hematologic control.

If neutralizing antibodies to recombinant interferon alfa2b appear, it should be replaced with natural interferon. Kaposi’s sarcoma – 30 million IU/day. However, at early diagnosis of the disease, treatment with the drug resulted in complete remission when used at a dose of 6 million IU/day for 6 weeks. In children (after benefit-risk ratio) – up to 6 million IU/day. If positive, treatment may be continued. Dengue fever (up to 72 hours after the onset of symptoms): Children – 50-100 mln IU/kg daily for 3 days. Adults – 3-6 million IU daily for 3 days. Chronic myeloleukemia (after achieving hematological remission): 3 million IU/kg daily until cytogenetic remission or possible bone marrow transplantation is achieved, or until disease regression is achieved.

Children (after benefit-risk comparison): 3 million IU/sq.m. every other day. Non-Hodgkin’s lymphoma of low to moderate malignancy (after achieving remission with polychemotherapy): 6 million IU 3 times per week for 1 year or more. Solid tumors: adults – 9 million IU per day in m/m or p/k for 4 weeks.

The maintenance dose is 6 million IU 3 times a week for 3 months. In case of a positive effect on the ongoing therapy the treatment can be continued up to 1 year in a maintenance dose. Children – 3-6 million IU/sq.m. according to the same scheme. In some cases, according to the physician’s benefit-risk analysis of the drug, special treatment regimens (including in the lesion site) may be used. In this case, the dose should be less than 3 million IU in both adults and children.

Special Instructions

Before treatment with Altevir for chronic viral hepatitis B and C it is recommended to perform liver biopsy to evaluate the degree of liver damage (signs of active inflammatory process and/or fibrosis). Treatment efficacy of chronic hepatitis C increases with combination therapy with Altevir and ribavirin. Use of Altevir is not effective in the development of decompensated cirrhosis or hepatic coma.

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

If platelet counts fall below 50×109/l or granulocyte counts fall below 0.75×109/l, it is recommended that the dose of Altevir be reduced by half with monitoring of blood tests after 1 week. If these changes persist, Altevir should be discontinued.

If platelet counts decrease below 25×109/l or if granulocyte counts fall below 0.5×109/l, then Altevir should be discontinued with monitoring of blood tests after 1 week.

In patients receiving preparations of interferon alfa-2b, antibodies that neutralize its antiviral activity may be detected in the serum. In almost all cases the 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.

Preparing the solution for intravenous injection: the volume of Altevir solution required for preparation of the required dose is taken, added to 100 ml of sterile 0.9% NaCl solution and injected for 20 min.

Contraindications

Hypersensitivity to recombinant interferon alfa-2b or any of the drug components, history of severe cardiovascular disease (uncontrolled CHF, recent myocardial infarction, marked cardiac rhythm disturbances), severe renal and/or hepatic insufficiency (including those caused by metastases), epilepsy and other severe CNS disorders, especially those manifested by depression, suicidal thoughts and attempts (including those caused by metastases).severe renal and/or hepatic failure (including metastases), epilepsy and other severe CNS disorders, especially those manifested by depression, suicidal thoughts and attempts (including history of suicidal ideation and attempts).chronic hepatitis with decompensated liver cirrhosis and in patients who have received or have recently received treatment with immunosuppressive drugs (not including the completed short-term GCS treatment), autoimmune hepatitis or other autoimmune disease, as well as receiving immunosuppressive drugs after transplantation, thyroid disease that cannot be controlled by conventional therapeutic methods. Decompensated lung diseases (including COPD), decompensated diabetes, hypercoagulation (including thrombophlebitis, pulmonary embolism), severe myelosuppression, pregnancy, breast-feeding.

Side effects

Most common: fever, weakness (are dose-dependent and reversible reactions, disappear within 72 hours after treatment interruption or discontinuation), 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, change in taste, irritability, insomnia, decreased BP.

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

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