Altevir (Interferon alfa-2b) solution for injection, 5 million IU/ml amp 1 ml N5 buy in Moscow, price from 637.00 rub. 89 pharmacies in Moscow

Nosological classification (ICD-10)

A63.0 Anogenital (venereal) warts
B18 Chronic viral hepatitis
B18.2 Chronic viral hepatitis C
C43 Malignant melanoma of the skin
C46 Kaposi's Sarcoma
C64 Malignant neoplasm of the kidney, other than the renal pelvis
C82 Follicular [nodular] non-Hodgkin's lymphoma
C83 Diffuse non-Hodgkin's lymphoma
C85 Other and unspecified types of non-Hodgkin's lymphoma
C90.0 Multiple myeloma
C91.4 Hairy cell leukemia
C92.1 Chronic myeloid leukemia
D10.7 Benign neoplasm of the hypopharynx

Composition and release form

Injection	0.5 or 1 ml
interferon alpha-2b human recombinant	1 million IU
3 million IU
5 million IU
10 million IU
15 million IU
excipients: sodium acetate; sodium chloride; ethylenediaminetetraacetic acid disodium salt; twin 80; dextran 40; water for injections

in ampoules, vials (1, 3, 5, 10, 15 million IU) or syringes (3, 5, 10, 15 million IU); in a cardboard pack 5 or 10 ampoules; 1 or 5 bottles; 1 or 3 syringes.

Altevir®

Depending on the indications for use, Altevir® is administered subcutaneously, intramuscularly and intravenously. Treatment must be started by a doctor. Then, with the permission of the doctor, the patient can administer the maintenance dose to himself (in cases where the drug is prescribed subcutaneously or intramuscularly).

Chronic hepatitis C:

Altevir® is administered subcutaneously or intramuscularly at a dose of 3 million IU 3 times a week for 24-48 weeks. In patients with a relapsing course of the disease and patients who have not previously received treatment with alpha-2b interferons, the effectiveness of treatment increases when using combination therapy with ribavirin. The duration of combination therapy is at least 24 weeks. Patients with genotype 1 of the chronic hepatitis C virus and a high viral load, in whom hepatitis C virus RNA is not detected in the blood serum by the end of the first 24 weeks of treatment, should be treated with Altevir® for 48 weeks.

Chronic hepatitis B:

Altevir is administered subcutaneously or intramuscularly at a dose of 5-10 million IU 3 times a week for 16-24 weeks. If there is no positive dynamics (according to the determination of hepatitis B virus DNA), treatment is stopped after 3-4 months of use.

Laryngeal papillomatosis:

Altevir is administered subcutaneously at a dose of 3 million IU/m2 3 times a week. Treatment begins after surgical (or laser) removal of the tumor tissue.

The dose is selected taking into account the tolerability of the drug. Achieving a positive response may require treatment for 6 months.

Genital warts:

Altevir is administered subcutaneously at a dose of 3 million: IU/m2 3 times a week. Treatment begins after surgical or laser removal of condylomas.

Achieving a positive response may require treatment for 6 months.

Hairy cell leukemia:

The recommended dose of Altevir® for subcutaneous administration to patients after or without splenectomy is 2 million IU/m2 3 times a week. In most cases, normalization of one or more hematological parameters occurs within 1-2 months. treatment. This dosage regimen should be followed continuously unless rapid progression of the disease or symptoms of severe intolerance to the drug occur.

Chronic myeloid leukemia:

The recommended dose of Altevir® as monotherapy is 4-5 million IU/m2 per day subcutaneously daily. If treatment allows to achieve control of the number of leukocytes, then to maintain hematological remission the drug should be used at the maximum tolerated dose (4-5 million IU/m2 daily). If therapy after 8-12 weeks has not led to partial hematological remission or a clinically significant decrease in the number of leukocytes, the drug should be discontinued.

Non-Hodgkin's lymphoma:

Altevir® is used as adjuvant therapy in combination with standard chemotherapy regimens subcutaneously at a dose of 5 million IU/m2 3 times a week for 2-3 months. The dose must be adjusted depending on the tolerability of the drug.

Melanoma:

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

Preparation of solution for intravenous administration: take the volume of Altevir® solution required to prepare the required dose, add to 100 ml of sterile 0.9% sodium chloride solution and administer within 20 minutes. The solution is prepared immediately before the intravenous administration procedure; this solution cannot be stored.

Multiple myeloma:

Altevir® is prescribed during the period of achieving stable remission at a dose of 3 million IU/m2 3 times a week subcutaneously.

Kaposi's sarcoma
in patients with AIDS:
the optimal dose has not been established. The drug can be used in doses of 10-12 million IU/m2 per day subcutaneously or intramuscularly. In case of stabilization of the disease or positive dynamics, therapy is continued until tumor regression occurs or discontinuation of the drug is required.

Kidney cancer.

The optimal dose and regimen have not been established. It is recommended to use subcutaneous injection in doses of 3 to 10 million IU/m2 3 times a week.

Pharmacodynamics

Interacting with specific receptors on the cell surface, interferon alpha-2b initiates a complex chain of changes inside the cell, including the induction of the synthesis of a number of specific cytokines and enzymes, and disrupts the synthesis of viral RNA and viral proteins in the cell. The result of these changes is nonspecific antiviral and antiproliferative activity associated with the prevention of viral 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 killer” cells involved in the antiviral response. Prevents cell proliferation, especially tumor cells. It has an inhibitory effect on the synthesis of some oncogenes, leading to inhibition of tumor growth.

Indications for Altevir®

In complex therapy in adults:

chronic viral hepatitis B (without signs of liver cirrhosis);

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

laryngeal papillomatosis, genital warts;

hairy cell leukemia; chronic myeloid leukemia; non-Hodgkin's lymphoma; melanoma; multiple myeloma; Kaposi's sarcoma due to AIDS; advanced kidney cancer.

Instructions for use ALTEVIR

Chronic hepatitis C:

Altevir is administered subcutaneously or intramuscularly at a dose of 3 million IU 3 times a week for 24-48 weeks. In patients with a relapsing course of the disease and patients who have not previously received treatment with alpha-2b interferons, the effectiveness of treatment increases when using combination therapy with ribavirin. The duration of combination therapy is at least 24 weeks. Patients with genotype 1 of the chronic hepatitis C virus and a high viral load, in whom hepatitis C virus RNA is not detected in the blood serum by the end of the first 24 weeks of treatment, should be treated with Altevir® for 48 weeks.

Chronic hepatitis B:

Laryngeal papillomatosis:

Altevir® is administered subcutaneously at a dose of 3 million IU/m2 3 times a week. Treatment begins after surgical (or laser) removal of the tumor tissue. The dose is selected taking into account the tolerability of the drug. Achieving a positive response may require treatment for 6 months.

Genital warts:

Altevir® is administered subcutaneously at a dose of 3 million IU/m2 3 times a week. Treatment begins after surgical or laser removal of condylomas. Achieving a positive response may require treatment for 6 months.

Hairy cell leukemia:

The recommended dose of Altevir® for subcutaneous administration to patients after or without splenectomy is 2 million IU/m2 3 times a week. In most cases, normalization of one or more hematological parameters occurs after 1-2 months of treatment. This dosage regimen should be followed continuously unless rapid progression of the disease or symptoms of severe intolerance to the drug occur.

Chronic myeloid leukemia:

Non-Hodgkin's lymphoma:

Melanoma:

Altevir® is used as adjuvant therapy in cases of high risk of relapse after tumor removal at a dose of 15 million IU/m2 IV 5 times a week for 4 weeks, then subcutaneously at a dose of 10 million IU/m2 3 times a week within 48 weeks. The dose must be adjusted depending on the tolerability of the drug.

Preparation of solution for intravenous administration:

take the volume of Altevir® solution required to prepare the required dose, add it to 100 ml of sterile 0.9% sodium chloride solution and administer it over 20 minutes. The solution is prepared immediately before the intravenous administration procedure; this solution cannot be stored.

Multiple myeloma:

Altevir® is prescribed during the period of achieving stable remission at a dose of 3 million IU/m2 3 times a week subcutaneously.

Kaposi's sarcoma in patients with AIDS:

the optimal dose has not been established. The drug can be used in doses of 10-12 million IU/m2 per day subcutaneously or intramuscularly. In case of stabilization of the disease or positive dynamics, therapy is continued until tumor regression occurs or discontinuation of the drug is required.

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

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 heart rhythm disturbances);

severe renal and/or liver failure (including those caused by the presence of metastases);

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

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

autoimmune hepatitis and other autoimmune diseases, as well as taking immunosuppressive drugs after transplantation;

thyroid disease that cannot be controlled by conventional therapeutic methods;

decompensated lung diseases (including COPD);

diabetes mellitus prone to ketoacidosis;

hypercoagulation (including thrombophlebitis, pulmonary embolism);

severe myelosuppression;

pregnancy;

breastfeeding period.

Side effects

Most often - fever, weakness (they are dose-dependent and reversible reactions, disappear within 72 hours after a break in 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, change in taste, 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 levels, thrombocytopenia, increased activity of liver enzymes.

Altevir

With laryngeal papillomatosis, complete or partial remission can be obtained, but the use of the drug is recommended preferably to prevent relapses with preliminary surgical removal of the tumor.

For genital warts and plantar warts, complete clinical and histological effectiveness was obtained in 60% of cases.

In subacute hepatitis, intraperitoneal and intramuscular administration of the drug significantly increases the likelihood of survival.

In acute hepatitis type B, the use of the drug is recommended if the concentration of bilirubin or the activity of “liver” enzymes remains high 4 weeks after the onset of the disease; if the test for the surface antigen of the hepatitis B virus is positive 5 weeks after the onset of the disease; if risk factors such as immunodeficiency, taking immunosuppressive drugs due to a concomitant disease, intense physical activity or taking ethanol in the prodromal or initial period of the disease appear.

The use of the drug for the treatment of adults with active chronic hepatitis B with a positive test for hepatitis B virus surface antigen resulted in a 50% seroconversion rate 6 months after a 4-month treatment regimen. When treating children with the drug, 40% seroconversion to the surface antigen of the hepatitis B virus was obtained 6 months after the start of treatment. Particularly effective in immunosuppressed patients with chronic active hepatitis B.

In chronic hepatitis C, the use of the drug normalizes serum ALT activity in 50% of cases, although half of them experience a relapse of the disease after stopping treatment.

The use of the drug for herpes zoster reduces the treatment time from 7-10 days to 3-4 days. The disappearance of pain usually occurs after 2-3 days (instead of 5-7 days). The use of the drug prevents the development of postherpetic neuritis.

After long-term treatment of asymptomatic carriers of HIV infection (3-52 months) with 3 million IU 3 times a week intramuscularly, a delay in the onset of symptoms associated with AIDS was observed by 40 months. In this group of patients, the incubation period of the disease was extended by 50 months; There were fewer comorbidities and complications, and there was no significant decrease in the absolute number or percentage of CD4+ lymphocytes.

Early use of interferon alfa, within the first 72 hours after the onset of dengue viral fever, can prevent the occurrence of severe hemorrhagic complications and shock.

The drug causes significant clinical regression or disease stabilization in hairy cell leukemia, even if the patient has previously undergone splenectomy.

In chronic myeloid leukemia, remission can be achieved with interferon monotherapy, however, since the drug gives a slower effect than cytostatics, its use is recommended to maintain remission previously achieved through chemotherapy.

The use of the drug prevents relapses for a year or more, prolongs life and significantly reduces the ratio of cells positive for the Philadelphia chromosome.

When treating patients with non-Hodgkin's lymphoma, it is recommended to use the drug after obtaining remission with chemotherapy and radiation therapy, which significantly reduces the frequency of relapses and increases survival time.

The drug should be used immediately after dissolution. Adding water should be done carefully along the wall of the vessel, avoiding the formation of foam. Do not use the drug if, after dissolution, sediment, turbidity or discoloration appears in it.

Although the drug has not been proven to have a direct cardiotoxic effect, it is possible that side effects such as fever, chills, and malaise may lead to an exacerbation of cardiovascular disease.

The use of various alpha interferons is associated with an increased risk of developing allergic or autoimmune manifestations such as bronchospasm, drug-induced lupus, psoriasis, atopic dermatitis, or thyroiditis. Although these phenomena occurred extremely rarely, the drug should be used with caution if the patient has a history of these diseases.

Adverse reactions caused by taking the drug are reversible. If they occur, it is advisable to reduce the dose or interrupt treatment and take appropriate measures in accordance with the patient's condition. Despite the fact that side effects decrease during treatment with the drug, if they persist or reappear, the patient must be carefully monitored.

Tests conducted did not reveal any teratogenicity or effects on fertility.

Studies of the effectiveness and safety of use during pregnancy have not been conducted. Taking this into account, the doctor should conduct a risk-benefit analysis of the drug in each specific case before prescribing it.

The drug was used in children with viral hepatitis B, laryngeal papillomatosis, as well as benign and malignant tumors. Side effects were similar to those seen in adults and consisted mainly of increased body temperature and general malaise. No growth disturbances or psychosomatic development were noted even after many months of continuous treatment with the drug.

Interaction

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

When prescribing Altevir® and theophylline simultaneously, 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 anticancer drugs (cytarabine, cyclophosphamide, doxorubicin, teniposide), the risk of developing toxic effects increases.

Directions for use and doses

S/c, i/m, i/v.

Treatment must be started by a doctor. Further, with the permission of the doctor, the patient can administer the maintenance dose to himself (in the case of subcutaneous or intramuscular administration).

For chronic viral hepatitis B - subcutaneously or intramuscularly 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 a study of hepatitis B virus DNA).

For chronic viral hepatitis C - subcutaneously or intramuscularly at a dose of 3 million IU 3 times a week for 6–12 months. In patients with a relapsing course of the 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 combination therapy is at least 6 months. For patients with chronic hepatitis C with genotype 1 of the virus and a high viral load, in whom hepatitis C virus RNA is not detected in the blood serum by the end of the first 6 months of treatment, Altevir® therapy should be carried out for 12 months.

Laryngeal papillomatosis - subcutaneously 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, therapy may be required for 6 months.

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

Chronic myeloid leukemia - the recommended dose of Altevir® as monotherapy is 4–5 million IU/m2 per day subcutaneously daily. To maintain the white blood cell count, a dose of 0.5–10 million IU/m2 may be required. If treatment allows to achieve control of the number of leukocytes, then to maintain hematological remission the drug should be used at the maximum tolerated dose (4-10 million IU/m2), daily. The drug should be discontinued after 8–12 weeks of treatment if therapy does not lead 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 subcutaneously at a dose of 5 million IU/m2 for 2–3 months. The dose must be adjusted depending on the tolerability of the drug.

For melanoma - Altevir® is used as adjuvant therapy when there is 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 must be adjusted depending on the tolerability of the drug.

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

For Kaposi's sarcoma in the setting 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 tumor regression occurs or drug discontinuation is required.

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

Altevir, 1 million IU/ml, solution for injection, 1 ml, 5 pcs.

S/c, i/m, i/v.

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

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

special instructions

Before treatment with Altevir® for chronic viral hepatitis B and C, it is recommended to perform a liver biopsy to assess the degree of liver damage (the presence of signs of an active inflammatory process and/or fibrosis). The effectiveness of treatment of chronic hepatitis C increases with combination therapy with Altevir® and ribavirin. The use of Altevir® is ineffective in the development of decompensated liver cirrhosis or hepatic coma.

If severe side effects develop during therapy with Altevir®, the dose of the drug should be reduced by 50% or the drug should be temporarily discontinued until they disappear. If side effects persist or reappear after dose reduction, or disease progression is observed, treatment with the drug should be discontinued.

If the platelet count decreases below 50·109/l or the granulocyte count below 0.75·109/l, it is recommended to reduce the Altevir® dose by 2 times with blood test monitoring every other week. If these changes persist after dose reduction, antiviral therapy should be discontinued.

If the platelet count decreases below 25·109/l or the granulocyte count below 0.5·109/l, the drug should be discontinued with blood test monitoring after a week.

In patients receiving interferon alpha-2b preparations, antibodies that neutralize its antiviral activity can be detected in the blood serum. 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 solution for intravenous administration: the volume of Altevir® solution required to prepare the required dose is added to 100 ml of sterile isotonic solution (0.9%) sodium chloride and administered over 20 minutes.

Altevir (Interferon alfa-2b) solution for injection, 5 million IU/ml amp 1 ml N5

Registration Certificate Holder

PHARMAPARK (Russia)

Dosage form

Medicine - Altevir® (Altevir)

Description

Injection

transparent, colorless.

1 ml

human recombinant interferon alpha-2b 3 million IU

Excipients

: sodium acetate, sodium chloride, ethylenediaminetetraacetic acid disodium salt, Tween-80, dextran 40, water for injection.

1 ml - ampoules (5) - contour cell packaging (1) - cardboard packs. 1 ml - ampoules (5) - contour cell packaging (2) - cardboard packs. 1 ml - bottles (1) - cardboard packs. 1 ml - bottles (5) - contour cell packaging (1) - cardboard packs. 1 ml - glass syringes (1) - contour cell packaging (1) - cardboard packs. 1 ml - glass syringes (1) - contour cell packaging (3) - cardboard packs. 1 ml - glass syringes (3) - contour cell packaging (1) - cardboard packs. 1 ml - glass syringes (3) - contour cell packaging (3) - cardboard packs.

Indications

As part of complex therapy in adults:

with chronic viral hepatitis B without signs of liver cirrhosis;
for chronic viral hepatitis C in the absence of symptoms of liver failure (monotherapy or combination therapy with ribavirin);
with papillomatosis of the larynx;
for genital warts;
for hairy cell leukemia, chronic myeloid leukemia, non-Hodgkin's lymphoma, melanoma, multiple myeloma, Kaposi's sarcoma against the background of AIDS, progressive kidney cancer.

Contraindications for use

history of severe cardiovascular disease (uncontrolled chronic heart failure, recent myocardial infarction, severe heart rhythm disturbances);
severe renal and/or liver failure (including those caused by the presence of metastases);
epilepsy, as well as severe dysfunction of the central nervous system, especially expressed by depression, suicidal thoughts and attempts (including a history);
chronic hepatitis with decompensated liver cirrhosis and in patients receiving or recently receiving treatment with immunosuppressants (with the exception of completed short-term treatment with corticosteroids);
autoimmune hepatitis or other autoimmune disease;
treatment with immunosuppressants after transplantation;
thyroid disease that cannot be controlled by conventional therapeutic methods;
decompensated lung diseases (including COPD);
decompensated diabetes mellitus;
hypercoagulation (including thrombophlebitis, pulmonary embolism);
severe myelodepression;
pregnancy;
lactation period (breastfeeding);
hypersensitivity to the components of the drug.

pharmachologic effect

Interferon. Altevir® has antiviral, immunomodulatory, antiproliferative and antitumor effects.

Interferon alpha-2b, interacting with specific receptors on the cell surface, initiates a complex chain of changes inside the cell, including the induction of the synthesis of a number of specific cytokines and enzymes, and disrupts the synthesis of viral RNA and viral proteins in the cell. The result of these changes is nonspecific antiviral and antiproliferative activity associated with the prevention of viral 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 killer” cells involved in antiviral immunity.

Prevents cell proliferation, especially tumor cells. It has an inhibitory effect on the synthesis of some oncogenes, leading to inhibition of tumor growth.

Drug interactions

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

When Altevir and theophylline are prescribed simultaneously, the concentration of the latter in the blood serum should be monitored and, if necessary, its dosage regimen should be changed.

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

Dosage regimen

Apply subcutaneously, intramuscularly and intravenously. Treatment must be started by a doctor. Then, with the doctor’s permission, the patient can administer a maintenance dose independently (in cases where the drug is prescribed subcutaneously or intramuscularly).

Chronic hepatitis B:

Altevir® is administered subcutaneously or intramuscularly 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 a study of hepatitis B virus DNA).

Chronic hepatitis C:

Altevir® is administered subcutaneously or intramuscularly at a dose of 3 million IU 3 times a week for 24-48 weeks. In patients with a relapsing course of the disease and patients who have not previously received treatment with interferon alfa-2b, the effectiveness of treatment increases with combination therapy with ribavirin. The duration of combination therapy is at least 24 weeks. Therapy with Altevir should be carried out for 48 weeks in patients with chronic hepatitis C and the 1st genotype of the virus with a high viral load, in whom hepatitis C virus RNA is not detected in the blood serum by the end of the first 24 weeks of treatment.

Laryngeal papillomatosis:

Hairy cell leukemia:

The recommended dose of Altevir for subcutaneous administration to patients after or without splenectomy is 2 million IU/m2 3 times a week. In most cases, normalization of one or more hematological parameters occurs after 1-2 months of treatment; it is possible to increase the treatment period to 6 months. This dosage regimen should be followed continuously unless rapid progression of the disease or symptoms of severe intolerance to the drug occur.

Chronic myeloid leukemia:

The recommended dose of Altevir as monotherapy is 4-5 million IU/m2 per day subcutaneously daily. To maintain the number of leukocytes, a dose of 0.5-10 million IU/m2 may be required. If treatment allows to achieve control of the number of leukocytes, then to maintain hematological remission the drug should be used at the maximum tolerated dose (4-10 million IU/m2 daily). The drug should be discontinued after 8-12 weeks if therapy does not lead to partial hematological remission or a clinically significant decrease in the number of leukocytes.

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 3 times a week for 2-3 months. The dose must be adjusted depending on the tolerability of the drug.

Melanoma:

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

Multiple myeloma

: Altevir® is prescribed during the period of achieving stable remission at a dose of 3 million IU/m2 3 times a week subcutaneously.

Kaposi's sarcoma due to AIDS:

the optimal dose has not been established. The drug can be used in doses of 10-12 million IU/m2/day subcutaneously or intramuscularly. If the disease stabilizes or responds to treatment, therapy is continued until tumor regression occurs or drug discontinuation is required.

Kidney cancer:

The optimal dose and regimen have not been established.
It is recommended to use the drug subcutaneously in doses of 3 to 10 million IU/m2 3 times a week. Preparation of a solution for intravenous administration:
Draw up the volume of Altevir solution required to prepare the required dose, add it to 100 ml of a sterile 0.9% sodium chloride solution and administer it over 20 minutes.

Overdose

Data on overdose of Altevir® are not provided.

Side effect

General reactions:

very often - fever, weakness (they are dose-dependent and reversible reactions, disappear within 72 hours after a break in treatment or its cessation), chills; less often - malaise.

From the side of the central nervous system:

very often - headache; less often - asthenia, drowsiness, dizziness, irritability, insomnia, depression, suicidal thoughts and attempts; rarely - nervousness, anxiety.

From the musculoskeletal system:

very often - myalgia; less often - arthralgia.

From the digestive system:

very often - loss of appetite, nausea; less often - vomiting, diarrhea, dry mouth, change in taste; rarely - abdominal pain, dyspepsia; a reversible increase in liver enzyme activity is possible.

From the cardiovascular system:

often - decreased blood pressure; rarely - tachycardia.

Dermatological reactions:

less often - alopecia, increased sweating;
rarely - skin rash, itching. From the hematopoietic system
: reversible leukopenia, granulocytopenia, decreased hemoglobin levels, thrombocytopenia are possible.

Other:

rarely - weight loss, autoimmune thyroiditis.

special instructions

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

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

If the platelet level decreases below 50×109/l or the granulocyte level below 0.75×109/l, it is recommended to reduce the Altevir dose by 2 times with blood test monitoring after 1 week. If these changes persist, the drug should be discontinued.

If the platelet level decreases below 25x109/l or the granulocyte level below 0.5x109/l, it is recommended to discontinue Altevir® with blood test monitoring after 1 week.

Storage conditions

The drug should be stored out of the reach of children, in accordance with SP 3.3.2-1248-03 at a temperature of 2° to 8°C; do not freeze.

Best before date

Shelf life: 18 months.

Transport at temperatures from 2° to 8°C; do not freeze.

Use during pregnancy and breastfeeding

Restrictions during pregnancy - Contraindicated. Restrictions when breastfeeding - Contraindicated.

The drug is contraindicated during pregnancy and lactation (breastfeeding).

Use for renal impairment

Restrictions for impaired renal function - With caution.

The drug is contraindicated in severe renal and/or liver failure (including those caused by the presence of metastases).

Use for liver dysfunction

Restrictions for liver dysfunction - With caution.

The drug is contraindicated in severe renal and/or liver failure (including those caused by the presence of metastases).

Terms of sale

The drug is available with a prescription.

Contacts for inquiries

PHARMSTANDARD JSC (Russia)

141701 Moscow region. Dolgoprudny, Likhachevsky pr-d, 5B Tel./fax E-mail