Altevir injection solution 3000000mln.IU / 1ml, No. 5

• As part of complex therapy in adults: with chronic viral hepatitis B without signs of liver cirrhosis; in chronic viral hepatitis C in the absence of symptoms of hepatic failure (monotherapy or combination therapy with ribavirin);

• with papillomatosis of the larynx; with genital warts;

• with hairy cell leukemia, chronic myeloid leukemia, non-Hodgkin's lymphoma, melanoma, multiple myeloma, Kaposi's sarcoma with AIDS, progressive kidney cancer.

Apply s / c, i / m and i / v. Treatment must be started by a physician. Further, with the permission of the doctor, the patient can inject himself a maintenance dose on his own (in cases where the drug is prescribed s / c or i / m). Chronic hepatitis B:

AltevirЃ is administered subcutaneously or intramuscularly at a dose of 5-10 million IU 3 times a week for 16-24 weeks.

Treatment is discontinued after 3-4 months of use in the absence of positive dynamics (according to a study of the DNA of the hepatitis B virus).

Chronic hepatitis C:

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

Laryngeal papillomatosis: AltevirЃ is administered subcutaneously at a dose of 3 million IU / m2 3 times a week.

Treatment begins after surgical (or laser) removal of tumor tissue. The dose is selected taking into account the tolerability of the drug.

Achieving a positive response may require 6 months of treatment. Hairy cell leukemia: the recommended dose of Altevir for SC administration to patients after or without splenectomy is 2 million IU / m2 3 times a week. 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 up to 6 months. This dosing regimen should be adhered to constantly, unless there is a rapid progression of the disease or the onset of symptoms of severe drug intolerance. Chronic myeloid leukemia: the recommended dose of Altevir as monotherapy is 4-5 million IU / m2 per day n / a daily.

To maintain the leukocyte count, a dose of 0.5-10 million IU / m2 may be required. If the treatment allows you to control the number of leukocytes, 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 if therapy did not lead to partial hematological remission or a clinically significant decrease in the number of leukocytes. Non-Hodgkin's lymphoma: AltevirЃ is used as an 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: AltevirЃ is used as an adjuvant therapy when there is a high risk of recurrence in adults after tumor removal.AltevirЃ is administered intravenously at a dose of 15 million IU / m2 5 times a week for 4 weeks, then s / c 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: AltevirЃ is prescribed during the period of achieving stable remission at a dose of 3 million IU / m2 3 times a week s / c. AIDS-related Kaposi's sarcoma: the optimal dose has not been established. The drug can be used in doses of 10-12 million IU / m2 / day s / c or i / m. In case of stabilization of the disease or response to treatment, therapy is continued until tumor regression occurs or drug withdrawal is required. Kidney cancer: The optimal dose and schedule have not been established. It is recommended to use the drug subcutaneously in doses from 3 to 10 million IU / m2 3 times a week. Preparation of solution for intravenous administration Collect the volume of Altevir solution,required to prepare the required dose, add to 100 ml of sterile 0.9% sodium chloride solution and inject over 20 minutes.

1 ml

human recombinant interferon alpha-2b

Excipients: sodium acetate, sodium chloride, tetraacetic acid ethylenediamine disodium salt, tween-80, dextran 40, water d / i.

• History of severe cardiovascular disease (uncontrolled chronic heart failure, recent myocardial infarction, severe cardiac arrhythmias);

• severe renal and / or hepatic impairment (including those caused by the presence of metastases);

• epilepsy, as well as severe dysfunctions of the central nervous system, especially expressed by depression, suicidal thoughts and attempts (including a history);

• chronic hepatitis with decompensated cirrhosis of the liver and in patients receiving or recently receiving treatment with immunosuppressants (with the exception of a completed short-term course of GCS treatment);

• autoimmune hepatitis or other autoimmune disease;

• treatment with immunosuppressants after transplantation;

• thyroid disease that cannot be controlled by conventional therapeutic methods;

• decompensated lung disease (including COPD); decompensated diabetes mellitus;

• hypercoagulation (including thrombophlebitis, pulmonary embolism);

• severe myelodepression;

• pregnancy;

• lactation period (breastfeeding);

• hypersensitivity to the components of the drug.

Pharmacological action Interferon.

AltevirЃ 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, 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 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',participating in antiviral immunity. Prevents cell proliferation, especially tumor cells. It has a depressing effect on the synthesis of some oncogenes, leading to inhibition of tumor growth.

Pharmacokinetics

Suction

With subcutaneous or intramuscular administration of interferon alfa-2b, its bioavailability ranges from 80% to 100%. After the introduction of interferon alfa-2b, Tmax in the blood plasma is 4-12 hours, T1 / 2 - 2-6 hours. 16-24 hours after administration, the recombinant interferon is not detected in the blood serum.

Metabolism

Metabolism is carried out in the liver. Alpha interferons are capable of disrupting oxidative metabolic processes, reducing the activity of microsomal liver enzymes of the cytochrome P450 system.

Withdrawal

It is excreted mainly by the kidneys by glomerular filtration.

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 termination), 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 - decreased appetite, nausea; less common - vomiting, diarrhea, dry mouth, change in taste; rarely - abdominal pain, dyspepsia; possibly a reversible increase in the activity of hepatic enzymes.

From the side of the cardiovascular system: often - lowering blood pressure; rarely - tachycardia.

Dermatological reactions: less often - alopecia, increased sweating; rarely - skin rash, skin itching.

From the hematopoietic system: reversible leukopenia, granulocytopenia, decreased hemoglobin levels, thrombocytopenia are possible.

Others: rarely - weight loss, autoimmune thyroiditis.

Application during pregnancy and lactation

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

Application for violations of liver function

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

Application for impaired renal function

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

special instructions

Prior to treatment with Altevir for chronic viral hepatitis B and C, a liver biopsy is recommended to assess the degree of liver damage (signs of an active inflammatory process and / or fibrosis). The effectiveness of the 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. In case of side effects during treatment with Altevir, the dose of the drug should be reduced by 50% or the drug should be temporarily canceled until they disappear. If side effects persist or reappear after lowering the dose, or if progression of the disease is observed, then treatment with Altevir should be discontinued. When the platelet count falls below 50x109 / l or the granulocyte count falls below 0.75x109 / l, it is recommended to reduce the dose of Altevir by 2 times with the control of the blood test after 1 week. If these changes persist, then the drug should be canceled. If the platelet count falls below 25x109 / l or the granulocyte count falls below 0.5x109 / l, it is recommended to discontinue AltevirЃ with a blood test control after 1 week. In patients receiving interferon alpha-2b preparations, antibodies can be detected in the blood serum that neutralize its antiviral activity. 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.5 x 109 / l, it is recommended to discontinue AltevirЃ with a blood test control after 1 week. In patients receiving interferon alpha-2b preparations, antibodies can be detected in the blood serum that neutralize its antiviral activity. 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.5 x 109 / l, it is recommended to discontinue AltevirЃ with a blood test control after 1 week. In patients receiving interferon alpha-2b preparations, antibodies can be detected in the blood serum that neutralize its antiviral activity. 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.

Overdose

Data on overdose of AltevirЃ are not provided.

Drug interactions

The drug interaction between Altevir and other drugs has not been fully studied. Altevir should be used with caution simultaneously with hypnotics and sedatives, narcotic analgesics and drugs that potentially have a myelodepressant effect. With the simultaneous appointment of Altevir and theophylline, the concentration of the latter in the blood serum should be monitored and, if necessary, the dosage regimen should be changed. When Altevir is used in combination with chemotherapeutic drugs (cytarabine, cyclophosphamide, doxorubicin, teniposide), the risk of toxic effects increases.