Altevir, 5 ml/ml 1 ml 5 pcs

Pharmacotherapeutic group: Cytokines

ATC code: L03AB05

PHARMACOLOGICAL PROPERTIES

Altevir®, a solution for injection, is recombinant human interferon alfa-2b produced from Escherichia coli cells with human interferon alfa-2b gene integrated into the genetic apparatus. The peptide sequence of the molecule, the biological activity and the basic pharmacological properties of the recombinant protein and human interferon alpha-2b are identical.

Altevir has antiviral, immunomodulatory, antiproliferative and anticancer effects. Interferon alfa-2b, interacting with specific receptors on the cell surface, initiates a complex chain of changes inside the cell, including the induction of synthesis of specific cytokines and enzymes, disrupts the synthesis of viral ribonucleic acid (RNA) and viral proteins in the cell.

The result of these changes is nonspecific antiviral and antiproliferative activity associated with prevention of virus replication in the cell, inhibition of cell proliferation and immunomodulatory action of interferon. Interferon alfa-2b stimulates the process of antigen presentation to immunocompetent cells, has the ability to stimulate phagocytic activity of macrophages, as well as cytotoxic activity of T-cells and “natural killers” involved in antiviral immunity. Prevents cell proliferation, especially tumor cells. It has inhibitory effect on synthesis of some oncogenes which inhibits tumor growth.

Pharmacokinetics.

Bioavailability of interferon alfa-2b is 80% to 100% during injection by injection or intramuscularly. Time of reaching Cmax is 4-12 hours, T1/2 – 2-6 hours accordingly. Recombinant interferon was not detected in serum 16-24 hours after injection. Metabolism is carried out in the liver. Interferon alpha can disrupt oxidative metabolic processes, reducing the activity of “hepatic” microsomal enzymes of the cytochrome P450 system. They are excreted mainly by the kidneys by glomerular filtration.

Indications

Active ingredient

Composition

Auxiliary substances:

Sodium acetate,

Sodium chloride,

Ethylenediaminetetetraacetic acid disodium salt,

Twin 80,

Dextran 40,

Water for injection.

How to take, the dosage

Injection, intramuscularly, intravenously.

The treatment must be started by a doctor. The patient can then self-administer a maintenance dose with the doctor’s permission (if injected subcutaneously or intramuscularly).

In chronic viral hepatitis B – p/cm or intramuscularly in a dose of 5-10 million ME 3 times a week for 16-24 weeks. The treatment is discontinued after 3-4 months of use with absence of positive dynamics (according to the data of hepatitis B virus DNA analysis).

In chronic viral hepatitis C – p/cm or i.m. In dose 3 mln ME 3 times a week during 6-12 months. In patients with relapsing course of disease and in patients who have not received interferon alfa-2b treatment the effectiveness is increased when using Altevir® in combination with ribavirin. Duration of combined therapy is at least 6 months. Patients with chronic hepatitis C with 1st genotype of virus and high viral load who do not have HCV RNA in blood serum by the end of first 6 months of therapy should be treated with Altevir® during 12 months.

Papillomatosis of the larynx – p/k in a dose of 3 million IU/m2 3 times a week. Treatment is started after surgical (laser) removal of tumor tissue. The dose is selected taking into account the tolerability of the drug. To achieve the therapeutic effect it may be necessary to carry out therapy for 6 months.

Hair cell leukemia – p/k in 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 period of treatment up to 6 months. This dosing regimen should be adhered to at all times, unless there is rapid progression of the disease or symptoms of severe intolerance to the drug.

Cronic myeloleukemia – The recommended dose of Altevir® as monotherapy is 4-5 million IU/m2 per day by p/u daily. A dose of 0.5-10 million IU/m2 may be required to maintain leukocyte counts. If treatment allows leukocyte count control, the drug should be used at the maximum tolerated dose (4-10 million IU/m2), daily, to maintain hematologic remission. The drug should be discontinued after 8-12 weeks of treatment if therapy has not resulted in partial hematological remission or a clinically significant decrease in leukocyte count.

In non-Hodgkin’s lymphoma -Altevir® is used as adjuvant therapy in combination with standard chemotherapy regimens. The drug is administered p/k in 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 if there is a high risk of recurrence in adults after tumor removal. Altevir® is given intravenously at a dose of 15 million IU/m2 5 times a week for 4 weeks, and then intravenously at a dose of 10 million IU/m2 3 times a week for 48 weeks. The dose should be adjusted according to drug tolerance.

In multiple myeloma – p/k in a dose of 3 million IU/m2 3 times a week. Altevir® is administered during the period of stable remission.

In AIDS Kaposi sarcoma – The optimal dose has not been established. The drug is used p/k or i/m at a dose of 10-12 million IU/m2 per day. If the disease stabilizes or if there is a response to treatment, therapy is continued until the tumor regresses or until the drug is withdrawn.

Kidney cancer – The optimal dose and route of administration have not been established. It is recommended to use p/k in doses of 3 to 10 million IU/m2 3 times a week.

Interaction

The drug interaction between Altevir® and other medicinal products has not been fully studied. Caution should be exercised when using Altevir® concomitantly with hypnotics and sedatives, narcotic analgesics and drugs with potential myelosuppressive effect.

In concomitant administration of Altevir® and theophylline, the latter’s serum concentrations should be monitored and the dosing regimen changed, if necessary.

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

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

Side effects

Overdose

Pregnancy use

Similarities