ALTEVYR

Active material: Interferon alfa
When ATH: L03AB05
CCF: Interferon. Antineoplastic, antiviral and immunomodulatory drugs
ICD-10 codes (testimony): A63.0, B18.1, B18.2, B21.0, B97.7, C43, C64, C82, C83, C90.0, Q91.4, Q92.1
When CSF: 09.01.05.01
Manufacturer: FARMAPARK OOO (Russia)

Pharmaceutical form, composition and packaging

Solution for injection clear, colorless.

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

0.5 ml – ampoule (5) – packings Valium planimetric (1) – packs cardboard.
0.5 ml – ampoule (5) – packings Valium planimetric (2) – packs cardboard.
0.5 ml – bottles (1) – packs cardboard.
0.5 ml – bottles (5) – packings Valium planimetric (1) – packs cardboard.
0.5 ml – Glass syringes (1) – packings Valium planimetric (1) – packs cardboard.
0.5 ml – Glass syringes (1) – packings Valium planimetric (3) – packs cardboard.
0.5 ml – Glass syringes (3) – packings Valium planimetric (1) – packs cardboard.
0.5 ml – Glass syringes (3) – packings Valium planimetric (3) – packs cardboard.

Solution for injection clear, colorless.

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

1 ml – ampoule (5) – packings Valium planimetric (1) – packs cardboard.
1 ml – ampoule (5) – packings Valium planimetric (2) – packs cardboard.
1 ml – bottles (1) – packs cardboard.
1 ml – bottles (5) – packings Valium planimetric (1) – packs cardboard.
1 ml – Glass syringes (1) – packings Valium planimetric (1) – packs cardboard.
1 ml – Glass syringes (1) – packings Valium planimetric (3) – packs cardboard.
1 ml – Glass syringes (3) – packings Valium planimetric (1) – packs cardboard.
1 ml – Glass syringes (3) – packings Valium planimetric (3) – packs cardboard.

Pharmacological action

Interferon. Altevir^® It has antiviral, immunomodulatory antiproliferative and antitumor action.

Interferon alpha-2b, interacting with specific receptors on the cell surface, It initiates a complex chain of changes within cells, 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 immunomodulatory effects 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”, involved in antiviral immunity.

Prevents cell proliferation, especially tumor. Has a depressing effect on the synthesis of some oncogenes, leading to inhibition of tumor growth.

Pharmacokinetics

Absorption

With subcutaneous or intramuscular administration of interferon alfa-2b, its bioavailability ranges from 80% to 100%. After the introduction of interferon alpha-2b T_max in plasma is 4-12 no, T_1/2 – 2-6 no. Through 16-24 h after the introduction of recombinant interferon in the blood serum is not determined.

Metabolism

Metabolism in the liver.

Alpha interferons are capable of disrupting oxidative metabolic processes, reducing the activity of hepatic microsomal enzymes of the cytochrome P450.

Deduction

Excreted mainly by the kidneys by glomerular filtration.

Testimony

In the combined therapy in adults:

- with chronic viral hepatitis B without signs of liver cirrhosis;

- with chronic viral hepatitis C in the absence of symptoms of liver 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, melanome, multiple myeloma, Kaposi's sarcoma on the background of AIDS, advanced kidney cancer.

Dosage regimen

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

Chronic hepatitis B: Altevir^® injected subcutaneously or intramuscularly in a dose 5-10 million. ME 3 once a week for 16-24 weeks. Treatment is stopped after 3-4 months of use in the absence of positive dynamics (according to the DNA study of the hepatitis B virus).

Chronic hepatitis C: Altevir^® injected subcutaneously or intramuscularly in a dose 3 million. ME 3 once a week for 24-48 weeks. In patients with a recurrent course of the disease and patients, not previously treated with interferon alfa-2b, the effectiveness of treatment is increased when combined therapy with ribavirin. The duration of the combination therapy is at least 24 weeks. Altevir therapy^® should be carried out 48 weeks for patients with chronic hepatitis C and genotype 1 of the virus with a high viral load, which by the end of the first 24 weeks of treatment in the blood serum is not determined by the RNA of the hepatitis C virus.

Laryngeal papillomatosis: Altevir^® injected s / c in a dose of 3 million. IU / m² 3 times a week. Treatment begins after surgery (or laser) removal of tumor tissue. The dose is selected taking into account the tolerability of the drug.. Achieving a positive response may require treatment for 6 months.

Volosatokletochnыy leukemia: recommended dose of Altevir^® for subcutaneous administration to patients after splenectomy or without it is 2 million. IU / m² 3 times a week. In most cases, the normalization of one or more hematological parameters occurs after 1-2 month of treatment, it is possible to increase the duration of treatment up to 6 months. This dosing regimen should be adhered to at all times., if at the same time there is no rapid progression of the disease or the onset of symptoms of severe drug intolerance.

Chronic myelogenous leukemia: recommended dose of Altevir^® as monotherapy – 4-5 million. IU / m² per day n / a daily. Dose may be required to maintain white blood cell count 0.5-10 million. IU / m². If treatment allows control of 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 must be canceled after 8-12 weeks, if therapy did not lead to partial hematologic remission or a clinically significant decrease in the number of leukocytes.

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

Melanoma: Altevir^® used as an adjuvant therapy in the presence of a high risk of recurrence in adults after tumor removal. Altevir^® introduced in / dose 15 million. IU / m² 5 once a week for 4 weeks, then s / c in a dose 10 million. IU / m² 3 once a week for 48 weeks. The dose must be adjusted depending on the tolerability of the drug..

Mnozhestvennaya myeloma: Altevir^® prescribed during the period of achieving stable remission in a dose 3 million. IU / m² 3 twice a week n / a.

Kaposi's sarcoma on the background of AIDS: optimal dose not established. The drug can be used in doses 10-12 million. IU / m²/day s / c or i / m. In case of stabilization of the disease or response to treatment, the therapy is continued until then, until tumor regression occurs or drug withdrawal is required.

Kidney cancer: the optimal dose and regimen of use 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 the solution for the on / in the

Collect the volume of Altevir solution^®, necessary to prepare the required dose, added to 100 ml sterile 0.9% sodium chloride solution and injected for 20 m.

Side effect

Common reactions: Often – fever, weakness (are dose-dependent and reversible reactions, disappear within 72 h after a break in treatment or its termination), chills; less frequently – malaise.

CNS: Often – headache; less frequently – asthenia, drowsiness, dizziness, irritability, insomnia, depression, suicidal thoughts and attempts; rarely – nervousness, anxiety.

On the part of the musculoskeletal system: Often – myalgia; less frequently – arthralgia.

From the digestive system: Often – decreased appetite, nausea; less frequently – vomiting, diarrhea, dry mouth, change in taste; rarely – abdominal pain, dyspepsia; possibly a reversible increase in the activity of hepatic enzymes.

Cardio-vascular system: often – decrease in blood pressure; rarely – tachycardia.

Dermatological reactions: less frequently – alopecia, increased perspiration; rarely – skin rash, itching.

From the hematopoietic system: reversible leukopenia possible, granulocytopenia, decrease in hemoglobin, thrombocytopenia.

Other: rarely – weight loss, autoimmune thyroiditis.

Contraindications

- a history of severe cardiovascular disease (uncontrolled chronic heart failure, recent myocardial infarction, expressed by cardiac arrhythmia);

— severe kidney and/or liver failure (incl. metastatic);

- Epilepsy, as well as severe dysfunctions of the central nervous system, especially depressed, suicidal thoughts and attempts (incl. history);

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

- autoimmune hepatitis or other autoimmune disease;

- treatment with immunosuppressants after transplantation;

- thyroid disease, uncontrollable by conventional therapeutic methods;

- decompensated lung diseases (incl. COPD);

- Decompensated diabetes;

- hypercoagulability (incl. tromboflebit, pulmonary embolism);

- severe myelodepression;

- Pregnancy;

- Lactation (breast-feeding);

- Hypersensitivity to the drug.

Pregnancy and lactation

The drug is contraindicated in pregnancy and lactation (breast-feeding).

Cautions

Before treatment with Altevir^® chronic viral hepatitis B and C, liver biopsy is recommended, to assess the extent of liver damage (signs of active inflammation and / or fibrosis). The effectiveness of the treatment of chronic hepatitis C increases with combination therapy with Altevir^® and ribavirin. Application of Altevir^® 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 temporarily cancel the drug until they disappear. If side effects persist or recur after dose reduction, or there is a progression of the disease, then treatment with Altevir® should be discontinued.

When the platelet count falls below 50×10⁹/L or granulocyte count below 0.75×10⁹/l It is recommended to reduce the dose of Altevir^® in 2 times with the control of the blood test through 1 week. If the specified changes persist, the drug should be discontinued.

With a decrease in the level of platelets below 25×10⁹/l or granulocyte count below 0.5 x10⁹/l it is recommended to cancel the drug Altevir^® with blood test control through 1 week.

Patients, receiving interferon alfa-2b drugs, antibodies can be detected in blood serum, neutralizing 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

Altevir overdose data^® not provided.

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, potentially having 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 using Altevir^® in combination with chemotherapy drugs (цitaraʙin, cyclophosphamide, doxorubicin, teniposide) the risk of developing toxic effects increases.

Conditions of supply of pharmacies

The drug is released under the prescription.

Conditions and terms

The drug should be stored out of reach of children, in accordance with the joint venture 3.3.2-1248-03 at a temperature from 2 ° С to 8 ° С; Do not freeze. Shelf life – 18 months.

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