Expiration date: 05/2025

Structure and Composition:

Injectable solution 1ml

interferon alfa-2b, recombinant human 1 million IU

3 million IU

5 million IU

Excipients: sodium chloride, sodium acetate, ethylenediamine tetraacetic acid disodium salt dextran 40 Tween 80 Water for Injection

in ampoules, vials (1, 3, 5, 10, 15 million IU) or syringes (3, 5, 10, 15 million IU) in a pack or carton 10 5 1 or 5 ampoules vials or 3 of the syringe 1.

Description pharmaceutical form:

Clear, colorless liquid.

Characteristic:

Interferon alpha-2b human recombinant Escherichia coli was isolated from the cells in which the genetic apparatus of the human gene incorporated interferon alfa-2b.

The polypeptide structure of the molecule, biological activity, and the main pharmacological properties of the recombinant protein identical to human interferon alpha-2b.

Pharmacokinetics:

When s / c or i / m administration of interferon alpha-2b bioavailability ranges from 80 to 100%. Tmax - 4-12 hours, T1 / 2 - 2.6 h, respectively. After 16-24 hours after administration of the recombinant alpha-2b interferon in serum is not determined. It is metabolized in the liver. Alpha interferons may violate the oxidative metabolic processes, reducing the activity of hepatic microsomal enzymes of the cytochrome P450 system. It is shown mainly by the kidneys by glomerular filtration.

Description of the pharmacological actions:

Interacts with specific receptors on the cell surface, interferon alpha-2b triggers a complex chain changes within the cell, including the induction of synthesis of a number of specific cytokines and enzymes gives the synthesis of viral RNA and viral proteins in the cell. The result of these changes is a non-specific antiviral and antiproliferative activity related to 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 and cytotoxic activity of T-cells and "natural killer" involved in the antiviral response. It prevents cell proliferation, especially cancer. It has a depressing effect on the synthesis of some oncogenes, resulting in inhibition of tumor growth.

Indications:

In the treatment of adults:

• chronic viral hepatitis B (without cirrhosis)
  
• chronic viral hepatitis C in the absence of signs of hepatic insufficiency (monotherapy or combination therapy in combination with ribavirin)
  
• laryngeal papillomatosis, genital warts
  
• hairy cell leukemia chronic myelogenous leukemia non-Hodgkin lymphoma, melanoma multiple myeloma, Kaposi's sarcoma on the background of AIDS progressive kidney cancer.
  

Contraindications:

• hypersensitivity to recombinant interferon alpha-2b or any of the components
  
• severe cardiovascular disease history (uncontrolled congestive heart failure, recent myocardial infarction, the expressed disturbances of heart rhythm)
  
• Severe renal and / or hepatic impairment (including caused by the presence of metastases)
  
• epilepsy and / or other serious violations of the central nervous system, especially manifested depression, suicidal thoughts and attempts (including history)
  
• chronic hepatitis with liver cirrhosis and decompensated patients on background therapy or after prior immunosuppressants (except transient state after completion of therapy GCS)
  
• autoimmune hepatitis and other autoimmune diseases, as well as receiving immunosuppressive drugs after transplantation
  
• thyroid disease, uncontrollable conventional therapies
  
• decompensated pulmonary disease (including COPD)
  
• diabetes mellitus prone to ketoacidosis
  
• hypercoagulation (including thrombophlebitis, pulmonary embolism)
  
• severe myelosuppression
  
• pregnancy
  
• during breastfeeding.
  

Application of pregnancy and breastfeeding:

Contraindicated during pregnancy. At the time of treatment should stop breastfeeding.

Side effect:

The most frequently - fever, fatigue (are dose-dependent and reversible reactions disappear within 72 hours after treatment interruption or discontinuation), headache, myalgia, chills, loss of appetite, nausea.

Less often - vomiting, diarrhea, arthralgia, asthenia, somnolence, dizziness, dry mouth, alopecia, depression, suicidal thoughts and attempts, malaise, sweating, taste alteration, irritability, insomnia, lower blood pressure.

Rarely - abdominal pain, skin rash, nervousness, itching skin, anxiety, weight loss, dyspepsia, tachycardia, autoimmune thyroiditis. Changes (reversible) laboratory parameters: leukopenia, granulocytopenia, decreased hemoglobin levels, thrombocytopenia, elevated liver enzymes.

Drug Interactions:

Drug interactions between Altevirom and other drugs are not fully understood. Caution should be used Altevir simultaneously with hypnotics and sedatives, analgesics and narcotic drugs, potentially providing myelosuppressive effect.

When concomitant administration of theophylline and Altevira necessary to control the concentration of the latter in blood serum and change the mode of its dosage, if necessary.

Altevira When applied in combination with anticancer chemotherapeutic drugs (cytarabine, cyclophosphamide, doxorubicin, teniposide) increases the risk of toxic effects.

Dosage and administration:

N / k / o, w / w.

Treatment should be initiated by a physician. Further, with the permission of the doctor, the patient a maintenance dose may be administered itself alone (in the case of subcutaneous or intramuscular injection).

In chronic viral hepatitis B - s / c or i / m at a dose of 5-10 million ME 3 times per week for 16-24 weeks. Treatment was stopped after 3-4 months of use in the absence of positive dynamics (according to a study of DNA hepatitis B).

In chronic viral hepatitis C - n / a or / m at a dose of 3 million IU 3 times a week for 6-12 months. Patients with recurrent disease and the patients, not previously treated with interferon alfa-2b, efficiency is improved by using Altevira in combination with ribavirin. The duration of the combination therapy - for at least 6 months. Patients with chronic hepatitis C virus genotype 1 and high viral load, in which the end of the first 6 months of treatment in the serum is not determined by HCV RNA C, Altevirom therapy should be 12 months.

Laryngeal papillomatosis - p / dose 3 million IU / m2 3 times a week. Treatment begins after the surgery (laser) removing tumor tissue. Dose picked based on tolerability. In order to achieve a therapeutic effect may require treatment for 6 months.

Leukemia Hairy - p / 2 at a dose million IU / m2 three times a week (after splenectomy patients without it). In most cases, normalization of one or more hematological parameters occurs after 1-2 months of treatment, may increase the duration of treatment up to 6 months. This dosing regimen should be followed consistently, if it does not there is a rapid progression of the disease or the occurrence of severe drug intolerance symptoms.

Chronic myelogenous leukemia - Altevira recommended dose as monotherapy by 4-5 million IU / m2 per day n / a daily basis. To keep the number of leukocytes may be required in a dose of 0.5-10 million IU / m2. If treatment allows for monitoring the number of cells, then to maintain remission drug should be used to the maximum tolerated dose (4-10 million IU / m2) daily. The drug should be discontinued after 8-12 weeks of treatment if the therapy did not lead to a partial hematologic remission or a clinically significant reduction in the number of leukocytes.

In non-Hodgkin's lymphoma - Altevir used as adjuvant therapy in combination with standard chemotherapy regimens. The drug is administered s / c at a dose of 5 million IU / m2 for 2-3 months. The dose should be adjusted depending on tolerability.

When melanoma - Altevir used as adjuvant therapy in high risk of recurrence in adults after tumor removal. Altevir introduced into / in a dose of 15 million IU / m2 5 times a week for 4 weeks, followed by - n / dose to 10 million IU / m2 three times a week for 48 weeks. The dose should be adjusted depending on tolerability.

In multiple myeloma - p / dose 3 million IU / m2 3 times a week. Altevir prescribe the period to achieve stable remission.

When the AIDS Kaposi's sarcoma background - the optimal dose has not been established. The drug is administered s / c or i / m at a dose of 10-12 million IU / m2 per day. In the case of stable disease or response to treatment therapy is continued until, until there is tumor regression or elimination of the drug is not required.

Kidney cancer - the optimal dose and application of the scheme have not been established. N is recommended to use / in a dose of 3 to 10 million IU / m2 three times a week.

Special instructions:

Before treatment Altevirom chronic viral hepatitis B and C, it is recommended to carry out a liver biopsy to assess the degree of damage (for signs of active inflammation and / or fibrosis). The effectiveness of the treatment of chronic hepatitis C in combination therapy increases Altevirom and ribavirin. Application Altevira effectively in the development of decompensated cirrhosis or hepatic coma.

With the development of serious side effects during therapy Altevirom, the dose should be reduced by 50%, or temporarily suspend the drug until their extinction. If side effects persist or reappear after a dose reduction, or there is disease progression, treatment with the drug should be discontinued.

By reducing the platelet count is below 50 x 109 / liter or below of granulocytes 0.75 x 109 / l, it is recommended to decrease the dose Altevira 2 times with a blood analysis control a week. If these changes persist after dose reduction, antiviral therapy should be discontinued.

With a decrease in platelet count below 25 x 109 / l or the number of granulocytes below 0.5 x 109 / L, the drug should be discontinued with the control of blood test after a week.

Patients receiving interferon preparations alpha-2b, serum antibodies may be determined by neutralizing its anti-viral activity. In almost all cases, the antibody titers are low, their appearance does not reduce the effectiveness of treatment or the occurrence of other autoimmune disorders.

Preparation of the solution for the on / in: Altevira volume of solution required to prepare the desired dose, was added to 100 ml of sterile isotonic solution (0.9%) and sodium chloride is introduced for 20 minutes.