2010/09/20

Altevir

Composition, structure and packing

Solution for injection transparent, colorless.

0.5 ml of human recombinant interferon alfa-2b 1 million IU
- - 3 mln.ME
- - 5 mln.ME
- - 10 mln.ME
- - 15 mln.ME

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

Solution for injection transparent, colorless.

1 ml of human recombinant interferon alfa-2b 1 mln.ME
- - 3 mln.ME
- - 5 mln.ME
- - 10 mln.ME
- - 15 mln.ME

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

Clinico-pharmacological group

Interferon. Antitumor, antiviral and immunomodulatory drug.

Pharmacological action

Interferon. Altevir has antiviral, immunomodulatory and antiproliferative antitumor effect.

Interferon alpha-2b, interacting with specific receptors on the cell surface initiates a complex chain of changes within the cell, which includes the induction of synthesis of a number of specific cytokines and enzymes that violates the synthesis of viral RNA and virus proteins in the cell. The result of these changes is a non-specific antiviral and antiproliferative activity related to the prevention of virus replication in cells, inhibition of cell proliferation and immunomodulatory effect of interferon. Interferon alpha-2b stimulates the process of antigen presentation immunocompetent cells, has the ability to stimulate the phagocytic activity of macrophages and cytotoxic activity of T cells and natural killer cells, participating in antiviral immunity.

It prevents the proliferation of cells, particularly cancer. Have a depressing effect on the synthesis of some oncogenes, leading to inhibition of tumor growth.

Pharmacokinetics

Absorption

When s / c or i / m administration of interferon alfa-2b bioavailability ranges from 80% to 100%. After the introduction of interferon alfa-2b Tmax in plasma is 4-12 h, T1 / 2 - 2.6 hours later 16-24 h after injection of recombinant interferon in the serum is not defined.

Metabolism

Metabolism is carried out in the liver.

Interferons alpha are able to violate the oxidative metabolic processes, reducing the activity of microsomal enzymes of liver cytochrome P450.

Withdrawal

Write mainly by the kidneys by glomerular filtration.

Indications for use of the drug

In the combined therapy in adults:
with chronic viral hepatitis B without signs of cirrhosis;
with chronic viral hepatitis C in the absence of symptoms of liver failure (monotherapy or combination therapy with ribavirin);
with laryngeal papillomatosis;
with genital warts;
at volosatokletochnom leukemia, chronic myeloid leukemia, Hodgkin's lymphoma, melanoma, multiple myeloma, Kaposi's sarcoma against a background of AIDS, progressive kidney cancer.

Dosage regimen

Apply n / a, i / m in / in. Treatment should be initiated by a doctor. Next, with the permission of a doctor patient can enter a self-supporting dose (in cases where the drug was appointed n / a or / m).

Chronic hepatitis B: Altevir ® injected sc or IM at a dose of 5-10 million, ME 3 times a week for 16-24 weeks. Treatment stopped after 3-4 months of treatment in the absence of positive dynamics (according to the study of hepatitis B virus DNA).

Chronic hepatitis C: Altevir ® injected sc or IM in doses of 3 million, ME 3 times a week for 24-48 weeks. In patients with recurrent angina and patients not previously treated with interferon alfa-2b, the effectiveness of treatment increases with the combination therapy with ribavirin. Duration of combination therapy is at least 24 weeks. Altevirom therapy should be 48 weeks patients with chronic hepatitis C genotype 1 virus with a high viral load, in which the end of the first 24 weeks of treatment in serum HCV RNA determined by S.

Laryngeal papillomatosis: Altevir ® injected sc at a dose of 3 million ME/m2 3 times a week. Treatment starts after surgery (or laser) removal of the tumor tissue. Dose is selected taking into account the tolerance of the drug. Achieving a positive response may require treatment for 6 months.

Volosatokletochny leukemia: the recommended dose Altevira for sc administration to patients after splenectomy with or without 2 million ME/m2 3 times a week. In most cases, the normalization of one or more hematological indices occurs after 1-2 months of treatment, may increase the duration of treatment to 6 months. This dosing regimen should be followed consistently, if this does not happen fast progression of disease or symptoms of severe intolerance to the drug.

Chronic myeloid leukemia: the recommended dose Altevira as monotherapy - 4-5 million ME/m2 day sc daily. To maintain the number of leukocytes may be required in a dose of 0.5-10 million ME/m2. If the treatment provided to control the number of leukocytes, then to maintain remission drug should be used in the maximum tolerated dose (4-10 million ME/m2 daily). The drug should be abolished in 8-12 weeks, if therapy has not led to a partial remission or clinically significant reduction in the number of leukocytes.

Non-Hodgkin's lymphoma: Altevir ® is used as an adjuvant therapy in combination with standard chemotherapy. The drug injected sc at a dose of 5 million ME/m2 3 times a week for 2-3 months. The dose must be adjusted depending on tolerability.

Melanoma: Altevir ® is used as an adjuvant therapy have a high risk of recurrence in adults after tumor removal. Altevir ® is introduced into / in a dose of 15 million ME/m2 5 times a week for 4 weeks, then sc in doses of 10 million ME/m2 3 times a week for 48 weeks. The dose must be adjusted depending on tolerability.

Multiple Myeloma: Altevir ® administered in the period to achieve stable remission in a dose of 3 million ME/m2 3 times a week n / k.

Kaposi's sarcoma against a background of AIDS: the optimal dose has not been established. The drug can be used in doses of 10-12 million ME/m2 / s / c or / m. In the case of stabilization of disease or response to treatment, therapy continued until at least until tumor regression or require removal of the drug.

Kidney cancer: optimal dose and pattern of use is not installed. We recommend using a drug sc in doses ranging from 3 to 10 million ME/m2 3 times a week.

Preparation of solution for i / in the introduction

Is picking up volume of the solution Altevira required for the preparation of the required dosage, is added to 100 ml of sterile 0.9% sodium chloride solution and injected within 20 min.

Side effect

General reaction: very often - fever, weakness (which are dose-dependent and reversible reactions disappear within 72 h after a break in treatment or its termination), chills, less often - ill.
From the side of the central nervous system: very often - headache less often - asthenia, drowsiness, dizziness, irritability, insomnia, depression, suicidal thoughts and attempts, seldom - nervousness, anxiety.
On the part of the musculoskeletal system: very often - myalgia; less often - arthralgia.
On the part of the digestive system: very often - loss of appetite, nausea, less often - vomiting, diarrhea, dry mouth, change in taste; rare - abdominal pain, dyspepsia, possibly a reversible increase in liver enzymes.
Since the cardiovascular system: often - BP reduction; rarely - tachycardia.

Dermatological reactions: less often - alopecia, increased sweating, rarely - skin rash, itchy skin.
On the part of the hemopoietic system: possible reversible leukopenia, granulocytopenia, reduced hemoglobin levels, thrombocytopenia.

Other: rarely - weight loss, autoimmune thyroiditis.

Contraindications to the use of the drug
severe cardiovascular disease in history (uncontrolled chronic heart failure, recent myocardial infarction, marked disturbances of heart rhythm);
severe renal and / or hepatic failure (including due to the presence of metastases);
epilepsy, and severe abnormalities in the CNS, especially manifested depression, suicidal thoughts and attempts (including history);
chronic hepatitis with decompensated cirrhosis and in patients receiving or recently received treatment for immunosuppressants (except completed short-course treatment of GCS);
autoimmune hepatitis or other autoimmune disease;
treatment of immunosuppressants after transplantation;
thyroid disease, uncontrollable conventional therapeutic methods;
decompensated lung disease (including COPD);
decompensated diabetes mellitus;
hypercoagulation (including thrombophlebitis, pulmonary embolism);
expressed mielodepressiya;
Pregnancy
Lactation (breastfeeding);
Hypersensitivity to the drug's components.

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 hepatic failure (including those caused by the presence of metastases).

Application for violations of renal function

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

Cautions

Before treatment Altevirom chronic viral hepatitis B and C is recommended to liver biopsy to assess the degree of liver damage (signs of active inflammation and / or fibrosis). The effectiveness of treatment of chronic hepatitis C increases with combination therapy Altevirom and ribavirin. Application Altevira not effective in the development of decompensated cirrhosis or hepatic coma.

In the case of side effects during treatment Altevirom dose should be reduced by 50% or temporarily lift the drug before their disappearance. If side effects persist or reappear after reducing the dose, or there is progression of the disease, the treatment Altevirom should be discontinued.

By reducing the level of platelet count below 50x109 / L or below the level of granulocytes 0.75x109 / l recommended reducing the dose Altevira 2 times the control blood after 1 week. If these changes persist, the drug should be abolished.

By reducing the level of platelet count below 25x109 / L or below the level of granulocytes 0.5 h109 / l recommended the abolition of the drug Altevir ® to control blood after 1 week.

Patients receiving the drug interferon alfa-2b, the serum can be determined by antibodies that neutralize its antiviral activity. In almost all cases, the antibody titers are low, their appearance does not lead to reduced effectiveness of treatment or the emergence of other autoimmune disorders.

Overdose

Data on drug overdose Altevir not available.

Drug Interactions

Drug Interactions between Altevirom and other drugs are not fully understood. Precautions should be applied Altevir ® simultaneously with hypnotics and sedatives, narcotic analgesics and drugs, potentially providing mielodepressivny effect.

At the same time appointing Altevira and theophylline should be monitored concentration of the latter in the blood serum and, if necessary change the mode of its dosing.

In applying Altevira in combination with chemotherapeutic drugs (cytarabine, cyclophosphamide, doxorubicin, tenipozid) increases the risk of toxic effects.

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Drug prescription.

Terms and Conditions of storage

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

Shipped at a temperature of 2 ° to 8 ° C Do not freeze