Altevir

Altevir – drug with anti-proliferative, antineoplastic, immunomodulatory, antiviral action.

Form of release and structure

Altevir release in the form of solution for injections: transparent, colourless (in ampoules on 0,5 or 1 ml, on 5 ampoules in planimetric plastic packagings, in a cardboard pack 1 or 2 packagings; in bottles on 0,5 or 1 ml, in a cardboard pack 1 bottle or on 5 bottles in planimetric plastic or strip packagings, in a cardboard pack 1 packaging; in syringes on 0,5 or 1 ml, on 1 or 3 syringes in planimetric plastic packagings, in a cardboard pack 1 or 3 packagings).

Structure of 0,5 or 1 ml of injection solution:

• Active ingredient: interferon alpha 2b human recombinant – 1, 3, 5, 10 or 15 million IU (international units);
• Additional components: sodium chloride, sodium acetate, disodium salt of ethylene diamine tetraacetic acid, a dextran 40, the twin-80, water for injections.

Indications to use

Altevir appoint the adult along with other medicines at treatment of the following diseases:

• The chronic viral hepatitis With proceeding without symptoms of a liver failure (in the form of monotherapy or in combination with ribaviriny);
• Chronic viral hepatitis In without symptoms of cirrhosis;
• Sharp-pointed condylomas;
• Throat papillomatosis;
• Multiple myeloma, hairy cell leukosis, the progressing kidney cancer, a myelosis, a nekhodzhkinsky lymphoma, Kaposha's sarcoma against the background of AIDS, a melanoma.

Contraindications

• Renal/liver failure in a heavy current (including connected with metastasises);
• Serious cardiovascular illnesses in the anamnesis (the myocardial infarction postponed in recent time, uncontrollable chronic heart failure, the expressed disturbances of a cordial rhythm);
• Hepatitis in a chronic current with dekompensirovanny cirrhosis and at the patients who are receiving or receiving in recent time therapy by immunodepressants (except a complete short course of treatment glucocorticosteroids);
• The expressed miyelodepressiya;
• Epilepsy, and also the heavy disturbances of functions of the central nervous system which in particular are expressed suicide attempts and thoughts, a depression (including in the anamnesis);
• Hypercoagulation, including thrombophlebitis, a thrombembolia of a pulmonary artery;
• Autoimmune hepatitis or other autoimmune diseases;
• Diseases of a thyroid gland which do not give in to control by the standard therapeutic methods;
• Use of drugs with an immunodepressive effect after transplantation;
• Dekompensirovanny diabetes mellitus;
• Dekompensirovanny pulmonary diseases, including a chronic obstructive pulmonary disease;
• Pregnancy and period of breastfeeding;
• Hypersensitivity to drug components.

Route of administration and dosage

Altevir enter subcutaneously (п / to), intramusculary (in oil) or intravenously (in/in).

There has to begin therapy the doctor. Further with its permission can enter a maintenance dose of the patient to itself independently (at п / to or introduction in oil).

The recommended dosing mode (a way of introduction / a one-time dose / frequency rate of use/duration of a course):

• Chronic hepatitis B: in oil or p/k/5-10 one million ME/3 of time a week / 16-24 weeks. If after 3-4 months of use of Altevir positive dynamics is absent (according to hepatitis B virus research DNA), therapy is cancelled;
• Chronic hepatitis C: in oil or p/k/3 one million ME/3 of time a week / 24-48 weeks. At recurrent disease, and also at the patients who were not receiving earlier treatment by interferon alpha 2b Altevir's efficiency increases at a combination with ribaviriny. The course lasting 48 weeks is appointed sick chronic hepatitis C and the first genotype of a virus with high virus loading in cases if by the end of the first 24 weeks of therapy of RNA of a virus of hepatitis C in blood serum is not defined;
• Throat papillomatosis: p/k/3 one million ^ME/m2/3 time a week / up to 6 months. Therapy is appointed after surgical/laser removal of tumoral fabric. At selection of a dose it is necessary to consider portability of drug;
• Hairy cell leukosis: p/k/2 one million ^ME/sq.m (after a splenectomy or without it)/3 times a week / from 1-2 to 6 months. It is necessary to adhere to the mode of dosing constantly if at the same time bystry progressing of a disease or emergence of symptoms of heavy intolerance of Altevir is not observed;
• Myelosis: p/k/4-5 one million ^{МЕ/м2/ежедневно/индивидуально}. For maintenance of number of leukocytes Altevir's dose can vary from 0,5 to 10 million ^ME/sq.m. In cases if therapy allows to achieve control of number of leukocytes, for maintenance of hematologic remission appoint the most tolerable dose (4-10 million ^ME/sq.m daily). In cases when in 8-12 weeks treatment to clinically significant decrease in number of leukocytes or partial hematologic remission does not bring, drug is cancelled;
• Nekhodzhkinsky lymphoma: p/k/5 one million ^ME/m2/3 time a week / 2-3 month. Altevir appoint as adjuvant therapy in a combination to standard schemes of chemotherapy. Depending on portability of drug dose adjustment is possible;
• Melanoma: in/in / 15 one million ^ME/m2/5 weekly / 4 weeks; then – p/k/10 one million ^ME/m2/3 time a week / 48 weeks. Altevir appoint as adjuvant therapy with high risk of a recurrence after an oncotomy. Depending on portability of drug dose adjustment is possible;
• Multiple myeloma: p/k/3 one million ^ME/m2/3 time during the week/period of achievement of steady remission;
• Kaposha's sarcoma against the background of AIDS: in oil or p/k/10-12 million ^ME/sq.m a day (the optimum dose is not defined) / at stabilization of a disease or the answer on Altevir carry out therapy until its cancellation is required or there will be no regress of a tumor;
• Kidney cancer: p/k/3-10 one million ^ME/m2/3 time a week (the optimum mode of dosing of Altevir is not set).

At preparation of solution for intravenous administration it is necessary to add 100 ml of sterile 0,9% of solution of sodium chloride to a necessary dose. The drug is administered for 20 minutes.

Side effects

• Central nervous system: very often – a headache; less often – sleeplessness, irritability, an adynamy, suicide attempts and thoughts, drowsiness, dizziness, a depression; seldom – uneasiness, nervousness;
• Alimentary system: very often – nausea, a loss of appetite; less often – diarrhea, vomiting, taste change, dryness in a mouth; seldom – dyspepsia, abdominal pains; reversible increase in activity of liver enzymes can be observed;
• Skeletal and muscular system: very often – a mialgiya; less often – an arthralgia;
• Cardiovascular system: often – a lowering of arterial pressure; seldom – tachycardia;
• Hemopoietic system: reversible granulocytopenia and leukopenia, thrombocytopenia, decrease in level of hemoglobin;
• General reactions: very often – weakness, fever (are reversible and dozozavisimy tests, pass within 3 days after a break in therapies or its cancellations), a fever; less often – an indisposition;
• Dermatological reactions: less often – the increased sweating, an alopecia; seldom – a skin itch and rash;
• Others: seldom – an autoimmune thyroiditis, decrease in body weight.

Special instructions

Before Altevir's appointment at treatment of a chronic viral hepatitis In and With for liver damage rate assessment (existence of symptoms of fibrosis and/or active inflammatory process) carrying out a biopsy of a liver is recommended. Efficiency of therapy of chronic hepatitis C increases at the combined use with ribaviriny. In cases of development of a hepatic coma or dekompensirovanny cirrhosis Altevir is inefficient.

At development of side reactions it is necessary to reduce Altevir's dose twice or to cancel drug until their disappearance. If disturbances remain or appear after reduction of a dose again, or progressing of a disease is observed, Altevir cancel.

At reduction of level of thrombocytes ^{lower than 50x109/l} or the level of granulocytes ^{lower than 0,75x109/l} it is recommended to reduce twice Altevir's dose under control of blood test in 7 days. If the described changes remain, cancel therapy.

In cases of decrease in level of thrombocytes ^{lower than 25x109/l} or the level of granulocytes lower than 0,5 ^h109/l drug is recommended to be cancelled with control of blood test in 7 days.

At treatment alpha 2b in blood serum of patients antibodies which neutralize its antiviral activity can be defined by interferon. In most cases antiserum capacities are low, their emergence does not lead to reduction of efficiency of therapy or development of other autoimmune disorders.

Medicinal interaction

Altevir's interaction with other drugs / substances was not completely studied.

Care is demanded by appointment in a combination with sedative/somnolent drugs, narcotic analgetics, medicines which potentially render miyelodepressivny effect.

At the combined appointment of Altevir with theophylline it is necessary to control serumal concentration of the last and, in case of need, to adjust the applied doses.

Altevir in a combination with chemotherapeutic medicines (Cytarabinum, cyclophosphamide, doxorubicine, tenipozidy) increases probability of emergence of toxic effects.

Terms and storage conditions

To store in the place, unavailable to children, at a temperature of 2-8 °C, not to freeze.

Period of validity – 1,5 years.