Altevir - instructions for use, dose, side effects, contraindications

Excipients: sodium acetate 0.00164 g, sodium chloride 0.005844 g, disodium edetate dihydrate 0.000075 g, polysorbate 80 0.0001 g, dextran 40 infusion solution 10% 0.05 g, water for injection up to 1.0 ml.

Description:

Transparent colorless liquid.

Pharmacotherapeutic group:Cytokine

ATX: & nbsp

L.03.A.B.05 Interferon alfa-2b

Pharmacodynamics:

Altevir®, a solution for injection, is an interferon alpha-2b human recombinant derived from Escherichia coli cells, in which the human interferon alpha-2b gene is embedded in 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 an antiviral, immunomodulatory, antiproliferative and antitumor effect. Interferon alfa-2b, interacting with specific receptors on the cell surface, initiates a complex chain of changes within the cell, including the induction of the synthesis of a number of specific cytokines and enzymes, disrupts the synthesis of viral ribonucleic acid (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 action of interferon. Interferon alfa-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 killers" involved in antiviral immunity. Prevents the proliferation of cells, especially tumor cells. Has a depressing effect on the synthesis of certain oncogenes, leading to inhibition of tumor growth.

Pharmacokinetics:When n / k or / m introduction of interferon alfa-2b bioavailability of it is from 80% to 100%. Time to reach C_max is 4-12 hours, T_1/2 - 2-6 hours respectively. After 16-24 hours after administration, recombinant interferon in serum is not determined. Metabolism is carried out in the liver. Alpha interferons can disrupt oxidative metabolic processes, reducing the activity of "hepatic" microsomal enzymes of the cytochrome P450 system.Derived mainly by the kidneys through glomerular filtration.

Indications:

Altevir® is used in complex therapy in adults:

- with chronic viral hepatitis B without signs of cirrhosis;

- with chronic viral hepatitis C in the absence of signs of hepatic insufficiency (monotherapy or combination therapy with ribavirin);

- with larynx papillomatosis, genital warts;

- with hairy cell leukemia, chronic myelogenous leukemia, non-Hodgkin's lymphoma, melanoma, multiple myeloma, Kaposi's sarcoma in AIDS patients, progressive kidney cancer.

Contraindications:

Hypersensitivity to recombinant interferon alpha-2b or any of the components of the drug.

Severe cardiovascular diseases in the anamnesis (uncontrolled chronic heart failure, suffered during the previous 6 months myocardial infarction, severe cardiac arrhythmias).

Severe renal and / or hepatic insufficiency, including, caused by the presence of metastases. Epilepsy and other severe dysfunctions of the central nervous system, especially manifested by depression, suicidal thoughts and attempts (including in the history). Chronic hepatitis with decompensated cirrhosis of the liver.

Conducted or conducted during the previous 6 months treatment with immunosuppressive drugs, not including a completed short-term course of treatment with glucocorticosteroids.

Autoimmune hepatitis or other autoimmune disease, a thyroid disease that can not be controlled by conventional therapeutic methods.

Decompensated lung diseases, including chronic obstructive pulmonary disease, decompensated diabetes mellitus, hypercoagulability, including thrombophlebitis, pulmonary embolism.

Pronounced myelosuppression.

Pregnancy and the period of breastfeeding.

Children under 18 years.

Pregnancy and lactation:

The drug Altevir ® is not used during pregnancy and breastfeeding.

Dosing and Administration:

Depending on the indications for use, the drug Altevir ® is administered subcutaneously, intramuscularly and intravenously. Treatment should be started by a doctor. Further, with the permission of the doctor, the patient who maintains a dose can inject himself independently (in cases where the drug is administered subcutaneously or intramuscularly).

Chronic hepatitis C: Altevir® is injected SC or I / m in a dose of 3 million IU 3 times a week for 24-48 weeks. In patients with recurrent disease and patients who have not previously received interferon alpha-2b treatment, the effectiveness of treatment increases with combined therapy with ribavirin. The duration of combined therapy is not less than 24 weeks. Patients with the first genotype of the virus of chronic hepatitis C and high viral load, who do not have hepatitis C RNA at the end of the first 24 weeks of serum treatment, should be treated with Altevir® for 48 weeks.

Chronic hepatitis B: Altevir is given by SC or IM in a dose of 5-10 million IU 3 times a week for 16-24 weeks. In the absence of positive dynamics (according to the definition of DNA of the hepatitis B virus) after 3-4 months of treatment stop treatment.

Papillomatosis of the larynx: Altevir is administered SC in a dose of 3 million IU / m² 3 times a week. Treatment begins after surgical (or laser) delete tumor tissue.

The dose is selected taking into account the tolerability of the drug. Achieving a positive response may require treatment within 6 months.

Genital warts: Altevir is administered SC in a dose of 3 million: IU / m² 3 times a week. Treatment is started after surgical or laser removal of genital warts.

Achieving a positive response may require treatment within 6 months.

Hairy cell leukemia: the recommended dose of Altevira® for SC administration to patients after splenectomy or without it is 2 million IU / m² 3 times a week. In most cases, the normalization of one and more hematological indicators comes in 1-2 months. treatment. This dosing regimen should be adhered to constantly, if This does not lead to rapid progression of the disease or the occurrence of symptoms of severe intolerance to the drug.

Chronic myelogenous leukemia: the recommended dose of Altevira® as a monotherapy is 4-5 million IU / m² in day s / to daily. If the treatment allows to control the number of leukocytes, then to maintain hematologic remission the drug should be applied at the maximum tolerated dose (4-5 million IU / m² daily). If therapy after 8-12 weeks did not lead to partial hematologic remission or clinically significant decrease in the number of white blood cells, the drug should be discarded.

Non-Hodgkin's Lymphoma: Altevir® is used as an adjuvant therapy in combination with standard chemotherapy regimens of SC in a dose 5 million IU / m² 3 times a week for 2-3 months. The dose is necessary adjust depending on tolerability of the drug.

Melanoma: Altevir® is used as an adjuvant therapy with a high risk of recurrence after removal of the tumor at a dose of 15 million IU / m² intravenously 5 times a week for 4 weeks, then sc in a dose of 10 million IU / m² 3 times a week for 48 weeks. The dose should be adjusted depending on the tolerability of the drug.

Preparation of a solution for intravenous administration: a volume of Altevira® solution necessary for the preparation of the required dose, is added to 100 ml of sterile 0.9% solution of sodium chloride and injected for 20 minutes. The solution is prepared immediately before the procedure of intravenous administration, this solution is not subject to storage.

Multiple myeloma: Altevir® is administered at a time when a stable remission in a dose of 3 million IU / m² 3 times a week.

Kaposi's Sarcoma in patients with AIDS: the optimal dose is not established. A drug can be used in doses 10-12 million IU / m² in the day n / k or / m. AT in case of stabilization of the disease or positive dynamics, therapy is continued until tumor regression occurs or drug withdrawal is required.

Kidney cancer. The optimal dose and schedule of application are not established. Recommended apply SC in doses of 3 to 10 million IU / m² 3 times a week.

Side effects:

Flu-like symptoms

Most often, at the beginning of Altevir ®, an interferon-like flu-like syndrome (fever, chills, headache, muscle and / or joint pain, weakness, nausea) can be observed. These manifestations are usually mild, observed at the beginning of treatment and decrease with continued treatment.

Reactions from the digestive system

Rarely noted vomiting, dry mouth, taste change, abdominal pain, indigestion, loss of appetite, weight loss.

Reactions from the nervous system

Rarely are irritability, nervousness, dizziness, insomnia, depression, suicidal thoughts and attempts, asthenia, drowsiness, malaise, anxiety.

Reactions from the cardiovascular system.

Rarely there is a decrease in blood pressure, tachycardia.

Reactions from the skin and subcutaneous tissue

Rarely with prolonged use of Altevir ®, it is possible to develop alopecia, increased sweating, skin rash, skin itching.

Reactions from the musculoskeletal system

Very rarely noted arthralgia.

Reactions from the endocrine system

Interferons can influence the function of the thyroid gland, very rarely causing the development of autoimmune thyroiditis. Against the background of long-term use of Altevir®, it is necessary to monitor the parameters once a month hormones of the thyroid gland.

Deviations of laboratory indicators

Rarely, there may be changes in laboratory parameters: leukopenia, granulocytopenia, decreased hemoglobin, thrombocytopenia, increased activity hepatic enzymes. These changes are dose-dependent and reversible and disappear within 72 hours after interruption of treatment or its cessation.

Overdose:In clinical trials, no cases of unintentional overdose have been reported. In case of exceeding the dose, including increasing the single volume or frequency of admission per week, immediately inform the doctor.In case of an overdose, the patient should be hospitalized for observation and, if necessary, maintenance therapy.

Interaction:

The interaction of Altevira® with other drugs is not fully understood. Caution should be used Altevir ®, along with sleeping pills and sedatives, narcotic analgesics and drugs that have a mielosupressive effect.

With the simultaneous use of Altevira® and theophylline, it is necessary to monitor the concentration of the latter in the serum and, if necessary, change the dosage regimen.

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

Special instructions:

Precautions for use

In case of side effects during treatment with Altevir ®, the dose should be reduced by 50% or temporarily discontinued. If side effects persist or occur again after a dose reduction, or if the disease progresses, Alvevir® treatment should be discontinued.

When the platelet count drops below 50x10⁹/ l or the level of granulocytes below 0.75^x10⁹/l It is recommended that the dose of Altevir® be reduced by a factor of 2 with a blood test done after 1 week. If these changes are retained, Altevir® should be canceled.

With a decrease in platelet count below 25x10⁹/ l or granulocyte level below 0.5 × 10⁹/l it is recommended to cancel the drug with a blood test after 1 week.

special instructions

Prior to the initiation of treatment with Altevir® for chronic viral hepatitis B and C, a liver biopsy is recommended to assess the degree of liver damage (signs of active inflammation and / or fibrosis). The effectiveness of treatment of chronic hepatitis C increases with combined therapy with Altevir ® and ribavirin. The use of Altevira ® is not effective in the development of decompensated liver cirrhosis or hepatic coma.

In patients receiving interferon alfa-2b preparations, antibodies neutralizing its antiviral activity may appear in the blood serum. Almost all antibody titers are low, their appearance does not lead to a decrease in the effectiveness of treatment or the occurrence of autoimmune disorders.

In the case of missing the dose, the injections continue, observing the interval of administration and not increasing the subsequent dose.

Effect on the ability to drive transp. cf. and fur:

Altevir® has little impact on the ability to drive vehicles and work with machines and mechanisms. If there is dizziness, drowsiness, confusion and weakness, you should stop driving the vehicle or work with machines and mechanisms.

Form release / dosage:

Solution for injection 1, 3, 5, 10 million IU / ml.

Packaging:

In hermetically sealed colorless glass ampoules of 1 ml, containing 1, 3, 5, 10 million IU / ml. 5 ampoules in a planar cell package; 1 contour mesh package in a cardboard bundle.

In sterile glass injection syringes with a glued needle and a protective cap made of polypropylene with a rubber insert per 1 ml containing 3 million IU / ml.

For 1 filled syringe in a contour acheikova package, 1 contour mesh package in a cardboard bundle.

Each pack contains instructions for use.

Storage conditions:

Store in accordance with SP 3.3.2-1248-03, at a temperature of 2 to 8 ° C, out of the reach of children. Do not freeze.Allowed a short-term storage for 10 days at a temperature of no higher than 25 ° C.

Transportation at a temperature of 2 to 8 ° C. Do not freeze. Short-term transportation is allowed for 10 days at a temperature of no higher than 25 ° C.

Shelf life:

2 years. Not applicable after expiry date.

Terms of leave from pharmacies:On prescription

Registration number:LS-001950

Date of registration:25.08.2006 / 22.12.2016

Expiration Date:Unlimited

The owner of the registration certificate:FARMAPARK, LLC FARMAPARK, LLC Russia

Manufacturer: & nbsp

FARMAPARK, LLC Russia

FARMSTANDART-UFAVITA, JSC Russia

Information update date: & nbsp16.07.2017

Illustrated instructions

Instructions

Altevir® (Altevir®)