Diffuse large cell B-cell lymphoma

Active substance:

Content

Pharmacological groups

Nosological classification (ICD-10)

Composition and release form

in ampoules, vials (1, 3, 5, 10, 15 million IU) or syringes (3, 5, 10, 15 million IU); in a pack of cardboard 5 or 10 ampoules; 1 or 5 bottles; 1 or 3 syringes.

Diffuse large cell B-cell lymphoma

Description of the dosage form

Transparent colorless liquid.

Characteristic

Interferon alpha-2b human recombinant isolated from cells Escherichia coli, In the genetic apparatus of which the human interferon alpha-2b gene is inserted.

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

pharmachologic effect

Pharmacodynamics

Interacting with specific receptors on the cell surface, interferon alpha-2b 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 RNA and virus proteins in the cell. The result of these changes is non-specific antiviral and anti-proliferative activity associated with the prevention of viral replication in the cell, inhibition of cell proliferation and the immunomodulatory effects of interferon.

Diffuse large cell B-cell lymphoma

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 cells involved in the antiviral response. Prevents cell proliferation, especially tumor. It has a depressing effect on the synthesis of certain oncogenes, leading to inhibition of tumor growth.

Pharmacokinetics

When s / c or / m introduction bioavailability of interferon alfa-2b is from 80 to 100%. Tmax – 4–12 h, T1/2 – 2–6 h, respectively. After 16-24 hours after administration, the recombinant interferon alpha-2b in the serum is not detected. Metabolized in the liver. Alpha interferons can interfere with oxidative metabolic processes, reducing the activity of hepatic microsomal enzymes of the cytochrome P450 system. Excreted mainly by the kidneys by glomerular filtration.

Altevir ® indications

In complex therapy in adults:

chronic viral hepatitis B (without signs of liver cirrhosis);

chronic viral hepatitis C in the absence of signs of liver failure (monotherapy or combination therapy with ribavirin);

laryngeal papillomatosis, genital warts;

hairy cell leukemia; chronic myeloid leukemia; non-Hodgkin’s lymphoma; melanoma; multiple myeloma; Kaposi’s sarcoma with AIDS; progressive kidney cancer.

Contraindications

hypersensitivity to recombinant interferon alpha-2b or any of the components of the drug;

history of severe cardiovascular diseases (uncontrolled chronic heart failure, recent myocardial infarction, marked cardiac arrhythmias);

severe renal and / or liver failure (in

epilepsy and / or other severe dysfunctions of the CNS, especially manifested by depression, suicidal thoughts and attempts (in

chronic hepatitis with decompensated liver cirrhosis and in patients with or after previous therapy with immunosuppressants (with the exception of the condition after the completion of short-term treatment of GCS);

autoimmune hepatitis and other autoimmune diseases, as well as taking immunosuppressive drugs after transplantation;

thyroid disease not controlled by conventional therapeutic methods;

decompensated lung disease (in

diabetes mellitus prone to ketoacidosis;

hypercoagulation (in

breastfeeding period.

Use during pregnancy and lactation

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

Side effects

Most often – fever, weakness (are dose-dependent and reversible reactions, disappear within 72 hours after a break in treatment or its termination), headache, myalgia, chills, loss of appetite, nausea.

Less often – vomiting, diarrhea, arthralgia, asthenia, drowsiness, dizziness, dry mouth, alopecia, depression, suicidal thoughts and attempts, malaise, increased sweating, changes in taste, irritability, insomnia, decreased blood pressure.

Rarely – abdominal pain, skin rash, nervousness, itchy skin, anxiety, weight loss, dyspepsia, tachycardia, autoimmune thyroiditis. Changes (reversible) laboratory parameters: leukopenia, granulocytopenia, decrease in hemoglobin level, thrombocytopenia, increased activity of liver enzymes.

Interaction

Drug interaction between Altevir ® and other drugs is not fully understood. Altevir ® should be used with caution at the same time as hypnotic drugs and sedatives, narcotic analgesics and drugs that have a myelosuppressive effect.

With the simultaneous appointment of Altevira ® and theophylline, it is necessary to control the concentration of the latter in serum and, if necessary, change the mode of its dosing.

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

Dosage and administration

Treatment must be initiated by a doctor. Further, with the permission of the doctor, the patient can administer the dose to himself (in the case of subcutaneous or intramuscular administration).

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

In chronic viral hepatitis C, n / a or intramuscular in a dose of 3 million IU 3 times a week for 6–12 months. In patients with a relapsing course of the disease and in patients who have not previously received treatment with interferon alfa-2b, the effectiveness is increased when using Altevira ® in combination with ribavirin. The duration of combination therapy is at least 6 months. Patients with chronic hepatitis C with 1 virus genotype and high viral load, in which the RNA of hepatitis C virus is not detected in the serum by the end of the first 6 months of treatment, Altevir ® therapy should be carried out for 12 months.

Laryngeal papillomatosis – s / c at a dose of 3 million IU / m 2 3 times a week. Treatment begins after the surgical (laser) removal of tumor tissue. The dose is selected taking into account the tolerability of the drug. To achieve a therapeutic effect, therapy for 6 months may be required.

Hairy cell leukemia – s / c at a dose of 2 million IU / m 2 3 times a week (for patients after and without splenectomy). In most cases, the normalization of one or more hematological parameters occurs within 1–2 months of treatment, it is possible to increase the duration of treatment up to 6 months. This dosing regimen should be adhered to continuously, unless, in this case, there is a rapid progression of the disease or the onset of symptoms of severe intolerance to the drug.

Chronic myeloid leukemia is the recommended dose of Altevira ® as monotherapy from 4–5 million IU / m 2 per day p / c daily. To maintain the number of leukocytes, it may be necessary to use a dose of 0.5-10 million IU / m 2. If treatment allows to achieve 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 / m 2) daily. The drug should be discontinued after 8–12 weeks of treatment if therapy did not lead to partial hematologic remission or a clinically significant decrease in the number of white blood cells.

In non-Hodgkin’s lymphoma, Altevir ® is used as adjuvant therapy in combination with standard chemotherapy regimens. The drug is injected s / c at a dose of 5 million IU / m 2 for 2–3 months. The dose must be adjusted depending on the tolerability of the drug.

For melanoma, Altevir ® is used as an adjuvant therapy, with a high risk of recurrence in adults after removal of the tumor. Altevir ® is administered intravenously at a dose of 15 million IU / m 2 5 times a week for 4 weeks, and then with a dose of 10 million IU / m 2 3 times a week for 48 weeks. The dose must be adjusted depending on the tolerability of the drug.

With multiple myeloma – s / c at a dose of 3 million IU / m 2 3 times a week. Altevir ® is prescribed in the period of achieving stable remission.

Diffuse large cell B-cell lymphoma

For Kaposi’s sarcoma with AIDS, the optimal dose has not been established. The drug is applied p / to or / m in a dose of 10-12 million IU / m 2 per day. In the case of stabilization of the disease or response to treatment, the therapy is continued until tumor regresses or the drug is withdrawn.

Kidney cancer – the optimal dose and pattern of use have not been established. It is recommended to apply sc in doses from 3 to 10 million IU / m 2 3 times a week.

special instructions

Before Altevir ® treatment of chronic viral hepatitis B and C, it is recommended to conduct a liver biopsy to assess the extent of its damage (presence of signs of an active inflammatory process and / or fibrosis). The effectiveness of the treatment of chronic hepatitis C increases with the combination therapy with Altevir ® and ribavirin. The use of Altevira ® is ineffective in the development of decompensated cirrhosis of the liver or hepatic coma.

With the development of severe side effects during therapy Altevir ®, the dose of the drug should be reduced by 50% or temporarily cancel the drug until they disappear. If side effects persist or reappear after dose reduction, or if disease progression is observed, then treatment with the drug should be stopped.

With a decrease in the number of platelets below 50 · 10 9 / l or the number of granulocytes below 0.75 · 10 9 / l, it is recommended to reduce the dose of Altevira ® 2 times with the control of a blood test after a week. If these changes persist after dose reduction, antiviral therapy should be discontinued.

With a decrease in the number of platelets below 25 · 10 9 / l or the number of granulocytes below 0.5 · 10 9 / l, the drug should be discontinued with control of a blood test after a week.

In patients receiving interferon alfa-2b preparations, antibodies can be detected in the 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 appearance of other autoimmune disorders.

Preparation of solution for on / in the introduction: The volume of Altevira ® solution required to prepare the required dose is added to 100 ml of sterile isotonic solution (0.9%) of sodium chloride and injected over 20 minutes.

Storage conditions of the drug Altevir ®

Keep out of the reach of children.

The shelf life of the drug Altevir ®

injection 1 million IU – 18 months.

injection 1 million IU / ml – 2 years. Allowed to store no more than 10 days at a temperature not higher than 25 ° C

injection 1 million IU / ml – 2 years. Allowed to store no more than 10 days at a temperature not higher than 25 ° C

injection of 3 million IU – 18 months.

injection of 3 million IU / ml – 2 years. Allowed to store no more than 10 days at a temperature not higher than 25 ° C

injection of 3 million IU / ml – 2 years. Allowed to store no more than 10 days at a temperature not higher than 25 ° C

injection of 5 million IU – 18 months.

injection solution of 5 million IU / ml – 2 years. Allowed to store no more than 10 days at a temperature not higher than 25 ° C

injection solution of 5 million IU / ml – 2 years. Allowed to store no more than 10 days at a temperature not higher than 25 ° C

injection of 10 million IU – 18 months.

injection 10 million IU / ml – 2 years. Allowed to store no more than 10 days at a temperature not higher than 25 ° C

injection 10 million IU / ml – 2 years. Allowed to store no more than 10 days at a temperature not higher than 25 ° C

injection 15 million IU – 18 months.

Do not use after the expiration date printed on the package.

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