Interferon alfa-2b human recombinant (Interferonum alpha-2b)

Pharmacodynamics Pharmacokinetics Indications Carefully Contraindications Dosing and Administration Side effects
Read on
Clinical and pharmacological group: & nbsp

Interferons

Antiviral drugs (excluding HIV)

Included in the formulation
  • Alpharone®
    lyophilizate locally for injections 
    NPP FARMAKLON, LLC     Russia
  • Viferon®
    gel locally externally 
    FERON, LLC     Russia
    • Included in the list (Order of the Government of the Russian Federation No. 2782-r of 30.12.2014):

    VED

    ONLS

    АТХ:

    L.03.A.B.05   Interferon alfa-2b

    Pharmacodynamics:

    Interferon. It is a highly purified recombinant protein with a molecular weight of 19,300 daltons. Obtained from a clone Escherichia coli by hybridization of the bacterial plasmids with the human leukocyte gene, which codes for the synthesis of interferon. In contrast to interferon, alpha-2a has arginine in position 23.

    Has antiviral effect, which is due to interaction with specific membrane receptors and induction of RNA synthesis and, ultimately, proteins. The latter, in turn, interfere with the normal reproduction of the virus or its release.

    Has immunomodulatory activity, which is associated with the activation of phagocytosis, stimulation of the formation of antibodies and lymphokines.

    It has an antiproliferative effect on tumor cells.

    The drug increases the phagocytic activity of macrophages, potentiates the cytotoxic effect of lymphocytes.

    Pharmacokinetics:

    It penetrates into the systemic bloodstream through the mucous membrane of the respiratory tract, it undergoes decay in the body, it is partially excreted unchanged, mainly through the kidneys. Local application for the treatment of viral infections provides a high concentration of interferon in the focus of inflammation. Metabolized by the liver, the half-life is 2-6 hours.

    Indications:

    - chronic hepatitis B;

    - hairy cell leukemia;

    - Renocellular carcinoma;

    - skin T-cellular lymphoma (mushroom mycosis and Cesari syndrome);

    - athepatitis B;

    - atactive hepatitis C;

    - chronic myelogenous leukemia;

    - Kaposi's sarcoma on the background of AIDS;

    - malignant melanoma;

    - primary (essential) and secondary thrombocytosis;

    - transitional form of chronic granulocytic leukemia and myelofibrosis;

    - multiple myeloma;

    - Ra kidney;

    - reticulosarcoma;

    - multiple sclerosis;

    - prevention and treatment of influenza and acute respiratory viral infection.

    ICD-10

    I.B15-B19.B16   Acute hepatitis B

    I.B15-B19.B18.1   Chronic viral hepatitis B without delta-agent

    I.B15-B19.B18.2   Chronic viral hepatitis C

    I.B20-B24.B21.0   The disease caused by HIV, with manifestations of Kaposi's sarcoma

    II.C43-C44.C43.9   Malignant melanoma of skin, unspecified

    II.C64-C68.C64   Malignant neoplasm of kidney, except for renal pelvis

    II.C81-C96.C84   Peripheral and cutaneous T-cell lymphomas

    II.C81-C96.C84.0   Mushroom mycosis

    II.C81-C96.C84.1   Sesari's disease

    II.C81-C96.C91.4   Hairy cell leukemia (Leukemic reticuloendotheliosis)

    II.C81-C96.C92.1   Chronic myeloid leukemia

    Contraindications:

    - dCompensated liver cirrhosis;

    - Psykhoz;

    - PHigh sensitivity to interferon alpha-2b;

    - severe cardiovascular diseases;

    - tsevere depression;

    - aalcohol or drug dependence;

    - autoimmune diseases;

    - acute myocardial infarction;

    - pronounced disturbances of the hematopoiesis system;

    - epilepsy and / or other impairment of functions CNS;

    - chronic hepatitis in patients receiving or shortly before receiving immunosuppressant therapy (except for short-term pre-treatment with steroids).

    Carefully:

    - liver disease;

    - zkidney kidney problems;

    - violation of bone marrow hematopoiesis;

    - propensity to autoimmune diseases;

    - propensity to suicidal attempts.

    Pregnancy and lactation:

    Recommendation FDA Category C. No safety information.Do not apply! Use during pregnancy is only possible if the potential benefit to the mother exceeds the potential harm to the child.

    During the use of the drug, contraceptive methods should be used.

    Information about penetration into breast milk is not present. Do not use during breastfeeding.

    Dosing and Administration:

    Enter intravenously or subcutaneously. The dose is set individually, depending on the diagnosis and the individual indicators of the patient.

    Subcutaneous administration at a dose of 0.5-1 μg / kg once a week for 6 months. The dose is selected taking into account the expected efficacy and safety. If the RNA of the virus is eliminated from the serum after 6 months, the treatment is continued for up to one year. If unwanted reactions occur during treatment, the dose is reduced by a factor of 2. If undesirable effects persist or reappear after a dose change, the treatment is stopped. Reduce the dose is also recommended with a decrease in the number of neutrophils less than 0.75 × 109/ l or the number of platelets less than 50 × 109/ l. Therapy is stopped with a decrease in the number of neutrophils less than 0.5 × 109/ l or platelets - less than 25 × 109/ l.If there is a marked violation of kidney function (clearance less than 50 ml / min), patients should be under constant supervision. If necessary, the weekly dose of the drug is reduced. A dose change with age is not required.

    Preparation of the solution: the powdered contents of the vial are dissolved in 0.7 ml of water for injection, the bottle is gently shaken until the powder is completely dissolved. The prepared solution should be examined before administration; In case of a color change, it should not be used. For administration, up to 0.5 ml of the solution is used, the residues are disposed of.

    For treatment of influenza and ARVI - aerosol for topical application 100 000 ME, administered 7 times a day, every 2 hours (daily dose - up to 20 000 IU) in the first two days of the disease, then 3 times a day (daily dose - up to 10 000 IU) for five days or until the symptoms of the disease completely disappear.

    Interferonotherapy is performed against the background of traditional symptomatic therapy, including the use of non-steroidal anti-inflammatory drugs (paracetamol, acetylsalicylic acid) with an increase in temperature above 38.5 ° C, antihistamines (diazolin, suprastin, tavegil), antitussives (kodelak), mucolytic drugs (medicine for cough, bromohexine), fortifying agents (calcium gluconate, vitamins).

    Side effects:

    From the gastrointestinal tract: a decrease in appetite, vomiting, constipation, dry mouth, mild abdominal pain, nausea, diarrhea, a violation of taste, a decrease in body weight, small changes in liver function.

    From the nervous system: dizziness, sleep disturbance, anxiety, aggressiveness, depression, neuropathy, suicidal tendencies, mental deterioration, memory disorders, nervousness, euphoria, paresthesia, tremor, drowsiness.

    From the side of the circulatory system: arterial hypotension or hypertension, cardiovascular system disorders, myocardial infarction, thrombocytopenia, tachycardia, arrhythmia, ischemic heart disease, leukopenia, granulocytopenia.

    From the respiratory system: cough, pneumonia, chest pain, small shortness of breath, swelling of the lung.

    From the skin: reversible alopecia, itching.

    Other: antibodies to natural or recombinant interferons, muscle stiffness, influenza-like symptoms.

    Overdose:

    No data.

    Interaction:

    The drug inhibits theophylline metabolism.

    It is not recommended simultaneous use of intranasal vasoconstrictor drugs (contributes to the additional drying of the nasal mucosa).

    Special instructions:

    During the period of application of the drug, it is necessary to monitor the patient's mental and neurological status.

    Patients with diseases of the cardiovascular system may have arrhythmia. If the arrhythmia does not decrease or increases, the dose should be reduced 2 times, or stop treatment.

    With severe oppression of bone marrow hematopoiesis, a regular study of the composition of peripheral blood is necessary.

    Impact on the ability to manage motor transport and other technical devices

    The aerosol formulation does not affect the ability to drive vehicles and service moving machinery.

    Instructions
    Up