Active substanceImmunoglobulin antithymocyteImmunoglobulin antithymocyte
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    Genzyme Europe BV     Netherlands
  • Dosage form: & nbsplyophilizate for solution for infusion
    Composition:

    1 ampoule contains:

    active substance: immunoglobulin fraction of blood plasma proteins of goats or rabbits 50 or 100 mg;

    adjuvant: stabilizer glycine (2.25%).

    Description:

    Dry porous mass from white to light pink with a yellowish tinge, hygroscopic.

    Pharmacotherapeutic group:Immunosuppressive agent - immunoglobulin
    ATX: & nbsp

    L.04.A.A.04   Immunoglobulin antitimotsitarny (rabbit)

    Pharmacodynamics:

    pharmachologic effect

    Antilimfolin - goat or rabbit immunoglobulin class G (predominantly monomer), does not contain a preservative and antibiotics. The drug is immunosuppressive, monitored for the absence of a surface antigen of the hepatitis B virus and antibodies to HIV-1, HIV-2 and hepatitis C viruses.

    With the help of complement-dependent lysis mechanisms, immunoglobulins (class G), isolated from the blood plasma of goats or rabbits, cause blockade of antigen-sensitive receptors of human lymphocytes, as well as their destruction. Antimipholin contains antibodies that recognize thymocytes and peripheral blood lymphocytes, which have a specific directivity against the receptors of T-lymphocytes involved in the mechanism of rejection. The presence of these antibodies gives Antilimfolin the functional properties inherent in monoclonal antibodies directed against various receptors present on the lymphocyte membrane.

    The drug provides suppression of unwanted autoimmune and transplantation immunological reactions. Unlike chemotherapeutic drugs (cyclophosphamide and azathioprine), it does not cause total inhibition of cellular metabolism, it has a more lenient effect on lymphocytes than immunosuppressants of other classes.

    Pharmacodynamics

    Cytotoxic effect Antilympholin in the form of severe lymphocytopenia (up to 50% of the baseline level) is observed 1-3 hours after the administration of the drug.The maximum content of antilymphocytic antibodies in the recipient's blood is reached in 6-8 hours from the moment of administration, lasts for 24-48 hours with subsequent gradual decrease during 3-5 days.

    Pharmacokinetics:Lysed lymphocytes and lymphocyte-immunoglobulin complexes are derived from the circulation of the cells of the reticuloendothelial system. Half-life of immunoglobulins class G Antilympholin in the bloodstream of the recipients is 5 ± 2 days.
    Indications:

    The drug is prescribed for adults and children over 12 years of age according to the following indications:

    - in transplantology - prevention and treatment of graft rejection reactions in patients with transplantation of allogeneic organs and tissues;

    - in hematology treatment of aplastic anemia.

    Contraindications:

    - An increased sensitivity of the patient to the serum proteins of animals from which the drug was obtained, detected during the first or subsequent administration of the drug;

    - viral and fungal diseases, sepsis;

    - planned or current pregnancy;

    - lactation period;

    - children under 12 years.

    Dosing and Administration:

    Antilimfolin dissolved in 250-450 ml of 0.9% solution of sodium chloride or 5% solution of dextrose and injected intravenously at a rate of 20-30 drops per minute. The solution is prepared ex tempore.

    Before using the drug to determine the sensitivity of the recipient to plasma proteins of goats or rabbits, 0.1 ml of a 1% solution of the drug should be administered intravenously. To obtain 1% solution of the drug in an ampoule with 50 mg of protein, 5 ml of a 0.9% solution of sodium chloride is injected. In the absence of a local and general reaction, intravenous administration of a therapeutic dose of Antilympholin begins.

    During the introduction of the drug, a biological sample must be performed: first 10-15 ml of the solution is injected, after which the drug should be discontinued for 15 minutes. In the absence during this period of clinical manifestations of allergic reactions (patient anxiety, redness of the face, pain in the muscles, bones, lower back, paresthesia, etc.), the drug is continued to drip.

    The dose of the drug administered, as well as the frequency of its administration, are determined individually for each patient depending on the nature of the disease (organ transplantation or treatment of aplastic anemia), the sensitivity of the patient to the drug and the general condition of the patient (leukocyte count, leukocyte count, platelet count, immunoglobulin and other things).Before the administration of the drug, 250-500 mg of methylprednisolone is injected intravenously to prevent the reaction to a heterogeneous protein.

    When transplanting organs and tissues to prevent a crisis of rejection the drug is administered daily at a dose of 10-15 mg / kg body weight of the patient for 10-14 days after transplantation. Depending on the condition of the transplanted organ (tissue) and the patient's condition, the administration of the drug can be continued in the same doses for another 5-7 days.

    To suppress the beginning of rejection reaction the drug is prescribed daily at a dose of 15-25 mg / kg for 10-14 days. If necessary, the term of treatment can be extended to the 21st day.

    For the treatment of aplastic anemia Antilimfolin is prescribed in a daily dose of 15-25 mg / kg body weight of the patient for 5 days. The drug is administered intravenously drip for 6-8 hours. Simultaneously, in order to prevent serum sickness for 1-5 days intravenously drip in a 0.9% solution of sodium chloride, inject methylprednisolone 2 mg / kg, followed by a transition to oral administration, a gradual dose reduction and a complete cancellation by day 14.

    The dose of the drug is individualized according to the results of laboratory blood tests.After infusion of the drug after 1-5 hours, the number of lymphocytes decreases by 20-70% of the initial level.

    The amount of the drug administered during the infusion is determined by the selected individual single dose (in mg / kg of body weight), the weight of the patient and the protein content in the ampoule (indicated on the label).

    Side effects:

    In some cases, the administration of the drug may be accompanied by a chill, an increase in the patient's body temperature to 37.5-38 ° C. These phenomena are due primarily to the specific lymphocytotoxic effect of the drug and the release of pyrogens from the destroyed lymphocytes. They develop usually 1-3 hours after the administration of Antilympholin and disappear after 4-5 hours, without requiring special therapy.

    Sometimes in patients on the 6th-8th day after the start of the course of intensive immunosuppressive therapy Antilympholin, there may be manifestations of serum sickness caused by the presence of a heterogeneous protein in the preparation: skin rash, malaise, headache, back pain, muscles, joints. In such cases, conventional desensitizing therapy with antiallergic drugs (10% calcium gluconate or calcium chloride solution, 1% chloropyramine solution and others) is recommended.If there are more severe manifestations of the syndrome of serum sickness (draining papular rashes on the skin, Quincke's edema, a drop in blood pressure), epinephrine (0.3-0.5 ml 0.1% solution intramuscularly), glucocorticosteroid hormones, and other antihistamines are additionally shown. It is possible to conduct plasmapheresis.

    In cases of severe manifestations of serum sickness, the subsequent use of Antimipholin should be discontinued.

    If further immunosuppressive therapy is necessary, in such patients, a drug obtained from the serum of other animals should be used.

    Possible reactions associated with immunosuppressive action - the risk of developing infectious diseases (it is recommended to use in combination with glucocorticosteroids, antibiotics or other antimicrobial agents, taking into account the patient's condition and the degree of inhibition of cellular and humoral immunity parameters).

    Long-term use of Antilympholin may promote the development of severe infections.

    Overdose:

    When an overdose of the drug may occur in a patient with leukopenia. The drug is discontinued.

    Interaction:

    The simultaneous use of antilimfolin with antibiotics, glucocorticosteroid drugs, cardiovascular, antihistamines, blood components and preparations does not adversely affect the patient's body.

    Combination of Antilimfolin with cyclosporine or azathioprine in the treatment of the rejection reaction of the transplanted organ causes an increase in the immunosuppressive effect of the drug
    Special instructions:

    The use of antilympholin should be carried out only in a hospital under the supervision of qualified medical personnel.

    Form release / dosage:Lyophilizate for solution for infusion.
    Packaging:

    For 50, 100 mg in ampoules.

    10 ampoules with instructions for use in a pack of cardboard.

    Storage conditions:

    In dry, protected from light, out of reach of children, at a temperature of + 5 ° to +15 ° C.

    Dissolved drug is not subject to storage.

    Shelf life:

    2 years.

    Do not use after the time specified on the package.

    Terms of leave from pharmacies:On prescription
    Registration number:P N002359 / 01
    Date of registration:22.07.2008
    Expiration Date:Unlimited
    The owner of the registration certificate:RUSSIAN RESEARCH INSTITUTE OF GERONTOLOGY OF ROSZDRAVA, FGU RUSSIAN RESEARCH INSTITUTE OF GERONTOLOGY OF ROSZDRAVA, FGU Russia
    Manufacturer: & nbsp
    Information update date: & nbsp16.08.2017
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