Clinical and pharmacological group: & nbsp

Immunosuppressive drugs

Included in the formulation
  • Zenapax
    solution d / infusion 
    Hoffmann-La Roche Ltd.     Switzerland
  • АТХ:

    L.04.A.C.01   Daclizumab

    Pharmacodynamics:

    The drug is a humanized monoclonal mouse antibody. Acts as an antagonist of interleukin-2 receptors by binding to the alpha chain of the interleukin-2 receptor, which is expressed on the surface of activated T-lymphocytes.

    As a result of specific binding of the antibody to the antigen, the activity of T-lymphocytes is suppressed and, as a result, the immune response is inhibited.

    Pharmacokinetics:

    The drug is administered intravenously, the therapeutic effect is achieved with a serum concentration of 0.5-0.9 μg / ml. The half-life in patients with a transplanted kidney is between 270 and 919 hours (an average of 480 hours).

    Indications:

    Prevention of rejection of the transplanted kidney (as part of a combination therapy).

    XXI.Z80-Z99.Z94   Presence of transplanted organs and tissues

    Contraindications:

    Hypersensitivity.

    Carefully:

    Age over 65 years. Diabetes mellitus, infections, malignant tumors (including in the anamnesis).

    Pregnancy and lactation:

    Category FDA - C. Controlled studies on humans were not performed. Daclizumab penetrates the placenta.Women of reproductive age before, during and for several months after completion of daclizumab therapy are recommended to use effective methods of contraception.

    There is no information on the penetration into breast milk. It is recommended to stop breastfeeding while taking daclizumab.

    Dosing and Administration:

    Intravenous administration of 1 mg / kg for 15 minutes 24 hours before surgery, then every 2 weeks after surgery. One course of treatment requires 5 doses.

    Side effects:

    From the nervous system: tingling and cramps in the legs, anxiety, headache, depression, impaired vision, dizziness, tremor, insomnia.

    On the part of the organs of the gastrointestinal tract: constipation or diarrhea, abdominal pain, nausea, vomiting, dyspepsia, hemorrhoids, flatulence, gastritis, epigastric pain.

    From the cardiovascular system: bleeding or thrombosis, hypertension or hypotension, tachycardia.

    From the genitourinary system: fluid retention, hematuria, kidney damage, oliguria, dysuria, lymphocele, hydronephrosis, hematuria, urinary retention.

    From the skin: acne, deterioration of skin regeneration, reactions at the injection site, itching, rash, sweating.

    From the musculoskeletal system: pain in the muscles and bones, pain in the joints.

    From the respiratory system: pulmonary edema, cough, shortness of breath, wheezing, rhinitis, pharyngitis, hypoxia, atelectasis, pleural effusion.

    Other: hypersensitivity to the drug.

    Overdose:

    Cases of overdose are not clinically described.

    Interaction:

    Not compatible with other solutions.

    Special instructions:

    During the course of treatment, it is necessary to have in immediate access the means for stopping the allergic reaction.

    Instructions
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