Clinical and pharmacological group: & nbsp

Immunosuppressive drugs

Included in the formulation
  • Simulect®
    lyophilizate in / in 
    Novartis Pharma AG     Switzerland
  • Included in the list (Order of the Government of the Russian Federation No. 2782-r of 30.12.2014):

    VED

    ONLS

    АТХ:

    L.04.A.C.02   Basiliximab

    Pharmacodynamics:

    It is a chimeric monoclonal antibody against the interleukin-2 receptor. Basiliximab Specifically binds to the alpha chain of the interleukin-2 receptor, antigen Cd25, on the surface of activated Tlymphocytes. Thus, the drug inhibits activation Tlymphocytes by interleukin-2-mediated pathway. In this connection, there is a reduction of the cellular immune response, which plays a major role in the processes of rejection.

    Pharmacokinetics:

    Clearance - 22-60 ml per hour in adults, 16-24 ml per hour in children. Maximum concentration in blood plasma - 4-10.4 days in adults and 5.2-17.8 days in children. The therapeutic concentration of the drug in the blood plasma is 0.2 μg / ml. The maximum concentration in the blood after intravenous administration of 20 mg of the drug is 2-12.2 mg / l.

    Indications:

    Prophylaxis of kidney transplant rejection in patients (as part of complex immunosuppressive therapy).

    XIX.T80-T88.T86.1   Dying and rejection of a kidney transplant

    XXI.Z80-Z99.Z94.0   Presence of a transplanted kidney

    Contraindications:

    Hypersensitivity.

    Carefully:

    Infection; za local tumor (including anamnesis).

    Pregnancy and lactation:

    Action category for the fetus by Food and Drug Administration (US Food and Drug Administration) - B. There were no controlled studies on humans. Basiliximab penetrates the placenta. Women of reproductive age before, during and for 2 months after the completion of basiliximab treatment are encouraged to use contraceptives. There is no information on the penetration into breast milk. The manufacturer recommends that you stop breastfeeding while taking basiliximab.

    Dosing and Administration:

    Enter intravenously (struino or drip) for 20-30 minutes.

    Adults / children weighing more than 40 kg - 20 mg two hours before transplantation and four days after.

    Children weighing less than 40 kg - also two injections, but a dose of 10 mg.

    If a transplant rejection occurs, the second administration is not performed.

    Side effects:

    From the gastrointestinal tract: nausea, vomiting, abdominal pain, dyspepsia, diarrhea, esophagitis, gastroenteritis, flatulence, gastrointestinal bleeding, ulcerative stomatitis, melena, gingival hyperplasia.

    On the part of the respiratory system: respiratory tract infection, dyspnea, bronchospasm, bronchitis, pulmonary edema, rhinitis, sinusitis, pharyngitis, pneumonia, cough.

    From the genitourinary system: infectious diseases of the urinary tract, bladder disorders, dysuria, anuria, renal tubular necrosis, urinary retention, hematuria, oliguria, albuminuria.

    From the cardiovascular system: hypertension, hypotension, heart failure, hematomas, gemmoragiya, purpura, thrombosis, thrombocytopenia, leukopenia, polycythemia, chest pain, arrhythmia, tachycardia, atrial fibrillation, angina, chest pain.

    From the musculoskeletal system: arthralgia, fractures, cramps, arthropathy, back pain.

    From the nervous system and sensory organs: tremor, headache, insomnia; asthenia, malaise, dizziness, neuropathy, hypoesthesia, paresthesia, agitation, anxiety, depression, cataracts, conjunctivitis, blurred vision.

    From the skin: surgical wound complications, herpes, skin ulceration, acne.

    Other: infection, malignant lymphoproliferative disease, pain, fever, edema, cysts, hypoglycemia, hypomagnesemia, increased body weight, hypoproteinemia, allergies.

    Overdose:

    Overdose is not clinically described, treatment is symptomatic.

    Interaction:

    It is not recommended to mix other drugs in one vial and / or concurrently with basiliximab, since there is insufficient information about its compatibility with other drugs.

    Special instructions:

    The drug is diluted in water for injection, saline solution or 5% glucose solution.

    Side effects do not depend on the age of the patient.

    The drug solution contains no preservatives, it should be stored in the refrigerator for no more than 24 hours, the solution for administration should not contain suspensions, sediment, should be transparent.

    The solution should not be shaken (it is possible to foam, in connection with which the concentration of the solution varies).

    Instructions
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