Generic Name and Formulations:
Basiliximab (recombinant) 10mg, 20mg; per vial; pwd for IV inj or infusion after reconstitution/dilution; contains mannitol; preservative-free.
Novartis Pharmaceuticals Corp
Indications for SIMULECT:
Organ rejection prophylaxis in renal transplant patients, in combination with cyclosporine and corticosteroids.
Adults and Children:
Give by bolus inj or IV infusion over 20–30 minutes. <35kg: initially 10mg within 2 hours prior to transplantation, then 10mg 4 days post-transplantation for a total of 2 doses. ≥35kg: initially 20mg within 2 hours prior to transplantation, then 20mg 4 days post-transplantation for a total of 2 doses. Withhold 2nd dose if severe hypersensitivity reactions or graft loss occurs.
Prescribe only by physicians experienced in immunosuppression therapy and management of organ transplantation patients.
Should be administered under qualified medical supervision. Risk of lymphoproliferative disorders and opportunistic infections; monitor. Previously-treated with basiliximab; monitor for severe hypersensitivity reactions in subsequent treatment. Elderly. Pregnancy (Cat.B); use effective contraception before, during and for 4 months after therapy. Nursing mothers: not recommended.
Concomitant vaccines: immune response may be impaired.
GI upset, constipation, peripheral edema, fever, hyper or hypokalemia, hyperglycemia, dyspnea, hypertension, headache, tremor, insomnia, anemia; infections, antibody formation, severe hypersensitivity reactions (discontinue if occurs).