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.
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).