Organ rejection prophylaxis:

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.

Boxed Warning:

Prescribe only by physicians experienced in immunosuppression therapy and management of organ transplantation patients.

Warnings/Precautions:

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.

Pharmacologic Class:

Interleukin-2 antagonist.

Interactions:

Concomitant vaccines: immune response may be impaired.

Adverse Reactions:

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).

How Supplied:

Single-use vial—1