• Organ rejection prophylaxis

Simulect Generic Name & Formulations

General Description

Basiliximab (recombinant) 10mg, 20mg; per vial; pwd for IV inj or infusion after reconstitution/dilution; contains mannitol; preservative-free.

Pharmacological Class

Interleukin-2 antagonist.

How Supplied

Single-use vial—1

Simulect Indications


Organ rejection prophylaxis in renal transplant patients, in combination with cyclosporine and corticosteroids.

Simulect Dosage and Administration

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.

Simulect Contraindications

Not Applicable

Simulect Boxed Warnings

Boxed Warning

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

Simulect 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.

Simulect Pharmacokinetics

See Literature

Simulect Interactions


Concomitant vaccines: immune response may be impaired.

Simulect Adverse Reactions

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).

Simulect Clinical Trials

See Literature

Simulect Note

Not Applicable

Simulect Patient Counseling

See Literature