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SIMULECT
Organ rejection prophylaxis
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Drug Name:

SIMULECT Rx

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

Company:
Novartis Pharmaceuticals Corp

Therapeutic Use:

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.

Warnings/Precautions:

Previously-treated with basiliximab; monitor for severe hypersensitivity reactions in subsequent treatment. Risk of lymphoproliferative disorders and opportunistic infections; monitor. Elderly. Pregnancy (Cat.B); use effective contraception before, during and for 4 months after therapy. Nursing mothers: not recommended.

Interactions:

Concomitant vaccines: immune response may be impaired.

Pharmacological Class:

Interleukin-2 antagonist.

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

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