basiliximab

FDA Drug Profile — Simulect

Drug Details

Generic Name
basiliximab
Brand Names
Simulect
Application Number
BLA103764
Sponsor
Novartis Pharmaceuticals Corporation
NDC Codes
4
Dosage Forms
INJECTION, POWDER, FOR SOLUTION, LIQUID
Routes
INTRAVENOUS
Active Ingredients
BASILIXIMAB

Indications and Usage

INDICATIONS AND USAGE Simulect ® (basiliximab) is indicated for the prophylaxis of acute organ rejection in patients receiving renal transplantation when used as part of an immunosuppressive regimen that includes cyclosporine, USP (MODIFIED), and corticosteroids. The efficacy of Simulect for the prophylaxis of acute rejection in recipients of other solid organ allografts has not been demonstrated.

Warnings

WARNINGS. See Boxed WARNING.