Finished product reference
Basiliximab
Injection, Powder, for Solution · Parenteral · 20 mg
- List code
- 7377
- Pharmacologic class
- Interleukin-2 Receptor Blocking Antibody
WARNING Only physicians experienced in immunosuppression therapy and management of organ transplantation patients should prescribe Simulect ® (basiliximab). The physician responsible for Simulect administration should have complete information requisite for the follow-up of the patient.
What it is and how it works
Mechanism class: Interleukin 2 Receptor Antagonists · Interleukin 2 Receptor-directed Antibody Interactions
Indications
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.
Dosage and administration (summary)
DOSAGE AND ADMINISTRATION Simulect ® (basiliximab) is used as part of an immunosuppressive regimen that includes cyclosporine, USP (MODIFIED) and corticosteroids. Simulect is for central or peripheral intravenous administration only. Reconstituted Simulect should be given either as a bolus injection or diluted to a volume of 25 mL (10-mg vial) or 50 mL (20-mg vial) with 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP and administered as an intravenous infusion over 20 to 30 minutes. Bolus administration may be associated with nausea, vomiting and local reactions, including pain.
Contraindications
CONTRAINDICATIONS Simulect ® (basiliximab) is contraindicated in patients with known hypersensitivity to basiliximab or any other component of the formulation. See composition of Simulect under DESCRIPTION. WARNINGS. See Boxed WARNING. General Simulect ® (basiliximab) should be administered under qualified medical supervision. Patients should be informed of the potential benefits of therapy and the risks associated with administration of immunosuppressive therapy.
Warnings and precautions
WARNINGS. See Boxed WARNING.
Storage and supply
HOW SUPPLIED Simulect ® (basiliximab) is supplied in a single-dose glass vial. Each carton contains one of the following 1 Simulect 10 mg vial…………………………………………………….NDC 0078-0393-61 1 Simulect 20 mg vial…………………………………………………….NDC 0078-0331-84 Store lyophilized Simulect under refrigerated conditions at 2ºC to 8ºC (36ºF to 46ºF).
Source: Basiliximab (Simulect) — US FDA prescribing information, 2025-12-12, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.
Reference information for professional sourcing and registration enquiries, not medical advice or a promotion. Drug information is condensed from US FDA prescribing information (public domain, via openFDA and DailyMed) and does not replace the product’s approved labelling in Iran. Availability, origin and documentation are confirmed per enquiry.
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