SIMULECT FOR INJECTION 20 MG/VIAL [SIN10441P]
Active ingredients: BASILIXIMAB
Last updated on 9 October 2026
Product Info
SIMULECT FOR INJECTION 20 MG/VIAL
[SIN10441P]
Product information
Active Ingredient and Strength | BASILIXIMAB - 20 MG/VIAL |
Dosage Form | INJECTION, POWDER, FOR SOLUTION |
Manufacturer and Country | NOVARTIS PHARMA STEIN AG - SWITZERLAND |
Registration Number | SIN10441P |
Licence Holder | NOVARTIS (SINGAPORE) PTE LTD |
Forensic Classification | PRESCRIPTION ONLY MEDICINES |
Anatomical Therapeutic Chemical (ATC) code | L04AC02 |
Prescription-only Medicines with Exemptions for Supply without Prescription | NA |
Indication
INDICATIONS
Simulect is indicated for the prophylaxis of acute organ rejection in de novo renal transplantation in adult and pediatric patients. It is to be used concomitantly with ciclosporin for microemulsion- and corticosteroid-based immunosuppression or in a triple maintenance immunosuppressive regimen containing ciclosporin for microemulsion, corticosteroids and either azathioprine or mycophenolate mofetil.
Dosing
DOSAGE REGIMEN AND ADMINISTRATION
Dosage regimen
General target population:
Adults
The standard total dose is 40 mg, given in two doses of 20 mg each. The first 20 mg dose should be given within 2 hours prior to transplantation surgery. Simulect must not be administered unless it is absolutely certain that the patient will receive the graft and concomitant immunosuppression. The second 20 mg dose should be given 4 days after transplantation. The second dose should be withheld if severe hypersensitivity reactions to Simulect or graft loss occur (see section WARNINGS AND PRECAUTIONS – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).
Special populations:
Pediatric patients (below 18 years)
In pediatric patients weighing less than 35 kg, the recommended total dose is 20 mg, given in two doses of 10 mg each. In pediatric patients weighing 35 kg or more, the recommended dose is the adult dose, i.e. a total dose of 40 mg, given in two doses of 20 mg each. The first dose should be given within 2 hours prior to transplantation surgery. Simulect must not be administered unless it is absolutely certain that the patient will receive the graft and concomitant immunosuppression. The second dose should be given 4 days after transplantation. The second dose should be withheld if severe hypersensitivity reactions to Simulect or graft loss occur (see section WARNINGS AND PRECAUTIONS – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).
No studies have been performed in pediatric patients below one year of age. (see section Clinical Pharmacology – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).
Geriatric patients (65 years or above)
There are limited data available on the use of Simulect in the elderly, but there is no evidence that elderly patients require a different dosage from younger adult patients.
Method of administration
Reconstituted Simulect can be administered either as an intravenous infusion over 20–30 minutes or as a bolus injection.
For information on reconstituting Simulect, see section INSTRUCTIONS FOR USE AND HANDLING – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.
Contraindications
CONTRAINDICATIONS
Simulect is contraindicated in patients with known hypersensitivity to basiliximab or any other component of the formulation (see section DESCRIPTION AND COMPOSITION/Excipients – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).