SIMULECT FOR INJECTION 20 mg/vial

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.

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).

DOSAGE AND ADMINISTRATION

Dosage

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 (1–17 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).

Geriatric patients (≥ 65 years)

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.