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Basiliximab

SIMULECT

Therapeutic Indications

Basiliximab is indicated for:

Prophylaxis of acute organ rejection in de novo allogeneic renal transplantation

Irrespective of gender only Children (1 year - 12 years old) , Adolescents (12 years - 18 years old)

Basiliximab is indicated for the prophylaxis of acute organ rejection in de novo allogeneic renal transplantation in adult and paediatric patients (1-17 years). It is to be used concomitantly with ciclosporin for microemulsion- and corticosteroid-based immunosuppression, in patients with panel reactive antibodies less than 80%, or in a triple maintenance immunosuppressive regimen containing ciclosporin for microemulsion, corticosteroids and either azathioprine or mycophenolate mofetil.

For this indication, the medical literature mentions below treatments (click for details):

Treatment 1: Intravenous - 10-20 mg 2 hours prior to transplantation surgery and 10-20 mg 4 days after transplantation

Prophylaxis of acute organ rejection in de novo allogeneic renal transplantation

Irrespective of gender only Adults (18 years old or older)

Basiliximab is indicated for the prophylaxis of acute organ rejection in de novo allogeneic renal transplantation in adult and paediatric patients (1-17 years). It is to be used concomitantly with ciclosporin for microemulsion- and corticosteroid-based immunosuppression, in patients with panel reactive antibodies less than 80%, or in a triple maintenance immunosuppressive regimen containing ciclosporin for microemulsion, corticosteroids and either azathioprine or mycophenolate mofetil.

For this indication, the medical literature mentions below treatments (click for details):

Treatment 1: Intravenous - 20 mg 2 hours prior to transplantation surgery and 20 mg 4 days after transplantation

Contraindications

Active ingredient Basiliximab is contraindicated in the following cases:

Lactation

No gender/age discrimination

Simulect is contraindicated in lactation. Basiliximab has potentially hazardous immunosuppressive effects with respect to the course of the suckling neonate exposed to basiliximab in breast milk.

There is no animal or human data available concerning excretion of basiliximab into breast milk. However, based on the IgG1 nature of basiliximab, excretion into milk should be expected. Breast-feeding must therefore be avoided.

Pregnancy

No gender/age discrimination

Simulect is contraindicated in pregnancy. Basiliximab has potentially hazardous immunosuppressive effects with respect to the course of gestation. Women of childbearing potential must use effective contraception during and up to 16 weeks after treatment.