Simulect Use In Pregnancy & Lactation

Pregnancy: Risk Summary: There is no adequate information for use in pregnant women. Simulect should not be given to pregnant women except in cases where the potential benefit for the mother outweighs the potential risk for the fetus.
Animal Data: No maternal toxicity, embryotoxicity, or teratogenicity was observed in cynomolgus monkeys 100 days post coitum following intravenous bolus injections of up to 5 mg/kg basiliximab administered twice weekly during the organogenesis period.
Lactation: There is no animal or human data available concerning excretion of basiliximab into breast milk. However, since Simulect is an immunoglobulin G (IgG_1K) antibody, it may cross the human placenta and may be excreted in human milk.
Women receiving Simulect should not breastfeed for 4 months following the last dose.
Females and males of reproductive potential: Contraception: Females of reproductive potential should use adequate contraception to prevent pregnancy and continue its use for an additional 4 months after the last dose of Simulect.
Infertility: No human data on the effect of basiliximab on fertility are available. Formal studies of the potential effect of Simulect on animal fertility have not been conducted.