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Women of child-bearing potential: Women of child-bearing potential should use adequate contraception to prevent pregnancy and continue its use for an additional 4 months after the last dose of Simulect.
Pregnancy: 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.
Breast-feeding: There is no animal or human data available concerning excretion of basiliximab into breast milk. However, since Simulect is an immunoglobulin G (IgG1κ) 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.
Fertility: 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 (see Pharmacology: Toxicology: NON-CLINICAL SAFETY DATA under Actions).
