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No studies have been performed in pregnant or lactating 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.
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.
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.
