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Pregnancy: There are no studies of Rapamune use in pregnant women. In animal studies, embryo/fetal toxicity was manifested as mortality and reduced fetal weights (with associated delays in skeletal ossification) (see Pharmacology: Toxicology: Preclinical safety data under Actions).
Rapamune should be used during pregnancy only if the potential benefit outweighs the potential risk to the embryo/fetus (see Precautions).
[Need for effective contraception: see statement in Precautions].
Lactation: Sirolimus is excreted in trace amounts in milk in lactating rats. It is not known whether sirolimus is excreted into human milk. A decision should be made whether to discontinue breast feeding or to discontinue Rapamune therapy.
