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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).
Lactation: Rapamune is excreted in trace amounts in milk of lactating rats. It is not known whether sirolimus is excreted in human milk. Because many drugs are excreted into human milk and because of the potential for adverse reactions in nursing infants from sirolimus, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
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