Pregnancy: There are no studies of Sirolimus (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).
Sirolimus (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 Sirolimus (Rapamune) therapy.