Animal studies with oral sirolimus reported evidence of embryo-fetal lethality which suggests administration of oral sirolimus to pregnant women can cause fetal harm. There are no controlled data in human pregnancy.

US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

No data available on use of this drug in pregnant women to inform a drug-related risk.

US FDA pregnancy category: Not assigned

Risk summary: This drug is systemically absorbed after topical administration and may result in fetal exposure.

Comments:
-Effective contraception should be initiated before therapy, during therapy, and for 12 weeks after therapy has been stopped.
-Ovarian cysts and menstrual disorders (including amenorrhea and menorrhagia) have been reported in females with the use of oral sirolimus.
-Azoospermia has been reported with the use of oral sirolimus and has been reversible upon discontinuation in most cases.

See references

Breastfeeding is not recommended during use of this drug.

Excreted into human milk: Data not available
Excreted into animal milk: Yes

After oral administration, sirolimus was present in the milk of lactating rats.

See references