There are no animal studies to evaluate the risk of exposure to the mother or the unborn child. Based on animal toxicology studies, this drug may impair fertility in females of reproductive potential. 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.

This drug should be used during pregnancy only when clearly necessary.

US FDA pregnancy category: Not Assigned

Risk Summary: Based on animal studies and its mechanism of action, this drug can cause fetal harm.

Comments:
-This drug can cause fetal harm when administered to pregnant women.
-Verify the pregnancy status of females of reproductive potential before starting treatment.
-Females of reproductive potential to use effective contraception during treatment and for at least 3 weeks after the last dose.

See references

Breastfeeding is not recommended during use of this drug.

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

Comments:
-This drug should not be used during breastfeeding and for at least 3 weeks following the last dose.
-The effects on the nursing infant and on milk production are unknown.

See references