Safety has not been established during pregnancy.

US FDA pregnancy category: Not assigned.

Risk summary: No data on this drug's use in pregnant women is available to inform a drug-related risk.

Comments:
-Highly effective contraception is required during treatment with this drug and for one week after the last dose.
-Advise pregnant patients of the potential risk to a fetus.

Animal studies have revealed evidence of embryofetal toxicity, including visceral and skeletal variations, malformations, and decreased fetal and maternal body weight. This drug was toxic to animals and caused malformations at 2-6 times higher than the maximum recommended human dose (MRHD). There are no controlled data in human pregnancy.

See references

Breastfeeding is not recommended during the use of this drug.

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

Comments:
-The effects on nursing infants are unknown.
-Advise women not to breastfeed during treatment and for 1 week after the last dose.

See references