Animal studies have failed to reveal evidence of embryotoxicity, fetotoxicity, malformations, or postnatal development impairment. There are no controlled data in human pregnancy.

AU TGA pregnancy category B2: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals are inadequate or may be lacking, but available data show no evidence of an increased occurrence of fetal damage.

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 if the benefit outweighs the risk.

AU TGA pregnancy category: B2
US FDA pregnancy category: Not assigned.

Risk summary: There are insufficient data available with use of this drug in pregnant women to inform a drug-related risk.

Comment: Effective contraception (at least 2 reliable forms) is required during therapy and for 1 to 2 months after the last dose; local protocol should be consulted regarding contraception timing.

See references

Use is not recommended and a decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.

Excreted into human milk: Unknown
Excreted into animal milk: Yes

Comments: The effects in the nursing infant are unknown.

Significant concentrations of this drug were found in the breastmilk of animal models, though there are no data regarding the presence of this drug in human milk, its effects on the breastfed infant, or on lactation.

See references