Animal studies have revealed evidence of teratogenicity and maternal toxicity including death. Animal data also show this drug may impair male and female fertility. 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.

Use should be avoided as this drug can cause fetal harm.

US FDA pregnancy category: Not Assigned

Comments:
-Pregnancy testing should be performed in females of reproductive potential prior to treatment initiation and intermittently during treatment.
-Females of reproductive potential should avoid becoming pregnant and be advised to use effective contraception during treatment and for at least 3 months after the last dose.
-Sexually active men should be advised to use condoms during treatment and for 6 months after last dose.

See references

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: Data not available

Comments: The effects in the nursing infant are unknown.

See references