Animal studies have revealed evidence of embryotoxicity (e.g., fetal death, post-implantation loss, low fetal weight, structural abnormalities) and maternal toxicity at 0.3 to 10 times the maximum recommended human dose (MRHD). There are no controlled data in human pregnancy. It is not known whether this drug can cause fetal harm or adversely affect reproductive capacity in humans.

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 is not recommended.

US FDA pregnancy category: Not assigned.

Risk Summary: Based on findings from animal studies and the mechanism of action, this drug can cause fetal harm when administered to a pregnant woman.

Comments:
-Adequate methods of contraception should be encouraged.
-If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential harm to the fetus.

See references

Use is not recommended.

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

Comments:
-The effects in the nursing infant are unknown.
-The manufacturer recommends that women do not breastfeed during therapy and for at least 1 month after the last dose.

See references