Oral administration of this drug to pregnant animals during organogenesis caused maternal toxicity, fetal malformations, and embryofetal death at doses below the maximum recommended equivalent human dose. 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 is not recommended.

US FDA pregnancy category: Not assigned.

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

Comments:
-This drug can harm a developing fetus.
-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.
-Advise females of reproductive potential to use effective contraception during therapy and for 1 month after.
-Advise males with female partners of reproductive potential to use effective contraception during therapy and for 1 month after.
-This drug can impair fertility in females and males of reproductive potential.

See references

Use is not recommended.

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

Comments:
-Because of the potential for serious adverse reactions in a breastfed child, advise a lactating woman not to breastfeed during therapy and for 1 month after the last dose.

See references