Animal studies have revealed evidence of embryotoxicity, teratogenicity, and embryofetal lethality. In animal studies at doses less than the equivalent human dose, this drug caused craniofacial malformations, malformed limbs, paws/digits, trunk and tail, dilation of brain, malpositioned/malformed eyes, misshapen head, small tongue, absent palate, teeth and viscera, diaphragmatic hernia, edema, heart defects, rib and vertebral abnormalities, malformed or absent structures in the appendicular skeleton. 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.

US FDA pregnancy category: Not assigned.

Risk Summary: Based on its mechanism of action and findings in animal studies, this drug can cause fetal harm when administered to a pregnant woman. It caused it caused embryotoxicity, fetotoxicity, and teratogenicity when given to animals during organogenesis at maternal exposures that were less than the human exposure at the recommended dose.

Comments:
-This drug can harm a developing fetus.
-Verify negative pregnancy status in females of reproductive potential within 7 days prior to initiating therapy.
-Advise females of reproductive potential to use effective contraception during therapy and for at least 30 days after the last dose.
-Advise males of the potential risk of exposure through semen and to use effective contraception, including a condom, even after a vasectomy, to avoid drug exposure to a pregnant partner or a female partner of reproductive potential during therapy and for at least 30 days after the last dose.
-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.
-It is not known if this drug is present in semen. Advise males to not donate semen during therapy and for at least 30 days after the last dose.
-This drug may impair fertility in males of reproductive potential. Men should seek advice on effective fertility preservation before beginning therapy.

See references

Use should be avoided.

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

Comments:
-There are no data on the presence of this drug or its active metabolites in human milk, the effects of the drug on the breastfed child, or its effect on milk production.
-Because of the potential for serious adverse reactions in a breastfed child, women taking this drug should not breastfeed during therapy and for at least 30 days after the last dose.

-The effects in the nursing infant are unknown.
-This drug can harm a nursing infant.

See references