This drug should be used during pregnancy only if the benefit outweighs the risk to the fetus.

US FDA pregnancy category: Not assigned.

Risk Summary: Insufficient data exist to inform a drug-associated risk.

Comments: 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.

Animal studies have revealed adverse developmental outcomes at doses greater than or equal to 4 mg/kg/day (approximately 23 times the AUC observed in humans at the recommended clinical dose of 3 mg once a day). 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.

See references

Breastfeeding is not recommended during use of this drug and for at least 28 days after the last dose.

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

Comments:
-Lactating women should interrupt breastfeeding and pump and discard breast milk during use of this drug and for 28 days after the last dose to minimize exposure to a breastfed child.
-The effects in the nursing infant are unknown.

See references