In animal studies, no teratogenicity was demonstrated in rats and rabbits with combined oral and subcutaneous administration during organogenesis at doses approximately 51 (rat) and 115 (rabbit) times human exposure. Pre and postnatal development studies have demonstrated no adverse effects in rat offspring with oral administration at doses approximately 10 times human exposure. 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 decision and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D and X are being phased out.

Benefit should outweigh risk

US FDA pregnancy category: Not assigned

Risk summary: No data available on use of this drug in pregnant women to inform a drug-related risk.

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Benefit should outweigh risk
UK: A decision should be made to 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: Yes

Comments: The effects in the nursing infant are unknown.

In rats administered oral doses of 1.8, 3, and 10 times human exposure, mean concentrations on lactation day 12 were 2.78, 5.49, and 44.02 ng/mL, respectively. There is no data on the presence of this drug in human milk, the effects on the breastfed infant, or the effect on milk production.

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