Animal studies have revealed evidence of reduced fetal weights, increased rates of digit and limb malformations in offspring, and increased number of stillborn pups. This drug did not affect the fertility, mating, or reproductive performance of adult male and female rats, but male rats displayed altered sperm quantity and quality that were reversible following an 8-week recovery period. There are no controlled data in human pregnancy.

US: To monitor the outcomes of pregnant women exposed to this drug, a pregnancy registry has been established. Physicians are encouraged to register patients and pregnant women are encouraged to register themselves by calling 1-855-633-8479.

US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

UK: Use during pregnancy is contraindicated.
US: Avoid use during pregnancy unless the benefits to the patient outweigh the potential risks to the fetus.

Comments: A serum pregnancy test should be obtained prior to treatment initiation and effective contraception should be used during therapy in women of childbearing potential.

US FDA pregnancy category: C

See references

A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the benefit of breastfeeding to the child and the benefit of the drug to the mother.

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

Comments: The effects in the nursing infant are unknown.

This drug is not likely to reach the bloodstream of the infant or cause any adverse effects in breastfed infants due to its poor oral absorption. However, an alternative medication may be considered during breastfeeding as there is no lactation literature available for this drug.

See references