In animal studies, this drug was teratogenic and caused embryofetal toxicity at exposures below the equivalent recommended human dose. Toxicities included increased postimplantation loss, and major malformations of the eyes (anophthalmia, microphthalmia), vertebrae/ribs (extra rib or ossification center; fused or absent neural arches, ribs, and sternebrae), skull (fused exoccipital) and diaphragm (hernia) at dose levels from 0.3% to 11% of the human exposure at the recommended dose. Additional abnormalities were found in the pelvic girdle, lung, thymus, liver, ureter, and umbilical artery. There are no controlled data in human pregnancy.

AU TGA pregnancy category D: Drugs which have caused, are suspected to have caused or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects. Accompanying texts should be consulted for further details.

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.

AU TGA pregnancy category: D
US FDA pregnancy category: Not assigned.

Risk Summary: Based on findings in animals and its mechanism of action, this drug can cause fetal harm when administered to a pregnant woman. Animal studies during the period of organogenesis revealed teratogenicity and embryofetal toxicity at exposures below the equivalent recommended human dose. Apprise pregnant women of the potential hazard to the fetus and the potential risk for loss of the pregnancy.

Comments:
-Female patients of reproductive potential should be encouraged to use effective contraception during therapy and for at least 6 months 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.
-TABLETS: Based on findings from genetic toxicity and animal reproduction studies, advise male patients with female partners of reproductive potential or who are pregnant to use effective contraception during therapy and for 3 months following the last dose.
-TABLETS: Advise male patients not to donate sperm during therapy and for 3 months following the last dose.

See references

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: Data not available

Comments:
-Because of the potential for serious adverse reactions in the breastfed infants, advise women not to breastfeed during therapy with this drug and for one month after the last dose.

No information is available on the use of this drug during breastfeeding. Because it is 82% bound to plasma proteins, the amount in milk is likely to be low.

See references