This drug should not be used during pregnancy or in patients of childbearing potential not using contraception.
-According to some authorities: Use is contraindicated.

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

Risk summary: Based on animal data, this drug may cause fetal harm; no data available on use of this drug in pregnant women.

Comments:
-A pregnancy exposure registry is available.
-Patients of childbearing potential should have pregnancy status verified before starting this drug.
-Patients of childbearing potential should be advised to use effective contraception during therapy and for at least 1 month after the last dose; local protocol should be consulted regarding contraception timing.

Animal studies have revealed evidence of fetal harm at maternotoxic doses. After oral administration to pregnant rabbits during organogenesis at doses at least 4 times the human exposure at the maximum recommended human dose (MRHD), an increased incidence of cardiac ventricular septal defect with truncus arteriosus communis and maternal toxicity (decreased body weight gain and food intake), which may have led to late spontaneous abortions and resorptions, were observed; no maternal toxicity or abortions/resorptions and no malformations of the heart and major vessels were seen in rabbits at an exposure about equal to the human exposure at the MRHD. After oral administration to pregnant rats during organogenesis, no developmental toxicity was observed up to the highest dose (36 times the human exposure [total AUC] at the MRHD); maternal toxicity (decreased body weight gain and food intake) was seen at doses at least 10 times the human exposure at the MRHD, but there was no maternal toxicity at 4 times the human exposure at the MRHD. In rats, drug-related material was transferred across the placenta, with fetal plasma levels of about 67% maternal levels on gestation day 19. There are no controlled data in human pregnancy.

To monitor the outcomes of pregnant women exposed to this drug, a pregnancy registry has been established. Health care providers should report exposure by calling 1-877-888-4231.

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.

See references

Breastfeeding is not recommended during use of this drug.
-According to some authorities: A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother and breastfeeding for the child.

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

Comments:
-The effects in the nursing infant are unknown; there is the potential for serious adverse reactions.

See references