The drug may cause fetal harm and may impair reproductive function and fertility. In animal reproduction studies, administration during organogenesis at exposures similar to those expected with the maximum recommended human dose resulted in embryotoxicity and fetotoxicity. Animal embryo-fetal development studies have revealed evidence of an increase postimplantation loss, and reduced fetal body weights, but have failed to show teratogenicity. 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 is not recommended.

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

Risk Summary: Based on findings from animal studies and its mechanism of action, this drug can cause fetal harm when administered to a pregnant woman.

Comments:
-This drug can harm a developing fetus.
-Verify the pregnancy status of females of reproductive potential prior to initiating treatment.
-Females of reproductive potential should use effective contraception during therapy and for at least 45 days after the last dose.
-Because of the potential for genotoxicity, males with female partners of reproductive potential should use condoms during therapy and for at least 90 days after the last dose.

See references

Use is not recommended.

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

Comments:
-Because of the potential for adverse reactions in breastfed children, women should not breastfeed during therapy and for 45 days after the last dose.

No information is available on the use of this drug during breastfeeding. Because it is 91% bound to plasma proteins, the amount in milk is likely to be low; however, its half-life is about 42 hours and it might accumulate in the infant.

See references