Animal studies have revealed that administering this drug during organogenesis resulted in embryofetal lethality and structural anomalies at exposures that were below those occurring clinically at the recommended human dose. There are no controlled data in human pregnancy. It is not known whether this drug can cause fetal harm or adversely affect reproductive capacity in humans.

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:
-All patients and their partners should use effective contraception during therapy and for at least 4 months after completion, and advised to consider fertility preservation before treatment.
-Patients using contraceptive steroids should use an additional contraceptive method, such as a barrier method, since the effect of this drug on contraceptive steroids has not been investigated and unchanged contraceptive effect may not be guaranteed.
-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.

See references

Because this drug is more than 97% bound to plasma proteins, the amount in milk is likely to be low; however, its half-life ranges from 55 to 99 hours and it might accumulate in the infant.

Use is not recommended.

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

Comments:
-The effects in the nursing infant are unknown.
-Breastfeeding is not recommended during use of this drug, and for at least 4 months after completion of therapy.

See references