Animal studies have revealed evidence of embryotoxicity and teratogenicity. 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: This drug can cause fetal harm when administered to a pregnant woman based on the mechanism of action and findings in animals. Animal studies revealed embryotoxicity and teratogenicity (e.g., thoracoabdominal closure, neural tube, and eye defects and malformations of the skeletal system of the fetus) when given in doses lower than the maximum cumulative human dose based on body surface area.

Comments:
-Advise female patients of reproductive potential to use highly effective contraception during therapy and for 6 months after.
-Advise males with female partners of reproductive potential to use effective contraception during therapy and for at least 3 months after.
-Male fertility may be compromised by this drug.
-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

Use is contraindicated.

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

Comments:
-Because of the potential for serious adverse events (e.g., carcinogenicity, myelosuppression) in nursing infants, nursing should be discontinued while taking this drug.
-The manufacturer recommends that breastfeeding be discontinued during therapy and for one month after.

No information is available on the use of this drug during breastfeeding. Most experts consider breastfeeding to be contraindicated during maternal antineoplastic drug therapy, especially alkylating agents.

See references