Animal studies have revealed evidence of embryotoxicity and teratogenicity at doses lower than equivalent therapeutic human doses. 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 animal data 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.
-Adequate methods of contraception should be encouraged.
-Advise females of reproductive potential to use effective contraception during therapy and for one month after.
-Because of the potential for genotoxicity, advise males with female partners of reproductive potential to use condoms during therapy and for 4 months.
-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: Yes

Comments:
-This drug can harm a nursing infant.
-Breastfeeding should be avoided for at least a week after a dose. Higher dosages probably require a longer abstinence period.
-Chemotherapy may adversely affect the normal microbiome and chemical makeup of breastmilk.
-Women who receive chemotherapy during pregnancy are more likely to have difficulty nursing their infant.

Limited data indicate that this drug is found in breastmilk for 2 days and its active metabolite is found in breastmilk for up to a week after a dose of 60 mg/m2, although the highest amounts occur during the first 4 days after a dose. Most experts recommend discontinuing breastfeeding during therapy.

See references