Animal studies have revealed evidence of embryotoxicity and teratogenicity (external, visceral, and skeletal abnormalities). 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 D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

Use is contraindicated.

AU TGA pregnancy category: D
US FDA pregnancy category: D

Comments:
-This drug can harm a developing fetus.
-Adequate methods of contraception should be encouraged.
-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:
-The effects in the nursing infant are unknown.
-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. Breastfeeding should be avoided for at least a week after a dose. Higher dosages probably require a longer abstinence period. Some experts consider breastfeeding to be contraindicated during therapy.

See references