In animal studies, an IV dose of this drug about 1/20th of the human dose on a mg/m2 basis during organogenesis caused maternal toxicity, embryotoxicity, and teratogenicity (e.g., skeletal abnormalities, exencephaly, encephalocele, anophthalmia); higher doses of about 1/7th and 1/2 of human dose on a mg/m2 basis resulted in 90% and 100% embryonic resorptions. There are no controlled data in human pregnancy; however, based on animal studies, this drug is expected to be teratogenic 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 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 not recommended.

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

Risk Summary: Based on animal data and its mechanism of action, this drug can cause fetal harm when administered to a pregnant woman. This drug was teratogenic in animal studies.

Comments:
-This drug can harm a developing fetus.
-Advise women of childbearing potential to avoid becoming pregnant.
-If this drug is used during pregnancy, or if the patient becomes pregnant while receiving this drug, the patient should be appraised of the potential hazard to the fetus.
-Studies in male animals indicate that this drug causes irreversible atrophy of the testes with accompanying spermatogenesis defects in the testes and epididymis, and reduced seminal vesicle and prostrate secretions.
-Both males and females being treated with this drug should use adequate contraception during therapy and up to 6 months after ending therapy.
-Patients should receive genetic consultation if the patient wishes to have children after ending the therapy with this drug.
-Because this drug may decrease male fertility, preservation of sperm may be considered for later fatherhood.

See references

Most sources consider breastfeeding to be contraindicated during maternal antineoplastic drug therapy. It may be possible to breastfeed safely during intermittent therapy with this drug after an appropriate period of breastfeeding abstinence; however, experts differ on the appropriate length of abstinence. 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.

UK: Use is contraindicated
(AU, US): A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.

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

Comments:
-The effects in the nursing infant are unknown.

See references