Animal studies have revealed evidence of embryotoxicity, teratogenicity, abortifacient effects, and adverse effects to fertility when administered to either the male or the female of the species. 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.

This drug should be used during pregnancy only if the benefit outweighs the risk.

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

Comments:
-This drug can cause fetal harm when administered to a pregnant woman.
-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.
-Women of childbearing potential should be advised to avoid pregnancy.
-Aspermia has been reported in men; animal studies show metaphase arrest and degenerative changes in germ cells.

See references

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:
-Most experts consider breastfeeding to be contraindicated during maternal antineoplastic drug therapy.
-It is probably impractical to resume breastfeeding after therapy with this drug is discontinued because of its long half-life.
-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.

See references