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 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.

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 contraindicated.

AU TGA pregnancy category: D
US FDA pregnancy category: IV: Not assigned; Oral: D

Risk Summary: Based on animal data this drug can cause fetal harm when administered to a pregnant woman. It was teratogenic in animal studies following administration during organogenesis. The solvent, DMA, may also cause fetal harm when administered to a pregnant woman. DMA at doses of approximately 40% of the daily dose of DMA in the busulfan dose on a mg/m2 basis given during organogenesis caused significant developmental anomalies.

Comments:
-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.
-This drug and DMA can impair fertility in men or women.
-Men should not to father a child during therapy and up to 6 months after completing therapy and should seek advice on cryoconservation of sperm prior to treatment because of the possibility of irreversible infertility.

See references

Most sources consider breastfeeding to be contraindicated during maternal antineoplastic drug therapy. It might be possible to breastfeed safely during intermittent therapy with a period of breastfeeding abstinence, although minimal data are available to determine an appropriate period to withhold breastfeeding.

Use is contraindicated.

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

Comments:
-Because of the potential for tumorigenicity in human and animal studies, breastfeeding should be discontinued during therapy with this drug.
-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