This drug causes teratogenic effects, embryotoxicity, abortion, and fetal defects in humans. It has also been reported to cause impairment of fertility, oligospermia and menstrual dysfunction in humans, during and for a short period after cessation of therapy.

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 X: Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits.

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.

AU, UK: Use is contraindicated.
US: Use is contraindicated for all indications except oncology.

AU TGA pregnancy category: D
US FDA pregnancy category: X (psoriasis and rheumatoid arthritis); Not assigned (all other conditions)

Risk Summary: This drug can cause teratogenic effects or fetal death when administered to a pregnant woman.

Comments:
-This drug should be used in the treatment of neoplastic diseases only when the potential benefit outweighs the risk to the fetus.
-This drug impairs fertility.
-Women of childbearing potential should not be started on this drug until pregnancy is excluded and should be fully counseled on the serious risk to the fetus should they become pregnant while undergoing treatment.
-Pregnancy should be avoided if either partner is receiving this drug, during and for a minimum of 3 months after therapy is completed for male patients, and during and for at least one ovulatory cycle after therapy is completed for female patients.

See references

Use is contraindicated.

Excreted into human milk: Yes

Comments:
-This drug may be toxic to nursing infants.
-Most sources consider breastfeeding to be contraindicated during maternal high-dose antineoplastic drug therapy with this drug. An abstinence period of at least one week after chemotherapy doses has been suggested.

Limited information indicates that a maternal dose of up to 65 mg (or 50 mg/m2) produces low levels of this drug in milk, leading some experts to state that low single or weekly doses, such as those used for ectopic pregnancy or rheumatoid arthritis, are of low risk to the breastfed infant, although some expert opinion warns against this use.

See references