Safety and efficacy have not been established during pregnancy.
-According to some authorities: Use is contraindicated.

AU TGA pregnancy category: D
US FDA pregnancy category: Not assigned.

Risk Summary: In animal studies, this drug caused an increase in early resorptions and maternal and embryofetal toxicity consisting of increased postimplantation loss, embryolethality, and fetal death.

Comments:
-This drug is not indicated for use in females.
-This drug can cause fetal harm and loss of pregnancy.
-Men should use effective contraception throughout treatment and for up to 6 months after the last dose.
-Due to potential exposure via seminal liquid, men should prevent contact with the ejaculate by another person throughout treatment.
-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 hazard to the fetus.

Animal studies have shown that this drug is embryotoxic, fetotoxic, and abortifacient. This drug crosses the placental barrier. There are no adequate or well-controlled studies in pregnant women.

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 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.

See references

Approximately 1.5% of the dose administered to the mother is expected to be excreted into maternal milk.

Safety and efficacy have not been established during breastfeeding.
-According to some authorities: Use is contraindicated.

Excreted into human milk: Unknown
Excreted into animal milk: Yes

Comments: There is a potential for serious adverse reactions in nursing infants.

See references