AU: Use during pregnancy is contraindicated.
UK, US: Use of this drug is not recommended during pregnancy, especially during the first trimester, based on the results of animal studies and the pharmacological action of this drug.

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

Comments:
-Advise women of childbearing potential to avoid becoming pregnant by using effective contraception during and up to 4 months after treatment.
-Instruct male patients not to father a child by using effective contraception during and up to 6 months after treatment, and to seek advice on sperm conservation prior to treatment due to the potential genotoxic and irreversible anti-fertility effects of this drug.

Animal studies have revealed developmental mortality (increased early resorptions, decreased live fetuses, decreased live births, post-implantation loss), and adverse effects on embryo-fetal development (decreased fetal weight, delayed ossification) at maternal doses that were significantly lower than the recommended human dose based on body surface area. Effects on fertility have been observed in some, but not all, animal studies. There are no controlled data in human pregnancy; however, this drug is presumed to be likely toxic to the human fetus at the recommended therapeutic dose.

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.

See references

AU, UK: Use is contraindicated during breastfeeding.
US: A decision should be made to discontinue breastfeeding or to 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