-Animal studies have revealed evidence of fetal harm including embryofetal death, abortion, reduced fetal weight, minor skeletal anomalies, and severe external or soft tissue malformations such as the absence of a lower jaw, tongue, stomach, and spleen. Maternotoxicity has occurred in rats at or above the recommended human dose including splenomegaly, reduced maternal weight gain, and decreased food consumption.
-There are no controlled data in human pregnancy.
-If this drug is used during pregnancy, or if the patient becomes pregnant while receiving this drug, the patient should be apprised of the potential hazard to the fetus.

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 is only recommended for use during pregnancy when there are no alternatives and the benefit outweighs the risk.

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

Comments: Women of childbearing age should be advised to avoid becoming pregnant while they or their male partner are receiving this drug and should use effective contraception during and up to 3 months after treatment.

See references

AU, UK: Use is contraindicated.
US: 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: Unknown

The effects in the nursing infant are unknown.

See references