Use should be avoided. If used during pregnancy or if pregnancy occurs, apprise the patient of potential hazard to the fetus.

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

As angiogenesis is a critical component of embryonic and fetal development, this drug is expected to cause fetal harm if administered to pregnant women. Animal data have revealed teratogenicity, embryotoxicity, and fetotoxicity in rats and rabbits. Fetal skeletal malformations of the ribs and vertebrae were observed in rats and cleft lip and cleft palate were observed in rabbits. There are no controlled data in human pregnancy.

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.

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Animal studies have reported that sunitinib and its metabolites were extensively excreted in milk at concentrations up to twelve times higher than in plasma.

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: Yes

Comments: The effects in the nursing infant are unknown.

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