Pregnancy: There are no studies in pregnant women using sunitinib.
Studies in animals have shown reproductive toxicity including fetal malformations (see Pharmacology: Pharmacokinetics under Actions). Sunitinib should not be used during pregnancy or in any woman not employing adequate contraception unless the potential benefit justifies the potential risk to the fetus. If sunitinib is used during pregnancy, or if the patient becomes pregnant while receiving sunitinib, the patient should be apprised of the potential hazard to the fetus. Women of childbearing potential should be advised to avoid becoming pregnant while receiving treatment with sunitinib.
Sunitinib (0.3, 1.0, 3.0 mg/kg/day) was evaluated in a pre- and post-natal development study in pregnant rats. Maternal body weight gains were reduced during gestation and lactation at >1 mg/kg/day but no maternal reproductive toxicity was observed up to 3 mg/kg/day (estimate exposure >2.3 times the AUC in patients administered the recommended daily dose [RDD]). Reduced offspring body weights were observed during the pre-weaning and post-weaning periods at 3 mg/kg/day. No development toxicity was observed at 1 mg/kg/day (approximate exposure ≥0.9 times the AUC in patients administered the RDD).
Fertility: Based on non-clinical findings, male and female fertility may be compromised by treatment with sunitinib (see Pharmacology: Pharmacokinetics under Actions).
Lactation: Sunitinib and/or its metabolites are excreted in rat milk. It is not known whether sunitinib or its primary active metabolite are excreted in human milk. Because drugs are commonly excreted in human milk and because of the potential for serious adverse reactions in nursing infants, women should not breastfeed while taking sunitinib.