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Pregnancy Category D: There are no studies in pregnant women using SUTENT. Studies in animals have shown reproductive toxicity including fetal malformations (see Preclinical Safety Data under Precautions). SUTENT should not be used during pregnancy or in women not using effective contraception, unless the potential benefit justifies the potential risk to the fetus. If SUTENT is used during pregnancy or if the patient becomes pregnant while on treatment with SUTENT, the patient should be apprised of the potential hazard to the foetus. Women of childbearing potential should be advised to use effective contraception and avoid becoming pregnant while receiving treatment with SUTENT.
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).
Nursing Mothers: : 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 active substances are commonly excreted in human milk and because of the potential for serious adverse reactions in nursing infants, women should not breast-feed while taking SUTENT.
