Nibinase Use In Pregnancy & Lactation

Pregnancy: There are no reported studies in pregnant women using sunitinib.
Studies in animals have reported reproductive toxicity including fetal malformations. 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 child-bearing 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 reported 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 reported during the pre-weaning and post-weaning periods at 3 mg/kg/day. No development toxicity was reported at 1 mg/kg/day (approximate exposure ≥0.9 times the AUC in patients administered the RDD).
Sunitinib did not cause genetic damage when tested in reported in vitro assays (bacterial mutation [AMES Assay], human lymphocyte chromosome aberration) and in vivo rat bone marrow micronucleus test.
Fertility: Based on reported non-clinical findings, male and female fertility may be compromised by treatment with sunitinib.
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 breast-feed while taking sunitinib.