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Sunitinib Pregnancy and Breastfeeding Warnings

Sunitinib is also known as: Sutent

Sunitinib Pregnancy Warnings

Sunitinib has been assigned to pregnancy category D by the FDA. Animal studies have revealed evidence of significant increases in the incidence of embryolethality and structural abnormalities, cleft lip, cleft palate, and developmental effects which consisted of fetal skeletal malformations of the ribs and vertebrae. There are no controlled data in human pregnancy. Sunitinib should only be given during pregnancy when there are no alternatives and benefit outweighs risk.

Because angiogenesis is a critical component of embryonic and fetal development, inhibition of angiogenesis following administration of sunitinib should be expected to result in adverse effects on pregnancy. If sunitinib 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. Women of childbearing potential should be advised to avoid becoming pregnant while receiving treatment with sunitinib. Effects on the female reproductive system were identified in animal studies, where decreased follicular development, endometrial atrophy, and vaginal atrophy were noted. No reproductive effects were observed in male animals dosed for fifty eight days prior to mating with untreated females. Fertility, copulation, conception indices, and sperm evaluation (morphology, concentration, and motility) were unaffected by sunitinib. 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.

Sunitinib Breastfeeding Warnings

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

There are no data on the excretion of sunitinib into 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.

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