Inlyta Use In Pregnancy & Lactation

Pregnancy: Axitinib may cause fetal harm when administered to a pregnant woman. Studies in pregnant mice have shown that axitinib caused toxic effects to the fetus (see Pharmacology: Toxicology: Preclinical safety data under Actions).
There are no adequate and well-controlled studies in pregnant women using axitinib. Women of childbearing potential should be advised to avoid becoming pregnant while receiving axitinib. If this drug is used during pregnancy, or if a patient becomes pregnant while receiving this drug, the patient should be apprised of the potential hazard to the fetus.
Lactation: No studies have been conducted in humans to assess the effect of axitinib on milk production, its presence in breast milk, or its effects on the breast-fed child. It is unknown whether axitinib is excreted in human milk.
Since many drugs are commonly excreted in human milk, and because of the potential for serious adverse reactions in nursing infants due to exposure to axitinib, a decision should be made whether to discontinue nursing or to discontinue axitinib, taking into account the importance of the drug to the mother.