Inlyta Use In Pregnancy & Lactation

Women of childbearing potential: Women of childbearing potential must use effective contraception during and up to 1 week after treatment.
Pregnancy: Axitinib may cause fetal harm when administered to a pregnant woman. Axitinib was teratogenic, embryotoxic and fetotoxic in mice at exposures lower than human exposure at the recommended starting dose. Oral axitinib administered twice daily to female mice prior to mating and through the first week of pregnancy caused an increase in post-implantation loss at all dose tested (≥15 mg/kg/dose, approximately 10 times the systemic exposure (AUC) in patients at the recommended starting dose). In an embryo-fetal developmental toxicity study, pregnant mice received oral doses of 0.15, 0.5 and 1.5 mg/kg/dose axitinib twice daily during the period of organogenesis. Embryo-fetal toxicities observed in the absence of maternal toxicity included malformation (cleft palate) at 1.5 mg/kg/dose (approximately 0.5 times the AUC in patients at the recommended starting dose) and variation in skeletal ossification at ≥0.5 mg/kg/dose (approximately 0.15 times the AUC in patients at the recommended starting dose) (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. Axitinib should not be used during pregnancy unless the clinical condition of the woman requires treatment with this medicinal product. 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. A risk to suckling child cannot be excluded.
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 benefit of breast feeding for child and the benefit of therapy for the woman.
Fertility: Based on non-clinical findings, axitinib has the potential to impair reproductive function and fertility in humans (see Pharmacology: Toxicology: Preclinical safety data under Actions).