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Cabozantinib Pregnancy and Breastfeeding Warnings

Cabozantinib is also known as: Cometriq

Cabozantinib Pregnancy Warnings

Embryolethality was observed in animals at exposures below the recommended human dose. Increased loss of pregnancy (at less than 1% of the human exposure by AUC at the recommended dose), delayed ossifications and skeletal variations (at approximately 0.03% of the human exposure by AUC at the recommended dose), and visceral malformations and variations including reduced spleen size and missing lung lobe (at approximately 11% of the human exposure by AUC at the recommended dose) were seen in animal studies. Animal studies showed impairment of male and female fertility. A decrease in sperm counts and reproductive organ weights (at approximately equal to the human exposure by AUC at the recommended dose) and a significant decrease in the number of live embryos and a significant increase in pre- and postimplantation losses (at approximately 50% of the human exposure by AUC at the recommended dose) was observed. In addition, hypospermia and absence of corpora lutea at 6% and 3%, respectively, the human exposure by AUC at the recommended dose and ovarian necrosis equal to the human exposure by AUC at the recommended dose was seen in animals. There are no controlled data in human pregnancy. 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.

FDA pregnancy category: D If used during pregnancy or if patient becomes pregnant, the patient should be warned of the potential hazards to the fetus. Comments: Females and males with female partners of childbearing age should use adequate methods of contraception during treatment and for at least 4 months after the last dose.

Cabozantinib Breastfeeding Warnings

A decision should be made to discontinue breast-feeding or discontinue the drug, taking into account the importance of the drug to the mother. Excreted into human milk: Unknown Excreted into animal milk: Unknown The effects in the nursing infant are unknown.

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