Cabozantinib Tablets

Warning and Precautions

Hemorrhage: Do not administer Cabozantinib if you have a recent history of hemorrhage. 

• Perforations and Fistulas: Monitor for symptoms. Discontinue Cabozantinib for unmanageable fistula or GI perforation. 
• Thrombotic Events: Discontinue Cabozantinib for myocardial infarction, cerebral infarction, or other serious thromboembolic events. 
• Hypertension and Hypertensive Crisis: Monitor blood pressure regularly. Interrupt for hypertension that is not adequately controlled with anti-hypertensive therapy. Discontinue Cabozantinib for hypertensive crisis or severe hypertension that cannot be controlled with anti-hypertensive therapy. 
• Diarrhea: May be severe. Interrupt Cabozantinib immediately until diarrhea resolves or decreases to Grade 1. Recommend standard antidiarrheal treatments. 
• Palmar-plantar erythrodysesthesia (PPE): Interrupt Cabozantinib treatment until PPE resolves or decreases to Grade 1. 
• Proteinuria: Monitor urine protein. Discontinue for nephrotic syndrome. 
• Osteonecrosis of the jaw: Withhold Cabozantinib for at least 28 days prior to invasive dental procedures and for development of ONJ. 
• Wound complications: Withhold Cabozantinib for dehiscence or complications requiring medical intervention. 
• Reversible posterior leukoencephalopathy syndrome (RPLS): Discontinue CABOMETYX. 
• Embryo-Fetal Toxicity: Can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception during treatment and for 4 months after the last dose.