Cabozantinib - Warnings and Precautions
The following warnings and precautions are taken directly from the US FDA-approved drug label for Cabozantinib. This is the same information dispensing pharmacists read.
5 WARNINGS AND PRECAUTIONS Hemorrhage: Do not administer CABOMETYX if recent history of hemorrhage.
Perforations and Fistulas: Monitor for symptoms.
Discontinue CABOMETYX for Grade 4 fistula or perforation.
Thromboembolic Events: Discontinue CABOMETYX for myocardial infarction or serious venous or arterial thromboembolic events.
Hypertension and Hypertensive Crisis: Monitor blood pressure regularly.
Interrupt for hypertension that is not adequately controlled with anti-hypertensive therapy.
Discontinue CABOMETYX for hypertensive crisis or severe hypertension that cannot be controlled with anti-hypertensive therapy.
Cardiac Failure: Monitor patients for signs and symptoms of cardiac failure throughout treatment.
Diarrhea: May be severe.
Interrupt CABOMETYX until diarrhea resolves or decreases to ≤Grade 1, resume at reduced dose.
Recommend standard antidiarrheal treatments.
Palmar-Plantar Erythrodysesthesia (PPE): Interrupt CABOMETYX treatment until PPE resolves or decreases to Grade 1.
Hepatotoxicity: When used in combination with nivolumab, higher frequencies of Grade 3 and 4 ALT and AST elevation may occur than with CABOMETYX alone.
Monitor liver enzymes before initiation of and periodically throughout treatment.
Consider withholding CABOMETYX and/or nivolumab, initiating corticosteroid therapy, and/or permanently discontinuing the combination for severe or life- threatening hepatotoxicity.
Adrenal Insufficiency: When used in combination with nivolumab, primary or secondary adrenal insufficiency may occur.
For Grade 2 or higher adrenal insufficiency, initiate symptomatic treatment, including hormone replacement as clinically indicated.
Withhold CABOMETYX and/or nivolumab depending on severity.
Proteinuria: Monitor urine protein.
Interrupt CABOMETYX until proteinuria resolves to ≤ Grade 1, resume CABOMETYX at a reduced dose.
Discontinue for nephrotic syndrome.
Osteonecrosis of the jaw (ONJ): Withhold CABOMETYX for at least 3 weeks prior to invasive dental procedures and for development of ONJ.
Impaired Wound Healing: Withhold CABOMETYX for at least 3 weeks before elective surgery.
Do not administer for at least 2 weeks following major surgery and adequate wound healing.
The safety of resumption of CABOMETYX after resolution of wound healing complications has not been established.
Applies to YOU?
Some warnings apply only to specific age groups, health conditions, or other medicines. Ask GoDavaii AI to filter which of these 114+ warnings apply to your profile.
Ask Health AI \u2192