Cabometyx Dosage

Important Dosage Information

• Stop treatment with CABOMETYX at least 3 weeks prior to scheduled surgery, including dental surgery [see Warnings and Precautions (5.1, 5.8, 5.9)].
• Do not substitute CABOMETYX tablets with cabozantinib capsules.
• Do not administer CABOMETYX with food. Administer at least 1 hour before or at least 2 hours after eating [see Clinical Pharmacology (12.3)].
• Swallow CABOMETYX tablets whole. Do not crush CABOMETYX tablets.
• Do not take a missed dose within 12 hours of the next dose.
• Modify the dose for certain patients with hepatic impairment and for patients taking drugs known to strongly induce or inhibit CYP450 [see Dosage and Administration (2.5, 2.6, 2.7)].

Recommended Dosage for Renal Cell Carcinoma

The recommended dosage of CABOMETYX is 60 mg once daily without food until the patient no longer experiences clinical benefit or experiences unacceptable toxicity.

Recommended Dosage for Hepatocellular Carcinoma

The recommended dosage of CABOMETYX is 60 mg once daily without food until disease progression or unacceptable toxicity.

Dosage Modifications for Adverse Reactions

Withhold CABOMETYX for:

• Intolerable Grade 2 adverse reactions
• Grade 3 or 4 adverse reactions
• Osteonecrosis of the jaw

Upon resolution/improvement (i.e., return to baseline or resolution to Grade 1) of an adverse reaction, reduce the dose as follows:

• If previously receiving 60 mg daily dose, resume treatment at 40 mg daily.
• If previously receiving 40 mg daily dose, resume treatment at 20 mg daily.
• If previously receiving 20 mg daily dose, resume at 20 mg if tolerated, otherwise, discontinue CABOMETYX.

Permanently discontinue CABOMETYX for any of the following:

• Severe hemorrhage
• Development of gastrointestinal (GI) perforation or Grade 4 fistula
• Acute myocardial infarction or arterial or venous thromboembolic events that require medical intervention
• Severe hypertension that cannot be controlled with anti-hypertensive therapy or hypertensive crisis
• Nephrotic syndrome
• Reversible posterior leukoencephalopathy syndrome

Dosage Modifications for Coadministration with Strong CYP3A4 Inhibitors

Reduce the daily CABOMETYX dose by 20 mg (for example, from 60 mg to 40 mg daily or from 40 mg to 20 mg daily). Resume the dose that was used prior to initiating the strong CYP3A4 inhibitor 2 to 3 days after discontinuation of the strong inhibitor [see Drug Interactions (7.1), Clinical Pharmacology (12.3)].

Dosage Modifications for Coadministration with Strong CYP3A4 Inducers

Increase the daily CABOMETYX dose by 20 mg (for example, from 60 mg to 80 mg daily or from 40 mg to 60 mg daily) as tolerated. Resume the dose that was used prior to initiating the strong CYP3A4 inducer 2 to 3 days after discontinuation of the strong inducer. Do not exceed a daily dose of 80 mg [see Drug Interactions (7.1), Clinical Pharmacology (12.3)].

Dosage Modifications for Patients with Moderate and Severe Hepatic Impairment

Reduce the starting dose of CABOMETYX to 40 mg once daily in patients with moderate hepatic impairment (Child-Pugh B). Avoid CABOMETYX in patients with severe hepatic impairment (Child-Pugh C) [see Use in Specific Populations (8.6), Clinical Pharmacology (12.3)].