Cabometyx Dosage

Recommended Dose

Do not substitute CABOMETYX tablets with cabozantinib capsules.

The recommended oral daily dose of CABOMETYX is 60 mg. Do not administer CABOMETYX with food. Instruct patients not to eat for at least 2 hours before and at least 1 hour after taking CABOMETYX. Continue treatment until patient no longer experiences clinical benefit or experiences unacceptable toxicity.

Swallow CABOMETYX tablets whole. Do not crush CABOMETYX tablets.

Do not take a missed dose within 12 hours of the next dose.

Do not ingest foods (e.g., grapefruit, grapefruit juice) or nutritional supplements that are known to inhibit cytochrome P450 during CABOMETYX treatment [see Drug Interactions (7)].

Dosage Adjustments

For Patients Undergoing Surgery

Stop treatment with CABOMETYX at least 28 days prior to scheduled surgery, including dental surgery.[see Warning and Precautions (5.1)].

For Adverse Reactions

Management of Grade ≤3 adverse reactions may require dose modifications and/or supportive care. If dose reduction is required, a 20 mg decrease from the previously administered dose is recommended. If Grade ≤3 adverse reaction is intolerable, withhold CABOMETYX. Withhold CABOMETYX for NCI CTCAE Grade 4 adverse reactions.

If the dose was withheld, 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:

• development of unmanageable fistula or GI perforation
• severe hemorrhage
• arterial thromboembolic event (e.g., myocardial infarction, cerebral infarction)
• hypertensive crisis or severe hypertension despite optimal medical management
• nephrotic syndrome
• reversible posterior leukoencephalopathy syndrome

In Patients Concurrently Taking a Strong CYP3A4 Inhibitor

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 CYP3A4 inhibitor 2 to 3 days after discontinuation of the strong inhibitor [see Drug Interactions (7), Clinical Pharmacology (12.3)].

In Patients Concurrently Taking a Strong CYP3A4 Inducer

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 CYP3A4 inducer 2 to 3 days after discontinuation of the strong inducer. The daily dose of CABOMETYX should not exceed 80 mg [see Drug Interactions (7), Clinical Pharmacology (12.3)].

In Patients with Hepatic Impairment

Reduce the starting dose of CABOMETYX to 40 mg once daily in patients with mild or moderate hepatic impairment. CABOMETYX is not recommended for use in patients with severe hepatic impairment [see Use in Specific Populations (8.6), Clinical Pharmacology (12.3)].