CABOMETYX

CABOMETYX- cabozantinib s-malate tablet
Exelixis, Inc.

1 INDICATIONS AND USAGE

1.1 Renal Cell Carcinoma

CABOMETYX is indicated for the treatment of patients with advanced renal cell carcinoma (RCC).

CABOMETYX, in combination with nivolumab, is indicated for the first-line treatment of patients with advanced RCC.

1.2 Hepatocellular Carcinoma

CABOMETYX is indicated for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib.

2 DOSAGE AND ADMINISTRATION

2.1 Important Dosage Information

  • Stop treatment with CABOMETYX at least 3 weeks prior to scheduled surgery, including dental surgery [see Warnings and Precautions (5.1, 5.10, 5.11)].
  • 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)].

2.2 Recommended Dosage for Renal Cell Carcinoma

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

The recommended dosage of CABOMETYX in combination with nivolumab is provided in the following table:

Table 1. Recommended Dosage of CABOMETYX in Combination with Nivolumab
Recommended Dosage Duration of Therapy
CABOMETYX 40 mg once daily without food until disease progression or unacceptable toxicity
Nivolumab 240 mg every 2 weeks (30-minute intravenous infusion) or 480 mg every 4 weeks (30- minute intravenous infusion) until disease progression or unacceptable toxicity for up to 2 years

2.3 Recommended Dosage for Hepatocellular Carcinoma

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

2.4 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:

Table 2. Recommended Dosage Reductions for CABOMETYX for Adverse Reactions
Recommended Dosage First Dosage Reduction To Second Dosage Reduction To
*
If previously receiving lowest dose, resume at same dose. If lowest dose not tolerated, discontinue CABOMETYX.
CABOMETYX 60 mg daily 40 mg daily 20 mg daily *
CABOMETYX 40 mg daily in combination with nivolumab 20 mg daily 20 mg every other day *

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

The following table represents dosage modifications that are different from those described above for CABOMETYX or in the Full Prescribing Information for the drug administered in combination:

Table 3. Recommended Specific Dosage Modifications for Hepatic Adverse Reactions for Combination
*
Consider corticosteroid therapy for hepatic adverse reactions if CABOMETYX is withheld or discontinued when administered in combination with nivolumab
After recovery, rechallenge with one or both of CABOMETYX and nivolumab may be considered. If rechallenging with nivolumab with or without CABOMETYX, refer to nivolumab Prescribing Information.
CABOMETYX in combination with nivolumab ALT or AST >3 times ULN but ≤10 times ULN with concurrent total bilirubin <2 times ULN Withhold * both CABOMETYX and nivolumab until adverse reactions recover to Grades 0 or 1
ALT or AST >10 times ULN or >3 times ULN with concurrent total bilirubin ≥2 times ULN Permanently discontinue both CABOMETYX and nivolumab

When administering CABOMETYX in combination with nivolumab for the treatment of advanced RCC, refer to the nivolumab prescribing information.

2.5 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)].

2.6 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)].

2.7 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)].

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