CABOMETYX- cabozantinib s-malate tablet
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.
CABOMETYX is indicated for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib.
- 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)].
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:
|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|
The recommended dosage of CABOMETYX is 60 mg once daily without food until disease progression or unacceptable toxicity.
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:
|Recommended Dosage||First Dosage Reduction To||Second Dosage Reduction To|
|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:
|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.
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)].
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)].
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)].
All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.