ation
8.3 Females and Males of Reproductive Potential
8.4 Pediatric Use
8.5 Geriatric Use
8.6 Hepatic Impairment
8.7 Renal Impairment
10 OVERDOSAGE
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.2 Pharmacodynamics
12.3 Pharmacokinetics
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
14 CLINICAL STUDIES
16 HOW SUPPLIED/STORAGE AND HANDLING
17 PATIENT COUNSELING INFORMATION
* Sections or subsections omitted from the full prescribing information are not listed. CLOSE
1 INDICATIONS AND USAGE
CABOMETYX is indicated for the treatment of patients with advanced renal cell carcinoma (RCC) who have received prior anti-angiogenic therapy.
2 DOSAGE AND ADMINISTRATION
2.1 Recommended Dose
Do not substitute CABOMETYX tablets with cabozantinib capsules.
The recommended 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.
2.2 Dosage Adjustments
For Patients Undergoing Surgery
Stop treatment with CABOMETYX at least 28 days prior to scheduled surgery, including dental surgery.
For Adverse Reactions
Withhold CABOMETYX for NCI CTCAE Grade 4 adverse reactions, and for Grade 3 or intolerable Grade 2 adverse reactions that cannot be managed with a dose reduction or supportive care.
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. CABO |
