HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use CABOMETYX safely and effectively. See full prescribing information for CABOMETYX.
CABOMETYX ® (cabozantinib) tablets, for oral use
Initial U.S. Approval: 2016
INDICATIONS AND USAGE
CABOMETYX is a kinase inhibitor indicated for the treatment of patients with advanced renal cell carcinoma (RCC) who have received prior anti-angiogenic therapy. (1)
DOSAGE AND ADMINISTRATION
Recommended Dose: 60 mg orally, once daily. (2.1)
Instruct patients not to eat for at least 2 hours before and at least 1 hour after taking CABOMETYX. (2.1)
Do NOT substitute CABOMETYX tablets with cabozantinib capsules. (2.1)
DOSAGE FORMS AND STRENGTHS
20 mg, 40 mg, and 60 mg tablets. (3)
CONTRAINDICATIONS
None (4)
WARNINGS AND PRECAUTIONS
Hemorrhage: Do not administer CABOMETYX if recent history of severe hemorrhage. (5.1)
GI Perforations and Fistulas: Monitor for symptoms. Discontinue CABOMETYX for fistulas that cannot be adequately managed or perforations. (5.2)
Thrombotic Events: Discontinue CABOMETYX for myocardial infarction, cerebral infarction, or other serious arterial thromboembolic events. (5.3)
Hypertension and Hypertensive Crisis: Monitor blood pressure regularly. Discontinue CABOMETYX for hypertensive crisis or severe hypertension that cannot be controlled with anti-hypertensive therapy. (5.4).
Diarrhea: May be severe. Interrupt CABOMETYX treatment immediately until diarrhea resolves or decreases to Grade 1. Recommend standard antidiarrheal treatments. (5.5)
Palmar-plantar erythrodysesthesia syndrome (PPES): Interrupt CABOMETYX treatment until PPES resolves or decreases to Grade 1. (5.6)
Reversible posterior leukoencephalopathy syndrome (RPLS): Discontinue CABOMETYX. (5.7)
Embryo-Fetal Toxicity: Can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception. (5.8, 8.1, 8.3)
ADVERSE REACTIONS
The most commonly reported (≥ 25%) adverse reactions are: diarrhea, fatigue, nausea, decreased appetite, palmar-plantar erythrodysesthesia syndrome (PPES), hypertension, vomiting, weight decreased, and constipation. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Exelixis, Inc. at 1-855-500-3935 or FDA at 1-800-FDA-1088 or WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
Strong CYP3A4 inhibitors: Reduce the CABOMETYX dosage. (2.2, 7)
Strong CYP3A4 inducers: Increase the CABOMETYX dosage. (2.2, 7)
USE IN SPECIFIC POPULATIONS
Mild to Moderate Hepatic Impairment: Reduce the CABOMETYX dosage. (2.2, 8.6)
Lactation: Advise not to breastfeed while taking CABOMETYX. (8.2)
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.
Revised: 4/2016
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1 Recommended Dose
2.2 Dosage Adjustments
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Hemorrhage
5.2 GI Perforations and Fistulas
5.3 Thrombotic Events
5.4 Hypertension and Hypertensive Crisis
5.5 Diarrhea
5.6 Palmar-Plantar Erythrodysesthesia Syndrome
5.7 Reversible Posterior Leukoencephalopathy Syndrome
5.8 Embryo-fetal Toxicity
6 ADVERSE REACTIONS
6.1 Clinical Trial Experience
7 DRUG INTERACTIONS
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.2 Lact |
