Dosing for CABOMETYX® (cabozantinib) aRCC monotherapy
CABOMETYX aRCC monotherapy dosing1
|RECOMMENDED STARTING DOSE*||60 mg once daily|
|FIRST REDUCTION||40 mg once daily|
|SECOND REDUCTION||20 mg once daily*|
You may need to adjust the CABOMETYX dose based on individual patient safety and tolerability.
For Intolerable Grade 2 ARs, Grade 3-4 ARs, and ONJ
Wait until improvement or resolution (return to baseline or resolution to Grade 1)
Restart CABOMETYX at a dose reduced by 20mg
For patients who previously received CABOMETYX at 20 mg once daily:
RESTART CABOMETYX at 20 mg once daily if tolerated, otherwise DISCONTINUE
- ONJ occurred in <1% of patients treated with CABOMETYX. Withhold CABOMETYX for development of ONJ until complete resolution
- Withhold CABOMETYX for at least 3 weeks prior to elective surgery. Do not administer CABOMETYX for at least 2 weeks after major surgery and until adequate wound healing is observed
- Permanently discontinue CABOMETYX for Grade 3 or 4 hemorrhage, development of a GI perforation or Grade 4 fistula, acute myocardial infarction or Grade 2 or higher cerebral infarction, Grade 3 or 4 arterial thromboembolic events or Grade 4 venous thromboembolic events, Grade 4 hypertension/hypertensive crisis or Grade 3 hypertension/hypertensive crisis that cannot be controlled, nephrotic syndrome, or reversible posterior leukoencephalopathy syndrome
- Modify dose for certain patients with hepatic impairment and patients taking drugs known to strongly induce or inhibit CYP3A4
DO NOT ADMINISTER CABOMETYX WITH FOOD
Administer CABOMETYX at least 1 hour before or at least 2 hours after eating
DO NOT CRUSH TABLET
- Do not substitute CABOMETYX tablets with cabozantinib capsules
Guidance for your patients if they miss a dose1
If the next scheduled dose is:
IN LESS THAN 12 HOURS
- Do not make up the missed dose
- Take the next dose at the usual time
IN 12 HOURS OR MORE
- Talk to your doctor or nurse if you miss a dose.
Recommended dose of CABOMETYX for patients with hepatic impairment1
Child-Pugh B: Reduce the starting dose of CABOMETYX to 40 mg once daily in patients with moderate hepatic impairment.
- Avoid CABOMETYX in patients with severe hepatic impairment (Child-Pugh C)
When strong CYP3A4 inhibitors cannot be avoided1
Reduce the daily dose of CABOMETYX if concomitant use with strong CYP3A4 inhibitors cannot be avoided.
Resume CABOMETYX at the dose used prior to initiating the strong CYP3A4 inhibitor 2-3 days after discontinuation of the strong inhibitor.
Examples of strong CYP3A4 inhibitors:†
- Grapefruit juice
When strong CYP3A4 inducers cannot be avoided1
Increase the daily dose of CABOMETYX if concomitant use with strong CYP3A4 inducers cannot be avoided.
Resume CABOMETYX at the dose used prior to initiating the strong CYP3A4 inducer 2-3 days after discontinuation of the strong inducer.
- Do not exceed a daily dose of 80 mg
Examples of strong CYP3A4 inducers:†
- St. John’s wort
†Examples listed may not be comprehensive.