Available in 3 strengths to help you find the right dose for your patients when needed1

Recommended
starting dose

down
60 mg CABOMETYX Dose

First reduction

down
40 mg CABOMETYX Dose

Second reduction

20 mg CABOMETYX Dose

Tablets shown are not actual size.

  • Do not substitute CABOMETYX tablets with cabozantinib capsules

Pharmacokinetics1

  • The predicted terminal half-life is approximately 99 hours
icon-data

Additional details around dosing and administration

Download the guide

You may need to adjust the CABOMETYX dose based on individual patient safety and tolerability1

If ARs occur, consider supportive care and/or adjust the dose

FOR INTOLERABLE GRADE 2 ARs, OR GRADE 3-4 ARs

Withhold Dosagenext
 

Withhold

CABOMETYX

next
Wait for Improvementnext
 

Wait

Until improvement or resolution (return to baseline or resolution to Grade 1)

next
Restart CABOMETYX
 

Restart

For patients who previously received 60 mg or 40 mg: RESTART CABOMETYX at a dose reduced by 20 mg

Resume

For patients who previously received 20 mg: RESUME CABOMETYX at 20 mg if tolerated; otherwise, DISCONTINUE

 

  • ONJ occurred in <1% of patients treated with CABOMETYX. Withhold CABOMETYX for development of ONJ until complete resolution
  • Permanently discontinue CABOMETYX for severe hemorrhage, development of a GI perforation or unmanageable fistula, serious thromboembolic event, hypertensive crisis or severe hypertension despite optimal medical management, nephrotic syndrome, or reversible posterior leukoencephalopathy syndrome

Dose Exchange Program: Supporting your patients

CABOMETYX Dose Exchange Program

  • Patients who require a dose reduction will receive a free 15-tablet supply of CABOMETYX in the new lower dose. Additional restrictions and eligibility rules apply
  • To obtain a Dose Exchange Program Form, contact your sales representative, call EASE at 1-844-900-EASE (3273), or visit www.EASE.us

AR=adverse reaction; GI=gastrointestinal; ONJ=osteonecrosis of the jaw.

Dosing

Support your patients who may require a dose reduction with our Dose Exchange Program

Download the form

Modifying the CABOMETYX dose can help to manage ARs1

  aRCC HCC
1L
(CABOSUN)
vs sunitinib
2L
(METEOR)
vs everolimus
2L+
(CELESTIAL)
vs placebo
Dose withholds1,2 73%
71%
70%
59%
84%
37%
Median duration of each dose withhold2 NA 7 days 9 days
Dose reductions1,3 46%
35%
60%
24%
62%
13%
Discontinuations1,3 21%
22%
10%
10%
16%
3%
Mean average daily dose2 49 mg 45 mg 37 mg

The overall efficacy results in the CABOMETYX trials were achieved in the context of dose modifications1

Recommended administration of CABOMETYX1

CABOMETYX Administration 1

Do not take CABOMETYX with food Take CABOMETYX at least 1 hour before or at least 2 hours after eating

CABOMETYX Administration 2

Swallow tablet whole DO NOT CRUSH

CABOMETYX Administration 3

8 oz of water

  • Stop treatment with CABOMETYX at least 28 days prior to scheduled surgery, including dental surgery
  • Do not substitute CABOMETYX tablets with cabozantinib capsules
  • Do not ingest foods (eg, grapefruit or grapefruit juice) or nutritional supplements that are known to inhibit cytochrome P450 during CABOMETYX treatment
  • A high-fat meal increased Cmax and AUC values by 41% and 57%, respectively, relative to fasting conditions in healthy subjects administered a single 140-mg oral dose of cabozantinib capsules
  • Modify the dose for certain patients with hepatic impairment and for patients taking drugs known to strongly induce or inhibit CYP450
    • 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)

aRCC=advanced renal cell carcinoma; AUC=area under the curve; Cmax=maximum concentration; HCC=hepatocellular carcinoma.

 

Guidance for your patients if they miss a dose

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

  • Take the missed dose as soon as possible
  • Take the next dose at the usual time

Drug Interactions1

When strong CYP3A4 inhibitors cannot be avoided

CABOMETYX Interactions 1

Reduce the daily dose of CABOMETYX if concomitant use with strong CYP3A4 inhibitors cannot be avoided.

 

  • Resume CABOMETYX at the dose that was used prior to initiating the strong CYP3A4 inhibitor 2 to 3 days after discontinuation of the strong inhibitor

Examples of strong CYP3A4 inhibitors

Boceprevir, clarithromycin, conivaptan, grapefruit juice, indinavir/ritonavir, itraconazole, ketoconazole, lopinavir/ritonavir, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir/ritonavir, and voriconazole.

When strong CYP3A4 inducers cannot be avoided

CABOMETYX Interactions 2

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 to 3 days after discontinuation of the strong inducer
    • Do not exceed a daily dose of 80 mg

Examples of strong CYP3A4 inducers

Rifampin, phenytoin, carbamazepine, and St. John’s Wort.

 

For more information about CYP3A4 inhibitors and inducers, visit FDA.gov

 

INDICATIONS

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

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

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

Hemorrhage: Severe and fatal hemorrhages occurred with CABOMETYX. The incidence of Grade 3 to 5 hemorrhagic events was 5% in CABOMETYX patients. Discontinue CABOMETYX for Grade 3 or 4 hemorrhage. Do not administer CABOMETYX to patients who have a recent history of hemorrhage, including hemoptysis, hematemesis, or melena.

Perforations and Fistulas: GastrointestinaI (GI) perforations, including fatal cases, occurred in 1% of CABOMETYX patients. Fistulas, including fatal cases, occurred in 1% of CABOMETYX patients. Monitor patients for signs and symptoms of perforations and fistulas, including abscess and sepsis. Discontinue CABOMETYX in patients who experience a fistula that cannot be appropriately managed or a GI perforation.

Thrombotic Events: CABOMETYX increased the risk of thrombotic events. Venous thromboembolism occurred in 7% (including 4% pulmonary embolism) and arterial thromboembolism in 2% of CABOMETYX patients. Fatal thrombotic events occurred in CABOMETYX patients. Discontinue CABOMETYX in patients who develop an acute myocardial infarction or serious arterial or venous thromboembolic event requiring medical intervention.

Hypertension and Hypertensive Crisis: CABOMETYX can cause hypertension, including hypertensive crisis. Hypertension occurred in 36% (17% Grade 3 and <1% Grade 4) of CABOMETYX patients. Do not initiate CABOMETYX in patients with uncontrolled hypertension. Monitor blood pressure regularly during CABOMETYX treatment. Withhold CABOMETYX for hypertension that is not adequately controlled with medical management; when controlled, resume at a reduced dose. Discontinue CABOMETYX for severe hypertension that cannot be controlled with anti-hypertensive therapy or for hypertensive crisis.

Diarrhea: Diarrhea occurred in 63% of CABOMETYX patients. Grade 3 diarrhea occurred in 11% of CABOMETYX patients. Withhold CABOMETYX until improvement to Grade 1 and resume at a reduced dose for intolerable Grade 2 diarrhea, Grade 3 diarrhea that cannot be managed with standard antidiarrheal treatments, or Grade 4 diarrhea.

Palmar-Plantar Erythrodysesthesia (PPE): PPE occurred in 44% of CABOMETYX patients. Grade 3 PPE occurred in 13% of CABOMETYX patients. Withhold CABOMETYX until improvement to Grade 1 and resume at a reduced dose for intolerable Grade 2 PPE or Grade 3 PPE.

Proteinuria: Proteinuria occurred in 7% of CABOMETYX patients. Monitor urine protein regularly during CABOMETYX treatment. Discontinue CABOMETYX in patients who develop nephrotic syndrome.

Osteonecrosis of the Jaw (ONJ): ONJ occurred in <1% of CABOMETYX patients. ONJ can manifest as jaw pain, osteomyelitis, osteitis, bone erosion, tooth or periodontal infection, toothache, gingival ulceration or erosion, persistent jaw pain, or slow healing of the mouth or jaw after dental surgery. Perform an oral examination prior to CABOMETYX initiation and periodically during treatment. Advise patients regarding good oral hygiene practices. Withhold CABOMETYX for at least 28 days prior to scheduled dental surgery or invasive dental procedures. Withhold CABOMETYX for development of ONJ until complete resolution.

Wound Complications: Wound complications were reported with CABOMETYX. Stop CABOMETYX at least 28 days prior to scheduled surgery. Resume CABOMETYX after surgery based on clinical judgment of adequate wound healing. Withhold CABOMETYX in patients with dehiscence or wound healing complications requiring medical intervention.

Reversible Posterior Leukoencephalopathy Syndrome (RPLS): RPLS, a syndrome of subcortical vasogenic edema diagnosed by characteristic finding on MRI, can occur with CABOMETYX. Evaluate for RPLS in patients presenting with seizures, headache, visual disturbances, confusion, or altered mental function. Discontinue CABOMETYX in patients who develop RPLS.

Embryo-Fetal Toxicity: CABOMETYX can cause fetal harm. Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Verify the pregnancy status of females of reproductive potential prior to initiating CABOMETYX and advise them to use effective contraception during treatment and for 4 months after the last dose.

ADVERSE REACTIONS

The most commonly reported (≥25%) adverse reactions are: diarrhea, fatigue, decreased appetite, PPE, nausea, hypertension, and vomiting.

DRUG INTERACTIONS

Strong CYP3A4 Inhibitors: If coadministration with strong CYP3A4 inhibitors cannot be avoided, reduce the CABOMETYX dosage. Avoid grapefruit or grapefruit juice.

Strong CYP3A4 Inducers: If coadministration with strong CYP3A4 inducers cannot be avoided, increase the CABOMETYX dosage. Avoid St. John’s wort.

USE IN SPECIFIC POPULATIONS

Lactation: Advise women not to breastfeed during CABOMETYX treatment and for 4 months after the final dose.

Hepatic Impairment: In patients with moderate hepatic impairment, reduce the CABOMETYX dosage. CABOMETYX is not recommended for use in patients with severe hepatic impairment.

Please see accompanying full Prescribing Information.

References: 1. CABOMETYX® (cabozantinib) Prescribing Information. Exelixis, Inc, 2019. 2. Data on file. Exelixis, Inc. 3. Abou-Alfa GK, Meyer T, Cheng AL, et al. Cabozantinib in patients with advanced and progressing hepatocellular carcinoma. N Engl J Med. 2018;379:54-63. doi:10.1056/NEJMoa1717002.

CABOMETYX now #1 TKI in new prescriptions for aRCC
CABOMETYX now approved in treatment of HCC