Dosing for CABOMETYX® (cabozantinib) DTC monotherapy
In patients who are RAI-R (or ineligible) and progressed on a prior VEGFR-targeted therapy1
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CABOMETYX is available in three tablet strengths1
RECOMMENDED STARTING DOSE* |
FIRST REDUCTION |
SECOND REDUCTION |
|
---|---|---|---|
Adult; pediatric† BSA ≥ 1.2 m2 |
![]() daily |
![]() daily |
![]() daily |
Pediatric† BSA < 1.2 m2 |
![]() daily |
![]() daily |
![]() every other day |
Adult; pediatric† BSA ≥ 1.2 m2 |
Pediatric† BSA < 1.2 m2 |
|
---|---|---|
RECOMMENDED STARTING DOSE* | ![]() daily |
![]() daily |
FIRST REDUCTION | ![]() daily |
![]() daily |
SECOND REDUCTION | ![]() daily |
![]() every other day |
-
Tablets shown are not actual size.
- *
-
Until disease progression or unacceptable toxicity administered as recommended.
- †
-
Pediatric defined as patients 12 years of age and older.
How to take CABOMETYX1

Take CABOMETYX at least 1 hour before or at least 2 hours after eating

Swallow whole
DO NOT CRUSH TABLET
- Withhold CABOMETYX for at least 3 weeks prior to elective surgery, including dental surgery. Do not administer CABOMETYX for at least 2 weeks after major surgery and until adequate wound healing is observed
- Do not substitute CABOMETYX tablets with cabozantinib capsules
- Do not administer CABOMETYX with food
- 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 CYP3A4
You can modify CABOMETYX dosing for safety and tolerability.1
For intolerable Grade 2 AEs, Grade 3-4 AEs and ONJ

Withhold CABOMETYX

Wait until improvement or resolution (return to baseline or resolution to Grade 1)

Restart CABOMETYX at a dose reduced by 20 mg
If previously receiving the lowest dose, resume at same dose. If lowest dose not tolerated, discontinue CABOMETYX.1
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.1
Pharmacokinetics
The predicted terminal half-life of CABOMETYX is approximately 99 hours.1
During the COSMIC-311 trial, the median average daily dose was 42.0 mg2
The overall efficacy results of CABOMETYX in the COSMIC-311 trial were achieved in the context of dose modifications1,3

CABOMETYX
discontinuation rates
due to AEs§
(Placebo 0%)

CABOMETYX
dose withholds
(Placebo 27%)

CABOMETYX
dose reductions
(Placebo 5%)
The most frequent adverse reactions (≥5%) leading to dose reduction of CABOMETYX were PPE, diarrhea, fatigue, proteinuria, and decreased appetite. Dose interruptions occurred in 72% patients receiving CABOMETYX. Adverse reactions requiring dosage interruption in ≥5% of patients were PPE, diarrhea, dyspnea, hypertension, decreased appetite and proteinuria.1
-
§AEs leading to discontinuation included fatigue (n=2), arthralgia (n=1), diarrhea (n=1), hypercalcemia (n=1), hypertension (n=1), large-intestine perforation (n=1), increased liver function test (n=1), myalgia (n=1), and renal impairment (n=1); one patient could have more than one treatment-related AE.2
AE=adverse event; BSA=body surface area; CYP3A4=cytochrome P450 family 3 subfamily A member 4; GI=gastrointestinal; ONJ=osteonecrosis of the jaw; PPE=palmar-plantar erythrodysesthesia; RAI-R=radioactive iodine-refractory; VEGFR=vascular endothelial growth factor receptor.
References:
- CABOMETYX® (cabozantinib) Prescribing Information. Exelixis, Inc, 2022.
- Brose MS, Robinson B, Sherman SI, et al. Cabozantinib for radioiodine-refractory differentiated thyroid cancer (COSMIC-311): a randomized, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2021;22(8):1126-1138. doi.org/10.106/S1470-2045(21)00332-6.
- Brose MS, Robinson B, Sherman SI, et al. Cabozantinib for radioiodine-refractory differentiated thyroid cancer (COSMIC-311): a randomised, double-blind, placebo-controlled, phase 3 trial [supplementary appendix]. Lancet Oncol. 2021;22(8):1126-1138. doi. org/10.1016/ S1470-2045(21)00332-6.