aBased on IMS data as of October 2018, subject to change without notice.1
WITH THE FIRST AND ONLY TKI WITH
SUPERIOR EFFICACY TO SUNITINIB2
CABOSUN was a randomized (1:1), open-label, multicenter trial of CABOMETYX vs sunitinib in 157 fi rst-line patients
with advanced RCC who had ≥1 IMDC risk factors.2
FIRST- AND SECOND-LINE aRCC
CABOMETYX® (cabozantinib) is indicated for the treatment of patients with advanced renal cell carcinoma (RCC).
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
fi stulas, including abscess and sepsis. Discontinue CABOMETYX in patients who
experience a fi stula 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.
© 2019 Exelixis, Inc. CA-1000 01/19
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.
IMPORTANT SAFETY INFORMATION
WARNINGS AND PRECAUTIONS