CABOMETYX may cause serious side effects, including:
Severe bleeding (hemorrhage). Tell your healthcare provider right away if you get any signs of bleeding during treatment with CABOMETYX, including:
coughing up blood or blood clots
vomiting blood or if your vomit looks like coffee-grounds
red or black (looks like tar) stools
menstrual bleeding that is heavier than normal
any unusual or heavy bleeding
A tear in your stomach or intestinal wall (perforation) or an
abnormal connection between 2 parts of your body (fistula). Tell
your healthcare provider right away if you get tenderness or pain
in your stomach-area (abdomen).
Blood clots, stroke, heart attack, and chest pain.
Get emergency help right away if you get:
swelling or pain in your arms or legs
shortness of breath
feel lightheaded or faint
sweating more than usual
numbness or weakness of your face, arm or leg, especially on one side of your body
sudden confusion, trouble speaking or understanding
sudden trouble seeing in one or both eyes
sudden trouble walking
dizziness, loss of balance or coordination
a sudden severe headache
High blood pressure (hypertension). Hypertension is
common with CABOMETYX and sometimes can be severe. Your
healthcare provider will check your blood pressure before
starting CABOMETYX and during treatment with CABOMETYX. If
needed, your healthcare provider may prescribe medicine to
treat your high blood pressure.
Diarrhea. Diarrhea is common with CABOMETYX and can
be severe. If needed, your healthcare provider may prescribe
medicine to treat your diarrhea. Tell your healthcare provider right
away, if you have frequent loose, watery bowel movements.
A skin problem called hand-foot skin reaction.
Hand-foot skin reactions are common and can be severe. Tell your
healthcare provider right away if you have rashes, redness, pain,
swelling, or blisters on the palms of your hands or soles of your
Reversible Posterior Leukoencephalopathy Syndrome
(RPLS). A condition called reversible posterior
leukoencephalopathy syndrome can happen during treatment with
CABOMETYX. Tell your healthcare provider right away if you have
headaches, seizures, confusion, changes in vision, or problems
Your healthcare provider may change your dose, temporarily stop, or
permanently stop treatment with CABOMETYX if you have certain side
The most common side effects of CABOMETYX are:
altered sense of taste
inflamed and sore mouth
Tell your healthcare provider if you have any side effect that bothers
you or that does not go away.
These are not all the possible side effects of CABOMETYX. For more
information, ask your healthcare provider or pharmacist. Call your
doctor for medical advice about side effects. You may report side
effects to FDA at 1-800-FDA-1088.
Before you take CABOMETYX, tell your healthcare provider about all of
your medical conditions, including if you:
have any unusual bleeding
have high blood pressure
Plan to have any surgery, including dental surgery. You should stop treatment with CABOMETYX at least 28 days before any scheduled surgery.
Have liver problems
Are pregnant, or plan to become pregnant. CABOMETYX can harm your unborn baby. If you are able to become pregnant, you should use effective birth control during treatment and for 4 months after your final dose of CABOMETYX. Talk to your healthcare provider about birth control methods that may be right for you. If you become pregnant or think you are pregnant, tell your healthcare provider right away.
Are breastfeeding or plan to breastfeed. It is not known if CABOMETYX passes into your breast milk. Do not breastfeed during treatment and for 4 months after your final dose of CABOMETYX.
Tell your healthcare provider about all the medicines you take,
including prescription or over-the-counter medicines, vitamins, and
herbal supplements. CABOMETYX and certain other medicines may affect
each other causing side effects.
What should I avoid while taking CABOMETYX?
Do not drink grapefruit juice, eat grapefruit or
supplements that contain grapefruit during treatment with CABOMETYX.
What is CABOMETYX?
CABOMETYX is indicated for the treatment of patients with advanced
renal cell carcinoma (RCC).
It is not known if CABOMETYX is safe and effective in children.
the Patient Information in the accompanying full Prescribing Information.