What CABOMETYX is
CABOMETYX is a cancer medicine that contains
the active substance cabozantinib.
It is used in adults to treat:
- advanced kidney cancer called advanced renal
cell carcinoma
- liver cancer when a specific anticancer
medicine (sorafenib) is no longer stopping the
disease from progressing.
CABOMETYX may be given in combination with
nivolumab for advanced kidney cancer. It is
important that you also read the package leaflet
of nivolumab. If you have any questions about
these medicines, please ask your doctor.
How CABOMETYX works
CABOMETYX blocks the action of proteins
called receptor tyrosine kinases (RTKs), which
are involved in the growth of cells and the
development of new blood vessels that supply
them. These proteins can be present in high
amounts in cancer cells, and by blocking their
action CABOMETYX can slow down the rate at
which the tumour grows and help to cut off the
blood supply that the cancer needs.

Do not take CABOMETYX
- if you are allergic to cabozantinib or any of
the other ingredients of this medicine (listed in
section 6).
Warnings and precautions
Talk to your doctor or pharmacist before taking
CABOMETYX if you:
- have high blood pressure
- have or have had an aneurysm (enlargement
and weakening of a blood vessel wall) or a tear
in a blood vessel wall
- have diarrhoea
- have a recent history of significant bleeding
- have had surgery within the last month (or if
surgical procedures are planned), including
dental surgery
- have inflammatory bowel disease (for
example, Crohn’s disease or ulcerative colitis,
diverticulitis, or appendicitis)
- have a recent history of blood clot in the leg,
stroke, or heart attack
- have thyroid problems. Your thyroid
function should be checked before you take
CABOMETYX and regularly while you are
taking it. Tell your doctor if you get tired more
easily, generally feel colder than other people,
or your voice deepens whilst taking this
medicine. If your thyroid gland is not producing
enough thyroid hormone, you may be treated
with thyroid hormone replacement
- have liver or kidney disease.
Tell your doctor if any of these affect you.
You may need treatment for them, or your doctor
may decide to change your dose of CABOMETYX
or stop treatment altogether. See also section
4 “Possible side effects”.
You should also tell your dentist that you are
taking CABOMETYX. It is important for you to
practice good mouth care during treatment with
CABOMETYX.

Children and adolescents
CABOMETYX is not recommended for children
or adolescents. The effects of CABOMETYX in
people younger than 18 years old are not known.
Other medicines and CABOMETYX
Tell your doctor or pharmacist if you are taking or
have recently taken any other medicines, including
medicines obtained without a prescription. This is
because CABOMETYX can affect the way some
other medicines work. Also, some medicines
can affect the way CABOMETYX works. This
could mean that your doctor needs to change the
dose(s) that you take. You should tell your doctor
about every medicine, but in particular if taking:
- Medicines that treat fungal infections, such as
itraconazole, ketoconazole and posaconazole
- Medicines used to treat bacterial infections
(antibiotics) such as erythromycin,
clarithromycin, and rifampicin
- Allergy medicines such as fexofenadine
- Medicines to treat angina pectoris (chest pain
owing to inadequate supply to the heart) such
as ranolazine
- Medicines used to treat epilepsy or fits such as
phenytoin, carbamazepine, and phenobarbital
- Herbal preparations containing St. John’s
Wort (Hypericum perforatum), sometimes used
for treating depression or depression-related
conditions such as anxiety
- Medicines used to thin the blood, such as
warfarin and dabigatran etexilate
- Medicines to treat high blood pressure or
other heart conditions, such as aliskiren,
ambrisentan, digoxin, talinolol, and tolvaptan
- Medicines for diabetes, such as saxagliptin
and sitagliptin
- Medicines used to treat gout, such as
colchicine
- Medicines used to treat HIV or AIDS, such as
efavirenz, ritonavir, maraviroc and emtricitabine
- Medicines used to prevent transplant rejection
(ciclosporin) and ciclosporin-based regimens in
rheumatoid arthritis and psoriasis
CABOMETYX with food
Avoid consuming grapefruit-containing products
for as long as you are using this medicine, as they
may increase the levels of CABOMETYX in your
blood.
Pregnancy, breast-feeding and fertility
Avoid becoming pregnant while being treated
with CABOMETYX. If you or your partner could
become pregnant, use adequate contraception
during treatment and for at least 4 months after
treatment has finished. Talk to your doctor about
which methods of contraception are appropriate
while you are taking CABOMETYX (see also under
Other medicines and CABOMETYX, above).
Tell your doctor if you or your partner become
pregnant or plan to become pregnant while you
are being treated with CABOMETYX.
Talk to your doctor BEFORE taking
CABOMETYX if you or your partner are
considering or planning to have a baby after
your treatment has finished. There is a possibility
your fertility could be affected by treatment with
CABOMETYX.
Women taking CABOMETYX should not breastfeed
during treatment and for at least 4 months
after treatment has finished, as cabozantinib and/
or its metabolites may be excreted in breast milk
and be harmful to your child.
If you take CABOMETYX whilst using oral
contraceptives, the oral contraceptives may
be ineffective. You should also use a barrier
contraceptive (e.g. condom or diaphragm) whilst
taking CABOMETYX and for at least 4 months
after treatment has finished.
Driving and using machines
Use caution when driving or using machines.
Keep in mind that treatment with CABOMETYX
may make you feel tired or weak and can affect
your ability to drive or use machines.
CABOMETYX contains lactose
CABOMETYX contains lactose (a type of sugar). If
you have been told by your doctor that you have
an intolerance to some sugars, talk to your doctor
before taking this medicine.
CABOMETYX contains sodium
This medicine contains less than 1 mmol sodium
(23 mg) per tablet, that is to say essentially
“sodium-free”.

Always take this medicine exactly as your doctor
or pharmacist has told you. Check with your
doctor or pharmacist if you are not sure.
You should continue to take this medicine until
your doctor decides to stop your treatment. If you
get serious side effects, your doctor may decide
to change your dose or stop treatment earlier than
originally planned. Your doctor will tell you if you
need your dose adjusted.
CABOMETYX should be taken once a day. The
usual dose is 60 mg, however your doctor will
decide on the right dose for you.

When CABOMETYX is given in combination with
nivolumab for the treatment of advanced kidney
cancer, the recommended dose of CABOMETYX
is 40 mg once a day.
You should not take CABOMETYX with food. You
should not eat anything for at least 2 hours before
taking CABOMETYX and for 1 hour after taking
the medicine. Swallow the tablet with a full glass
of water. Do not crush the tablets.
If you take more CABOMETYX than you should
If you have taken more CABOMETYX than you have
been instructed to, talk to a doctor or go to the
hospital with the tablets and this leaflet straight away.
If you forget to take CABOMETYX
- If there are still 12 hours or more before your
next dose is due, then take the missed dose as
soon as you remember. Take the next dose at
the normal time.
- If your next dose is due in less than 12 hours,
then do not take the dose that you have missed.
Take your next dose at the normal time.
If you stop using CABOMETYX
Stopping your treatment may stop the effect
of the medicine. Do not stop treatment with
CABOMETYX unless you have discussed this with
your doctor.
When CABOMETYX is given in combination
with nivolumab, you will first be given nivolumab
followed by CABOMETYX.
Please refer to the package leaflet of nivolumab
in order to understand the use of this medicine. If
you have any further questions on the use of this
medicine, ask your doctor.

Like all medicines, this medicine can cause side
effects, although not everybody gets them. If you
get side effects, your doctor may tell you to take
CABOMETYX at a lower dose. Your doctor may
also prescribe other medicines to help control
your side effects.
Tell your doctor straight away if you notice any
of the following side effects – you may need
urgent medical treatment:
• Symptoms including pain in the abdomen,
nausea (feeling sick), vomiting, constipation, or
fever. These may be signs of a gastrointestinal
perforation, a hole that develops in your
stomach or intestine that could be lifethreatening.
• Severe or uncontrollable bleeding with
symptoms such as: vomiting blood, black
stools, bloody urine, headache, coughing up
blood.
• Swelling, pain in your hands and feet, or
shortness of breath.
• A wound that does not heal.
• Fits, headaches, confusion, or finding it
difficult to concentrate. These may be signs
of a condition called posterior reversible
encephalopathy syndrome (PRES). PRES is
rare (it affects less than 1 in 1000 people).
• Feeling drowsy, confused or loss of
consciousness. This may be due to liver
problems.
• Pain in the mouth, teeth and/or jaw, swelling or
sores inside the mouth, numbness or a feeling
of heaviness in the jaw, or loosening of a tooth.
These could be signs of bone damage in the
jaw (osteonecrosis).

Other side effects with CABOMETYX alone include:
Very common side effects (may affect more than
1 in 10 people)
• Stomach upset, including diarrhoea, nausea,
vomiting, constipation, indigestion and
abdominal pain,
• Blisters, pain of the hands or soles of the feet,
rash or redness of the skin
• Decreased appetite, weight loss, altered sense
of taste
• Fatigue, weakness, headache, dizziness
• Hypertension (high blood pressure)
• Anaemia (low levels of red blood cells)
• Low level of platelets
• Redness, swelling or pain in the mouth or
throat, difficulty in speaking, hoarseness,
cough
• Changes in blood tests used to monitor general
health and function of your organs (including
the liver, and kidney), low levels of electrolytes
(like magnesium, or potassium)
• Shortness of breath
• Reduced thyroid activity; symptoms can
include tiredness, weight gain, constipation,
feeling cold and dry skin
• Swelling in your legs and arms
• Pain in the arms, hands, legs or feet
• Low level of albumin in blood
Common side effects (may affect up to 1 in
10 people)
• Abscess (collection of pus, with swelling and
inflammation)

• Dehydration
• Difficulty in swallowing
• Ringing in ears (tinnitus)
• Blood clots in the blood vessels and lungs
• Low level of white blood cells
• Increased or decreased blood sugar level
• Decrease in levels of calcium, sodium and
phosphate in the blood
• Increase in level of potassium in the blood
• Increase in the level of bilirubin in the blood
(which may result in jaundice/yellow skin or
eyes)
• Increase in amylase levels in the blood
• Increase in lipase levels in the blood
• Increase in cholesterol or triglyceride levels in
the blood
• Numbness, tingling, burning sensation or pain
in the limbs
• A painful tear or abnormal connection of the
tissues in your body (fistula)
• Gastro-oesophageal reflux disease (bringing up
stomach acid)
• Haemorrhoids (piles)
• Dry mouth and pain in the mouth
• Feeling drowsy, confused or loss of
consciousness due to liver problems
• Dry skin, severe itching of skin, acne
• Thickening of the skin outer layer
• Alopecia (hair loss and thinning), hair colour
change
• Pain in joints, muscle spasms
• Protein in urine (seen in tests)
• A burning or stinging sensation of the tongue

Uncommon side effects (may affect 1 in
100 people)
• Fits
• Inflammation of the pancreas
• Decrease in bile flow from the liver
• Bone damage in the jaw
• Wound complications
Not known (proportion of people affected not
known)
• Stroke
• Heart attack
• An enlargement and weakening of a blood
vessel wall or a tear in a blood vessel wall
(aneurysms and artery dissections)
The following side effects have been reported
with CABOMETYX in combination with
nivolumab:
Very common side effects (may affect more than
1 in 10 people)
• Infections of the upper respiratory tract
• Reduced thyroid activity; symptoms can
include tiredness, weight gain, constipation,
feeling cold and dry skin
• Increased thyroid activity; symptoms can
include rapid heart rate, sweating and weight
loss
• Decreased appetite, altered sense of taste
• Headache, dizziness
• Hypertension (high blood pressure)
• Difficulty in speaking, hoarseness (dysphonia),
cough and shortness of breath
• Stomach upset, including diarrhoea, nausea,
vomiting, indigestion, abdominal pain and
constipation
• Redness, swelling or pain in the mouth or
throat (stomatitis)
• Skin rash sometimes with blisters, itching,
pain of the hands or soles of the feet, rash or
redness of the skin
• Pain in joints (arthralgia), muscle spasm,
muscle weakness and aching muscles
• Protein in the urine (seen in test)
• Feeling tired or weak, fever and oedema
(swelling)
Common side effects (may affect up to 1 in
10 people)
• Serious lung infection (pneumonia)
• Increase in some white blood cells called
eosinophils
• Allergic reaction (including anaphylactic
reaction)
• Decreased secretion of hormones produced
by adrenal glands (glands situated above the
kidneys)
• Dehydration
• Inflammation of the nerves (causing numbness,
weakness, tingling or burning pain of the arms
and legs)
• Ringing in ears (tinnitus)
• Dry eyes and blurred vision
• Changes in the rhythm or rate of the heartbeat,
fast heart rate
• Blood clots in the blood vessels

• Inflammation of the lungs (pneumonitis,
characterised by coughing and difficulty
breathing), blood clots in the lung, fluid around
the lungs
• Nose bleeding
• Inflammation of the colon (colitis), dry mouth,
pain in the mouth, inflammation of the stomach
(gastritis) and haemorrhoids (piles)
• Inflammation of the liver (hepatitis)
• Dry skin and severe itching of skin
• Alopecia (hair loss and thinning), hair colour
change
• Inflammation of the joints (arthritis)
• Kidney failure (including abrupt loss of kidney
function)
• Pain, chest pain
Uncommon side effects (may affect 1 in
100 people)
• Allergic reactions related to the infusion of the
medicine nivolumab
• Inflammation of the pituitary gland situated at
the base of the brain (hypophysitis), swelling of
the thyroid gland (thyroiditis)
• A temporary inflammation of the nerves that
causes pain, weakness and paralysis in the
extremities (Guillain Barré syndrome); muscle
weakness and tiredness without atrophy
(myasthenic syndrome)
• Inflammation of the brain
• Inflammation of the eye (which causes pain
and redness)
• Inflammation of the heart muscle
• Inflammation of the pancreas (pancreatitis),
intestinal perforation, burning or painful
sensation in the tongue (glossodynia)
• Skin disease with thickened patches of red
skin, often with silvery scales (psoriasis)
• Hives (itchy rash)
• Muscle tenderness of weakness, not caused
by exercise (myopathy), bone damage in the
jaw, painful tear or abnormal connection of the
tissues in your body (fistula)
• Inflammation of the kidney
Changes in test results
CABOMETYX in combination with nivolumab may
cause changes in the results of tests carried out
by your doctor. These include:
• Abnormal liver function tests (increased
amounts of the liver enzymes aspartate
aminotransferase, alanine aminotransferase
or alkaline phosphatase in your blood, higher
blood levels of the waste product bilirubin)
• Abnormal kidney function tests (increased
amounts of creatinine in your blood)
• High (hyperglycaemia) or low (hypoglycaemia)
sugar levels in the blood
• A decreased number of red blood cells (which
carry oxygen), white blood cells (which are
important in fighting infection) or platelets (cells
which help the blood to clot)
• An increased level of the enzyme that breaks
down fats and of the enzyme that breaks down
starch
• Decrease in levels of amount of phosphate
• Increased or decreased amount of calcium or
potassium
• Increased or decreased blood levels of
magnesium or sodium
• Increased blood levels of magnesium
• Decrease in body weight
• Increase in triglyceride levels in the blood
• Increase in cholesterol levels in the blood
Reporting of side effects
If you get any side effects, talk to your doctor
or pharmacist. This includes any possible side
effects not listed in this leaflet. You can also report
side effects directly via the national reporting
system. By reporting side effects, you can help
provide more information on the safety of this
medicine.

To report any side effect(s):
• Saudi Arabia:
The National Pharmacovigilance and Drug Safety
Centre (NPC)
Fax: +966-11-205-7662
Call NPC at +966-11-2038222,
Ext 2317-2356-2340
Toll free phone: 8002490000; SFDA Call Center:
19999
Email: npc.drug@sfda.gov.sa
Website: http://ade.sfda.gov.sa/

Keep this medicine out of the sight and reach of
children.
Do not use this medicine after the expiry date which
is stated on the bottle label and carton after EXP.
The expiry date refers to the last day of that month.
Store below 30°C.
Do not throw away any medicines via wastewater
or household waste. Ask your pharmacist how to
throw away medicines you no longer use. These
measures will help protect the environment.