Patient leaflet - Cabozantinib 60 mg film-coated tablets
1. What Cabozantinib is and what it is used for
Cabozantinib 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.
Advanced neuroendocrine tumours – tumours that originate from the
pancreas, stomach, bowels, lung or other organs. It is given when patients with these tumours no longer respond to a previous treatment option.
Cabozantinib is also used to treat locally advanced or metastatic differentiated thyroid cancer, a type of cancer in the thyroid gland, in adults when radioactive iodine and anticancer medicine treatments are no longer stopping the disease from progressing.
Cabozantinib 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 Cabozantinib works
Cabozantinib 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 this medicine can slow down the rate at which the tumour grows and help to cut off the blood supply that the cancer needs.
2. What you need to know before you take Cabozantinib
Do not take Cabozantinib
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 Cabozantinib 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 heart failure (can include symptoms like shortness of breath, feeling
tired, fainting, swollen ankles and legs)
have thyroid problems. Tell your doctor if you get tired more easily, generally
feel colder than other people, or your voice deepens whilst taking this medicine.
- 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 Cabozantinib or stop treatment altogether. See also section 4 “Possible side effects”.
You should also tell your dentist that you are taking this medicine. It is important for you to practice good mouth care during treatment.
Children and adolescents
Cabozantinib is not recommended for children or adolescents. The effects of this medicine in people younger than 18 years old are not known.
Other medicines and Cabozantinib
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 Cabozantinib can affect the way some other medicines work. Also, some medicines can affect the way Cabozantinib 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
Cabozantinib with food
Avoid consuming grapefruit-containing products for as long as you are using this medicine, as they may increase the levels of Cabozantinib in your blood.
Pregnancy, breast-feeding and fertility
Avoid becoming pregnant while being treated with Cabozantinib. 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 this medicine (see also under Other medicines and Cabozantinib, above).
Tell your doctor if you or your partner become pregnant or plan to become pregnant while you are being treated with this medicine.
Talk to your doctor BEFORE taking this medicine 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 this medicine.
Women taking this medicine should not breast-feed 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 this medicine whilst using oral contraceptives, the oral contraceptives may be ineffective. You should also use a barrier contraceptive (e.g. condom or diaphragm) whilst taking this medicine 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 Cabozantinib may make you feel tired or weak and can affect your ability to drive or use machines.
Cabozantinib contains lactose
This medicine 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.
Cabozantinib contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially “sodium-free”.
3. How to take Cabozantinib
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.
Cabozantinib should be taken once a day. The usual dose is 60 mg, however your doctor will decide on the right dose for you.
When this medicine is given in combination with nivolumab for the treatment of advanced kidney cancer, the recommended dose of Cabozantinib is 40 mg once a day.
You should not take Cabozantinib with food. You should not eat anything for at least 2 hours before 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 Cabozantinib than you should
If you have taken more of this medicine 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 Cabozantinib
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 Cabozantinib
Stopping your treatment may stop the effect of the medicine. Do not stop treatment with this medicine unless you have discussed this with your doctor.
When this medicine is given in combination with nivolumab, you will first be given nivolumab followed by Cabozantinib.
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.
4. Possible side effects
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 Cabozantinib 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 life-threatening. Gastrointestinal perforation is common (it may affect up to 1 in 10 people). · Severe or uncontrollable bleeding with symptoms such as: vomiting blood,
black stools, bloody urine, headache, coughing up blood. It is common (it may affect up to 1 in 10 people)
Feeling drowsy, confused or loss of consciousness. This may be due to liver
problems which are common (they may affect up to 1 in 10 people). · Swelling, or shortness of breath. These are very common (they may affect
more than 1 in 10 people).
A wound that does not heal. It is uncommon (it may affect 1 in 100 people) · Fits, headaches, confusion, or finding it difficult to concentrate. These may be
signs of a condition called posterior reversible encephalopathy syndrome (PRES). PRES is uncommon (it may affect 1 in 100 people). · 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). It is uncommon (it may affect 1 in 100 people).
Other side effects with Cabozantinib alone include:
Very common side effects (may affect more than 1 in 10 people)
Anaemia (low levels of red blood cells which carry oxygen), low levels of
platelets (cells which help the blood to clot)
Reduced thyroid activity; symptoms can include tiredness, weight gain,
constipation, feeling cold and dry skin
- Decreased appetite, altered sense of taste
Decreased amount of magnesium, potassium or calcium in the blood · Decreased amount of protein albumin in blood (which carries substances
such as hormones, medicines, and enzymes throughout your body) · Headache, dizziness
- High blood pressure (hypertension)
- Bleeding
Difficulty in speaking, hoarseness (dysphonia), cough and shortness of breath · Stomach upset, including diarrhoea, nausea, vomiting, constipation,
indigestion and abdominal pain
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
- Pain in the arms, hands, legs or feet, pain in joints
Feeling tired or weak, inflammation of the oral and gastrointestinal mucosa,
swelling in your legs and arms
- Weight loss
Abnormal liver function tests (increased amounts of the liver enzymes
aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase)
Common side effects (may affect up to 1 in 10 people)
- Abscess (collection of pus, with swelling and inflammation) · Dehydration
- Decreased amount of phosphate and sodium in the blood · Increased amount of potassium in the blood
Increased amount of the waste product bilirubin in the blood (which may
result in jaundice/yellow skin or eyes)
High (hyperglycaemia) or low (hypoglycaemia) sugar levels in the blood · Inflammation of the nerves (causing numbness, weakness, tingling or
burning pain of the arms and legs)
- Ringing in ears (tinnitus)
Blood clots in the veins, low blood pressure (hypotension) · Blood clots in the lungs, inflammation of the lining of the nose (allergic
rhinitis)
Inflammation of the pancreas, 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, difficulty in swallowing, flatulence
Severe itching of skin, alopecia (hair loss and thinning), dry skin, acne, hair
colour change, thickening of the skin outer layer, redness of the skin · Muscle spasms
- Protein in urine (seen in tests)
Abnormal liver function tests (increased amounts of the liver enzyme
gamma-glutamyl transferase in your blood)
Abnormal kidney function tests (increased amounts of creatinine in your
blood)
Increased level of the enzyme that breaks down fats (lipase) and of the
enzyme that breaks down starch (amylase)
- Increase in cholesterol or triglyceride levels in the blood · Low levels of white blood cells (which are important in fighting infection) · Lung infection (pneumonia)
Uncommon side effects (may affect 1 in 100 people)
- Fits, stroke
- Severe high blood pressure
- Blood clots in the arteries
- Decrease in bile flow from the liver
- A burning or painful sensation in the tongue (glossodynia) · Heart attack
Heart failure (can include symptoms like shortness of breath, feeling tired,
fainting, swollen ankles and legs)
Clot/ embolus that travelled through your arteries and become stuck · Collapsed lung with air trapped in the space between the lung and chest,
often causing shortness of breath (pneumothorax)
Not known (proportion of people affected not known)
An enlargement and weakening of a blood vessel wall or a tear in a blood
vessel wall (aneurysms and artery dissections)
- Inflammation of the blood vessels in the skin (cutaneous vasculitis)
The following side effects have been reported with Cabozantinib 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
- High blood pressure (hypertension)
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 severe itching of 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)
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 · Anaemia (low levels of red blood cells which carry oxygen), low levels of
white blood cells (which are important in fighting infection), low levels of platelets (cells which help the blood to clot)
An increased level of the enzyme that breaks down fats (lipase) and of the
enzyme that breaks down starch (amylase)
- Decreased amount of phosphate
- Increased or decreased amount of potassium
- Decreased or increased blood levels of calcium, magnesium, or sodium · Decrease in body weight
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 redness of the 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
- Increase in triglyceride levels in the blood
- Increase in cholesterol levels in the blood
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
Clot/ embolus that travelled through your arteries and become stuck · 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
Collapsed lung with air trapped in the space between the lung and chest,
often causing shortness of breath (pneumothorax)
Not known (proportion of people affected not known)
- Inflammation of the blood vessels in the skin (cutaneous vasculitis) · Progressive destruction and loss of intrahepatic bile ducts and jaundice
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 (see details below). By reporting side effects, you can help provide more information on the safety of this medicine.
United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
5. How to store Cabozantinib
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 carton after EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
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.
6. Contents of the pack and other information What Cabozantinib contains
The active substance is cabozantinib (S)-malate.
Cabozantinib 20 mg film-coated tablets: Each tablet contains cabozantinib (S)-malate equivalent to 20 mg of cabozantinib.
Cabozantinib 40 mg film-coated tablets: Each tablet contains cabozantinib (S)-malate equivalent to 40 mg of cabozantinib.
Cabozantinib 60 mg film-coated tablets: Each tablet contains cabozantinib (S)-malate equivalent to 60 mg of cabozantinib.
The other ingredients are:
- Tablet contents: microcrystalline cellulose, lactose, hydroxypropylcellulose, croscarmellose sodium, magnesium stearate. (see section 2 for lactose content)
- Film coating: hypromellose, titanium dioxide (E171), triacetin, iron oxide yellow (E172)
What Cabozantinib looks like and contents of the pack
Cabozantinib 20 mg film-coated tablets are light yellow to yellow in colour, approximately 6 mm in diameter, round shaped, debossed with “C7” on one side and plain on other side.
Cabozantinib 40 mg film-coated tablets are light yellow to yellow in colour, approximately 8 mm in length, triangle shaped, debossed with “C5” on one side and plain on other side.
Cabozantinib 60 mg film-coated tablets are light yellow to yellow in colour, approximately 11 mm in length and 5.5 mm in width, oval shaped, debossed with "C3" on one side and plain on other side.
Cabozantinib is available in blister packs.
Cabozantinib 20 mg film-coated tablets
Cabozantinib 20 mg film-coated tablets are packed in PVC/PVDC or OPA/Al./PVC blisters or unit-dose blisters with aluminium foil, in cartons containing 30, 40 or 120 film-coated tablets.
Cabozantinib 40 mg film-coated tablets
Cabozantinib 40 mg film-coated tablets are packed in PVC/PVDC or OPA/Al./PVC blisters or unit-dose blisters with aluminium foil, in cartons containing 30, 40 or 120 film-coated tablets.
Cabozantinib 60 mg film-coated tablets
Cabozantinib 60 mg film-coated tablets are packed in PVC/PVDC or OPA/Al./PVC blisters or unit-dose blisters with aluminium foil, in cartons containing 30, 40 or 120 film-coated tablets.
Not all pack variants may be marketed.
Marketing Authorisation Holder
Sun Pharma UK Limited
6-9 The Square,
Stockley Park,
Uxbridge
UB11 1FW
Manufacturer
Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132JH Hoofddorp
The Netherlands
Terapia S.A.
Str. Fabricii nr. 124
Cluj-Napoca, 400640
Romania
This leaflet was last revised in 08/2026
5273861