Patient leaflet - Lenvatinib 10 mg hard capsules
1. What Lenvatinib is and what it is used for
What Lenvatinib is
Lenvatinib is a medicine that contains the active substance lenvatinib.
Thyroid cancer
Lenvatinib is used on its own to treat progressive or advanced thyroid cancer in adults when radioactive iodine treatment has not helped to stop the disease.
Liver cancer
Lenvatinib can also be used on its own to treat liver cancer (hepatocellular carcinoma) in adults who have not previously been treated with another anticancer medicine that travels through the bloodstream. People get Lenvatinib when their liver cancer has spread or cannot be taken out by surgery.
Uterine cancer
Lenvatinib can also be used together with another anticancer medicine called pembrolizumab to treat advanced cancer of the lining of the uterus (endometrial carcinoma) in adults whose cancer has spread after being previously treated with another anticancer medicine that travels through the bloodstream and cannot be taken out by surgery or radiation treatment.
Kidney cancer
Lenvatinib can also be used in combination with pembrolizumab as the first treatment for adults with advanced kidney cancer (advanced renal cell carcinoma). It is also used in combination with everolimus to treat adults with advanced kidney cancer where other treatments (so-called “VEGF-targeted therapy”) have not helped stop the disease.
How Lenvatinib works
Lenvatinib blocks the action of proteins called receptor tyrosine kinases (RTKs), which are involved in the development of new blood vessels that supply oxygen and nutrients to cells and help them to grow. These proteins can be present in high amounts in cancer cells, and by blocking their action Lenvatinib may slow the rate at which the cancer cells multiply and the tumour grows and help to cut off the blood supply that the cancer needs.
2. What you need to know before you take Lenvatinib
Do not take Lenvatinib if you are:
allergic to lenvatinib or any of the other ingredients of this
medicine (listed in section 6)
breast-feeding (see the section below on Contraception,
pregnancy and breast-feeding).
Warnings and precautions
Talk to your doctor or pharmacist before taking Lenvatinib if you:
- have high blood pressure
are a woman able to become pregnant (see the section
below on Contraception, pregnancy and breast-feeding)
- have a history of heart problems or stroke
- have liver or kidney problems
- have had recent surgery or radiotherapy
need to have a surgical procedure. Your doctor may
consider stopping Lenvatinib if you will be undergoing a major surgical procedure as Lenvatinib may affect wound healing. Lenvatinib may be restarted once adequate wound healing is established
- are over 75 years old
- belong to an ethnic group other than White or Asian
- weigh less than 60 kg
have a history of abnormal connections (known as a fistula)
between different organs in the body or from an organ to the skin
have or have had an aneurysm (enlargement and
weakening of a blood vessel wall) or a tear in a blood vessel wall
have or have had 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. You may be advised to have a dental check-up before starting Lenvatinib as bone damage in the jaw (osteonecrosis) has been reported in patients treated with Lenvatinib. If you need to undergo an invasive dental treatment or dental surgery, tell your dentist that you are being treated with Lenvatinib, particularly when you are also receiving or have received injections of bisphosphonates (used to treat or prevent bone disorders)
are receiving or have received some medicines used to
treat osteoporosis (antiresorptive medicines) or cancer medicines which alter formation of blood vessels (so called angiogenesis inhibitors), as the risk of bone damage in the jaw may be increased.
Before taking Lenvatinib, your doctor may carry out some tests, for example to check your blood pressure and your liver or kidney function and to see if you have low levels of salt and high levels of thyroid stimulating hormone in your blood. Your doctor will discuss the results of these tests with you and decide whether you can be given Lenvatinib. You may need to have additional treatment with other medicines, to take a lower dose of Lenvatinib, or to take extra care due to an increased risk of side effects.
If you are not sure talk to your doctor before taking Lenvatinib.
Conditions you need to look out for
During treatment of your cancer, the breakdown of tumour cells may leak substances into the blood which may lead to a group of complications called tumour lysis syndrome (TLS). This may lead to changes in your kidneys and can be life-threatening. Your doctor will observe and may give you a treatment to reduce the risk. Tell your doctor immediately if you experience signs of TLS (see section 4; Possible side effects).
Children and adolescents
Lenvatinib is not currently recommended for use in children and adolescents younger than 18 years old.
Other medicines and Lenvatinib
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes herbal preparations and medicines without a prescription.
Contraception, pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
If you could become pregnant, use highly effective
contraception while taking this medicine, and for at least one month after you finish treatment. Because it is not known if Lenvatinib can reduce the effect of the oral contraceptive pill, if this is your normal method of contraception you should ensure you also add a barrier method such as the cap or condoms if you have sex during treatment with Lenvatinib
Do not take lenvatinib if you are planning to become
pregnant during your treatment. This is because it may seriously harm your baby
If you become pregnant while being treated with Lenvatinib,
tell your doctor immediately. Your doctor will help you decide whether the treatment should be continued
Do not breast-feed if you are taking Lenvatinib. This is
because the medicine passes into breast milk and may seriously harm your breast-fed baby.
Driving and using machines
Lenvatinib may cause side effects that can affect your ability to drive or use machines. Avoid driving or using machines if you feel dizzy or tired.
Information on sodium content
This medicine contains less than 1 mmol sodium (23 mg) per capsule, that is to say essentially ‘sodium-free’.
3. How to take Lenvatinib
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
How much to take
Thyroid cancer
- The recommended dose of Lenvatinib is usually 24 mg once a day (2 capsules of 10 mg and 1 capsule of 4 mg)
- If you have severe liver or kidney problems the recommended dose is 14 mg once a day (1 capsule of 10 mg and 1 capsule of 4 mg)
- Your doctor may reduce your dose if you have problems with side effects.
Liver cancer
- The recommended dose of Lenvatinib depends on your body weight when you first start treatment. The dose is usually 12 mg once a day (3 capsules of 4 mg) if you weigh 60 kg or more and 8 mg once a day (2 capsules of 4 mg) if you weigh less than 60 kg
- Your doctor may reduce your dose if you have problems with side effects.
Uterine cancer
The recommended dose of Lenvatinib is 20 mg once a day
(2 capsules of 10 mg), in combination with pembrolizumab. The pembrolizumab is given by your doctor as an injection in your vein, either 200 mg every 3 weeks or 400 mg every 6 weeks
- Your doctor may reduce your dose if you have problems with side effects.
Kidney cancer
- The recommended daily dose of Lenvatinib is 20 mg once a day (two 10 mg capsules) in combination with pembrolizumab either 200 mg every 3 weeks or 400 mg every 6 weeks administered as an intravenous infusion over 30 minutes
- The recommended daily dose of Lenvatinib is 18 mg once a day (one 10 mg capsule and two 4 mg capsules) in combination with one 5 mg tablet of everolimus once a day
- If you have severe liver or kidney problems the recommended daily dose of Lenvatinib is 10 mg once a day (1 capsule of 10 mg) in combination with one 5 mg tablet of everolimus once a day. If you are receiving lenvatinib in combination with pembrolizumab, your doctor or pharmacist will check to see how much pembrolizumab you should receive
- Your doctor may reduce your dose if you experience side effects.
Taking this medicine
You can take the capsules with or without food
- Do not open the capsules to avoid exposure to the contents of the capsule
- Swallow the capsules whole with water. If you cannot swallow the capsules whole, other medicines containing lenvatinib should be used.
- Take the capsules at about the same time each day.
How long to take Lenvatinib
You will usually carry on taking this medicine as long as you are getting benefit.
If you take more Lenvatinib than you should
If you take more Lenvatinib than you should, talk to a doctor or pharmacist straight away. Take the medicine pack with you.
If you forget to take Lenvatinib
Do not take a double dose (two doses at the same time) to make up for a forgotten dose.
What to do if you forget to take your dose depends on how long it is until your next dose.
- If it is 12 hours or more until your next dose: take the missed dose as soon as you remember. Then take the next dose at the normal time
- If it is less than 12 hours until your next dose: skip the missed dose. Then take the next dose at the normal time.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Tell your doctor straight away if you notice any of the following side effects - you may need urgent medical treatment:
- feeling numb or weak on one side of your body, severe headache, seizure, confusion, difficulty talking, vision changes or feeling dizzy - these may be signs of a stroke, bleeding in your brain, or the effect on your brain of a severe increase in blood pressure
- chest pain or pressure, pain in your arms, back, neck or jaw, being short of breath, rapid or irregular heart rate, coughing, bluish colour to lips or fingers, feeling very tired – these may be signs of a heart problem, a blood clot in your lung or a leak of air from your lung into your chest so your lung cannot inflate
- severe pain in your belly (abdomen) - this may be due to a hole in the wall of your gut or a fistula (a hole in your gut which links through a tube-like passage to another part of your body or skin)
- black, tarry, or bloody stools, or coughing up of blood - these may be signs of bleeding inside your body
yellow skin or yellowing of the whites of the eyes (jaundice)
or drowsiness, confusion, poor concentration – these may be signs of liver problems
diarrhoea, feeling and being sick (nausea and vomiting)
- these are very common side effects that can become serious if they cause you to become dehydrated, which can lead to kidney failure. Your doctor can give you medicine to reduce these side effects
- 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)
- nausea, shortness of breath, irregular heartbeat, muscular cramps, seizure, clouding of urine and tiredness. These symptoms may be complications due to the breakdown products of dying cancer cells and known as tumour lysis syndrome (TLS).
Tell your doctor straight away if you notice any of the side effects below.
The following side effects may happen with this medicine when given alone:
Very common (may affect more than 1 in 10 people):
- high or low blood pressure
- loss of appetite or weight loss
- feeling sick (nausea) and being sick (vomiting), constipation, diarrhoea, abdominal pain, indigestion
- feeling very tired or weak
- hoarse voice
- swelling of the legs
- rash
- dry, sore, or inflamed mouth, odd taste sensation
- joint or muscle pain
- feeling dizzy
- hair loss
- bleeding (most commonly nosebleeds, but also other types of bleeding such as blood in the urine, bruising, bleeding from the gums or gut wall)
- trouble sleeping
- changes in urine tests for protein (high) and urinary infections (increased frequency in urination and pain in passing urine)
- headache
- back pain
- redness, soreness and swelling of the skin on the hands and feet (palmar-plantar erythrodysaesthesia)
- underactive thyroid (tiredness, weight gain, constipation, feeling cold, dry skin)
- changes in blood test results for potassium levels (low) and calcium levels (low)
- decrease in the number of white blood cells
- changes in blood test results for liver function
- low levels of platelets in the blood which may lead to bruising and difficulty in wound healing
- changes in blood test results for magnesium (low), cholesterol (high) and thyroid stimulating hormone (high)
- changes in blood test results for kidney function and kidney failure
- increase in lipase and amylase (enzymes involved in digestion).
Common (may affect up to 1 in 10 people):
- loss of body fluids (dehydration)
- heart palpitations
- dry skin, thickening and itching of the skin
- feeling bloated or having excess wind
- heart problems or blood clots in the lungs (difficulty breathing, chest pain) or other organs which may include chest pain or pressure, pain in your arms, back, neck or jaw, being short of breath, rapid or irregular heart rate, coughing, bluish colour to lips or fingers, and feeling very tired
- liver failure
- drowsiness, confusion, poor concentration, loss of consciousness that may be signs of liver failure
- feeling unwell
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Digital signature
- inflammation of the gallbladder
- stroke
anal fistula (a small channel that forms between the anus
and the surrounding skin)
- a hole (perforation) in the stomach or intestines
signs of a stroke, including feeling numb or weak on one
side of your body, severe headache, seizure, confusion, difficulty talking, vision changes or feeling dizzy.
Uncommon (may affect up to 1 in 100 people):
- painful infection or irritation near the anus
- mini-stroke
- liver damage
severe pain in the upper left part of the belly (abdomen)
which may be associated with fever, chills, nausea and vomiting (splenic infarction)
- inflammation of the pancreas
- wound healing problems
- bone damage in the jaw (osteonecrosis)
- inflammation of the colon (colitis)
severe difficulty breathing and chest pain, caused by a leak
of air from your lung into your chest so your lung cannot inflate
decreased secretion of hormones produced by adrenal
glands.
Rare (may affect up to 1 in 1,000 people):
- Tumour lysis syndrome (TLS).
Not Known (the following side effects have been reported since the marketing of lenvatinib but the frequency for them to occur is not known):
other types of fistulae (an abnormal connection between
different organs in the body or between the skin and an underlying structure such as throat and windpipe). Symptoms depend on where the fistula is located. Talk to your doctor if you experience any new or unusual symptoms such as coughing when swallowing
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 may happen with this medicine when given in combination with pembrolizumab:
Very common (may affect more than 1 in 10 people):
changes in urine tests for protein (high) and urinary
infections (increased frequency in urination and pain in passing urine)
low levels of platelets in the blood which may lead to
bruising and difficulty in wound healing
- decrease in the number of white blood cells
- decrease in the number of red blood cells
underactive thyroid (tiredness, weight gain, constipation,
feeling cold, dry skin) and changes in blood test results for thyroid stimulating hormone (high)
overactive thyroid (symptoms can include rapid heart rate,
sweating and weight loss)
- changes in blood test results for calcium levels (low)
- changes in blood test results for potassium levels (low)
- changes in blood test results for cholesterol levels (high)
- changes in blood test results for magnesium levels (low)
- loss of appetite or weight loss
- feeling dizzy
- headache
- back pain
- dry, sore, or inflamed mouth, odd taste sensation
bleeding (most commonly nosebleeds, but also other types
of bleeding such as blood in the urine, bruising, bleeding from the gums or gut wall)
- high blood pressure
- hoarse voice
feeling sick (nausea) and being sick (vomiting),
constipation, diarrhoea, abdominal pain, indigestion
- increase in amylase (enzyme involved in digestion)
- increase in lipase (enzyme involved in digestion)
- changes in blood test results for liver function
changes in blood test results for kidney function and kidney
failure
redness, soreness and swelling of the skin on the hands
and feet (palmar-plantar erythrodysaesthesia)
- rash
- joint or muscle pain
- feeling very tired or weak
- trouble sleeping
- swelling of the legs.
Common (may affect up to 1 in 10 people):
- loss of body fluids (dehydration)
- trouble sleeping
- heart palpitations
- low blood pressure
heart problems or blood clots in the lungs (difficulty
breathing, chest pain) or other organs which may include chest pain or pressure, pain in your arms, back, neck or jaw, being short of breath, rapid or irregular heart rate, coughing, bluish colour to lips or fingers, and feeling very tired
- inflammation of the pancreas
- feeling bloated or having excess wind
- indigestion
- inflammation of the gallbladder
- dry skin, thickening and itching of the skin
- hair loss
- kidney failure
- feeling unwell
- inflammation of the colon (colitis)
urinary infections (increased frequency in urination and pain
in passing urine)
decreased secretion of hormones produced by adrenal
glands
- a hole (perforation) in the stomach or intestines.
Uncommon (may affect up to 1 in 100 people):
signs of a stroke, including feeling numb or weak on one
side of your body, severe headache, seizure, confusion, difficulty talking, vision changes or feeling dizzy
- mini-stroke
signs of a heart problem, including chest pain or pressure,
pain in your arms, back, neck or jaw, being short of breath, rapid or irregular heart rate, coughing, bluish colour to lips or fingers, and feeling very tired
severe difficulty breathing and chest pain, caused by a leak
of air from your lung into your chest so your lung cannot inflate
- painful infection or irritation near the anus
anal fistula (a small channel that forms between the anus
and the surrounding skin)
liver failure or signs of liver damage, including yellow skin or
yellowing of the whites of the eyes (jaundice) or drowsiness, confusion, poor concentration
- wound healing problems
other types of fistulae (an abnormal connection between
different organs in the body or from the skin to an underlying structure such as throat and windpipe). Symptoms would depend on where the fistula is located. Talk to your doctor if you experience any new or unusual symptoms such as coughing when swallowing.
Rare (may affect up to 1 in 1,000 people):
- Tumour lysis syndrome (TLS).
Not Known (the following side effects have been reported since the marketing of lenvatinib but the frequency for them to occur is not known):
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 may happen with this medicine when given in combination with everolimus:
Very common (may affect more than 1 in 10 people):
low levels of platelets in the blood which may lead to
bruising and difficulty in wound healing
- decrease in the number of white blood cells
underactive thyroid (tiredness, weight gain, constipation,
feeling cold, dry skin) and changes in blood test results for thyroid stimulating hormone (high)
changes in blood test results for potassium levels (low) and
calcium levels (low)
changes in blood test results for magnesium (low) and
cholesterol (high)
- loss of appetite or weight loss
- trouble sleeping
- headache
bleeding (most commonly nosebleeds, but also other types
of bleeding such as blood in the urine, bruising, bleeding from the gums or gut wall)
- high blood pressure
- hoarse voice
feeling sick (nausea) and being sick (vomiting),
constipation, diarrhoea, abdominal pain, indigestion
- sore, or inflamed mouth, odd taste sensation
increase in lipase and amylase (enzymes involved in
digestion)
- changes in blood test results for liver function
redness, soreness and swelling of the skin on the hands
and feet (palmar-plantar erythrodysaesthesia)
- rash
- back pain
- joint or muscle pain
- changes in urine tests for protein (high)
changes in blood test results for kidney function and kidney
failure
- feeling very tired or weak
swelling of the legs.
Common (may affect up to 1 in 10 people):
- urinary infections (increased frequency in urination and pain in passing urine)
- loss of body fluids (dehydration)
- feeling dizzy
- heart palpitations
- heart problems or blood clots in the lungs (difficulty breathing, chest pain) or other organs which may include chest pain or pressure, pain in your arms, back, neck or jaw, being short of breath, rapid or irregular heart rate, coughing, bluish colour to lips or fingers, and feeling very tired
- low blood pressure
- severe difficulty breathing and chest pain, caused by a leak of air from your lung into your chest so your lung cannot inflate
- dry mouth
- feeling bloated or having excess wind
- inflammation of the gallbladder
- hair loss
- feeling unwell
- a hole (perforation) in the stomach or intestines.
Uncommon (may affect up to 1 in 100 people):
- painful infection or irritation near the anus
- signs of a stroke, including feeling numb or weak on one side of your body, severe headache, seizure, confusion, difficulty talking, vision changes or feeling dizzy
- mini-stroke
- inflammation of the pancreas
- anal fistula (a small channel that forms between the anus and the surrounding skin)
- inflammation of the colon (colitis)
- liver failure or signs of liver damage, including yellow skin or yellowing of the whites of the eyes (jaundice) or drowsiness, confusion, poor concentration
- bone damage in the jaw (osteonecrosis)
- dry skin, thickening and itching of the skin
- wound healing problems
- other types of fistulae (an abnormal connection between different organs in the body or between the skin and an underlying structure such as throat and windpipe). Symptoms depend on where the fistula is located. Talk to your doctor if you experience any new or unusual symptoms such as coughing when swallowing
- decreased secretion of hormones produced by adrenal glands.
Rare (may affect up to 1 in 1,000 people):
- Tumour lysis syndrome (TLS).
Not Known (the following side effects have been reported since the marketing of lenvatinib but the frequency for them to occur is not known):
- an enlargement and weakening of a blood vessel wall or a tear in a blood vessel wall (aneurysms and artery dissections).
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Lenvatinib
Keep this medicine out of the sight and reach of children.
Do not take this medicine after the expiry date which is stated on the carton and blister after ‘EXP’. The expiry date refers to the last day of that month.
Store in the original package in order to protect from moisture.
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 Lenvatinib contains
The active substance is lenvatinib
Lenvatinib 4 mg hard capsules: Each hard capsule contains
4 mg of lenvatinib (as besilate)
Lenvatinib 10 mg hard capsules: Each hard capsule contains 10 mg of lenvatinib (as besilate).
- The other ingredients are sodium hydrogen carbonate, mannitol, microcrystalline cellulose, hydroxypropylcellulose, low-substituted hydroxypropylcellulose and talc. The capsule shell contains hypromellose, black iron oxide (E172), yellow iron oxide (E172), red iron oxide (E172) and titanium dioxide. The printing ink contains shellac, potassium hydroxide and black iron oxide (E172).
What Lenvatinib looks like and contents of the pack
Lenvatinib 4 mg hard capsules are size 4 (approximately
14.3 mm) capsules with a caramel opaque body and caramel opaque cap, printed with “L7VB” over “4”
Lenvatinib 10 mg hard capsules are size 4 (approximately
14.3 mm) capsules with a rich yellow opaque body and caramel opaque cap, printed with “L7VB” over “10”.
- Lenvatinib capsules are available in oPA/Al/PVC/Al blisters containing 30, 60 or 90 hard capsules and oPA/Al/PVC/ Al unit-dose blisters containing 30x1, 60x1 or 90x1 hard capsules
Lenvatinib capsules are also available in oPA/Al/PVC/
PE/Al blisters with desiccant containing 30, 60 or 90 hard capsules and oPA/Al/PVC/PE/Al unit-dose blisters with desiccant containing 30x1, 60x1 or 90x1 hard capsules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Accord Healthcare Limited
Sage House, 319 Pinner Road
North Harrow, Middlesex
HA1 4HF
United Kingdom
Manufacturers
Accord Healthcare Limited
Sage House, 319 Pinner Road
North Harrow, Middlesex
HA1 4HF
United Kingdom
Synthon Hispania S.L.
Calle De Castello 1,
Sant Boi De Llobregat,
Barcelona, 08830
Spain
Synthon B.V.
Microweg 22
Nijmegen
Gelderland, 6545 CM
Netherlands
This leaflet was last revised in September 2026.
If you would like a leaflet with larger text, please contact
01271 385257
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Date sent:
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Supplier:
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CRF number:
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