Patient Medication Information: uses, side effects, how to take - Lenvima
What LENVIMA is used for:
- LENVIMA is used alone to treat adults with a type of thyroid cancer that can no longer be treated with radio-active iodine.
LENVIMA is used to treat adults with a type of kidney cancer that has spread called advanced renal cell carcinoma (RCC):
- that has not been treated previously and cannot be cured with surgery or radiation. For these patients, LENVIMA may be used with the medicine pembrolizumab.
- that has been treated previously with a vascular endothelial growth factor (VEGF)-targeted therapy. For these patients, LENVIMA may be used with the medicine everolimus.
- LENVIMA is used alone to treat adults with a type of liver cancer that cannot be removed with surgery.
Serious Warnings and Precautions
LENVIMA should be prescribed and managed only by a healthcare professional who is experienced in anticancer drugs.
Serious or life-threatening side-effects can include:
- High blood pressure along with complications, including Artery Dissection (separation of the artery layers)
- Heart failure, including cases that could lead to death
- Blood clots, including cases that could lead to death
- Gastrointestinal perforation (tears in the stomach or intestinal wall) or fistula (abnormal connection between two or more body parts)
- Liver injury, including cases that could lead to death
- Kidney injury, including cases that could lead to death
- Bleeding, including cases that could lead to death
- A nervous system disorder called Posterior Reversible Encephalopathy Syndrome
LENVIMA is used along with another medicine called pembrolizumab to treat adults with cancer of the endometrium (lining of the uterus) that:
- has worsened after anti-cancer treatment that contained platinum;
- cannot be cured by surgery or radiation;
- is not microsatellite instability high (MSI-H); or
- is not mismatch repair deficient (dMMR).
How LENVIMA works:
LENVIMA targets a group of proteins known to be involved in the growth and spread of certain types of cancer. These proteins start the process of creating new blood vessels that allow certain types of tumours to grow. LENVIMA works by blocking the creation of these proteins in tumour cells, which slows down the growth of new blood vessels in these tumours. This cuts off the supply of nutrients and oxygen to the tumour, which slows or prevents its growth. LENVIMA also acts directly on cancer cells in other ways to kill them or slow down their rate of growth.
The ingredients in LENVIMA are:
Medicinal ingredients: lenvatinib (as lenvatinib mesylate)
Non-medicinal ingredients: black iron oxide, calcium carbonate, ferric oxide red, ferric oxide yellow, hydroxypropylcellulose, low-substituted hydroxypropylcellulose, mannitol, microcrystalline cellulose, potassium hydroxide, propylene glycol, shellac, talc, and titanium dioxide.
LENVIMA comes in the following dosage forms:
Capsules: 4 mg and 10 mg.
Do not use LENVIMA if:
- you are allergic to lenvatinib or any of the other ingredients in LENVIMA.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take LENVIMA. Talk about any health conditions or problems you may have, including if you:
- are or were taking other cancer medicines
- have high blood pressure
- have heart problems
- have an abnormal heart rhythm (also known as QT-prolongation)
- have a family history of abnormal heart rate
- have or have had kidney problems
- have or have had liver problems
- have any bleeding problems
- have a history of blood clots in your arteries, including stroke, heart attack, or change in vision
- have diarrhea
- recently had or plan on having surgery
- recently had or plan to have dental problems or procedures
- are taking, or have taken, an osteoporosis medicine
- are pregnant or plan to become pregnant.
- are breastfeeding or plan to breastfeed.
Other warnings you should know about:
Fertility: For both men and women, LENVIMA may decrease your ability to have a child. Talk to your healthcare professional about this if you want to have a child.
Female Patients:
Pregnancy
- It is not known if LENVIMA will harm your unborn baby. Avoid becoming pregnant while taking LENVIMA and for at least one month after your last dose.
- You should use effective methods of birth control while taking LENVIMA. Continue to use birth control for at least one month after taking your last dose.
- Oral contraceptives may not work as well if taken with LENVIMA. If you are taking an oral contraceptive, you should also use a barrier method such as a condom.
- Talk with your healthcare professional about birth control methods to prevent pregnancy while you are taking LENVIMA.
- Tell your healthcare professional right away if you become pregnant or think you are pregnant while taking LENVIMA.
Breastfeeding:
- It is not known if LENVIMA passes into your breast milk. You and your healthcare professional should decide if you will take LENVIMA or breastfeed. You should not do both.
- Male Patients:
While taking LENVIMA:
- Your female partner should not get pregnant by you, and
- You must use effective birth control methods, like a condom with spermicide.Talk to your healthcare professional about birth control methods that may be right for you.
- Blood pressure:
- Your blood pressure should be well controlled before you start taking LENVIMA.
- Your healthcare professional should check your blood pressure regularly when you take LENVIMA.
- If blood pressure becomes a problem, your healthcare professional may prescribe medicine to treat your high blood pressure. Your healthcare professional may also lower your dose of LENVIMA or stop your treatment with LENVIMA.
- Surgery: If you are planning on having surgery, tell your healthcare professional you are taking LENVIMA. You should stop taking LENVIMA before a major surgery. This is to be sure the wound can heal.
- Kidney failure: Kidney failure has happened with LENVIMA treatment. Drink fluids during treatment with LENVIMA to help prevent too much fluid loss (dehydration). Call your healthcare professional if you have diarrhea or vomiting.
- QT prolongation: Changes in the electrical activity of your heart can happen with LENVIMA treatment. This is called QT prolongation. These can cause changes in your heartbeat that can be life threatening. Your healthcare professional will decide if you need heart monitoring or
- blood tests during your treatment with LENVIMA.
- The following patients may be less able to tolerate LENVIMA:
- Patients 65 years old, or older
- Thyroid and kidney cancer patients of Asian race
- Liver cancer patients of Caucasian race
- Patients with existing high blood pressure, liver or kidney disease
- Patients who weigh less than 60 kg
- Patients who are female
You should not take LENVIMA if you had other anticancer treatments within 4 weeks.
Blood and urine tests:
- Your healthcare professional will check your urine regularly while you are taking LENVIMA. This is to determine how your kidneys are working and whether you have protein in your urine.
- Blood tests will be done before you start taking LENVIMA. These will be repeated every two weeks for the first two months and then again at least once a month while you are taking this medicine. This will help your healthcare professional to know if any changes happen to your blood after taking LENVIMA. These blood tests will also check how your liver is working and whether you have too little calcium in your blood (hypocalcemia).
- You may have changes in your thyroid hormone levels when taking LENVIMA. Your thyroid medicine dose may need to be changed. Your doctor should check your thyroid hormone level every month during treatment with LENVIMA.
Taking LENVIMA with pembrolizumab can cause serious side effects that are immune-mediated. This means they result from an immune or inflammation response in the body. These can include:
- Adrenal insufficiency (decreased release of hormones from the adrenal glands)
- Myocarditis (inflammation of the heart muscle)
- Pneumonitis (inflammation of the lungs)
- Myasthenic syndrome (muscle problems)
See the Serious side effects and what to do about them table, below, for more information on these and other serious side effects.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
The following may interact with LENVIMA:
- medicines known to cause heart rhythm changes
- antipsychotic medicines
- antidepressants, medicines used to treat depression
- medicines to relieve pain
- antibiotics, medicines used to treat bacterial infections
- pentamidine a medicine used to treat specific types of infections
- medicines used to treat malaria
- azole antifungals (e.g., ketoconazole, fluconazole, voriconazole), medicines used to treat fungal infections
- specific medicines for nausea like domperidone and ondansetron
- medicines to treat cancer
- medicines for asthma and chronic obstructive pulmonary disease
- oral contraceptives. Birth control pills may not work as well if taken with LENVIMA
- thyroid medicine
How to take LENVIMA:
Take LENVIMA:
- exactly as prescribed by your healthcare professional
- once a day
- at the same time each day
with or without food
- continue to take your dose every day unless your healthcare professional tells you to stop or change your dose
Swallow LENVIMA capsules whole with water. Do NOT open, chew, crush, or split LENVIMA capsules.
If LENVIMA capsule(s) cannot be swallowed whole:
- Use a small cup to measure about 1 tablespoon of water or apple juice.
- Add LENVIMA capsules into the cup of water or apple juice. Be careful not to break or crush the capsules.
- Let the capsules sit in the liquid for about 10 minutes, then stir the contents for another 3 minutes.
- Swallow the mixture.
- After swallowing, rinse the cup with a little more water or apple juice. Swirl the contents around the cup and then swallow the liquid.
Usual dose:
Your healthcare professional will decide the best daily dose for you. It will depend on the type of cancer you have as well any other conditions you might have like liver problems.
If your daily dose of LENVIMA is:
4 mg: It takes one capsule to make up the dose
8 mg: It takes two capsules to make up the dose
10 mg: It takes one capsule to make up the dose
12 mg: It takes three capsules to make up the dose
14 mg: It takes two capsules to make up the dose
18 mg: It takes three capsules to make up the dose
20 mg: It takes two capsules to make up the dose
24 mg: It takes three capsules to make up the dose
All daily doses of LENVIMA are packaged on cards. This will help you to take the right dose each day. Each card holds 5 doses. Take one dose a day. Each carton contains 6 cards. There are 30 daily doses in a carton. Record the start date on the line above the first dose from each card.
Your healthcare professional may decide to:
- change your dose during treatment,
- change how often you take your dose,
- stop treatment for some time, (then resume at the same or a lower dose), or
- completely stop treatment.
Once your dose is reduced, you should never go back to a higher dose.
Overdose:
If you think you, or a person you are caring for, have taken too much LENVIMA, contact a healthcare professional, hospital emergency department, regional poison control centre or Health Canada’s toll-free number, 1-844 POISON-X (1-844-764-7669) immediately, even if there are no signs or symptoms.
Missed dose:
If you miss a dose of LENVIMA, take it as soon as you remember. However, if your next dose is due within 12 hours, then skip the missed dose and take the next dose at your regular time.
Possible side effects from using LENVIMA:
These are not all the possible side effects you may have when taking LENVIMA. Some of these side effects may occur when taking LENVIMA or when taking LENVIMA with pembrolizumab or everolimus. If you experience any side effects not listed here, tell your healthcare professional.
- change in taste
- decreased appetite and weight
- dry mouth
- excess gas
- fever
- hair loss
- headache, dizziness
- indigestion
- mouth sores, hoarseness, voice changes
- muscle, joint and back pain
- nausea, vomiting, constipation, abdominal pain
- nosebleeds
- protein in your urine
- rash, redness, itching, or blister and peeling of your skin on your hands and soles of your feet
- runny nose, sneezing
- swelling in arms, hands, legs, or feet
- tiredness, trouble sleeping
- trouble breathing, cough
- weakness
LENVIMA can cause abnormal test results. Your healthcare professional will decide when to perform tests and will interpret the results. This may include heart monitoring (electrocardiogram or ECG), blood or urine tests.
Serious side effects and what to do about them
Some of these side effects may occur when taking LENVIMA or when taking LENVIMA with pembrolizumab or everolimus.
| Frequency/Side Effect/Symptom | Talk to your healthcare professional | Stop taking this drug and get immediate medical help | |
|---|---|---|---|
| Frequency/Side Effect/Symptom | Talk to your healthcare professional | Stop taking this drug and get immediate medical help | |
| Frequency/Side Effect/Symptom | Talk to your healthcare professional | Stop taking this drug and get immediate medical help | |
| Frequency/Side Effect/Symptom | Talk to your healthcare professional | Stop taking this drug and get immediate medical help | |
| Frequency/Side Effect/Symptom | Talk to your healthcare professional | Stop taking this drug and get immediate medical help | |
| Only if severe | In all cases | ||
| Only if severe | In all cases | ||
| Only if severe | In all cases | ||
| Only if severe | In all cases | ||
| Only if severe | In all cases | ||
| Very common | |||
| Hypertension (high blood pressure): Headaches, vision disorders, nausea, and vomiting | X | ||
| Bleeding: Black, tarry, or bloody stools, or coughing up of blood, sudden and severe headache with nausea, vomiting and loss of consciousness | X | ||
| Diarrhea: Passing loose or more frequent stools (bowel movements) than normal | X | ||
| Common | |||
| Liver problems: Yellowing of the skin or eyes, dark urine, abdominal pain, nausea, vomiting, loss of appetite, bleeding or bruising more easily than normal, itchiness, or feeling very tired | X | ||
| Hypothyroidism (low level of thyroid hormone in the blood): Changes in heart rate, appetite or weight; tiredness; feeling cold; swelling at front of the neck, abnormal levels of thyroid stimulating hormone in the blood | X | ||
| Hypocalcemia (low level of calcium in the blood): Muscle aches, cramps or stiffness; tingling in lips, fingers and feet; fast heartrate | X | ||
| Blood clots: Chest pain or pressure; pain in your arms, back, neck or jaw; shortness of breath; numbness or weakness on one | X | ||
| side of your body; trouble talking; sudden severe headache; or sudden vision changes | |||
| Wound complications (a wound that does not heal) | X | ||
| Perforation (tear in your stomach or intestinal wall) or fistula (an abnormal connection between two or more body parts): Severe abdominal pain, chills, fever, nausea, vomiting, or a leak of air from your lung into the chest causing sudden chest pain and/or difficulty breathing | X | ||
| Ascites (an abnormal build-up of fluid in the abdomen): Sudden weight gain, swollen belly, belly pain, nausea, vomiting, heartburn | X | ||
| Kidney problems: Nausea, vomiting, swelling (hands, feet, or around your eyes), foamy urine and fatigue | X | ||
| QT prolongation (an abnormal heart signal): Fainting, seizures or fits. | X | ||
| Infections (including pneumonia and sepsis): Fever, chills, shivering, fast heartrate, rapid breathing | X | ||
| Dehydration (dry mouth, excessive thirst): Thirst, headache, loss of appetite, feel tired and weak, lack of sweating, decreased blood pressure and urine, dark yellow urine | X | ||
| Urinary tract infection (infection in urinary system including kidneys, ureters, bladder and urethra): Pain or burning sensation while urinating, frequent urination, blood in urine, pain in the pelvis, strong smelling urine, cloudy urine | X | ||
| Pancreatitis (inflammation of the pancreas): upper abdominal pain, | X | ||
| fever, rapid pulse, nausea, vomiting, tenderness when touching the abdomen | |||
| Myocardial infarction (heart attack): chest pain; feeling of pressure, heaviness or squeezing across the chest; occasionally pain in other parts of the body, pain may feel like it is spreading from the chest to the arms, back, neck or jaw | X | ||
| Adrenal insufficiency (decreased release of hormones from the adrenal glands): weakness, fatigue, dizziness upon standing, loss of appetite, nausea, vomiting, diarrhea. | X | ||
| Pneumonitis (inflammation of the lungs): shortness of breath, chest pain, cough. | X | ||
| Uncommon | |||
| Osteonecrosis (severe jaw bone 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. | X | ||
| Right ventricular dysfunction (weakness in muscle that pumps blood on the right side of heart): swelling in legs or ankles, shortness of breath, chest pain and discomfort, palpitations (missed, racing or pounding heartbeat), pain or discomfort in the upper right side of stomach. | X | ||
| Sinus tachycardia (increased heart rate [more than 100 beats per minute]): shortness of breath, lightheadedness, dizziness, chest pain, headache, palpitations (missed, racing or pounding heartbeat). | X | ||
| Ventricular fibrillation (irregular heart rhythm): chest pain that moves to left arm, fast heartbeat, dizziness, nausea, shortness of breath. | X | ||
| Myocarditis (inflammation of the heart muscle): abnormal heartbeat, chest pain, fatigue, fever and other signs of infection like muscle aches, sore throat and diarrhea. | X | ||
| Myasthenic syndrome (muscle problems): weakness and fatigue of the muscles. | X | ||
| Rare | |||
| Heart failure (heart does not pump as well as it should): Shortness of breath; swelling of ankles and feet | X | ||
| Posterior Reversible Encephalopathy Syndrome (PRES): Headache, seizures, weakness, confusion, high blood pressure, blindness or change in vision, or problems thinking | X | ||
| Very Rare | |||
| Artery Dissection: A sudden severe pain in the back, chest or abdomen | X | ||
| Artery Aneurysm (a bulge in the wall of any artery including in the chest, arms, legs, heart, and brain): Symptoms will differ by the site. They can be cough, coughing up blood. Strong pain high in your neck or in your back when you didn’t hurt yourself. Problems swallowing. Hoarse voice. Unusual pulsing in your chest or abdomen | X | ||
| Cholecystitis (Inflammation of the gallbladder): fever, nausea, pain that radiates to your shoulder or back, severe pain in your upper right abdomen, vomiting | X | ||
| Unknown | |||
| Tumor lysis syndrome (the sudden, rapid death or breakdown of cancer cells due to treatment): nausea, shortness of breath, irregular heartbeat, heart rhythm disturbances, less frequent urination, cloudy urine, muscle spasms or twitching, tiredness, joint pain, severe muscle weakness, seizures. | X | ||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.
Reporting side effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
- Visiting the Web page on Adverse Reaction Reporting (canada.ca/drug-device-reporting) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
NOTE: Contact your healthcare professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
Storage:
- Store LENVIMA at 15°C to 30°C.
- Keep out of reach and sight of children.
- Do not use LENVIMA that is out of date or no longer needed. Ask your healthcare professional how to safely throw away LENVIMA capsules.
If you want more information about LENVIMA:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada Drug Product Database website: (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website www.eisai.ca, or by calling 1-877-873-4724.
Date of Authorization: 2026-05-05
LENVIMA® is a registered trademark owned by Eisai R&D Management Co., Ltd.