Lenvatinib belongs to the group of cancer-fighting medications called antineoplastics, and specifically to the family of medications called protein kinase inhibitors. It is used to treat thyroid cancer that has recurred or metastasized (spread) or progressed despite radioactive-iodine treatment.

Lenvatinib is used with other medications to treat advanced renal cell carcinoma and advanced endometrial carcinoma. It is also used to treat hepatocellular carcinoma.

Lenvatinib works by recognizing and attaching to certain types of cancer cells. This may slow down or stop cancers from growing and dividing.

This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

The recommended adult dose of lenvatinib depends on the type of cancer being treated. Make sure you are clear on the correct number of capsules to take each day. Your doctor may adjust the dose based on side effects that you experience, until a balance between side effects and effectiveness is reached.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

Lenvatinib may be taken with food or on an empty stomach. Swallow the capsules whole, with water. Avoid contact with the powder inside the capsules. Do not open the capsules. Do not crush or chew the medication. If you have difficulty swallowing the capsules whole, you may dissolve the capsules (do not open them) in a small cup containing 1 tablespoon of water or apple juice. Let them sit for about 10 minutes, then stir the mixture for another 3 minutes. Swallow the mixture. Then rinse the cup with a small amount of water or apple juice and swallow the liquid to make sure you receive the full dose. It is important to take this medication exactly as prescribed by your doctor. If you miss a dose, take it as soon as possible and continue with your regular schedule. If it is more than 12 hours since the missed dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store this medication at room temperature, protect it from light and moisture, and keep it out of the reach of children.

4 mg 
Each hard hypromellose capsule with a yellowish-red body and yellowish-red cap, marked in black ink with “Є” on the cap and “LENV 4 mg” on the body, contains lenvatinib mesylate equivalent to 4 mg of lenvatinib. Nonmedicinal ingredients: calcium carbonate, mannitol, microcrystalline cellulose, hydroxypropylcellulose, low-substituted hydroxypropylcellulose, and talc; capsule shell: hypromellose, titanium dioxide (E171), yellow iron oxide (E172), and red iron oxide (E172); printing ink: shellac, black iron oxide (E172), potassium hydroxide, and propylene glycol.

10 mg 
Each hard hypromellose capsule with a yellow body and yellowish-red cap, marked in black ink with “Є” on the cap and “LENV 10 mg” on the body, contains lenvatinib mesylate equivalent to 10 mg lenvatinib. Nonmedicinal ingredients: calcium carbonate, mannitol, microcrystalline cellulose, hydroxypropylcellulose, low-substituted hydroxypropylcellulose, and talc; capsule shell: hypromellose, titanium dioxide (E171), yellow iron oxide (E172), and red iron oxide (E172); printing ink: shellac, black iron oxide (E172), potassium hydroxide, and propylene glycol.

Do not take this medication if you are allergic to lenvatinib or any ingredients of the medication.

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• abdominal pain
• changed sense of taste
• constipation
• cough
• decreased appetite
• diarrhea
• dizziness
• dry mouth
• gas
• hair loss
• headache
• heartburn
• hoarseness
• mouth sores
• muscle weakness
• nausea
• runny nose
• sneezing
• tiredness
• trouble sleeping
• vomiting
• weight loss

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• breathing difficulty
• fever
• high blood pressure
• jawbone problems (e.g., mouth pain, swelling, sores, numbness, loose tooth)
• lung inflammation (e.g., shortness of breath, chest pain, cough)
• rash, redness, or itching of the palms of the hands or soles of the feet
• signs of blood clots (e.g., coughing up blood; pains in chest, groin, or leg – especially in calf of leg)
• signs of bleeding problems (e.g., unusual nosebleeds, bruising, blood in urine, coughing blood, bleeding gums, cuts that don’t stop bleeding)
• signs of dehydration (e.g., decreased urine, dry skin, dry and sticky mouth, sleepiness, dizziness, headache, thirst, confusion)
• signs of heart failure (e.g., shortness of breath; fatigue; swelling in legs, ankles, or feet)
• signs of heart rhythm irregularity (e.g., dizziness, palpitations, fainting, feeling of rapid, pounding heartbeat)
• signs of infection (symptoms may include fever or chills, severe diarrhea, shortness of breath, prolonged dizziness, headache, stiff neck, weight loss, or listlessness)
• signs of kidney problems (e.g., increased urination at night, decreased urine production, blood in the urine, change of urine colour)
• signs of liver problems (e.g., nausea, vomiting, diarrhea, loss of appetite, weight loss, yellowing of the skin or whites of the eyes, dark urine, pale stools)
• signs of low calcium levels (e.g., muscle aches; cramps or stiffness; tingling in the lips, fingers, or feet; fast heartrate)
• swelling in the arms, hands, legs, or feet
• symptoms of decreased release of hormones from adrenal glands (e.g., weakness, fatigue, dizziness, loss of appetite, nausea, vomiting, diarrhea)
• symptoms of gallbladder inflammation (e.g., fever, nausea, pain radiating to shoulder or back, severe abdominal pain, vomiting)
• symptoms of decreased thyroid function (e.g., constipation, dry skin, tiredness, weight gain, sensitivity to the cold)
• symptoms of a urinary tract infection (e.g., pain when urinating, urinating more often than usual, low back or flank pain)

• wounds that do not heal

Stop taking the medication and seek immediate medical attention if any of the following occur:

• abnormal fluid build-up in the abdomen (e.g., sudden weight gain, swollen belly, belly pain, nausea, vomiting)
• signs of aortic dissection (e.g., sudden severe pain in the back, chest, or abdomen)
• signs of an artery aneurysm (bulge in the wall of any artery; e.g., chest, arm, leg, brain, heart – cough, coughing blood, unusual pain high in neck or back, problems swallowing, pulsing sensation in chest or abdomen)
• signs of a tear in the stomach or intestinal wall or an abnormal connection between two body parts (e.g., severe abdominal pain, nausea, vomiting, chills, fever or a leakage of air from the lungs causing sudden chest pain of difficulty breathing)
• signs of pancreatitis (e.g., abdominal pain on the upper left side, back pain, nausea, fever, chills, rapid heartbeat, swollen abdomen)
• signs of stroke (e.g., sudden or severe headache; sudden loss of coordination; vision changes; sudden slurring of speech; or unexplained weakness, numbness, or pain in arm or leg)
• signs of a heart attack (e.g., chest pain or pressure, pain extending through shoulder and arm, nausea and vomiting, sweating)
• signs of posterior reversible encephalopathy syndrome (e.g., headache, seizures, weakness, confusion, high blood pressure, vision changes, difficulty thinking clearly)
• very high blood pressure (e.g., headache, vision changes, nausea and vomiting)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Abnormal heart rhythms: This medication can cause abnormal heart rhythms. Certain medications (e.g., sotalol, quinidine, chlorpromazine, pimozide, moxifloxacin, mefloquine, pentamidine, arsenic trioxide, tacrolimus) can increase the risk of a type of abnormal heart rhythm called QT prolongation and should not be used in combination with lenvatinib. You are more at risk for this type of abnormal heart rhythm and its complications if you:

• are female
• are older than 65 years of age
• have a family history of sudden death due to heart attack or similar heart problems
• have a history of heart disease or abnormal heart rhythms
• have a slow heart rate
• have congenital prolongation of the QT interval
• have diabetes
• have had a stroke
• have low potassium, magnesium, or calcium levels
• have nutritional deficiencies

If you have heart disease and abnormal heart rhythms, or are taking certain medications (e.g., verapamil, atazanavir), discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Birth control: Effective birth control should be practiced while using this medication. Anyone taking this medication who could impregnate another should use a spermicide in addition to a barrier method of birth control (e.g., condoms). Anyone taking this medication who could become pregnant must also use reliable birth control while taking lenvatinib and for at least 1 month after stopping the medication. The effectiveness of hormonal contraceptives, such as birth control pills has not been determined. Barrier methods of birth control are recommended.

Bleeding: Lenvatinib may cause a reduced number of platelets in the blood, which can make it difficult to stop cuts from bleeding. If you notice any signs of bleeding, such as frequent nosebleeds, unexplained bruising, or black and tarry stools, notify your doctor as soon as possible. Your doctor will order routine blood tests to make sure potential problems are caught early.

Blood clots: This medication may increase the chance of blood clot formation, causing reduction of blood flow to organs or the extremities.

If you have a history of clotting you may be at increased risk of experiencing blood clot-related problems such as heart attack or stroke. Discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. The safety of using this medication within 6 months of experiencing a blood clot has not been studied.

Gastrointestinal problems and fistula formation: Lenvatinib can cause perforation of the stomach or intestines or fistula formation (an abnormal connection between two body parts), resulting in a collapsed lung. If you experience severe abdominal pain, fever, vomiting, or nausea, or sudden chest pain and/or difficulty breathing, contact your doctor immediately.

Heart function: This medication may cause symptoms of heart failure. Contact your doctor as soon as possible if you develop symptoms of heart problems such as shortness of breath, chest pain, rapid heartbeat, or swollen ankles.

High blood pressure: Lenvatinib can cause increased blood pressure. If you have high blood pressure, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Kidney function/failure: This medication can cause decreased kidney function or kidney failure. If you experience puffy hands, face, or feet, high blood pressure, unusual muscle cramping, or darkened urine, this medication may be affecting how well your kidneys are working. If you notice any of these symptoms, contact your doctor as soon as possible.

Liver function: This medication is broken down by the liver. Liver disease or reduced liver function may cause this medication to build up in the body, causing side effects. If you have liver problems, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. Your doctor may want to test your liver function regularly with blood tests while you are taking this medication.

Lenvatinib has been reported to cause a decrease in liver function, which has in rare cases caused liver failure. If you experience symptoms of liver problems such as fatigue, feeling unwell, loss of appetite, nausea, yellowing of the skin or whites of the eyes, dark urine, pale stools, abdominal pain or swelling, and itchy skin, contact your doctor immediately.

Reversible posterior leukoencephalopathy syndrome (RPLS): This is a rare disease of the brain that may occur when using medications like lenvatinib. If you experience signs and symptoms of RPLS, such as headache, seizures, change in awareness or consciousness or vision changes, contact your doctor immediately.

Surgery: This medication causes changes to the blood and may slow down the healing process for wounds. Make sure anyone involved in your medical care knows you are taking lenvatinib.

Thyroid function: This medication can affect the way the body uses thyroid hormones. If you take thyroid replacement medication, your doctor may need to adjust the dose while you are taking lenvatinib.

Pregnancy: Lenvatinib is likely to harm the developing baby if it is taken during pregnancy. This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, contact your doctor immediately.

Breast-feeding: It is not known if lenvatinib passes into breast milk. If you are breast-feeding and taking this medication, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using this medication have not been established for children.

Seniors: People over the age of 65 years may be more at risk of side effects from this medication.

There may be an interaction between lenvatinib and any of the following:

• alfuzosin
• amphotericin B
• anagrelide
• antiarrhythmics (e.g., disopyramide, dronedarone, flecainide, procainamide, propafenone, sotalol)
• anti-malarial medications (e.g., chloroquine, mefloquine, primaquine)
• antipsychotics (e.g., aripiprazole, cariprazine, chlorpromazine, clozapine, haloperidol, olanzapine, quetiapine, risperidone)
• apomorphine
• atomoxetine
• "azole" antifungals (e.g., itraconazole, ketoconazole, voriconazole)
• beta agonists (e.g., formoterol, salbutamol, salmeterol, vilanterol)
• bilastine
• buprenorphine
• buserelin
• capecitabine
• danazol
• degarelix
• desmopressin
• domperidone
• donepezil
• efavirenz
• eliglustat
• fluorouracil
• fostemsavir
• general anaesthetics (medication to put you to sleep for surgery)
• goserelin
• hydroxychloroquine
• Hydroxyzine
• inotuzumab
• irinotecan
• laxatives
• leuprolide
• levetiracetam
• lithium
• loperamide
• lopinavir
• macrolide antibiotics (e.g., azithromycin, clarithromycin, erythromycin)
• methadone
• metoclopramide
• metronidazole
• mifepristone
• mirtazapine
• pasireotide
• pitolisant
• rilpivirine
• rivastigmine
• romidepsin
• quinine
• quinolone antibiotics (e.g., ciprofloxacin, levofloxacin, moxifloxacin, norfloxacin)
• ranolazine
• selective serotonin reuptake inhibitors (SSRIs; e.g., citalopram, fluoxetine, sertraline)
• serotonin antagonists (anti-emetic medications; e.g., granisetron, ondansetron)
• solifenacin
• solriamfetol
• sphingosine 1-phosphate (S1P) receptor inhibitors (e.g., fingolimod, ponesimod, siponimod)
• tacrolimus
• tamoxifen
• testosterone
• tetrabenazine
• trazodone
• tricyclic antidepressants (e.g., amitriptyline, clomipramine, desipramine, nortriptyline)
• other tyrosine kinase inhibitors (e.g., bosutinib, dasatinib, nilotinib, sunitinib)
• vardenafil
• vilanterol
• vorinostat
• warfarin

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.