Lenvatinib is used to treat a certain type of thyroid cancer that has returned or that has spread to other parts of the body and cannot be treated with radioactive iodine. Lenvatinib is also used along with everolimus (Afinitor, Zortress) to treat renal cell carcinoma (RCC, a type of cancer that begins in the kidney) in people who have previously received treatment with another chemotherapy medication. Lenvatinib is also used along with pembrolizumab (Keytruda) as an initial treatment for advanced renal cell carcinoma. Lenvatinib is also used to treat hepatocellular carcinoma (HCC; a type of liver cancer) that cannot be treated with surgery. Lenvatinib is also used along with pembrolizumab (Keytruda) to treat a certain type of cancer of the endometrium (lining of the uterus) that has spread to other parts of the body or worsened during or after treatment with chemotherapy medications or that cannot be treated with surgery or radiation therapy. Lenvatinib is in a class of medications called kinase inhibitors. It works by blocking the action of an abnormal protein that signals cancer cells to multiply. This helps stop the spread of cancer cells.

Lenvatinib comes as a capsule to take by mouth. It is usually taken once daily with or without food. Take lenvatinib at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take lenvatinib exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Swallow the capsules whole; do not open, chew, or crush them.

If you are unable to swallow the capsules, you may dissolve them in water or apple juice. Place the prescribed number of capsules (up to 5 capsules) into a small (20 mlL) container or oral syringe. Add about 3 mL of water or apple juice. Do not break or crush the capsules. Leave the capsules in the liquid for at least 10 minutes and then stir the contents for at least 3 minutes. Drink the mixture. After drinking the mixture, add another 2 mL of water or apple juice to the container or oral syringe. Swirl the contents a few times and swallow the mixture. Repeat until there is no mixture left in the container or oral syringe.

Lenvatinib capsules can be given through certain types of feeding tubes. If you have a feeding tube, ask your doctor how you should take the medication. Follow the directions carefully.

Your doctor may decrease your dose of lenvatinib or tell you to stop taking the medication for a time or permanently if you experience serious side effects. Be sure to talk to your doctor about how you are feeling during your treatment with lenvatinib.

The length of your treatment depends on how well you respond to the medication and the side effects you experience. Continue to take lenvatinib even if you feel well. Do not stop taking lenvatinib without talking to your doctor.

Ask your pharmacist or doctor for a copy of the manufacturer’s information for the patient.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before taking lenvatinib,

• tell your doctor and pharmacist if you are allergic to lenvatinib, any other medications, or any of the ingredients in lenvatinib capsules. Ask your pharmacist for a list of the ingredients.
• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention if you are taking or have taken any medication for osteoporosis. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor if you have or have ever had seizures; high blood pressure; a stroke; a heart attack; headaches; changes in vision, especially those due to blood clots; a fistula (abnormal connection between 2 organs inside your body or between an organ and the outside of your body); a tear in the wall of your stomach or intestine; QT interval prolongation (an irregular heart rhythm that can lead to fainting, loss of consciousness, seizures, or sudden death); heart failure; low levels of calcium, potassium, or magnesium in your blood; osteoporosis; bleeding problems; problems with your mouth, teeth, or gums; thyroid problems; or heart, kidney, or liver disease. Also tell your doctor if you have severe diarrhea or vomiting or you think you may be dehydrated.
• you should know that lenvatinib may decrease fertility in men and women. However, you should not assume that you or your partner cannot become pregnant. Tell your doctor if you are pregnant or plan to become pregnant. You will need to have a pregnancy test before you begin treatment with lenvatinib. If you can become pregnant, you should use birth control during your treatment with lenvatinib and for at least 30 days after your final dose. If you become pregnant while you are taking lenvatinib, call your doctor immediately. Lenvatinib may harm the fetus.
• tell your doctor if you are breastfeeding or plan to breastfeed. You should not breastfeed while taking lenvatinib and for 1 week after your final dose.
• tell your doctor if you are planning to have any surgery, including dental surgery. Your doctor will probably tell you to stop your treatment with lenvatinib at least 7 days before your scheduled surgery because it can affect wound healing. Your doctor will tell you when to start taking lenvatinib again after your surgery.
• you should know that your blood pressure may increase during your treatment with lenvatinib. Your doctor will probably monitor your blood pressure during your treatment.
• you should know that lenvatinib may cause osteonecrosis of the jaw (ONJ, a serious condition of the jaw bone), especially if you have dental surgery or treatment while you are taking the medication. A dentist should examine your teeth and perform any needed treatments, including cleaning or fixing ill-fitted dentures, before you start to take lenvatinib. Be sure to brush your teeth and clean your mouth properly while you are taking lenvatinib. Tell your doctor or dentist if you have or have had mouth, teeth, or jaw pain; mouth sores or swelling; numbness or a feeling of heaviness in the jaw; or any loose teeth. Talk to your doctor before having any dental treatments while you are taking this medication. Your doctor will probably tell you to stop your treatment with lenvatinib at least 7 days before your scheduled dental procedure.

Unless your doctor tells you otherwise, continue your normal diet.

If your next dose is due in 12 hours or more, take the missed dose as soon as you remember it. However, if the next dose will be taken in less than 12 hours, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

Lenvatinib may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• fatigue or tiredness
• rash, redness, itching, or peeling of skin on palms and sole(s) of the feet
• diarrhea
• nausea
• constipation
• heartburn
• decreased appetite
• weight loss
• change in ability to taste food
• cough
• hoarseness
• mouth sores
• dry mouth
• headache
• joint and muscle pain
• difficulty falling asleep or staying asleep
• hair loss
• fever
• burning during urination
• rash

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately or get emergency medical treatment:

• shortness of breath or trouble breathing
• swelling of legs and ankles
• chest pain
• numbness or weakness of the face, arm, or leg on one side of your body
• pain in arms, back, neck, or jaw
• sudden, severe headache
• slow or difficult speech
• sudden changes in vision
• yellowing of the skin or eyes
• stomach pain
• dark (tea-colored) urine
• light-colored stools
• seizures
• weakness
• confusion
• severe and persistent nose bleeds
• bloody vomit
• black, tarry, or bloody stools
• coughing up blood or blood clots
• heavy menstrual bleeding
• vomiting, diarrhea, or signs of dehydration
• wounds that do not heal

Lenvatinib may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Lenvatinib capsules that have been dissolved in water or apple juice can be stored in the refrigerator for up to 24 hours after mixing.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA’s Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can’t be awakened, immediately call emergency services at 911.

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body’s response to lenvatinib. If you are being treated for endometrial cancer, your doctor will order a lab test before you begin your treatment to see whether your cancer can be treated with lenvatinib.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

• Lenvima^®