Lenvatinib, Oral

________________________________________________________________________

KEY POINTS

• This medicine is taken by mouth to treat differentiated thyroid cancer. Take it exactly as directed.
• Call your healthcare provider right away if you feel faint, lightheaded, or if your heartbeat is irregular while taking this medicine. These may be signs of a condition called long QT syndrome that may cause death.
• Keep all appointments for tests to see how this medicine affects you.
• This medicine may cause liver problems, bleeding, or other unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

________________________________________________________________________

What are other names for this medicine?

Type of medicine: antineoplastic (anticancer); chemotherapy

Generic and brand names: lenvatinib, oral; Lenvima

What is this medicine used for?

This medicine is taken by mouth to treat differentiated thyroid cancer that is growing and cannot be treated by radioactive iodine.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine
• A stroke or transient ischemic attack (TIA)
• A tear or hole in your stomach or intestines
• Blood clots or bleeding problems
• Heart disease, stroke, or an irregular heartbeat
• High blood pressure
• Liver or kidney problems
• Low levels of calcium, magnesium, or potassium in the blood
• Long QT syndrome (problems with electrical activity in the heart muscle)
• Seizures

This medicine may make you sterile (unable to have children) whether you are a man or a woman. If you plan to have children someday, talk with your healthcare provider before you start treatment.

Females of childbearing age: This medicine is not usually given to pregnant women because it can harm the baby. If you are pregnant, tell your healthcare provider. Do not become pregnant during treatment with this medicine and for at least 2 weeks after stopping this medicine. Talk with your healthcare provider about effective birth control methods. If you become pregnant, contact your healthcare provider right away. Do not breast-feed while you are taking this medicine.

How do I use it?

Check the label on the medicine for directions about your specific dose. Take this medicine exactly as your healthcare provider prescribes. Do not take more of it or for longer than prescribed. Taking too much increases the risk of serious side effects. Do not stop taking this medicine without your healthcare provider's approval.

Check with your healthcare provider before using this medicine in children under age 18.

You may take this medicine with or without food. Swallow the capsules whole. Do not open, crush, or chew them.

What if I miss a dose?

If you miss a dose, and it is more than 12 hours until the next scheduled dose, take it as soon as you remember. If it is less than 12 hours until your next dose, skip the missed dose and take the next one as directed. Do not take double doses. If you are not sure of what to do if you miss a dose, or if you miss more than one dose, contact your healthcare provider.

What if I overdose?

If you or anyone else has intentionally taken too much of this medicine, call 911 or go to the emergency room right away. If you pass out, have seizures, weakness or confusion, or have trouble breathing, call 911. If you think that you or anyone else may have taken too much of this medicine, call the poison control center. Do this even if there are no signs of discomfort or poisoning. The poison control center number is 800-222-1222.

Symptoms of an acute overdose may include: severe diarrhea, rash, irregular heartbeat.

What should I watch out for?

This medicine may cause severe bleeding, or perforation of the stomach, small intestine, or large intestine. These problems may happen with or without warning symptoms. If you have abdominal pain, a black tarry bowel movement, a bloody bowel movement, or any unusual bruising or bleeding, contact your healthcare provider right away.

Call your healthcare provider right away if you feel faint, lightheaded, or if your heartbeat is irregular while taking this medicine. These may be signs of a condition called long QT syndrome that may cause death.

This medicine can cause liver problems. You will need to have blood tests regularly to see how this medicine affects you. Keep all appointments for these tests. Contact your healthcare provider right away if you develop loss of appetite; yellowish skin or eyes; dark urine; light-colored bowel movements; severe stomach pain; or severe tiredness. These are signs of possible liver damage.

This medicine can increase your blood pressure. Your blood pressure needs to be checked regularly while you are taking this medicine. Talk with your healthcare provider about this.

This medicine increases the risk for reversible posterior leukoencephalopathy syndrome (RPLS). Call your healthcare provider right away if you have:

• Headache
• Seizures
• Weakness
• Confusion
• Trouble seeing or changes in vision
• Problems thinking

You need to have regular exams and lab tests to see how this medicine affects you. Keep all appointments for tests.

This medicine may cause or worsen diarrhea. If you get diarrhea while taking this medicine, ask your healthcare provider what medicine you can take to treat diarrhea. Do not take medicine to treat diarrhea without your provider's approval. Drink plenty of liquid while you have diarrhea.

This medicine may make you feel tired, weak, or cause blurred vision. Do not drive or operate machinery unless you are fully alert and can see clearly.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking this medicine.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; tightness in your chest; swelling of your lips, tongue, and throat); sudden weakness, numbness, or tingling, especially on one side of your body; sudden or severe headache; sudden trouble with vision, speech, balance, or walking.

Serious (Report these to your healthcare provider right away.): Yellowish eyes or skin; light-colored bowel movements; dark urine; unusual bruising or bleeding; unusual tiredness or weakness; trouble urinating; decreased urination; severe stomach pain; chest pain; irregular heartbeat; fainting; shortness of breath; seizures; trouble thinking or concentrating; confusion; trouble seeing; swelling in hands or feet or any unusual swelling.

Other: Diarrhea, nausea; vomiting; minor stomach pain; joint or muscle pain; headache; redness, itching, or peeling of the skin on your hands and feet; decreased appetite; weight loss; mouth sores; hoarseness.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• Antibiotics such as azithromycin (Zithromax, Zmax), ciprofloxacin (Cipro), clarithromycin (Biaxin), erythromycin (E.E.S., Ery-Tab, Erythrocin), levofloxacin (Levaquin), moxifloxacin (Avelox), pentamidine (NebuPent, Pentam), rifabutin (Mycobutin), rifampin (Rifadin), rifapentine (Priftin), and sulfamethoxazole/trimethoprim (Bactrim, Septra)
• Antidepressants such as amitriptyline, citalopram (Celexa), escitalopram (Lexapro), fluoxetine (Prozac), imipramine (Tofranil), nortriptyline (Pamelor), sertraline (Zoloft), and trazodone
• Antifungal medicines such as fluconazole (Diflucan), itraconazole (Sporanox), and ketoconazole (Nizoral)
• Antipsychotic medicines such as asenapine (Saphris), chlorpromazine, haloperidol (Haldol), iloperidone (Fanapt), pimozide (Orap), thioridazine, and ziprasidone (Geodon)
• Artemether/lumefantrine (Coartem)
• Cancer medicines such as arsenic trioxide (Trisenox), ceritinib (Zykadia), crizotinib (Xalkori), nilotinib (Tasigna), pazopanib (Votrient), sorafenib (Nexavar), toremifene (Fareston), vandetanib (Caprelsa), and vemurafenib (Zelboraf)
• Chloroquine
• Dextromethorphan/quinidine (Nuedexta)
• Diuretics (water pills) such as amiloride, bumetanide, chlorothiazide (Diuril), furosemide (Lasix), hydrochlorothiazide (Microzide), spironolactone (Aldactone), torsemide (Demadex), and triamterene (Dyrenium)
• Doxepin (Silenor)
• Heart medicines such as amiodarone (Cordarone, Pacerone), digoxin (Lanoxin), disopyramide (Norpace), dofetilide (Tikosyn), dronedarone (Multaq), flecainide, ibutilide (Corvert), ivabradine (Procoralan), procainamide, propafenone (Rythmol), ranolazine (Ranexa), and sotalol (Betapace, Sorine)
• HIV medicines such as emtricitabine/rilpivirine/tenofovir (Complera, Odefsey), rilpivirine (Edurant), ritonavir (Norvir), and saquinavir (Invirase)
• Immunosuppressants such as cyclosporine (Gengraf, Neoral, Sandimmune), sirolimus (Rapamune), and tacrolimus (Astagraf, Prograf, Protopic)
• Methadone (Dolophine, Methadose)
• Mifepristone (Korlym, Mifeprex)
• Nausea medicines such as dolasetron (Anzemet), granisetron (Sancuso), ondansetron (Zofran), and promethazine
• Ombitasvir/paritaprevir/ritonavir/dasabuvir (Viekira)
• Paroxetine (Brisdelle, Paxil, Pexeva)
• Quinine
• Vardenafil (Levitra, Staxyn)

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine at room temperature. Keep the container tightly closed. Protect it from heat, high humidity, and bright light.

---

This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicine in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.