Lenvatinib oral capsule

What is this medication?

LENVATINIB (len VA ti nib) is a medicine that targets proteins in cancer cells and stops the cancer cells from growing. It treats endometrial cancer, kidney cancer, liver cancer, and thyroid cancer.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): LENVIMA

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• dental or gum disease
• diabetes (high blood sugar)
• high blood pressure
• heart disease
• blood clots
• irregular heartbeat or rhythm
• low levels of calcium, magnesium, or potassium in the blood
• inflammatory bowel disease
• kidney disease
• liver disease
• protein in your urine
• having or recent surgery
• thyroid disease
• an unusual or allergic reaction to lenvatinib, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medication?

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. Swallow the capsules whole. Do not cut, crush or chew this medicine. Take your medicine at regular intervals. Do not take it more often than directed. Do not stop taking except on your doctor's advice.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If your next dose is to be taken in less than 12 hours, then do not take the missed dose. Take the next dose at your regular time. Do not take double or extra doses.

What may interact with this medication?

Do not take this medicine with any of the following medications:

• cisapride
• dronedarone
• pimozide
• thioridazine

This medicine may also interact with the following medications:

• alfuzosin
• bedaquiline
• certain antibiotics like azithromycin, clarithromycin or erythromycin
• certain medicines for bladder problems like solifenacin, tolterodine
• certain medicines for depression, anxiety, or psychotic disturbances
• certain medicines for fungal infections like ketoconazole, posaconazole, voriconazole, fluconazole, and itraconazole
• certain medicines for irregular heart beat like amiodarone, dofetilide, flecainide, propafenone, quinidine
• chloroquine
• ciprofloxacin
• dofetilide
• ezogabine
• fingolimod
• granisetron
• leuprolide
• lopinavir; ritonavir
• methadone
• metronidazole
• mifepristone
• octreotide
• ondansetron
• other medicines that prolong the QT interval (cause an abnormal heart rhythm) like ziprasidone
• pasireotide
• pentamidine
• promethazine
• quinine
• ranolazine
• rifampin
• rilpivirine
• romidepsin
• saquinavir
• tacrolimus
• telavancin
• telithromycin
• tetrabenazine
• tizanidine
• toremifene
• vardenafil
• vorinostat

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your doctor for regular check-ups. Report any side effects. Continue your course of treatment unless your doctor tells you to stop. You will need blood work done while you are taking this medicine.

Do not become pregnant while taking this medicine or for 30 days after stopping it. Women should inform their doctor if they wish to become pregnant or think they might be pregnant. There is a potential for serious side effects to an unborn child. Talk to your health care professional or pharmacist for more information. Do not breast-feed an infant while taking this medicine or for 1 week after stopping it. This medicine may interfere with the ability to have a child. Talk with your doctor or health care professional if you are concerned about your fertility.

Before having surgery, talk to your health care provider to make sure it is ok. This drug can increase the risk of poor healing of your surgical site or wound. You will need to stop this drug for 1 week before surgery. After surgery, wait at least 2 weeks before restarting this drug. Make sure the surgical site or wound is healed enough before restarting this drug. Talk to your health care provider if questions.

Be careful brushing and flossing your teeth or using a toothpick because you may get an infection or bleed more easily. If you have any dental work done, tell your dentist you are receiving this medicine.

This medicine may increase your risk to bruise or bleed. Call your doctor or health care professional if you notice any unusual bleeding.

This drug may make you feel generally unwell. This is not uncommon, as chemotherapy can affect healthy cells as well as cancer cells. Report any side effects. Continue your course of treatment even though you feel ill unless your doctor tells you to stop.

This medicine may interfere with the ability to have a child. You should talk with your doctor or health care professional if you are concerned about your fertility.

What side effects may I notice from receiving this medication?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions (skin rash, itching or hives, swelling of the face, lips, or tongue)
• bleeding (bloody or black, tarry stools; red or dark brown urine; spitting up blood or brown material that looks like coffee grounds; red spots on the skin; unusual bruising or bleeding from the eye, gums, or nose)
• headache
• heartbeat rhythm changes (trouble breathing; chest pain; dizziness; fast, irregular heartbeat; feeling faint or lightheaded, falls)
• increase in blood pressure
• jaw pain, especially after dental work
• kidney injury (trouble passing urine or change in the amount of urine)
• light-colored stool
• liver injury (dark yellow or brown urine; general ill feeling or flu-like symptoms; loss of appetite; right upper belly pain; unusually weak or tired; yellowing of the eyes or skin)
• low potassium levels (trouble breathing; chest pain; dizziness; fast, irregular heartbeat; feeling faint or lightheaded, falls; muscle cramps or pain)
• seizures
• stomach pain
• stroke (changes in vision; confusion; trouble speaking or understanding; severe headaches; sudden numbness or weakness of the face, arm or leg; trouble walking; dizziness; loss of balance or coordination)
• swelling of the ankles

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• diarrhea
• joint pain
• lack or loss of appetite
• mouth sores
• muscle pain
• nausea, vomiting
• weight loss

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children.

Store between 20 and 25 degrees C (68 and 77 degrees F). Throw away any unused medicine after the expiration date.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.