Lenvatinib oral capsule

What is this medicine?

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

How should I use this medicine?

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.

What side effects may I notice from receiving this medicine?

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

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• breathing problems

• chest pain or palpitations

• dizziness

• feeling faint or lightheaded, falls

• headache

• high blood pressure

• seizures

• signs and symptoms of bleeding such as 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

• signs and symptoms of a dangerous change in heartbeat or heart rhythm like chest pain; dizziness; fast or irregular heartbeat; palpitations; feeling faint or lightheaded, falls; breathing problems

• signs and symptoms of kidney injury like trouble passing urine or change in the amount of urine

• signs and symptoms of liver injury like dark yellow or brown urine; general ill feeling or flu-like symptoms; light-colored stools; loss of appetite; nausea; right upper belly pain; unusually weak or tired; yellowing of the eyes or skin

• signs and symptoms of low potassium like muscle cramps or muscle pain; chest pain; dizziness; feeling faint or lightheaded, falls; palpitations; breathing problems; or fast, irregular heartbeat

• signs and symptoms of a stroke like 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

• stomach pain

• swelling of the legs or ankles

• unusually weak or tired

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

• loss of appetite

• mouth sores

• muscle pain

• nausea, vomiting

• weight loss

What may interact with this medicine?

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

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.

Where should I keep my medicine?

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.

What should I tell my health care provider before I take this medicine?

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

• diabetes

• high blood pressure

• heart disease

• history of blood clots

• history of irregular heartbeat

• history of low levels of calcium, magnesium, or potassium in the blood

• inflammatory bowel disease

• kidney disease

• liver disease

• protein in your urine

• recent or planning to have surgery

• thyroid disease

• an unusual or allergic reaction to lenvatinib, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

What should I watch for while using this medicine?

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.