What are the possible side effects of LENVIMA^®?

LENVIMA may cause serious side effects, including:

• high blood pressure (hypertension). High blood pressure is a common side effect of LENVIMA and can be serious. Your blood pressure should be well controlled before you start taking LENVIMA. Your health care provider should check your blood pressure regularly during treatment with LENVIMA. If you develop blood pressure problems, your health care provider may prescribe medicine to treat your high blood pressure, lower your dose of LENVIMA, or stop your treatment with LENVIMA
• heart problems. LENVIMA can cause serious heart problems that may lead to death. Call your health care provider right away if you get symptoms of heart problems, such as shortness of breath or swelling of your ankles
• problem with blood clots in your blood vessels (arteries). Get emergency medical help right away if you get any of the following symptoms:
  • severe chest pain or pressure
  • pain in your arms, back, neck, or jaw
  • shortness of breath
  • numbness or weakness on one side of your body
  • trouble talking
  • sudden severe headache
  • sudden vision changes
• liver problems. LENVIMA may cause liver problems that may lead to liver failure and death. Your health care provider will check your liver function before and during treatment with LENVIMA. Tell your health care provider right away if you have any of the following symptoms:
  
  • your skin or the white part of your eyes turns yellow (jaundice)
  • dark “tea-colored” urine
  • light-colored bowel movements (stools)
  • feeling drowsy, confused or loss of consciousness
• kidney problems. Kidney failure, which can lead to death, has happened with LENVIMA treatment. Your heath care provider should do regular blood tests to check your kidneys
• increased protein in your urine (proteinuria). Proteinuria is a common side effect of LENVIMA and can be serious. Your health care provider should check your urine for protein before and during your treatment with LENVIMA. If you develop protein in your urine, your health care provider may decrease your dose of LENVIMA or stop your treatment
• diarrhea. Diarrhea is a common side effect of LENVIMA and can be serious. If you get diarrhea, ask your health care provider about what medicines you can take to treat your diarrhea. It is important to drink more water when you get diarrhea. Tell your health care provider or go to the emergency room if you are unable to drink enough liquids and your diarrhea is not able to be controlled
• an opening in the wall of your stomach or intestines (perforation) or an abnormal connection between two or more body parts (fistula). Get emergency medical help right away if you have severe stomach (abdomen) or chest pain
• changes in the electrical activity of your heart called QT prolongation. QT prolongation can cause irregular heartbeats that can be life threatening. Your health care provider will do blood tests during your treatment with LENVIMA to check the levels of potassium, magnesium, and calcium in your blood, and check the electrical activity of your heart with an ECG
• low levels of blood calcium (hypocalcemia). Your health care provider will check your blood calcium levels during treatment with LENVIMA and may tell you to take a calcium supplement if your calcium levels are low
• a condition called reversible posterior leukoencephalopathy syndrome (RPLS). Call your health care provider right away if you get severe headache, seizures, weakness, confusion, or blindness or change in vision
• bleeding. LENVIMA may cause serious bleeding problems that may lead to death. Tell your health care provider if you have any signs or symptoms of bleeding during treatment with LENVIMA, including:
  • severe and persistent nose bleeds
  • vomiting blood
  • red or black (looks like tar) stools
  • blood in your urine
  • coughing up blood or blood clots
  • heavy or new onset vaginal bleeding
• change in thyroid hormone levels. You may have changes in your thyroid hormone levels when taking LENVIMA. Your health care provider may need to change your dose of thyroid medicine while you are taking LENVIMA. Your health care provider should check your thyroid hormone levels every month during treatment with LENVIMA
• wound healing problems. If you need to have a surgical procedure, tell your health care provider that you are taking LENVIMA. LENVIMA should be stopped until your wound heals

LENVIMA may cause fertility problems in males and females. Talk to your health care provider if this is a concern for you.

These are not all the possible side effects of LENVIMA. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

The most common side effects of LENVIMA in people treated for liver cancer include:

• tiredness
• decreased appetite
• joint and muscle pain
• weight loss
• stomach (abdomen) pain
• rash, redness, itching, or peeling of your skin on your hands and feet
• hoarseness
• bleeding
• change in thyroid hormone levels
• nausea

LENVIMA may cause high blood pressure (hypertension)

• High blood pressure is a common side effect of LENVIMA and can be serious
• As directed by your health care provider, you should check your blood pressure regularly during treatment
• Talk to your health care provider about your blood pressure, as medicine to control it may be required