What you should
know about
certain side effects

Pay attention to side effects

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.

• 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 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 health 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.

• 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) 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

  Your health care provider should check your thyroid hormone levels every month during treatment with LENVIMA.

• Wound healing problems

  Wound healing problems have happened in some people who take LENVIMA. Tell your health care provider if you plan to have any surgery before or during treatment with LENVIMA.

  • You should stop taking LENVIMA at least 1 week before planned surgery.
  • Your health care provider should tell you when you may start taking LENVIMA again after surgery.
• Severe jaw bone problems (osteonecrosis)

  Severe jaw bone problems have happened in some people who take LENVIMA. Certain risk factors such as taking a bisphosphonate medicine or the medicine denosumab, having dental disease, or an invasive dental procedure may increase your risk of getting jaw bone problems. Your health care provider should examine your mouth before you start and during treatment with LENVIMA. Tell your dentist that you are taking LENVIMA. It is important for you to practice good mouth care during treatment with LENVIMA. Tell your health care provider right away if you get signs or symptoms of jaw bone problems during treatment with LENVIMA, including jaw pain, toothache, or sores on your gums. Tell your health care provider if you plan to have any dental procedures before or during treatment with LENVIMA. You should avoid having invasive dental procedures if possible, during treatment with LENVIMA. Stopping your bisphosphonate medicine before an invasive dental procedure may help decrease your risk of getting these jaw problems.

  • You should stop taking LENVIMA at least 1 week before planned dental surgery or invasive dental procedures.
  • Your health care provider should tell you when you may start taking LENVIMA again after dental procedures.
• LENVIMA may cause fertility problems in males and females. Talk to your health care provider if this is a concern for you.
• Your health care provider may need to reduce your dose of LENVIMA, or delay or completely stop treatment, if you have certain side effects.
• 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 or visit www.fda.gov/medwatch.

Talk to your doctor about any side effects you may experience

The most common side effects of LENVIMA in people treated for thyroid cancer include tiredness; joint and muscle pain; decreased appetite; weight loss; nausea; mouth sores; headache; vomiting; rash, redness, itching, or peeling of your skin on your hands and feet; stomach (abdomen) pain; and hoarseness.

The most common side effects of LENVIMA when given with everolimus in people treated for kidney cancer include tiredness; joint and muscle pain; decreased appetite; vomiting; nausea; mouth sores; swelling in your arms and legs; cough; stomach (abdomen) pain; trouble breathing; rash; weight loss; and bleeding.

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.