Important Safety Information

LENVATINIB may cause serious side effects, including

  • high blood pressure (hypertension): High blood pressure is a common side effect of LENVATINIB and can be serious. Your blood pressure should be well controlled before you start taking LENVATINIB. Your health care provider should check your blood pressure regularly during treatment with LENVATINIB. If you develop blood pressure problems, your health care provider may prescribe medicine to treat your high blood pressure, lower your dose of LENVATINIB, or stop your treatment with LENVATINIB
  • heart problems: 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: LENVATINIB 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 LENVATINIB. 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)
  • increased protein in your urine (proteinuria): Proteinuria is a common side effect of LENVATINIB and can be serious. Your health care provider should check your urine for protein before and during your treatment with LENVATINIB. If you develop protein in your urine, your health care provider may decrease your dose of LENVATINIB or stop your treatment
  • diarrhea: Diarrhea is a common side effect of LENVATINIB 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
  • kidney problems: Kidney failure has happened with LENVATINIB treatment. Your health care provider should do regular blood tests to check your kidneys
  • an opening in the wall of your stomach or intestines (perforation) or an abnormal connection between 2 parts of your gastrointestinal tract (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 LENVATINIB 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 LENVATINIB
  • 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: LENVATINIB 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 LENVATINIB, including severe and persistent nose bleeds; vomiting blood; red or black (looks like tar) stools; 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 LENVATINIB. Your health care provider may need to change your dose of thyroid medicine while you are taking LENVATINIB. Your health care provider should check your thyroid hormone levels every month during treatment with LENVATINIB

The most common side effects of LENVATINIB 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 the skin on your hands and feet; stomach (abdomen) pain; and hoarseness.

The most common side effects of LENVATINIB 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.

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