What should I tell my health care provider before taking LENVIMA® (lenvatinib)?

Before you take LENVIMA, tell your health care provider if you

  • have high blood pressure
  • have heart problems
  • have a history of blood clots in your arteries (type of blood vessel), including stroke, heart attack, or change in vision
  • have or have had kidney or liver problems
  • have a history of a tear (perforation) in your stomach or intestine, or an abnormal connection between 2 parts of your gastrointestinal tract (fistula)
  • have headaches, seizures, or vision problems
  • have any bleeding problems
  • are pregnant or plan to become pregnant. LENVIMA can harm your unborn baby
    • Females who are able to become pregnant should use an effective method of birth control during treatment with LENVIMA and for at least 2 weeks after the last dose of LENVIMA. Talk with your health care provider about birth control methods you can use during this time
    • Tell your health care provider right away if you become pregnant or think you are pregnant during treatment with LENVIMA
  • are breastfeeding or plan to breastfeed. It is not known if LENVIMA passes into your breast milk. Do not breastfeed during treatment with LENVIMA

Tell your health care provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Know the medicines you take. Keep a list of your medicines to show to your health care provider and pharmacist when you get a new medicine.

Important
Safety Information

EXPAND COLLAPSE

Indication: LENVIMA® (lenvatinib) is a prescription medicine that is used to treat certain kinds of cancer.

  • LENVIMA is used by itself to treat differentiated thyroid cancer (DTC), a type of thyroid cancer, that can no longer be treated with radioactive iodine and is progressing
  • LENVIMA is used along with another medicine, everolimus, to treat advanced RCC, a type of kidney cancer, after one course of treatment with another anti-cancer medicine

It is not known if LENVIMA is safe and effective in children.

Important Safety Information

LENVIMA® (lenvatinib) 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: 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)
  • 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
  • kidney problems: Kidney failure has happened with LENVIMA 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 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
  • 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; 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

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 the skin on your hands and feet; stomach (abdomen) pain; and hoarseness.

The most common side effects of LENVIMA 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.

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.

Please see full Prescribing Information.

Indication: LENVIMA® (lenvatinib) is a prescription medicine that is used to treat certain kinds of cancer.

  • LENVIMA is used by itself to treat differentiated thyroid cancer (DTC), a type of thyroid cancer, that can no longer be treated with radioactive iodine and is progressing
  • LENVIMA is used along with another medicine, everolimus, to treat advanced RCC, a type of kidney cancer, after one course of treatment with another anti-cancer medicine

It is not known if LENVIMA is safe and effective in children.

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Next section: How to take LENVIMA

This Web site contains information relating to various medical conditions and treatment. Such information is provided for educational purposes only and is not meant to be a substitute for the advice of a physician or other health care professionals. You should not use this information for diagnosing a health problem or disease. In order for you to make intelligent health care decisions, you should always consult with a physician or other health care provider for your, or your loved ones’, personal medical needs. Individual responses to treatment may vary.

This site is intended for residents of the United States only. The products discussed herein may have different product labeling in different countries.

To report suspected adverse reactions, contact Eisai Inc. at 1-888-274-2378 or the FDA at 1-800-FDA-1088 or www.FDA.gov/medwatch.

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Important
Safety Information

EXPAND COLLAPSE

Indication: LENVIMA® (lenvatinib) is a prescription medicine that is used to treat certain kinds of cancer.

  • LENVIMA is used by itself to treat differentiated thyroid cancer (DTC), a type of thyroid cancer, that can no longer be treated with radioactive iodine and is progressing
  • LENVIMA is used along with another medicine, everolimus, to treat advanced RCC, a type of kidney cancer, after one course of treatment with another anti-cancer medicine

It is not known if LENVIMA is safe and effective in children.

Important Safety Information

LENVIMA® (lenvatinib) 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: 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)
  • 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
  • kidney problems: Kidney failure has happened with LENVIMA 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 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
  • 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; 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

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 the skin on your hands and feet; stomach (abdomen) pain; and hoarseness.

The most common side effects of LENVIMA 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.

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.

Please see full Prescribing Information.

Indication: LENVIMA® (lenvatinib) is a prescription medicine that is used to treat certain kinds of cancer.

  • LENVIMA is used by itself to treat differentiated thyroid cancer (DTC), a type of thyroid cancer, that can no longer be treated with radioactive iodine and is progressing
  • LENVIMA is used along with another medicine, everolimus, to treat advanced RCC, a type of kidney cancer, after one course of treatment with another anti-cancer medicine

It is not known if LENVIMA is safe and effective in children.

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Eisai Inc. does not review the information contained on the following Web site for content, accuracy, or completeness. Use of and access to the information is subject to the terms, limitations, and conditions set by the Web site producer. Eisai Inc. makes no claims about the accuracy or any other aspect of the information contained on this Web site, nor does Eisai Inc. endorse this Web site.

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