Dosing With LENVIMA® (lenvatinib)

LENVIMA 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 to treat adults with a type of kidney cancer called advanced renal cell carcinoma (RCC):

along with the medicine pembrolizumab as your first treatment when your kidney cancer has spread or cannot be removed by surgery.
along with the medicine everolimus after one course of treatment with another anti-cancer medicine.

LENVIMA is used by itself as the first treatment for a type of liver cancer called hepatocellular carcinoma (HCC) when it cannot be removed by surgery.
LENVIMA is used along with another medicine called pembrolizumab to treat advanced endometrial carcinoma (EC), a type of uterine cancer:

when a laboratory test shows that your tumor is mismatch repair proficient (pMMR) or not microsatellite instability high (MSI-H), and
you have received anti-cancer treatment, and it is no longer working, and
your cancer cannot be cured by surgery or radiation

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

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Important Safety Information & Full Prescribing Information

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Differentiated thyroid
cancer (DTC)
Advanced kidney cancer (RCC)
as your first treatment*
Advanced kidney cancer (RCC)
after 1 previous treatment^†
Inoperable liver cancer (HCC)
Advanced endometrial cancer*

*Taken in combination with pembrolizumab.

†Taken in combination with everolimus after one course of treatment with another anti-cancer medicine.

About
LENVIMA
- - About
    LENVIMA
  - Clinical trial results with LENVIMA
  - How does LENVIMA work?
  - What you should know about certain side effects
Starting
LENVIMA
- - Starting
    LENVIMA
  - What to tell your doctor
  - How to take LENVIMA
  - Receiving your prescription
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Patient Support
- - Financial Info &
    Patient Support
  - Financial info and help
  - Patient support

Watch this important demo on how to open your LENVIMA blister card

LENVIMA^® (lenvatinib) Indications and Important Safety Information

What is LENVIMA?

LENVIMA 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 to treat adults with a type of kidney cancer called advanced renal cell carcinoma (RCC):

along with the medicine pembrolizumab as your first treatment when your kidney cancer has spread or cannot be removed by surgery
along with the medicine everolimus after one course of treatment with another anti-cancer medicine (anti-angiogenic therapy)

LENVIMA is used by itself as the first treatment for a type of liver cancer called hepatocellular carcinoma (HCC) when it cannot be removed by surgery
LENVIMA is used along with another medicine called pembrolizumab to treat advanced endometrial carcinoma (EC), a type of uterine cancer:

when a laboratory test shows that your tumor is mismatch repair proficient (pMMR) or not microsatellite instability high (MSI-H), and
you have received anti-cancer treatment, and it is no longer working, and
your cancer cannot be cured by surgery or radiation

The safety and efficacy of LENVIMA have not been established in children.

IMPORTANT SAFETY INFORMATION

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 healthcare provider should check your blood pressure regularly during treatment with LENVIMA. If you develop blood pressure problems, your healthcare 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 healthcare 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 healthcare provider will check your liver function before and during treatment with LENVIMA. Tell your healthcare provider right away if you develop 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 healthcare 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 healthcare 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 healthcare provider about what medicines you can take to treat your diarrhea. It is important to drink more water when you get diarrhea. Tell your healthcare 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 develop 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 healthcare provider will do blood tests before and during your treatment with LENVIMA to check the levels of potassium, magnesium, and calcium in your blood, and may check the electrical activity of your heart with an electrocardiogram (ECG)

low levels of blood calcium (hypocalcemia): Your healthcare 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 healthcare 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 healthcare provider if you develop 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 healthcare provider should check your thyroid hormone levels before starting and every month during treatment with LENVIMA

wound healing problems: Wound healing problems have happened in some people who take LENVIMA. Tell your healthcare 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 healthcare 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 healthcare 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 healthcare provider right away if you have any signs or symptoms of jaw bone problems during treatment with LENVIMA, including jaw pain, toothache, or sores on your gums and if you plan to have any dental procedures before or during treatment with LENVIMA.

You should stop taking LENVIMA at least 1 week before planned dental surgery or invasive dental procedures
Your healthcare provider should tell you when you may start taking LENVIMA again after dental procedures

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 in people treated for kidney cancer in combination with everolimus 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, decrease in thyroid hormone levels, and nausea.

The most common side effects of LENVIMA when given in combination with pembrolizumab include decrease in thyroid hormone levels, tiredness, joint and muscle pain, nausea, decreased appetite, vomiting, mouth sores, weight loss, stomach-area (abdomen) pain, urinary tract infection, constipation, headache, bleeding, rash, redness, itching, or peeling of your skin on your hands and feet, hoarseness, and rash.

LENVIMA may cause fertility problems in males and females and can harm your unborn baby.
Tell your healthcare provider if you are:

pregnant or plan to become pregnant. For females who are able to become pregnant, your healthcare provider should do a pregnancy test before you start treatment with LENVIMA. Use an effective method of birth control (contraception) during treatment with LENVIMA and for 30 days after the last dose of LENVIMA
breastfeeding or plan to breastfeed. It is not known if LENVIMA passes into your breast milk. Do not breastfeed during treatment with LENVIMA and for 1 week after the last dose

Your healthcare 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.

For more information about LENVIMA, please see full Prescribing Information.

This website 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 .

LENVIMA® is a registered trademark used by Eisai Inc. under license from Eisai R&D Management Co., Ltd. © 2023 Eisai Inc.
All rights reserved. The trademarks used are owned by their respective owners.
All rights reserved.LENV-US9650 09/23

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