Your path forward with LENVIMA STARTS NOW

Your path forward with LENVIMA STARTS NOW

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What’s insideInside this brochure, you will find information about how LENVIMA® (lenvatinib) and KEYTRUDA® (pembrolizumab) are thought to work, tips to help you manage your treatment, side effects and what to do if you experience them, and patient support.

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Table of Contents

LENVIMA® (lenvatinib)

What is LENVIMA? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

What to tell your health care provider . . . . . . . . . . . . . . . . . . . 6

How LENVIMA is thought to work . . . . . . . . . . . . . . . . . . . . . . 7

Important Safety Information for LENVIMA . . . . . . . . . . . . . . 8-9

Information about certain side effects . . . . . . . . . . . . . . . . . . 10-11

Staying on top of your medication . . . . . . . . . . . . . . . . . . . . . 12-13

How to fill your prescription . . . . . . . . . . . . . . . . . . . . . . . . . . 14

Financial information and help . . . . . . . . . . . . . . . . . . . . . . . . 15

Patient support resources . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16

LENVIMA in combination with KEYTRUDA® (pembrolizumab)

Using LENVIMA and KEYTRUDA in combination . . . . . . . . . . . 17-18

Learn how KEYTRUDA works . . . . . . . . . . . . . . . . . . . . . . . . . . 19

What to tell your health care provider before taking KEYTRUDA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20

What to expect when taking KEYTRUDA . . . . . . . . . . . . . . . . . 21

Important Safety Information for KEYTRUDA . . . . . . . . . . . . . 22-23

Questions about insurance coverage or financial assistance for KEYTRUDA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24

Patient support program for KEYTRUDA . . . . . . . . . . . . . . . . . 25

Please read the Important Safety Information for LENVIMA on pages 8-9 and the accompanying Patient Information, and please read the Important Safety Information for KEYTRUDA on pages 22-23 and the accompanying Medication Guide and discuss them with your health care provider. The physician Prescribing Information for LENVIMA and for KEYTRUDA also are available.

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http://www.lenvima.com

http://www.lenvima.com/pdfs/prescribing-information.pdf#page=51

https://www.merck.com/product/usa/pi_circulars/k/keytruda/keytruda_mg.pdf

http://www.lenvima.com/pdfs/prescribing-information.pdf

https://www.merck.com/product/usa/pi_circulars/k/keytruda/keytruda_pi.pdf

Finding strength and courage in the face of cancer starts with learning about your treatment

When you’re facing cancer, think of information as your partner. This guide is designed to give you the information you need to help you stay prepared throughout your journey with LENVIMA® (lenvatinib).

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Please read the Important Safety Information for LENVIMA on pages 8-9 and the accompanying Patient Information and discuss them with your health care provider. The physician Prescribing Information also is available.

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What is LENVIMA?

LENVIMA® (lenvatinib) is a prescription medicine used to treat people with certain kinds of cancer

Differentiated Thyroid Cancer (DTC)• 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.

Advanced Kidney Cancer (RCC)• LENVIMA is used along with another medicine called everolimus to treat

adults with a type of kidney cancer called advanced renal cell carcinoma (RCC) after one course of treatment with another anti-cancer medicine.

Inoperable Liver Cancer (HCC)• 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 can also be used in combination with another medicine to treat certain types of cancer. See page 17 for more information.

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

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. LENVIMA may cause serious side effects, including 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.

Important Safety Information for LENVIMA





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What to tell your health care provider

Are you and your health care provider considering LENVIMA? As you talk through your treatment options, be sure to discuss the information on this page.

Before you take LENVIMA, tell your health care provider about all of your medical conditions, including 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 two or more body parts (fistula)• have headaches, seizures, or vision problems• have any bleeding problems• plan to have surgery, a dental procedure, or have had a recent surgery.

You should stop taking LENVIMA at least 1 week before planned surgery.• are pregnant or plan to become pregnant. LENVIMA can harm your unborn baby.

Females who are able to become pregnant: ◦ Your health care provider should do a pregnancy test before you start treatment with LENVIMA.

◦ You should use an effective method of birth control during treatment with LENVIMA and for at least 30 days 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 and for at least 1 week after the last dose.

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

Especially tell your health care provider if you are taking, or have taken, an osteoporosis medicine.

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.




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Get to know LENVIMA

What is LENVIMA? FDA-approved LENVIMA is an oral therapy that helps block tumor growth in certain types of cancer. Understanding what LENVIMA is can help you in your journey. LENVIMA is a signal-blocking oral drug called a tyrosine kinase inhibitor (TKI).

How LENVIMA is thought to work

LENVIMA helps block these signals by targeting certain proteins on cancer cells that cause the cells to grow and multiply. As a result, LENVIMA helps prevent tumors from growing and spreadingHealthy cells also contain these proteins and may be affected by LENVIMA. This can sometimes cause serious side effects

Growth signals

Active signal receptors*

Cancer cells

Tumor

Blood vessels

Cancer cells send out signals that tell the body to make more blood vessels

The cancer uses these new blood vessels to grow and spread

Cancer cells

Tumor

LENVIMA

Cancer cells

Tumor

Blocked signal receptors*


LENVIMA may cause serious side effects, including 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.

*Signal receptors are proteins on cells.

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Important Safety Information

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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 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 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 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 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 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 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 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 healthcare provider should check



your thyroid hormone levels before starting and every month during treatment with LENVIMA® (lenvatinib).

• 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 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. The most common side effects of LENVIMA when given with KEYTRUDA® (pembrolizumab) include decrease in thyroid hormone levels, increased blood pressure, tiredness, diarrhea, joint and muscle pain, nausea, decreased appetite, vomiting, mouth sores, weight loss, stomach-area (abdomen) pain, urinary tract infection, protein in your urine, 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 during treatment with LENVIMA and for at least 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 at least 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.

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Important Safety Information (continued)

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Please read the Patient Information for LENVIMA and discuss it with your health care provider. The physician Prescribing Information also is available.

http://www.fda.gov/medwatch



http://lenvima.com/pdfs/prescribing-information.pdf


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Take an active role in your treatmentIt’s important to have an open and ongoing conversation with your health care team while taking LENVIMA. Informing your health care team of your side effects can give them insights into how to help manage your side effects.

Important Safety Information for LENVIMA® (lenvatinib)

LENVIMA may cause serious side effects, including 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 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. LENVIMA may cause serious side effects, including 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. LENVIMA may cause serious side effects, including 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. LENVIMA may cause serious side effects, including 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.

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Every medication has side effects and impacts each person differently. Below is information about certain side effects for LENVIMA. If you have any side effects, tell your health care provider about them right away.

What you should know about certain side effects

Blood pressure In clinical trials, some people taking LENVIMA developed high blood pressure. It’s important to monitor your blood pressure. Tell your health care provider immediately if your blood pressure levels are high.These tips may help manage blood pressure:• Get your blood pressure checked regularly. Some people find it

helpful to use a blood pressure monitor at home• Eat a healthy diet with plenty of whole grains, and try to limit

sodium and alcohol• Exercise lightly• If you’re a smoker, consider quitting

DiarrheaIf you experience diarrhea, tell your health care provider right away, and try these tips:• Eat easy-to-digest foods like applesauce, bananas, toast, and rice• Drink plenty of water and avoid alcohol

FatigueFeeling tired can be a common side effect.Tell your health care provider if you feel overly tired, and try these tips:• Rest—if you’re able to take short naps during the day, the extra rest

may help• Move—moderate daily exercise may help• Hydrate—try to drink more water. Dehydration can make you feel tired• Reach out—don’t be afraid to ask for help. Your health care team is

always available to support you

This is not the full list of possible side effects you may experience while taking LENVIMA. Please read the Important Safety Information for LENVIMA on pages 8-9 and the accompanying Patient Information and discuss them with your health care provider. The physician Prescribing Information also is available.


LENVIMA may cause serious side effects, including 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.

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Staying on top of your medication

How should you take LENVIMA?LENVIMA is an oral medication, taken once a day at the same time, with or without food.Your health care provider will tell you how much LENVIMA to take and when to take it. Your health care provider may choose to adjust your dose, stop treatment for some time, or completely stop treatment with LENVIMA if you have side effects.


LENVIMA may cause serious side effects, including 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 ECG.LENVIMA may cause serious side effects, including 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.

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Capsules pictured are not actual size.Pembrolizumab infusion not pictured.Everolimus tablet not pictured.Please see the pembrolizumab Medication Guide or the everolimus Patient Information or talk to your health care provider about how to take these medicines in combination with LENVIMA.

LENVIMA capsules come in color-coded cards that contain medicine for 5 days.

This is just one example of a LENVIMA blister card. The card your health care provider prescribed may look different than this one.

The number of capsules you need to take may vary, depending on your prescribed dosage.

LENVIMA capsules come in 2 strengths:

4 mg Capsule imprint:

€ LENV 4 mg

10 mg Capsule imprint:

€ LENV 10 mg






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Miss a dose of LENVIMA?If you miss a dose of LENVIMA, take it as soon as you remember. If your next dose is due within 12 hours, skip the missed dose and take the next dose at your regular time.

Take too much LENVIMA?If you take too much LENVIMA, call your health care provider or go to the nearest hospital emergency room right away.

Cannot swallow LENVIMA capsules whole?If you cannot swallow LENVIMA capsules whole, follow these steps.

What if I...


LENVIMA may cause serious side effects, including 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. LENVIMA may cause serious side effects, including bleeding: LENVIMA may cause serious bleeding problems that may lead to death. Tell your healthcare 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.

Remember to take the exact number of capsules prescribed by your health care provider.

Step 1: Use a medicine cup to measure about 1 tablespoon of water or apple juice and pour into a small glass

Step 2: Place the LENVIMA capsules into the small glass without breaking or crushing them

Step 3: Leave the capsules in the liquid for at least 10 minutes

Step 4: Stir the contents of the glass for at least 3 minutes

Step 5: Drink the mixture. After drinking, rinse the glass with a small amount of additional water or apple juice and swallow the liquid




How to fill your prescription

There are multiple ways to receive your LENVIMA prescription. It could be through a Specialty Pharmacy, your health care provider’s office/clinic, or a hospital pharmacy.

Talk to your health care team to find out how you will receive LENVIMA.

LENVIMA may cause serious side effects, including a change in thyroid hormone levels: Your healthcare provider should check your thyroid hormone levels before starting and every month during treatment with LENVIMA. LENVIMA may cause serious side effects, including 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.

Important Safety Information for LENVIMA® (lenvatinib)

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Financial information and help

There are several available options to help you pay for your LENVIMA prescription. Your pharmacy will help you determine which program is the right fit for you.

Eisai Assistance ProgramIf you need further information or help paying for LENVIMA, the Eisai Assistance Program may be able to help. Contact the Eisai Assistance Program directly at 1-866-613-4724. • Determine your insurance coverage for LENVIMA and where to access your medication• Manage your out-of-pocket costs for LENVIMA and determine eligibility

for assistance if you cannot afford your medication

LENVIMA $0 Co-pay Program for Eligible PatientsWith the LENVIMA $0 Co-pay Program, eligible commercially insured patients will pay as little as $0 out of pocket for each prescription. Eisai will pay up to a maximum of $40,000 per year to assist with the out-of-pocket costs for LENVIMA.* For assistance with the LENVIMA $0 Co-pay Program, call 855-347-2448.* Maximum benefit and eligibility: Depending on the insurance plan, patients could have additional financial responsibility for any amounts over Eisai’s maximum liability. Not available to patients enrolled in state or federal health care programs, including Medicare, Medicaid, Medigap, VA, DoD, or TRICARE. Offer only available to patients with private, commercial insurance. See www.LENVIMAREIMBURSEMENT.com for complete terms and conditions.

For additional assistance, contact the Eisai Assistance Program at www.LenvimaReimbursement.com or call 1-866-61-EISAI (1-866-613-4724).

For more information about LENVIMA financial assistance that may be available, contact your pharmacy or health care provider’s office.

LENVIMA may cause serious side effects, including 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.





http://www.LENVIMAREIMBURSEMENT.com

http://www.LenvimaReimbursement.com

These resources may help

Eisai Assistance Program

The Eisai Assistance Program can help you:• Understand how your therapy may be covered

by your insurance*• Learn more about out-of-pocket costs

for your treatment• Determine eligibility for assistance if

you cannot afford your medication• Access helpful resources and

educational materials with a LENVIMA Welcome Kit

For assistance, please contact the Eisai Assistance Program:

Phone: 1-866-61-EISAI (1-866-613-4724) Fax: 1-855-246-5192 Hours: 8 am to 8 pm ET, Monday through Friday www.LenvimaReimbursement.com

* EISAI cannot guarantee payment of any claim. Coding, coverage, and reimbursement may vary significantly by payer, plan, patient, and setting of care. Actual coverage and reimbursement decisions are made by individual payers following the receipt of claims. For additional information, customers should consult with their payers for all relevant coding, reimbursement, and coverage requirements. It is the sole responsibility of the provider to select the proper code and ensure the accuracy of all claims used in seeking reimbursement. All services must be medically appropriate and properly supported in the patient medical record.

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http://www.LenvimaReimbursement.com

Using LENVIMA® (lenvatinib) and KEYTRUDA® (pembrolizumab) in combinationIf you have advanced kidney cancer or advanced endometrial cancer, your health care provider may prescribe a combination treatment of LENVIMA and KEYTRUDA. Here is some information to know.

Advanced Kidney Cancer• KEYTRUDA and LENVIMA are prescription medicines used together to treat

a kind of kidney cancer called advanced renal cell carcinoma (RCC) as your first treatment when your kidney cancer has spread or cannot be removed by surgery.

Advanced Endometrial Cancer• KEYTRUDA and LENVIMA are prescription medicines used together to treat

a kind of uterine cancer called endometrial carcinoma: ◦ when your tumor is not microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR), and

◦ you have received anti-cancer treatment, and it is no longer working, and ◦ your cancer cannot be cured by surgery or radiation (advanced endometrial carcinoma).

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

What is the most important information I should know about KEYTRUDA?KEYTRUDA is a medicine that may treat certain cancers by working with your immune system. KEYTRUDA can cause your immune system to attack normal organs and tissues in any area of your body and can affect the way they work. These problems can sometimes become severe or life-threatening and can lead to death. You can have more than one of these problems at the same time. These problems may happen any time during treatment or even after your treatment has ended.

For more information on LENVIMA specifically, please refer to pages 2-16 of this brochure.


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To learn more about taking LENVIMA with KEYTRUDA, visit KeytrudaLenvima.com





http://www.keytrudalenvima.com

What are the most common side effects of LENVIMA when given with KEYTRUDA

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

This is not the full list of possible side effects you may experience while taking LENVIMA with KEYTRUDA. Please see the Important Safety Information (pages 8-9 for LENVIMA and pages 22-23 for KEYTRUDA) as well as the Patient Information for LENVIMA and the Medication Guide for KEYTRUDA.

For more information on LENVIMA specifically, please refer to pages 2-16 of this brochure.

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To learn more about taking LENVIMA with KEYTRUDA, visit KeytrudaLenvima.com







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KEYTRUDA is a type of treatment called immunotherapy. KEYTRUDA is not chemotherapy or radiation therapy.

Learn how KEYTRUDA works

Cancer cells may use PD-1 pathway to hide from T cells

KEYTRUDA blocks PD-1 pathway to help prevent cancer cells from hiding

T cells help detect and fight cancer cells but also can attack normal cells

The immune system and T cellsThe immune system is your body’s natural defense against disease. It sends types of cells called T cells throughout your own body to detect and fight infections and diseases—including cancer.

How cancer cells can hide from your immune system’s T cellsOne way your immune system controls the activity of T cells is through the PD-1 pathway. However, some cancer cells hide from T-cell attack by taking control of the PD-1 pathway. This stops T cells from attacking cancer cells.

How KEYTRUDA helps your body fight cancerKEYTRUDA is a type of immunotherapy that works by blocking the PD-1 pathway. KEYTRUDA helps the immune system do what it was meant to do: detect and fight cancer cells. KEYTRUDA can cause your immune system to attack normal organs and tissues in any area of your body and can affect the way they work. These problems can sometimes become serious or life-threatening and can lead to death.

T cells fight cancer cells

Immune system sends T cells to detect cancer cells

Cancer cells may grow and spread

Cancer cells may use PD-1 pathway to hide from T cells

This stops T cells from attacking cancer cells

Important Safety Information for KEYTRUDAKEYTRUDA is a medicine that may treat certain cancers by working with your immune system. KEYTRUDA can cause your immune system to attack normal organs and tissues in any area of your body and can affect the way they work. These problems can sometimes become severe or life-threatening and can lead to death. You can have more than one of these problems at the same time. These problems may happen any time during treatment or even after your treatment has ended.

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Please read the Important Safety Information for KEYTRUDA on pages 22-23 and the accompanying Medication Guide and discuss them with your health care provider. The physician Prescribing Information also is available.


http://merck.com/product/usa/pi_circulars/k/keytruda/keytruda_mg.pdf


Important Safety Information for KEYTRUDACall or see your health care provider right away if you develop any signs or symptoms of the following problems or if they get worse. These are not all of the signs and symptoms of immune system problems that can happen with KEYTRUDA:Lung problems: cough, shortness of breath, or chest pain.

What to tell your health care provider before taking KEYTRUDA

Before you receive KEYTRUDA, tell your health care provider about all of your medical conditions, including if you:• have immune system problems such as Crohn’s disease,

ulcerative colitis, or lupus• have received an organ transplant, such as a kidney or liver• have received or plan to receive a stem cell transplant that uses

donor stem cells (allogeneic)• have received radiation treatment to your chest area• have a condition that affects your nervous system, such as

myasthenia gravis or Guillain-Barré syndrome • are pregnant or plan to become pregnant. KEYTRUDA can harm

your unborn babyFemales who are able to become pregnant:

◦ Your health care provider will give you a pregnancy test before you start treatment with KEYTRUDA.

◦ You should use an effective method of birth control during and for at least 4 months after the final dose of KEYTRUDA. Talk to your health care provider about birth control methods that you can use during this time.

◦ Tell your health care provider right away if you think you may be pregnant or if you become pregnant during treatment with KEYTRUDA.

• are breastfeeding or plan to breastfeed. It is not known if KEYTRUDA passes into your breast milk. Do not breastfeed during treatment with KEYTRUDA and for 4 months after your final dose of KEYTRUDA.

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

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What to expect when taking KEYTRUDA® (pembrolizumab)

How will I receive KEYTRUDA?Your health care provider will give you KEYTRUDA into your vein through an intravenous (IV) line over 30 minutes. Treatments usually take place at your health care provider’s office or an infusion clinic. Be sure to communicate with your health care provider to schedule your upcoming treatments. If you miss any appointments, call your health care provider as soon as possible to reschedule.

Scheduling treatments with KEYTRUDA• In adults, KEYTRUDA is usually given every 3 weeks or every 6

weeks depending on the dose that you are receiving.• No matter which treatment schedule you are on, you will receive the

same amount of KEYTRUDA over the course of treatment. • Talk to your health care provider about the treatment schedule that is

right for you. They can help answer questions.The adult dose given every 6 weeks is approved based on specific types of data showing how this dose works in the body. Studies are ongoing to provide additional information about clinical benefit.

How long will I stay on KEYTRUDA?Every patient is different. For that reason, your health care provider will decide how many treatments you need, based on your experience with KEYTRUDA.

How will I be monitored while on KEYTRUDA?

Your oncology health care team will keep track of how you are responding to treatment through imaging and laboratory tests. They will also do blood tests to check you for side effects.

Learn more at https://www.keytrudalenvima.com/taking-keytruda-and-lenvima/

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Important Safety Information for KEYTRUDAIntestinal problems: diarrhea (loose stools) or more frequent bowel movements than usual; stools that are black, tarry, sticky, or have blood or mucus; or severe stomach-area (abdomen) pain or tenderness. Liver problems: yellowing of your skin or the whites of your eyes; severe nausea or vomiting; pain on the right side of your stomach area (abdomen); dark urine (tea colored); or bleeding or bruising more easily than normal.


https://www.keytrudalenvima.com/taking-keytruda-and-lenvima/



KEYTRUDA is a medicine that may treat certain cancers by working with your immune system. KEYTRUDA can cause your immune system to attack normal organs and tissues in any area of your body and can affect the way they work. These problems can sometimes become severe or life-threatening and can lead to death. You can have more than one of these problems at the same time. These problems may happen any time during treatment or even after your treatment has ended.Call or see your health care provider right away if you develop any signs or symptoms of the following problems or if they get worse. These are not all of the signs and symptoms of immune system problems that can happen with KEYTRUDA:Lung problems: cough, shortness of breath, or chest pain.Intestinal problems: diarrhea (loose stools) or more frequent bowel movements than usual; stools that are black, tarry, sticky, or have blood or mucus; or severe stomach-area (abdomen) pain or tenderness.Liver problems: yellowing of your skin or the whites of your eyes; severe nausea or vomiting; pain on the right side of your stomach area (abdomen); dark urine (tea colored); or bleeding or bruising more easily than normal. Hormone gland problems: headaches that will not go away or unusual headaches; eye sensitivity to light; eye problems; rapid heartbeat; increased sweating; extreme tiredness; weight

gain or weight loss; feeling more hungry or thirsty than usual; urinating more often than usual; hair loss; feeling cold; constipation; your voice gets deeper; dizziness or fainting; changes in mood or behavior, such as decreased sex drive, irritability, or forgetfulness. Kidney problems: decrease in the amount of your urine; blood in your urine; swelling of your ankles; loss of appetite. Skin problems: rash; itching; skin blistering or peeling; painful sores or ulcers in your mouth or in your nose, throat, or genital area; fever or flu-like symptoms; swollen lymph nodes.Problems can also happen in other organs and tissues. Signs and symptoms of these problems may include: chest pain; irregular heartbeat; shortness of breath; swelling of ankles; confusion; sleepiness; memory problems; changes in mood or behavior; stiff neck; balance problems; tingling or numbness of the arms or legs; double vision; blurry vision; sensitivity to light; eye pain; changes in eyesight; persistent or severe muscle pain or weakness; muscle cramps; low red blood cells; bruising. Infusion reactions that can sometimes be severe or life-threatening. Signs and symptoms of infusion reactions may include chills or shaking, itching or rash, flushing, shortness of breath or wheezing, dizziness, feeling like passing out, fever, and back pain.

Important Safety Information for KEYTRUDA® (pembrolizumab)

What you should know about KEYTRUDA when used in combination with LENVIMA® (lenvatinib) for advanced kidney cancer or advanced endometrial cancer

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Continued on next page.

Please read the Medication Guide for KEYTRUDA and discuss it with your health care provider. The physician Prescribing Information also is available.

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Rejection of a transplanted organ. Your health care provider should tell you what signs and symptoms you should report and they will monitor you, depending on the type of organ transplant that you have had.Complications, including graft-versus-host disease (GVHD), in people who have received a bone marrow (stem cell) transplant that uses donor stem cells (allogeneic). These complications can be serious and can lead to death. These complications may happen if you underwent transplantation either before or after being treated with KEYTRUDA. Your health care provider will monitor you for these complications. Getting medical treatment right away may help keep these problems from becoming more serious. Your health care provider will check you for these problems during treatment with KEYTRUDA. They may treat you with corticosteroid or hormone replacement medicines. They may also need to delay or completely stop treatment with KEYTRUDA if you have severe side effects.Before you receive KEYTRUDA, tell your health care provider if you have immune system problems such as Crohn’s disease, ulcerative colitis, or lupus; have had an organ transplant or have had or plan to have a bone marrow (stem cell) transplant that uses donor stem cells (allogeneic); have had radiation treatment in your chest area; have a condition that affects your nervous system, such as myasthenia gravis or Guillain-Barré syndrome.If you are pregnant or plan to become pregnant, tell your health care

provider. KEYTRUDA can harm your unborn baby. If you are able to become pregnant, you will be given a pregnancy test before you start treatment. Use effective birth control during treatment and for at least 4 months after your final dose of KEYTRUDA. Tell them right away if you think you may be pregnant or you become pregnant during treatment with KEYTRUDA. Tell your health care provider if you are breastfeeding or plan to breastfeed. It is not known if KEYTRUDA passes into your breast milk. Do not breastfeed during treatment with KEYTRUDA and for 4 months after your final dose of KEYTRUDA.Tell your health care provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Common side effects of KEYTRUDA when given with LENVIMA® (lenvatinib) include low levels of thyroid hormone; high blood pressure; feeling tired; diarrhea; joint and muscle pain; nausea; decreased appetite; vomiting; mouth sores; weight loss; stomach-area (abdominal) pain; urinary tract infection; protein in your urine; constipation; headache; bleeding; blisters or rash on the palms of your hands and soles of your feet; hoarseness; rash; liver problems; and kidney problems.These are not all the possible side effects of KEYTRUDA. Talk to your health care provider for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

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Important Safety Information for KEYTRUDA® (pembrolizumab) (continued)

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Please read the Medication Guide for KEYTRUDA and discuss it with your health care provider. The physician Prescribing Information also is available.




If you have questions about insurance coverage or financial assistance, we can helpLearn about The Merck Access Program for KEYTRUDAThe Merck Access Program can help answer questions such as:• Does my insurance cover KEYTRUDA?• What options may be available to eligible patients for co-pay assistance?• Should I be referred to the Merck Patient Assistance Program?

Important Safety Information for KEYTRUDAHormone gland problems: headaches that will not go away or unusual headaches; eye sensitivity to light; eye problems; rapid heartbeat; increased sweating; extreme tiredness; weight gain or weight loss; feeling more hungry or thirsty than usual; urinating more often than usual; hair loss; feeling cold; constipation; your voice gets deeper; dizziness or fainting; changes in mood or behavior, such as decreased sex drive, irritability, or forgetfulness.

How to find out moreIf you would like to speak with a representative with The Merck Access Program, please call 855-257-3932 between 8 am and 8 pm Eastern Time, Monday through Friday. Or visit The Merck Access Program at merckaccessprogram-keytruda.com.

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http://merckaccessprogram-keytruda.com

http://KeytrudaLenvima.com



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Patient support throughout your treatmentPatients who have been prescribed KEYTRUDA for an approved indication can access additional support and resources from KEY+YOU, the patient support program for KEYTRUDA. KEY+YOU helps eligible patients manage practical and emotional challenges, offering the following:

You should always look to your health care provider as your main source of support. KEY+YOU does not take the place of talking to your health care provider or health care team.

Important Safety Information for KEYTRUDAKidney problems: decrease in the amount of your urine; blood in your urine; swelling of your ankles; loss of appetite. Skin problems: rash; itching; skin blistering or peeling; painful sores or ulcers in your mouth or in your nose, throat, or genital area; fever or flu-like symptoms; swollen lymph nodes.

Phone Support1-on-1 phone access

to KEY+YOU representatives who can connect you to

helpful organizations

Ongoing E-mailsCommunications that

focus on practical skills you can use

every day

Online InformationAccess to online

resources that may help you deal with stress, talk about

difficult topics, and more

To sign up for the KEY+YOU Patient Support Program, eligible patients and caregivers can:

Call 85-KEYTRUDA (855-398-7832)

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Committed to your treatment journey

For more resources and information, visit www.lenvima.com

In this brochure you will find helpful information about:

• Understanding your treatment• Managing treatment• Financial assistance• Patient support

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

LENVIMA® is a registered trademark used by Eisai Inc. under license from Eisai R&D Management Co., Ltd. © 2022 Eisai Inc. All rights reserved. The trademarks used are owned by their respective owners. Copyright © 2022 Merck & Co., Inc., Kenilworth, NJ, USA and its affiliates. All rights reserved. US-KLX-00040 11/21




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