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Frequently Asked Questions About KEYTRUDA® (pembrolizumab) and LENVIMA® (lenvatinib)

Frequently asked questions about KEYTRUDA and LENVIMA

About KEYTRUDA and LENVIMA

What is KEYTRUDA + LENVIMA?

KEYTRUDA and LENVIMA are two separate prescription medicines. KEYTRUDA is manufactured by Merck. LENVIMA is manufactured by Eisai.

They are used together to treat:

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

Are KEYTRUDA and LENVIMA kinds of chemotherapy?

KEYTRUDA is not chemotherapy—it is an immunotherapy. LENVIMA is also not a chemotherapy. It is a targeted therapy also known as a tyrosine kinase inhibitor (TKI).

See how KEYTRUDA and LENVIMA work

What should I tell my doctor before taking KEYTRUDA and LENVIMA?

If you and your doctor are considering KEYTRUDA + LENVIMA, be sure to discuss the treatment information found here.

About KEYTRUDA

What is KEYTRUDA?

KEYTRUDA is not chemotherapy—it is an immunotherapy and it works with your immune system to help fight cancer. Immunotherapies such as KEYTRUDA may stop cancer cells from hiding. KEYTRUDA may enable T cells to find and attack cancer cells. This helps your immune system do what it’s designed to do: detect and fight cancer.

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. Find out more about how KEYTRUDA works.

About LENVIMA

What is LENVIMA?

LENVIMA is not a chemotherapy. LENVIMA is an oral therapy that helps block tumor growth in certain types of cancer and is a kind of targeted therapy called a tyrosine kinase inhibitor (TKI).

LENVIMA is thought to work by blocking the signals cancer cells send out that tell the body to make more blood vessels. The cancer uses these new blood vessels to grow and spread. 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 certain tumors from growing and spreading.

Healthy cells also contain these proteins and may be affected by LENVIMA. This can sometimes cause serious side effects.

See how LENVIMA is thought to work

About your treatment

How is KEYTRUDA administered and for how long?

Treatments with KEYTRUDA usually take place at your health care provider’s office or an infusion clinic.

KEYTRUDA is usually given every 3 weeks. Your health care provider will give you KEYTRUDA into your vein through an intravenous (IV) line over 30 minutes.

Your health care provider will decide how many treatments you need, and will do blood tests to check you for side effects.

How will I take LENVIMA?

Take LENVIMA exactly as your health care provider tells you to take it. LENVIMA is an oral medication, a capsule, and should be 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. They may also adjust your dose during treatment, stop treatment for some time, or completely stop treatment with LENVIMA if you have side effects.

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.

If you cannot swallow LENVIMA capsules whole, follow these steps:

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

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

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

For more information, see what to expect when taking LENVIMA.

What should I do if I forget to take 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.

For more information, see what to expect when taking LENVIMA.

What should I do if I 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.

For more information about how to take LENVIMA, see what to expect when taking KEYTRUDA and LENVIMA.

How will I receive LENVIMA?

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.

If your medicine is being supplied through a Specialty Pharmacy, your health care team will tell you which one. It is important to know the name of your Specialty Pharmacy and to respond promptly to their phone calls and communications.

Please note the Specialty Pharmacy information will be provided to you by your health care team.

Learn how you will receive your LENVIMA prescription

What should I do if I plan to have surgery or had a recent surgery?

Before you take LENVIMA, tell your health care provider about all of your medical conditions, including if you plan to have surgery, a dental procedure, or have had a recent surgery. You should stop taking LENVIMA at least 1 week before your planned surgery.

How long will I stay on KEYTRUDA + LENVIMA?

Every patient is different. For that reason, your health care provider will decide how long you remain on treatment based on your experiences with KEYTRUDA and LENVIMA. If you have severe side effects while taking KEYTRUDA, your health care provider may need to delay or completely stop treatment. They will also tell you how much LENVIMA to take and when to take it. Your health care provider may change your dose during treatment, stop treatment for some time, or completely stop treatment with LENVIMA if you have side effects.

Be sure to let your health care provider know right away if you start to feel any new or worsening symptoms or side effects, or have any questions.

For more information, see what to expect when taking LENVIMA.

Side effects

What should I do if I experience any side effects?

It’s important to have an open and ongoing conversation with your health care team. If you experience any changes in the way you feel, or have new or different symptoms, discuss those changes with your health care team. Getting medical treatment right away may help keep these problems from becoming more serious.

Your health care provider may treat you with corticosteroids or hormone replacement medicines. Your health care provider may also need to delay or completely stop treatment with KEYTRUDA if you have severe side effects. Your health care provider will do blood tests to check you for side effects.

If you have side effects with LENVIMA, your health care provider may change your dose during treatment, stop treatment for some time, or completely stop treatment. Keep in mind, your health care provider will tell you how much LENVIMA to take and when to take it. Do not change the dose of your medicine on your own.

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.

Learn more about side effects and what to tell your doctor before and during treatment .

Download the symptom tracker

When should I report side effects to my health care provider?

Be sure to tell your health care provider immediately about all side effects, so they can help address them right away.

Support for KEYTRUDA and LENVIMA

What support is available to me?

Because KEYTRUDA is manufactured by Merck and LENVIMA is manufactured by Eisai, they have separate resources available to help support patients.

The KEY+YOU Patient Support Program for KEYTRUDA is offered through Merck and is designed to offer educational resources to help with the challenges you may be facing with cancer. Patients prescribed KEYTRUDA for an appoved indication can receive online activities, emails, direct mail, or phone support.

The Eisai Assistance Program for LENVIMA offers support to patients by providing information and resources to help you get access to LENVIMA.

Does my insurance cover KEYTRUDA?

If you need further information or help paying for KEYTRUDA (with or without insurance coverage), Merck may be able to help. Contact The Merck Access Program at 855-257-3932. The Merck Access Program can help answer questions like:

  • Does my insurance cover KEYTRUDA?
  • What are the co-pay assistance options for eligible patients?
  • Should I be referred to the Merck Patient Assistance Program?
    • If you do not have insurance or your insurance does not cover KEYTRUDA, you may be eligible for free product from the Merck Patient Assistance Program if you meet certain financial and medical criteria.

Does my insurance cover LENVIMA?

The Eisai Assistance Program is your resource for information about coverage of LENVIMA and available financial assistance options. It will help you:

  • 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

If 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 866-613-4724.

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.

Who can I talk to if I have a question or need help with KEYTRUDA?

Questions or concerns about KEYTRUDA, your cancer, or any cancer treatments you are taking should be directed to your health care team.

If you have questions about KEYTRUDA, please call 85-KEYTRUDA (855-398-7832).

Who can I talk to if I have a question or need help with LENVIMA?

Questions or concerns about LENVIMA, your cancer, or any cancer treatments you are taking should be directed to your health care team.

If you have additional questions, please contact the medical information line at 1-888-274-2378.

FDA-Approved Indications

  • 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.
  • 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.
Important Safety Information for KEYTRUDA® (pembrolizumab)

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.

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 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.

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

Important Safety Information for LENVIMA® (lenvatinib)

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 have any of the following symptoms: your skin or the white part of your eyes turn 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.

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 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.

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

Please read the accompanying Patient Information for LENVIMA and discuss it with your doctor. The physician Prescribing Information also is available.