Actor
Portrayal

Dan’s Patient Story

Dan is a real patient. KEYTRUDA + LENVIMA may not work for everyone. This is Dan’s story.

Dan and Julie were compensated for their time.

Speaking up and having a supportive care team helped Dan take an active role in his treatment

A life-changing diagnosis

When meeting Dan, three things stand out––his mustache, his love of Hawaiian shirts, and his positive outlook on life. That positivity was put to the test when he was told his advanced kidney cancer had returned after surgery. Dan recalls the “clarifying moment” when he returned home from his doctor and told his partner, Julie. “We had a good cry together, and then I just said... ‘we just need to get through this together.’ And that's what we did.”

We’re just going to fight it, and we’re just going to go after it.

– Dan’s reaction to his advanced kidney cancer diagnosis

Making a plan to move forward together

Julie was Dan’s main supporter during treatment. She made sure to be at every treatment, no matter what. “She was my rock,” said Dan, “she never missed an appointment.”


As Dan’s caregiver, Julie has advice for supporting your loved one through treatment.


Julie’s Tips for Caregivers

  1. Bring a notebook to every appointment
    Save the doctor’s instructions and write down any questions.

    Your loved one might not remember what was said or may be embarrassed to discuss something with their health care team.

  2. Make a plan with your loved one
    Take care of the small stuff, so they can focus on their treatment.

    Dan and Julie made a plan—Dan would drive to each appointment and Julie would drive home after his appointment.

  3. Take care of yourself
    Remember to eat, sleep, and take short breaks.

    You have more responsibility as a caregiver, so it’s important to stay healthy. Avoiding burn out helps you be the best supporter you can be.

If you’re not healthy, you’re no good to the people you’re caregiving for.

– Julie’s advice for avoiding burnout as a caregiver

The power of communication

With his care team in his corner, Dan looked at options to help him treat his advanced kidney cancer. After talking with his doctor, they decided on treatment with KEYTRUDA + LENVIMA.


Dan’s doctor, nurses, and hospital staff also played crucial roles in his journey, and he was not afraid to communicate openly with them throughout treatment. “I think you have to ask questions,” he said, and encourages others to do the same. Speaking up helped Dan build a strong relationship with his team, and he says they “became like family.”


As his treatment continued, Dan and his team started to see the results they were hoping for. He let his care team know about the side effects he was having during treatment. He felt tired, had diarrhea, and had issues with his thyroid. He was also diagnosed with gout. By keeping his care team informed of his side effects, they could better keep him on track.


Dan is grateful for his care team’s support throughout his treatment. “It meant the world to me,” said Dan, “having a great care team like that.” 


I am a very big advocate of my own health. If there's something going on, I'm not afraid to go to the doctor.

– Dan's approach to treatment

By writing down what the doctor said, making a treatment plan, and taking care of each other, Dan and Julie took steps to move forward. “We were going to get through it together,” said Julie, and these tips helped them do just that.

Speaking up and looking forward

When cancer returns, it may be disheartening. But Dan explored his treatment options with his doctor and never gave up. Whether working through challenges or recognizing personal triumphs, he always kept his care team informed.


Always the center of attention, Dan can add his hospital staff to the connections he shares with his high school friends, fellow veterans, and college fraternity brothers. And while his treatment journey has made a huge impact on him, it hasn’t affected his positive mindset.


Dan tells those facing a similar diagnosis to keep a “positive mental attitude.” He hopes to inspire others by continuing to make the most of each day. “I'm going to live my life [to] the fullest and try to make a difference in what I do.”


Experiences with KEYTRUDA + LENVIMA differ among individuals. KEYTRUDA + LENVIMA will not work for everyone, and it's important to be informed about possible side effects. Always talk to your doctor or health care team if you have questions about your treatment.

You also might be interested in:

About KEYTRUDA and LENVIMA
Results From Clinical Trials
Side Effects

FDA-Approved Indications

  • KEYTRUDA and LENVIMA are prescription medicines used together to treat:
  • a kind of kidney cancer called advanced renal cell carcinoma (RCC) in adults as your first treatment when your kidney cancer has spread or cannot be removed by surgery.
  • a kind of uterine cancer called advanced endometrial carcinoma in adults:
    • 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 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 or tissue. 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 or tissue 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 or tissue transplant, including corneal 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 with KEYTRUDA and for 4 months after your last 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 last 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 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 jawbone problems (osteonecrosis): Severe jawbone 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 jawbone 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 jawbone 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 in combination with KEYTRUDA 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 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.

This website contains information relating to various medical conditions and treatment. Such information is provided for educational purposes 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.

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.

Copyright © 2024 Merck & Co., Inc., Rahway, NJ, USA and its affiliates. All rights reserved.
This site is intended only for residents of the United States, its territories, and Puerto Rico.
The trademarks used are owned by their respective owners.

US-KLR-00601 09/24

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FDA-Approved Indications
  • KEYTRUDA and LENVIMA are prescription medicines used together to treat:
  • a kind of kidney cancer called advanced renal cell carcinoma (RCC) in adults as your first treatment when your kidney cancer has spread or cannot be removed by surgery.
  • a kind of uterine cancer called advanced endometrial carcinoma in adults:
    • 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 (advanced endometrial carcinoma).
  • The safety and efficacy of LENVIMA have not been established 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 or tissue. 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 or tissue 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 or tissue transplant, including corneal 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 with KEYTRUDA and for 4 months after your last 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 last 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 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 jawbone problems (osteonecrosis): Severe jawbone problems (osteonecrosis): Severe jawbone 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 jawbone 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 jawbone 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 in combination with KEYTRUDA 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 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 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.

FDA-Approved Indications

  • KEYTRUDA and LENVIMA are prescription medicines used together to treat:
  • a kind of kidney cancer called advanced renal cell carcinoma (RCC) in adults as your first treatment when your kidney cancer has spread or cannot be removed by surgery.
  • a kind of uterine cancer called advanced endometrial carcinoma in adults:
    • 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 for KEYTRUDA® (pembrolizumab)

Important Safety Information for LENVIMA® (lenvatinib)

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 or tissue. 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 or tissue 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 or tissue transplant, including corneal 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 with KEYTRUDA and for 4 months after your last 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 last 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.

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 jawbone problems (osteonecrosis): Severe jawbone 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 jawbone 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 jawbone 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 in combination with KEYTRUDA 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 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.

Expand for indications
  • KEYTRUDA and LENVIMA are prescription medicines used together to treat:
  • a kind of kidney cancer called advanced renal cell carcinoma (RCC) in adults as your first treatment when your kidney cancer has spread or cannot be removed by surgery.
  • a kind of uterine cancer called advanced endometrial carcinoma in adults:
    • 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 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 or tissue. 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 or tissue 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 or tissue transplant, including corneal 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 with KEYTRUDA and for 4 months after your last 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 last 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 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 jawbone problems (osteonecrosis): Severe jawbone 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 jawbone 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 jawbone 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 in combination with KEYTRUDA 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 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.