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Side Effects With KEYTRUDA® (pembrolizumab) and LENVIMA® (lenvatinib)

Side effects with KEYTRUDA and LENVIMA

Side Effects May Occur With KEYTRUDA® (pembrolizumab) and LENVIMA® (lenvatinib)

Side effects may occur with KEYTRUDA and LENVIMA

Every medication has side effects and impacts each person differently. Here’s some important information about certain side effects. If you have any side effects, tell your doctor about them right away.


Side effects of KEYTRUDA

Serious side effects

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. These problems may happen any time during treatment or even after your treatment has ended.

Call or see your doctor right away if you develop any symptoms of the following problems or these symptoms get worse:

Lung problems (pneumonitis)
  • Shortness of breath
  • Chest pain
  • New or worse cough
Liver problems, including hepatitis
  • Yellowing of your skin or the whites of your eyes
  • Nausea or vomiting
  • Pain on the right side of your stomach area (abdomen)
  • Dark urine
  • Bleeding or bruising more easily than normal
Kidney problems, including nephritis and kidney failure
  • Change in the amount or color of your urine
Skin problems
  • Rash
  • Itching
  • Blisters, peeling or skin sores
  • Painful sores or ulcers in your mouth or in your nose, throat, or genital area
Problems in other organs
  • Changes in eyesight
  • Severe or persistent muscle or joint pains
  • Severe muscle weakness
  • Low red blood cells (anemia)
  • Swollen lymph nodes, rash or tender lumps on skin, cough, shortness of breath, vision changes, or eye pain (sarcoidosis)
  • Confusion, fever, muscle weakness, balance problems, nausea, vomiting, stiff neck, memory problems, or seizures (encephalitis)
  • Pain, numbness, tingling, or weakness in your arms or legs, or bladder or bowel problems, including the need to urinate more often, leaking of urine, trouble urinating, or constipation (myelitis)
  • Shortness of breath, irregular heartbeat, feeling tired, or chest pain (myocarditis)
Intestinal problems (colitis) that can lead to tears or holes in your intestine
  • Diarrhea or more bowel movements than usual
  • Stools that are black, tarry, sticky, or have blood or mucus
  • Severe stomach-area (abdomen) pain or tenderness
Hormone gland problems (especially the thyroid, pituitary, adrenal glands, and pancreas)
  • Rapid heartbeat
  • Weight loss or weight gain
  • Increased sweating
  • Feeling more hungry or thirsty
  • Urinating more often than usual
  • Hair loss
  • Feeling cold
  • Constipation
  • Your voice gets deeper
  • Muscle aches
  • Feeling very weak
  • Dizziness or fainting
  • Headaches that will not go away or unusual headache
Infusion (IV) reactions that can sometimes be severe and life‑threatening
  • Chills or shaking
  • Shortness of breath or wheezing
  • Itching or rash
  • Flushing
  • Dizziness
  • Fever
  • Feeling like passing out

Rejection of a transplanted organ. People who have had an organ transplant may have an increased risk of organ transplant rejection. Your doctor should tell you what signs and symptoms you should report and 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 severe and can lead to death. These complications may happen if you underwent transplantation either before or after being treated with KEYTRUDA. Your doctor will monitor you for the following signs and symptoms: skin rash, liver inflammation, stomach-area (abdominal) pain, and diarrhea.

Getting medical treatment right away may help keep these problems from becoming more serious. Your doctor will check you for these problems during treatment with KEYTRUDA. Your doctor may treat you with corticosteroid or hormone replacement medicines. Your doctor may also need to delay or completely stop treatment with KEYTRUDA, if you have severe side effects.

Common side effects

Common side effects of KEYTRUDA when given with LENVIMA include feeling tired; high blood pressure; joint and muscle pain; diarrhea; decreased appetite; low levels of thyroid hormone; nausea; mouth sores; vomiting; weight loss; stomach-area (abdominal) pain; headache; constipation; urinary tract infection; hoarseness; bleeding; low magnesium level; blisters or rash on the palms of your hands and soles of your feet; shortness of breath; cough; and rash.

These are not all the possible side effects of KEYTRUDA. Tell your doctor if you have any side effect that bothers you or that does not go away. For more information, ask your doctor or pharmacist.

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.


Side effects of LENVIMA

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 health care provider should check your blood pressure regularly during treatment with LENVIMA. If you develop blood pressure problems, your health care provider may prescribe medicine to treat your high blood pressure, lower your dose of LENVIMA, or stop your treatment with LENVIMA.
Problem with blood clots in your blood vessels (arteries)
  • Get emergency 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
Kidney problems
  • Kidney failure, which can lead to death, has happened with LENVIMA treatment. Your health care provider should do regular blood tests to check your kidneys.
Diarrhea
  • Diarrhea is a common side effect of LENVIMA and can be serious. If you get diarrhea, ask your health care provider about what medicines you can take to treat your diarrhea. It is important to drink more water when you get diarrhea. Tell your health care provider or go to the emergency room if you are unable to drink enough liquids and your diarrhea is not able to be controlled.
Changes in the electrical activity of your heart called QT prolongation
  • QT prolongation can cause irregular heartbeats that can be life threatening. Your health care provider will do blood tests during your treatment with LENVIMA to check the levels of potassium, magnesium, and calcium in your blood, and check the electrical activity of your heart with an ECG.
A condition called reversible posterior leukoencephalopathy syndrome (RPLS)
  • Call your health care provider right away if you get severe headache, seizures, weakness, confusion, or blindness or change in vision.
Change in thyroid hormone levels
  • You may have changes in your thyroid hormone levels when taking LENVIMA. Your health care provider may need to change your dose of thyroid medicine while you are taking LENVIMA. Your health care provider should check your thyroid hormone levels every month during treatment with LENVIMA.
Heart problems
  • LENVIMA can cause serious heart problems that may lead to death. Call your health care provider right away if you get symptoms of heart problems, such as shortness of breath or swelling of your ankles.
Liver problems
  • LENVIMA may cause liver problems that may lead to liver failure and death. Your health care provider will check your liver function before and during treatment with LENVIMA. Tell your health care provider right away if you have any of the following symptoms:
    • your skin or the white part of your eyes turns yellow (jaundice)
    • dark “tea-colored” urine
    • light-colored bowel movements (stools)
    • feeling drowsy, confused or loss of consciousness
Increased protein in your urine (proteinuria)
  • Proteinuria is a common side effect of LENVIMA and can be serious. Your health care provider should check your urine for protein before and during your treatment with LENVIMA. If you develop protein in your urine, your health care provider may decrease your dose of LENVIMA or stop your treatment.
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) or chest pain.
Low levels of blood calcium (hypocalcemia)
  • Your health care 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.
Bleeding
  • LENVIMA may cause serious bleeding problems that may lead to death. Tell your health care provider if you have any signs or symptoms of bleeding during treatment with LENVIMA, including:
    • severe and persistent nose bleeds
    • vomiting blood
    • red or black (looks like tar) stools
    • blood in your urine
    • coughing up blood or blood clots
    • heavy or new onset vaginal bleeding
Wound healing problems
  • Wound healing problems have happened in some people who take LENVIMA. Tell your health care 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 health care provider should tell you when you may start taking LENVIMA again after surgery.

The most common side effects of LENVIMA when given with KEYTRUDA in people treated for uterine cancer include tiredness; joint and muscle pain; decreased appetite; change in thyroid hormone levels; nausea; mouth sores; vomiting; weight loss; stomach (abdomen) pain; headache; constipation; urinary tract infection; hoarseness; bleeding; low magnesium level; rash, redness, itching, or peeling of your skin on your hands and feet; trouble breathing; cough; and rash.

LENVIMA may cause fertility problems in males and females. Talk to your health care provider if this is a concern for you.

These are not all the possible side effects of LENVIMA. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tips for Managing Your Treatment With KEYTRUDA® (pembrolizumab) and LENVIMA® (lenvatinib)

Tips for managing your treatment

Paying close attention to how you are feeling throughout treatment is very important. Learn tips that may help you manage your treatment and talk to your doctor if something feels different.

Talking to Your Doctor About KEYTRUDA® (pembrolizumab) and LENVIMA® (lenvatinib)

Start the conversation with your doctor

Use this resource to make the most of conversations with your doctor.

KEYTRUDA and LENVIMA in Combination

KEYTRUDA and LENVIMA are prescription medicines used together to treat a kind of uterine cancer called advanced endometrial carcinoma:

  • that is not microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR), and
  • that has been treated with an anti-cancer medicine, and it did not work or is no longer working, and
  • that cannot be cured by surgery or radiation.

This use is approved based on how many patients responded to treatment and how long they responded. Studies are ongoing to provide additional information about clinical benefit.

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. These problems may happen any time during treatment or even after your treatment has ended.

Call or see your doctor right away if you develop any symptoms of the following problems or these symptoms get worse:

Lung problems (pneumonitis). Symptoms of pneumonitis may include shortness of breath, chest pain, or new or worse cough.

Intestinal problems (colitis) that can lead to tears or holes in your intestine. Signs and symptoms of colitis may include diarrhea or more 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, including hepatitis. Signs and symptoms of liver problems may include yellowing of your skin or the whites of your eyes, nausea or vomiting, pain on the right side of your stomach area (abdomen), dark urine, or bleeding or bruising more easily than normal.

Hormone gland problems (especially the thyroid, pituitary, adrenal glands, and pancreas). Signs and symptoms that your hormone glands are not working properly may include rapid heartbeat, weight loss or weight gain, increased sweating, feeling more hungry or thirsty, urinating more often than usual, hair loss, feeling cold, constipation, your voice gets deeper, muscle aches, feeling very weak, dizziness or fainting, or headaches that will not go away or unusual headache.

Kidney problems, including nephritis and kidney failure. Signs of kidney problems may include change in the amount or color of your urine.

Skin problems. Signs of skin problems may include rash, itching, blisters, peeling or skin sores, or painful sores or ulcers in your mouth or in your nose, throat, or genital area.

Problems in other organs. Signs and symptoms of these problems may include changes in eyesight; severe or persistent muscle or joint pains; severe muscle weakness; low red blood cells (anemia); swollen lymph nodes, rash or tender lumps on skin, cough, shortness of breath, vision changes, or eye pain (sarcoidosis); confusion, fever, muscle weakness, balance problems, nausea, vomiting, stiff neck, memory problems, or seizures (encephalitis); pain, numbness, tingling, or weakness in the arms or legs; bladder or bowel problems including needing to urinate more frequently, urinary incontinence, difficulty urinating, or constipation (myelitis); and shortness of breath, irregular heartbeat, feeling tired, or chest pain (myocarditis).

Infusion (IV) reactions that can sometimes be severe and life-threatening. Signs and symptoms of infusion reactions may include chills or shaking, shortness of breath or wheezing, itching or rash, flushing, dizziness, fever, or feeling like passing out.

Rejection of a transplanted organ. People who have had an organ transplant may have an increased risk of organ transplant rejection if they are treated with KEYTRUDA.

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 severe and can lead to death. These complications may happen if you underwent transplantation either before or after being treated with KEYTRUDA. Your doctor will monitor you for the following signs and symptoms: skin rash, liver inflammation, abdominal pain, and diarrhea.

Getting medical treatment right away may help keep these problems from becoming more serious. Your doctor will check you for these problems during treatment with KEYTRUDA. Your doctor may treat you with corticosteroid or hormone replacement medicines. Your doctor may also need to delay or completely stop treatment with KEYTRUDA if you have severe side effects.

Before you receive KEYTRUDA, tell your doctor if you have immune system problems such as Crohn’s disease, ulcerative colitis, or lupus; have had an organ transplant or plan to have or have had a bone marrow (stem cell) transplant that used donor stem cells (allogeneic); have lung or breathing problems; have liver problems; or have any other medical problems.

If you are pregnant or plan to become pregnant, tell your doctor. KEYTRUDA can harm your unborn baby. If you are able to become pregnant, your doctor will give you a pregnancy test before you start treatment. Use effective birth control during treatment and for at least 4 months after the final dose of KEYTRUDA. Tell your doctor right away if you think you may be pregnant or you become pregnant during treatment with KEYTRUDA.

If you are breastfeeding or plan to breastfeed, tell your doctor. 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 doctor 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 feeling tired; high blood pressure; joint and muscle pain; diarrhea; decreased appetite; low levels of thyroid hormone; nausea; mouth sores; vomiting; weight loss; stomach-area (abdominal) pain; headache; constipation; urinary tract infection; hoarseness; bleeding; low magnesium level; blisters or rash on the palms of your hands and soles of your feet; shortness of breath; cough; and rash.

These are not all the possible side effects of KEYTRUDA. Tell your doctor if you have any side effect that bothers you or that does not go away. For more information, ask your doctor or pharmacist.

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 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.

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.

The most common side effects of LENVIMA when given with KEYTRUDA in people treated for uterine cancer include tiredness; joint and muscle pain; decreased appetite; change in thyroid hormone levels; nausea; mouth sores; vomiting; weight loss; stomach (abdomen) pain; headache; constipation; urinary tract infection; hoarseness; bleeding; low magnesium level; rash, redness, itching, or peeling of your skin on your hands and feet; trouble breathing; cough; and rash.

LENVIMA may cause fertility problems in males and females. Talk to your healthcare provider if this is a concern for you.

These are not all the possible side effects of LENVIMA. Call your doctor for medical advice about side effects.

You 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.