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Taking KEYTRUDA® (pembrolizumab) and LENVIMA® (lenvatinib)

Taking KEYTRUDA and LENVIMA

What to Expect When Taking KEYTRUDA® (pembrolizumab) and LENVIMA® (lenvatinib)

What to expect when taking KEYTRUDA and LENVIMA

KEYTRUDA is an infusion and LENVIMA is a capsule. The information below can help give you a better understanding of how you will get and take each medication.


What to expect when taking KEYTRUDA

How Will I Receive KEYTRUDA® (pembrolizumab)?

How will I receive KEYTRUDA?

Your health care provider will give you KEYTRUDA into your vein through an intravenous (IV) line. Treatments usually take place at your health care provider’s office or an infusion clinic.

Treatment With KEYTRUDA® (pembrolizumab) Is Usually Given Over 30 Minutes Every 3 Weeks

How long does treatment take?

Treatment with KEYTRUDA is usually given over 30 minutes every 3 weeks.

How long will I stay on KEYTRUDA?

Every patient is different. For that reason, your doctor will decide how many treatments you need, based on your experience with KEYTRUDA.

You can also learn about tips for managing your health while on KEYTRUDA.


What to expect when taking LENVIMA

How Will I Receive My LENVIMA® (lenvatinib) Prescription?

How will I receive my LENVIMA prescription?

You will receive your prescription through a Specialty Pharmacy, your doctor’s office/clinic, or a hospital pharmacy.

Talk to your health care team to find out how you will receive LENVIMA. LENVIMA is available through 6 Specialty Pharmacies: Accredo, Biologics, CVS, Onco360, Optum, and US Bioservices. 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. If you do not see your Specialty Pharmacy listed here, contact your health care team.

How Will I Take LENVIMA® (lenvatinib)?

How will I take LENVIMA?

LENVIMA is an oral medication and should be taken once a day at the same time, with or without food. Your doctor will tell you how much LENVIMA to take and when to take it. Your doctor 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® (lenvatinib) , 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.

What if I miss a dose?

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 Take Too Much LENVIMA® (lenvatinib), Call Your Health Care Provider or Go to the Nearest Hospital Emergency Room Right Away.

What if I take too much?

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

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

The number of capsules you need to take may vary based on what your doctor prescribes.

LENVIMA® (lenvatinib) Capsules Come in Color-coded Cards That Contain Medicine for 5 Days
This is just one example of a LENVIMA blister card. The card your doctor prescribed may look different than this one.

What if I cannot swallow LENVIMA capsules whole?

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

If You Cannot Swallow LENVIMA® (lenvatinib) 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 1: Use a medicine cup to measure about 1 tablespoon of water or apple juice and pour into a small glass

If You Cannot Swallow LENVIMA® (lenvatinib) Capsules Whole, Follow These Steps (Step 2): Place the LENVIMA® (lenvatinib) Capsules Into the Small Glass Without Breaking or Crushing Them

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

If You Cannot Swallow LENVIMA® (lenvatinib) Capsules Whole, Follow These Steps (Step 3): Leave the Capsules in the Liquid for at Least 10 Minutes

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

If You Cannot Swallow LENVIMA® (lenvatinib) Capsules Whole, Follow These Steps (Step 4): Stir the Contents of the Glass for at Least 3 Minutes

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

If You Cannot Swallow LENVIMA® (lenvatinib) Capsules Whole, Follow These Steps (Step 5): Drink the Mixture. After Drinking, Rinse the Glass With a Small Amount of Additional Water or Apple Juice and Swallow the Liquid

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

Additional Educational Resources About KEYTRUDA® (pembrolizumab) and LENVIMA® (lenvatinib) for Patients

Additional educational resources for patients

Discover additional resources that you may find helpful during your treatment journey with KEYTRUDA and LENVIMA.

Discover Additional Resources That You May Find Helpful During Your Treatment Journey With KEYTRUDA® (pembrolizumab) and LENVIMA® (lenvatinib)

FDA-Approved Indication

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

  • when your tumor is not microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR), and
  • you have received anti-cancer treatment, and it is no longer working, and
  • your cancer cannot be cured by surgery or radiation (advanced endometrial carcinoma).

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

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 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.

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.