KEYTRUDA QLEX NOW FDA-APPROVED

ADMINISTERED OVER 1 MINUTE

KEYTRUDA QLEX is a subcutaneous injection given every 3 weeks in the abdomen or thigh by a healthcare provider. Refers to injection time only. Actual clinic time may vary.

IT'S TRU. KEYTRUDA QLEX.

On this page:

What is KEYTRUDA QLEX?

KEYTRUDA QLEX is an FDA-approved immunotherapy. KEYTRUDA QLEX and KEYTRUDA both contain the same immunotherapy. KEYTRUDA QLEX also contains an enzyme called berahyaluronidase alfa.

A faster way to receive your treatment compared to KEYTRUDA

KEYTRUDA QLEX is

Administered over 1 or 2 minutes as an injection given under the skin in the stomach area (abdomen) or thigh by a healthcare provider.

1-minute injection

Every 3 weeks
OR

2-minute injection

Every 6 weeks

Refers to injection time only. Actual clinic time may vary.

Your doctor will decide how many treatments you need.

For comparison, infusion with KEYTRUDA is given into your vein through an intravenous (IV) line by a healthcare provider over 30 minutes, every 3 or 6 weeks. In children, KEYTRUDA is usually given every 3 weeks.

In a clinical trial, KEYTRUDA QLEX was comparable to KEYTRUDA

In a clinical trial, 377 patients with advanced non–small cell lung cancer (NSCLC) received either KEYTRUDA QLEX every 6 weeks + chemotherapy (251 patients) or KEYTRUDA every 6 weeks + chemotherapy (126 patients). All patients in the trial had no previous drug treatment and did not have an abnormal EGFR, ALK, or ROS1.

In a clinical trial comparing KEYTRUDA QLEX to KEYTRUDA:

  • People who received either treatment were shown to have similar amounts of medicine in the blood. (This was studied to ensure that the subcutaneous injection is comparable to the infusion.)

If I’ve already started on KEYTRUDA, can I ask my doctor to switch to KEYTRUDA QLEX?

Your doctor can help you decide if switching from KEYTRUDA to KEYTRUDA QLEX is right for you at any time during your treatment.

Is KEYTRUDA QLEX right for you?

Every patient is different. You should speak with your doctor to understand your treatment options—and find out if KEYTRUDA QLEX is right for you.

Select a cancer type:

KEYTRUDA QLEX and KEYTRUDA both contain the same active immunotherapy. KEYTRUDA QLEX also contains an enzyme called berahyaluronidase alfa.

In a clinical trial comparing KEYTRUDA QLEX to KEYTRUDA, 377 patients with advanced non–small cell lung cancer (NSCLC) received either KEYTRUDA QLEX every 6 weeks + chemotherapy (251 patients) or KEYTRUDA every 6 weeks + chemotherapy (126 patients). All patients in the trial had no previous drug treatment and did not have an abnormal EGFR, ALK, or ROS1.

  • People who received either treatment were shown to have similar amounts of medicine in the blood. (This was studied to ensure that the subcutaneous injection is comparable to the infusion.)

In that same clinical trial, results also found that:

  • KEYTRUDA QLEX had consistent safety with KEYTRUDA.

During treatment with KEYTRUDA QLEX, side effects can occur and should be treated as early as possible. In clinical trials with KEYTRUDA QLEX, some patients stopped treatment due to side effects. Tell your doctor if you have any side effect that bothers you or that does not go away.

KEYTRUDA QLEX is

Administered over 1 or 2 minutes as an injection given under the skin in the stomach area (abdomen) or thigh by a healthcare provider.

1-minute injection

Every 3 Weeks
OR

2-minute injection

Every 6 Weeks

Refers to injection time only. Actual clinic time may vary.

Your doctor will decide how many treatments you need.

  • In adults with , KEYTRUDA QLEX is usually given every 3 weeks or every 6 weeks, depending on the dose that you are receiving.
  • Treatments usually take place at your doctor’s office or an infusion clinic.

Talk to your doctor about the treatment schedule that is right for you. Your doctor can help answer questions about your treatment options.

Getting started with KEYTRUDA QLEX

Questions to ask before your first treatment appointment

Watch next:

Explore resources and support

Call 855-398-7832 and press 1 for support. Available from 8am–7pm ET (Eastern Time), Monday–Friday.

Need information about whether your insurance provider covers KEYTRUDA QLEX, or about potential financial assistance options after you have been prescribed KEYTRUDA QLEX?

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

  • Does my insurance cover KEYTRUDA QLEX?
  • What are the co-pay assistance options for eligible patients?
  • How can I find out if I’m eligible for the Merck Patient Assistance Program?

The Merck Access Program

Visit The Merck Access Program website for more information and to enroll.

To speak to a Merck Access Program representative:

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Support Near Me is a third-party website where people living with cancer can find local resources.

These resources may help with the daily challenges of living with cancer, such as housing, food, transportation, and more.

Access to Support Near Me is licensed by Merck solely as a convenience for patients and caregivers. Merck does not control the content of this site and has not taken steps to verify the accuracy of the listing provided. The organizations listed on the site do not imply an endorsement or referral by Merck, nor do they signify the organizations' endorsement of Merck or its products.

Frequently asked questions about KEYTRUDA QLEX

KEYTRUDA QLEX is an injection under the skin (subcutaneous) that is given over 1 or 2 minutes by a healthcare provider.

KEYTRUDA QLEX is

Administered over 1 or 2 minutes as an injection given under the skin in the stomach area (abdomen) or thigh by a healthcare provider.

1-minute injection

Every 3 Weeks
OR

2-minute injection

Every 6 Weeks

Refers to injection time only. Actual clinic time may vary.

Your doctor will decide how many treatments you need.

KEYTRUDA QLEX is given as an injection under the skin, not into a vein. That is why a port surgery is not required. It’s important to note that you may still need a port if your treatment plan involves another treatment, such as chemotherapy.

KEYTRUDA QLEX also gives you the ability to choose where you get your injection: in the stomach area (abdomen) or thigh.

KEYTRUDA QLEX is a faster way to receive your treatment compared to KEYTRUDA.

  • Your doctor will give you KEYTRUDA into your vein through an intravenous (IV) line. Treatments are given over 30 minutes. Treatments usually take place at your doctor’s office or an infusion clinic.
  • In adults with , KEYTRUDA is usually given every 3 weeks or every 6 weeks depending on the dose that you are receiving. In children, KEYTRUDA is usually given every 3 weeks.

30 minutes per intravenous infusion

Every 3 Weeks
Every 6 Weeks

Your doctor will decide how many treatments you need, based on your experience with KEYTRUDA.

KEYTRUDA QLEX is a subcutaneous immunotherapy that is injected under the skin by a healthcare provider.

In this type of injection, a short needle is used to inject the medication just under the skin, into the fatty tissue layer between the skin and the muscle in the stomach area (abdomen) or thigh.

KEYTRUDA QLEX is a subcutaneous (under the skin) injection that is injected in the stomach area (abdomen) or thigh.

KEYTRUDA QLEX is given as an injection under the skin, not into a vein. That is why a port surgery is not required. It’s important to note that you may still need a port if your treatment plan involves another treatment, such as chemotherapy.

Your doctor can help you decide if switching from KEYTRUDA to KEYTRUDA QLEX is right for you at any time during your treatment.

You may need to contact your insurance company for information about your coverage.

Before your appointment

Arrange transportation to your appointment

Make sure you have someone to drive you to and from treatment, or another reliable method of transportation.

Wear clothing that allows easy access to the injection site

For example, shorts and a loose-fitting shirt will give the doctor or nurse access to your stomach area (abdomen) and thighs.

Be sure to bring the following to your treatment appointment:

  • Any paperwork you need to fill out or have already filled out
  • A list of all the medications you’re currently taking, including prescription and over-the-counter medicines or supplements
  • Insurance cards

During your appointment

Remember, the injection will take a minute or two*

Taking deep breaths may help you stay relaxed throughout your appointment.

Make a note of where you received the injection

Remember to choose a different spot for your next injection.

Ask about your next appointment and any other questions you may have.

After your appointment

If you get any follow-up instructions, keep them somewhere handy, like your refrigerator door.

Track and manage how you're feeling

Keep a journal to write down how you feel before, during, and after treatment, and any questions you may have for your next appointment.

Tracking and sharing your symptoms early and often can help your healthcare provider better address your needs.This downloadable symptom tracker may help you remember symptoms and side effects to discuss with your doctor.

Stay in touch with your healthcare team

Speak up early and often. Let them know if you experience any side effects and ask what you can do to manage them. Remember to call or see your healthcare provider right away if you develop any new or worsening signs or symptoms.

KEYTRUDA QLEX is given as an injection under the skin (subcutaneous) over 1 minute every 3 weeks or 2 minutes every 6 weeks by a healthcare provider. Refers to injection time only. Actual clinic time may vary.

Side effects of KEYTRUDA QLEX

Side effects may occur while taking KEYTRUDA QLEX

During treatment with KEYTRUDA QLEX, side effects can occur and should be treated as early as possible. In clinical trials with KEYTRUDA QLEX, some patients stopped treatment due to side effects. Tell your doctor if you have any side effect that bothers you or that does not go away.

Serious side effects

KEYTRUDA QLEX is a medicine that may treat certain cancers by working with your immune system. KEYTRUDA QLEX 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 anytime during treatment or even after your treatment has ended.

Call or see your healthcare 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 QLEX:

Lung problems:
  • Cough
  • Shortness of breath
  • Chest pain
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)
  • Bleeding or bruising more easily than normal
Kidney problems:
  • Decrease in your amount of 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
Intestinal problems:
  • Diarrhea (loose stools) or more frequent 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:
  • 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
Problems can also happen in other organs and tissues. These are not all of the signs and symptoms of immune system problems that can happen with KEYTRUDA QLEX. Call or see your healthcare provider right away for any new or worsening signs or symptoms, which 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
Allergic and injection-related reactions that can sometimes be severe or life-threatening, can happen during treatment with KEYTRUDA QLEX. Tell your healthcare provider right away if you get any signs or symptoms, including:
  • Chills or shaking
  • Itching or rash
  • Flushing
  • Shortness of breath or wheezing
  • Dizziness
  • Feeling like passing out
  • Fever
  • Back pain

Rejection of a transplanted organ or tissue. Your healthcare provider should tell you what signs and symptoms you should report and 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 QLEX. Your healthcare provider will monitor you for these complications.

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

Who should not receive KEYTRUDA QLEX?

Do not receive KEYTRUDA QLEX if you are allergic to berahyaluronidase, hyaluronidase or any of the inactive ingredients in KEYTRUDA QLEX. See the end of this Medication Guide for a complete list of ingredients in KEYTRUDA QLEX.

Common side effects

The most common side effects of KEYTRUDA QLEX when given with certain chemotherapy medicines include: nausea, tiredness, and muscle, bone, and joint pain.

The most common side effects seen with pembrolizumab given into the vein (intravenous pembrolizumab), which may happen with KEYTRUDA QLEX, are shown below:

  • when used alone include: feeling tired, pain, including pain in muscles, rash, diarrhea, fever, cough, decreased appetite, itching, shortness of breath, constipation, bones or joints and stomach-area (abdominal) pain, nausea, and low levels of thyroid hormone.
  • when used alone that are more common in children than in adults include: fever, vomiting, headache, stomach area (abdominal) pain, and low levels of white blood cells.
  • when used with certain chemotherapy or chemotherapy with radiation therapy medicines include: feeling tired or weak, nausea, constipation, diarrhea, decreased appetite, rash, vomiting, cough, trouble breathing, fever, hair loss, inflammation of the nerves that may cause pain, weakness, and paralysis in the arms and legs, swelling of the lining of the mouth, nose, eyes, throat, intestines, or vagina, mouth sores, headache, weight loss, stomach-area (abdominal) pain, joint and muscle pain, trouble sleeping, blisters or rash on the palms of your hands and soles of your feet, urinary tract infection, and low levels of thyroid hormone.
  • when used with chemotherapy and bevacizumab include: tingling or numbness of the arms or legs, hair loss, low red blood cell count, feeling tired or weak, nausea, low white blood cell count, diarrhea, high blood pressure, decreased platelet count, constipation, joint aches, vomiting, urinary tract infection, rash, low levels of thyroid hormone, and decreased appetite.
  • when used with axitinib include: diarrhea, feeling tired or weak, high blood pressure, liver problems, low levels of thyroid hormone, decreased appetite, blisters or rash on the palms of your hands and soles of your feet, nausea, mouth sores or swelling of the lining of the mouth, nose, eyes, throat, intestines, or vagina, hoarseness, rash, cough, and constipation.
  • when used with enfortumab vedotin include: rash, tingling or numbness of the arms or legs, feeling tired, itching, diarrhea, hair loss, weight loss, decreased appetite, dry eye, nausea, constipation, changes in sense of taste, and urinary tract infection.

These are not all of the possible side effects of KEYTRUDA QLEX.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Side effects of KEYTRUDA

Side effects may occur while taking KEYTRUDA

During treatment with KEYTRUDA, side effects can occur and should be treated as early as possible. In clinical trials with KEYTRUDA, some patients stopped treatment due to side effects. Tell your doctor if you have any side effect that bothers you or that does not go away.

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. You can have more than one of these problems at the same time. These problems may happen anytime during treatment or even after your treatment has ended.

Call or see your healthcare 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
  • Chest pain
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)
  • Bleeding or bruising more easily than normal
Kidney problems:
  • Decrease in your amount of 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
Intestinal problems:
  • Diarrhea (loose stools) or more frequent 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:
  • 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
Problems can also happen in other organs and tissues. These are not all of the signs and symptoms of immune system problems that can happen with KEYTRUDA. Call or see your health care provider right away for any new or worsening signs or symptoms, which 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
  • Back pain

Rejection of a transplanted organ or tissue. Your healthcare 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 healthcare provider will monitor you for these complications.

Getting medical treatment right away may help keep these problems from becoming more serious. Your healthcare provider will check you for these problems during treatment with KEYTRUDA. Your healthcare provider may treat you with corticosteroid or hormone replacement medicines. Your healthcare provider 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 used alone include: feeling tired, pain, including pain in muscles, rash, diarrhea, fever, cough, decreased appetite, itching, shortness of breath, constipation, bones or joints and stomach-area (abdominal) pain, nausea, and low levels of thyroid hormone.

Side effects of KEYTRUDA when used alone that are more common in children than in adults include: fever, vomiting, headache, stomach area (abdominal) pain, and low levels of white blood cells.

Common side effects of KEYTRUDA when given with certain chemotherapy or chemotherapy with radiation therapy medicines include: feeling tired or weak, nausea, constipation, diarrhea, decreased appetite, rash, vomiting, cough, trouble breathing, fever, hair loss, inflammation of the nerves that may cause pain, weakness, and paralysis in the arms and legs, swelling of the lining of the mouth, nose, eyes, throat, intestines, or vagina, mouth sores, headache, weight loss, stomach-area (abdominal) pain, joint and muscle pain, trouble sleeping, blisters or rash on the palms of your hands and soles of your feet, urinary tract infection, low levels of thyroid hormone, skin irritation in the radiation area, trouble swallowing and dry mouth.

Common side effects of KEYTRUDA when given with chemotherapy and bevacizumab include: tingling or numbness of the arms or legs, hair loss, low red blood cell count, feeling tired or weak, nausea, low white blood cell count, diarrhea, high blood pressure, decreased platelet count, constipation, joint aches, vomiting, urinary tract infection, rash, low levels of thyroid hormone, and decreased appetite.

Common side effects of KEYTRUDA when given with axitinib include: diarrhea, feeling tired or weak, high blood pressure, liver problems, low levels of thyroid hormone, decreased appetite, blisters or rash on the palms of your hands and soles of your feet, nausea, mouth sores or swelling of the lining of the mouth, nose, eyes, throat, intestines, or vagina, hoarseness, rash, cough, and constipation.

Common side effects of KEYTRUDA when given with enfortumab vedotin include: rash, tingling or numbness of the arms or legs, feeling tired, itching, diarrhea, hair loss, weight loss, decreased appetite, dry eye, nausea, constipation, changes in sense of taste, and urinary tract infection.

These are not all the possible side effects of KEYTRUDA.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

FDA-Approved Indications

KEYTRUDA is a prescription medicine used to treat:

  • a kind of lung cancer called non–small cell lung cancer (NSCLC).
    • It may be used in combination with chemotherapy that contains platinum and another chemotherapy medicine before surgery when you have early-stage NSCLC, which can be removed by surgery, and then continued alone after surgery to help prevent your lung cancer from coming back.
    • It may be used with the chemotherapy medicines pemetrexed and a platinum as your first treatment when your lung cancer has spread (advanced NSCLC) and is a type called “nonsquamous” and your tumor does not have an abnormal “EGFR” or “ALK” gene.
    • It may be used with the chemotherapy medicines carboplatin and either paclitaxel or paclitaxel protein-bound as your first treatment when your lung cancer has spread (advanced NSCLC) and is a type called “squamous.”
    • It may be used alone as your first treatment when your lung cancer has not spread outside your chest (stage III) and you cannot have surgery or chemotherapy with radiation, or your NSCLC has spread to other areas of your body (advanced NSCLC), and your tumor tests positive for “PD-L1” and does not have an abnormal “EGFR” or “ALK” gene.
    • It may also be used alone for advanced NSCLC if you have tried chemotherapy that contains platinum and it did not work or is no longer working and, your tumor tests positive for “PD-L1” and if your tumor has an abnormal “EGFR” or “ALK” gene, you have also received an “EGFR” or “ALK” inhibitor medicine that did not work or is no longer working.
    • It may be used alone as a treatment in adults for your lung cancer to help prevent your lung cancer from coming back after your tumor(s) has been removed by surgery and you have received platinum-based chemotherapy, and you have stage IB and your tumor(s) is 4 cm or greater in size, stage II, or stage IIIA NSCLC.
  • a kind of skin cancer called melanoma.
    • It may be used when your melanoma has spread or cannot be removed by surgery (advanced melanoma), or
    • It may be used in adults and children 12 years of age and older with stage IIB, stage IIC, or stage III melanoma, to help prevent melanoma from coming back after it and lymph nodes that contain cancer have been removed by surgery.
  • a kind of cancer called head and neck squamous cell cancer (HNSCC).
    • It may be used alone in adults with HNSCC before surgery when your cancer can be removed by surgery, has spread to nearby tissues, and your tumor tests positive for “PD-L1,” and then continued in combination with radiation with or without cisplatin after surgery, and then continued alone to help prevent your head and neck cancer from coming back."
    • It may be used with the chemotherapy medicines fluorouracil and a platinum as your first treatment when your head and neck cancer has spread or returned and cannot be removed by surgery.
    • It may be used alone as your first treatment when your head and neck cancer has spread or returned and cannot be removed by surgery, and your tumor tests positive for “PD-L1.”
    • It may be used alone when your head and neck cancer has spread or returned, and you have received chemotherapy that contains platinum and it did not work or is no longer working.
  • a kind of bladder and urinary tract cancer called urothelial cancer.
    • It may be used with the medicine enfortumab vedotin in adults when your bladder or urinary tract cancer has spread or cannot be removed by surgery (advanced urothelial cancer).
    • It may be used alone when your bladder or urinary tract cancer has spread or cannot be removed by surgery (advanced urothelial cancer), and you are not able to receive chemotherapy that contains platinum (medicines called either cisplatin or carboplatin).
    • It may be used alone when your bladder or urinary tract cancer has spread or cannot be removed by surgery (advanced urothelial cancer), and you have received chemotherapy that contains platinum, and it did not work or is no longer working.
    • It may be used alone when your cancer has not spread to nearby tissue in the bladder, but is at high-risk for spreading (high-risk, non-muscle invasive bladder cancer [NMIBC]) and when your tumor is a type called “carcinoma in situ” (CIS), and you have tried treatment with Bacillus Calmette-Guerin (BCG) and it did not work, and you are not able to or have decided not to have surgery to remove your bladder.
  • a kind of cancer that is shown by a laboratory test to be a microsatellite instability-high (MSI-H) or a mismatch repair deficient (dMMR) solid tumor. It may be used in adults and children to treat:
    • cancer that has spread or cannot be removed by surgery (advanced cancer), and
    • has progressed following treatment, and you have no satisfactory treatment options.
  • a kind of cancer called colon or rectal cancer. It may be used when your cancer:
    • has spread or cannot be removed by surgery (advanced colon or rectal cancer), and
    • has been shown by a laboratory test to be microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR).
  • a kind of stomach cancer called gastric or gastroesophageal junction (GEJ) adenocarcinoma.
    • It may be used in adults in combination with fluoropyrimidine and platinum chemotherapy as your first treatment when your stomach cancer:
      • is HER2-negative, and your tumor tests positive for “PD-L1,” and
      • has spread or cannot be removed by surgery (advanced gastric cancer).
  • a kind of cancer called esophageal or certain gastroesophageal junction (GEJ) carcinomas that cannot be cured by surgery or a combination of chemotherapy and radiation therapy.
    • It may be used in combination with platinum- and fluoropyrimidine-based chemotherapy medicines when your tumor tests positive for “PD-L1.”
    • It may be used alone when:
      • you have received one or more types of treatment, and it did not work or it is no longer working, and
      • your tumor is a type called “squamous,” and
      • your tumor tests positive for “PD-L1.”
  • a kind of cancer called cervical cancer.
    • It may be used with chemotherapy and radiation therapy when your cervical cancer has spread nearby to the lower part of your vagina or to pelvic organs or has affected your kidneys (Stage III to IVA FIGO 2014 classification).
    • It may be used with chemotherapy medicines, with or without the medicine bevacizumab, when:
      • your cervical cancer does not go away (persistent), has returned, or has spread (advanced cervical cancer), and
      • your tumor tests positive for “PD‑L1.”
    • It may be used alone when your cervical cancer:
      • has returned, or has spread (advanced cervical cancer), and
      • you have received chemotherapy, and it did not work or is no longer working, and
      • your tumor tests positive for “PD‑L1.”
  • a kind of kidney cancer called renal cell carcinoma (RCC).
    • It may be used in adults with the medicine axitinib as your first treatment when your kidney cancer has spread or cannot be removed by surgery (advanced RCC).
    • It may be used alone if you are at intermediate-high or high risk of your kidney cancer (RCC) coming back after surgery to:
      • remove all or part of your kidney, or
      • remove all or part of your kidney and also surgery to remove cancer that has spread to other parts of the body (metastatic lesions).
  • a kind of uterine cancer called advanced endometrial carcinoma.
    • It may be used with the chemotherapy medicines carboplatin and paclitaxel, and then may be used alone, in adults:
      • when your cancer has spread (advanced), or
      • if your cancer has returned.
    • It may be used alone in adults:
      • if your cancer is shown by a laboratory test to be 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.
  • a kind of skin cancer called cutaneous squamous cell carcinoma (cSCC). It may be used when your skin cancer has returned or spread, and cannot be cured by surgery or radiation.
  • a kind of cancer called triple-negative breast cancer (TNBC).
    • It may be used with chemotherapy medicines as treatment before surgery and then continued alone after surgery when you have early-stage breast cancer, and are at high risk of your breast cancer coming back (high-risk early-stage triple-negative breast cancer [TNBC]).
    • It may be used with chemotherapy medicines when your breast cancer has returned and cannot be removed by surgery or has spread (advanced TNBC), and tests positive for “PD-L1.”

PD-L1 = programmed death ligand 1;

EGFR = epidermal growth factor receptor;

ALK = anaplastic lymphoma kinase;

FIGO = International Federation of Gynecology and Obstetrics;

HER2 = human epidermal growth factor receptor 2.

Important Safety Information

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 used alone include feeling tired; pain, including pain in muscles; rash; diarrhea; fever; cough; decreased appetite; itching; shortness of breath; constipation; bones or joints and stomach-area (abdominal) pain; nausea; and low levels of thyroid hormone.

In children, when KEYTRUDA is used alone, fever, vomiting, headache, stomach area (abdominal) pain, and low levels of white blood cells and red blood cells (anemia) are more common than in adults.

Common side effects of KEYTRUDA when given with certain chemotherapy or chemotherapy with radiation therapy medicines include feeling tired or weak; nausea; constipation; diarrhea; decreased appetite; rash; vomiting; cough; trouble breathing; fever; hair loss; inflammation of the nerves that may cause pain, weakness, and paralysis in the arms and legs; swelling of the lining of the mouth, nose, eyes, throat, intestines, or vagina; mouth sores; headache; weight loss; stomach-area (abdominal) pain; joint and muscle pain; trouble sleeping; blisters or rash on the palms of your hands and soles of your feet; urinary tract infection; low levels of thyroid hormone; skin irritation in the radiation area; trouble swallowing; and dry mouth.

Common side effects of KEYTRUDA when given with enfortumab vedotin include rash; tingling or numbness of the arms or legs; feeling tired; itching; diarrhea; hair loss; weight loss; decreased appetite; dry eye; nausea; constipation; changes in sense of taste; and urinary tract infection.

Common side effects of KEYTRUDA when given with chemotherapy and bevacizumab include tingling or numbness of the arms or legs; hair loss; low red blood cell count; feeling tired or weak; nausea; low white blood cell count; diarrhea; high blood pressure; decreased platelet count; constipation; joint aches; vomiting; urinary tract infection; rash; low levels of thyroid hormone; and decreased appetite.

Common side effects of KEYTRUDA when given with axitinib include diarrhea; feeling tired or weak; high blood pressure; liver problems; low levels of thyroid hormone; decreased appetite; blisters or rash on the palms of your hands and soles of your feet; nausea; mouth sores or swelling of the lining of the mouth, nose, eyes, throat, intestines, or vagina; hoarseness; rash; cough; and constipation.

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.