Approved for patients with 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, who have tried another cancer medicine.

Approved for patients with 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, who have tried another cancer medicine. 

KEYTRUDA 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, or
  • you have colon or rectal cancer, and you have received chemotherapy with fluoropyrimidine, oxaliplatin, and irinotecan but it did not work or is no longer working.

It is not known if KEYTRUDA is safe and effective in children with MSI-H cancers of the brain or spinal cord (central nervous system cancers).

To find out more, call 85-KEYTRUDA (855-398-7832)


MEDICATION GUIDE
KEYTRUDA® (key-true-duh)
(pembrolizumab)
injection

 
Open all
What is the most important information I should know about KEYTRUDA? 

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 serious or life-threatening and can lead to death.

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
  • 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
  • severe stomach-area (abdomen) pain or tenderness

Liver problems (hepatitis). Signs and symptoms of hepatitis 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
  • feeling less hungry than usual
  • 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 heart beat
  • 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
  • dizziness or fainting
  • 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

Problems in other organs. Signs of these problems may include:

  • rash
  • changes in eyesight
  • severe or persistent muscle or joint pains
  • severe muscle weakness
  • low red blood cells (anemia)
  • 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
  • feeling like passing out

Complications of stem cell transplantation that uses donor stem cells (allogeneic) after treatment with KEYTRUDA. These complications can be severe and can lead to death. Your doctor will monitor you for signs of complications if you are an allogeneic stem cell transplant recipient.

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.

What is KEYTRUDA? 

KEYTRUDA is a prescription medicine used to treat:

  • a kind of skin cancer called melanoma that has spread or cannot be removed by surgery (advanced melanoma).
  • a kind of lung cancer called non-small cell lung cancer (NSCLC).
    • KEYTRUDA may be used alone when your lung cancer:
      • has spread (advanced NSCLC) and,
      • tests positive for “PD-L1” and,
        • as your first treatment if you have not received chemotherapy to treat your advanced NSCLC and your tumor does not have an abnormal “EGFR” or “ALK” gene,
          or
        • you have received chemotherapy that contains platinum to treat your advanced NSCLC, and it did not work or it is no longer working, and
        • if your tumor has an abnormal “EGFR” or “ALK” gene, you have also received an EGFR or ALK inhibitor medicine and it did not work or is no longer working.
    • KEYTRUDA may be used with the chemotherapy medicines pemetrexed and carboplatin as your first treatment when your lung cancer:
      • has spread (advanced NSCLC) and
      • is a type of lung cancer called “nonsquamous”.
  • a kind of cancer called head and neck squamous cell cancer (HNSCC) that:
      • has returned or spread and
      • you have received chemotherapy that contains platinum and it did not work or is no longer working.
  • a kind of cancer called classical Hodgkin lymphoma (cHL) in adults and children when:
      • you have tried a treatment and it did not work or
      • your cHL has returned after you received 3 or more types of treatment.
  • a kind of bladder and urinary tract cancer called urothelial carcinoma. KEYTRUDA may be used 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 a medicine called cisplatin, or
      • you have received chemotherapy that contains platinum, and it did not work or is no longer working.
  • 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. KEYTRUDA 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, or
      • you have colon or rectal cancer, and you have received chemotherapy with fluoropyrimidine, oxaliplatin, and irinotecan but it did not work or is no longer working.
  • It is not known if KEYTRUDA is safe and effective in children with MSI-H cancers of the brain or spinal cord (central nervous system cancers).

PD-L1 = programmed death ligand 1;
EGFR = epidermal growth factor receptor;
ALK = anaplastic lymphoma kinase.

What should I tell my doctor before receiving KEYTRUDA? 

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
  • have lung or breathing problems
  • have liver problems
  • have any other medical problems
  • are pregnant or plan to become pregnant
    • KEYTRUDA can harm your unborn baby.
    • Females who are able to become pregnant should use an effective method of birth control during and for at least 4 months after the final dose of KEYTRUDA. Talk to your doctor about birth control methods that you can use during this time.
    • Tell your doctor right away if you become pregnant during treatment with KEYTRUDA.
  • 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 doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.

How will I receive KEYTRUDA? 
  • Your doctor will give you KEYTRUDA into your vein through an intravenous (IV) line over 30 minutes.
  • KEYTRUDA is usually given every 3 weeks.
  • Your doctor will decide how many treatments you need.
  • Your doctor will do blood tests to check you for side effects.
  • If you miss any appointments, call your doctor as soon as possible to reschedule your appointment.
What are the possible side effects of KEYTRUDA? 

KEYTRUDA can cause serious side effects. See “What is the most important information I should know about KEYTRUDA?”

Common side effects of KEYTRUDA when used alone include: feeling tired, itching, diarrhea, decreased appetite, rash, fever, cough, shortness of breath, pain in muscles, bones or joints, constipation, and nausea.

In children, feeling tired, vomiting and stomach-area (abdominal) pain, and increased levels of liver enzymes and decreased levels of salt (sodium) in the blood are more common than in adults.

These are not all the possible side effects of KEYTRUDA. For more information, ask your doctor or pharmacist.

Tell your doctor if you have any side effect that bothers you or that does not go away.

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

General information about the safe and effective use of
KEYTRUDA 

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. If you would like more information about KEYTRUDA, talk with your doctor. You can ask your doctor or nurse for information about KEYTRUDA that is written for healthcare professionals. For more information, go to www.keytruda.com.

What are the ingredients in KEYTRUDA? 

Active ingredient: pembrolizumab

Inactive ingredients:

KEYTRUDA for injection: L-histidine, polysorbate 80, and sucrose. May contain hydrochloric acid/sodium hydroxide.

KEYTRUDA injection: L-histidine, polysorbate 80, sucrose, and Water for Injection, USP.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

KEYTRUDA is a prescription medicine used to treat 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. KEYTRUDA 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, or
  • you have colon or rectal cancer, and you have received chemotherapy with fluoropyrimidine, oxaliplatin, and irinotecan but it did not work or is no longer working.

It is not known if KEYTRUDA is safe and effective in children with MSI-H cancers of the brain or spinal cord (central nervous system cancers).

Important Safety Information About
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 serious or life-threatening and can lead to death.

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 (hepatitis). Signs and symptoms of hepatitis 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, feeling less hungry than usual, 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, 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.

Problems in other organs. Signs of these problems may include rash, changes in eyesight, severe or persistent muscle or joint pains, severe muscle weakness, low red blood cells (anemia), 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.

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; 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. Females who are able to become pregnant should use an effective method of birth control during treatment and for at least 4 months after the final dose of KEYTRUDA. Tell your doctor right away if 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 include feeling tired, itching, diarrhea, decreased appetite, rash, fever, cough, shortness of breath, pain in muscles, bones or joints, constipation, and nausea.

In children, feeling tired, vomiting and stomach-area (abdominal) pain, and increased levels of liver enzymes and decreased levels of salt (sodium) in the blood are more common than in adults.

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.





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