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Advanced head and neck squamous cell cancer

IS KEYTRUDA RIGHT FOR YOU?

Immunotherapy may be right for you.
It’s TRU. KEYTRUDA.

Understanding head and neck squamous cell cancer (HNSCC)

“Head and neck cancer” is a term used to describe cancers in and around the head and neck, such as in the throat, lips, gums, or tongue. The specific type of head and neck cancer you have depends on what kinds of cells are affected and where the cancer actually started. For many, head and neck cancer begins in squamous cells found in the head and neck region. This type of cancer is called head and neck squamous cell cancer (HNSCC).

Always talk to your doctor about your treatment options. If you have advanced HNSCC, your doctor may consider:

KEYTRUDA alone as your first treatment if your HNSCC has spread or returned and cannot be removed by surgery, and your tumor tests positive for PD-L1

KEYTRUDA with chemotherapy as your first treatment if your HNSCC has spread or returned and cannot be removed by surgery

KEYTRUDA alone if your HNSCC has spread or returned, and you have received chemotherapy that contains platinum and it did not work or is no longer working

Learn how biomarker testing may impact treatment options

These cards explain what PD-L1 is and how testing for this biomarker could help determine how KEYTRUDA may fit into your treatment plan for HNSCC.

PD-L1 = programmed death ligand 1.

A biomarker test for PD-L1 may help your doctor develop a treatment plan

Doctors can use a biomarker test for PD-L1 to help determine if a treatment like KEYTRUDA may be right for certain people with head and neck squamous cell cancer.

Learn what a biomarker test is on the next card.

What is a biomarker test?

A biomarker test checks whether a cancer contains a specific biomarker that could help your doctor determine your treatment plan. One type of biomarker is called PD-L1.

Learn more about PD-L1 biomarker testing on the next card.

Why test for PD-L1?

PD-L1 is present on some normal (and cancer) cells. It can bind to another protein on cells in the immune system called PD-1. PD-1 acts as a type of “off switch” that helps keep immune cells from attacking other cells in the body. Here's how it works:

  • When PD-1 and PD-L1 attach, it sends a signal to leave the normal (and cancer) cells alone and not attack them.
  • Some cancer cells have large amounts of PD-L1, which helps them hide from your immune system.

Learn how therapies like KEYTRUDA can treat certain cancers by working with your immune system on the next card.

How does KEYTRUDA work?

Immunotherapies that target either PD-1 or PD-L1 can stop them from attaching and help keep cancer cells from hiding.

KEYTRUDA is one specific type of immunotherapy that may:

  • Block PD-1 from attaching to PD-L1, which helps prevent cancer cells from “hiding,” and
  • Help the immune system to find and fight cancer cells.

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.

Learn how to get a biomarker test for PD-L1 on the next card.

How can I get a biomarker test for PD-L1?

To determine if the cancer is using PD-L1 to “hide” from your immune system, talk to your doctor about biomarker testing for PD-L1. Ask your doctor:

  • Has the tumor already been tested for PD-L1 or can it be tested now for PD-L1?
  • How does the test result impact my treatment options?

Learn more about a possible next step on the following card.

Ask your doctor if KEYTRUDA is right for you

A cancer diagnosis can be overwhelming, especially when it comes to understanding your treatment options. A biomarker test for PD-L1 may help your doctor determine your treatment plan.

More information about KEYTRUDA:

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KEYTRUDA is not chemotherapy or radiation therapy—it is an immunotherapy and it works with your immune system to help fight certain cancers

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.

KEYTRUDA is a treatment approved by the FDA for certain people with HNSCC:

It may be used alone for people whose cancer tests positive for PD-L1 or used with platinum and fluorouracil chemotherapy medicines, as your first treatment

OR

when you have received chemotherapy that contains platinum and it did not work or is no longer working.

Find out if KEYTRUDA is right for you

To determine your treatment options, your doctor may consider your medical history in addition to the traits of your individual cancer.

KEYTRUDA may be right for you even if you’ve had other types of cancer treatments, such as:

Surgery

Removes cancer cells.

Radiation therapy

Uses high-energy rays (like x-rays) to kill cancer cells.

Chemotherapy

A treatment option that uses a drug to treat the cancer. It can be given in many ways, such as an IV line into the vein or as a pill that you swallow.

Targeted therapy

Uses medicines that target and disrupt certain parts of the cancer cell and the signals that are needed for cancer to grow and spread.

Patient support throughout your treatment

Patients who have been prescribed KEYTRUDA for an approved indication can access additional support from KEY+YOU, the patient support program for KEYTRUDA. KEY+YOU helps eligible patients by offering educational resources and support information throughout treatment.

FDA-Approved Indications

KEYTRUDA is a prescription medicine used to treat a kind of cancer called head and neck squamous cell cancer (HNSCC).

  • KEYTRUDA 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.
  • KEYTRUDA 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.”
  • KEYTRUDA 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.

PD-L1 = programmed death ligand 1.

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 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; bleeding, blisters, or rash on the palms of your hands and soles of your feet; urinary tract infection; and low levels of thyroid hormone.

Common side effects of KEYTRUDA when given with 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; bleeding, blisters, or rash on the palms of your hands and soles of your feet; urinary tract infection; and low levels of thyroid hormone.

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.