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

KEYTRUDA is a medicine that may treat your melanoma by working with your immune system. KEYTRUDA can cause your immune system to attack normal organs and tissues in many areas of your body and can affect the way they work. These problems can sometimes become serious or life-threatening.

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
  • dark urine
  • nausea or vomiting
  • feeling less hungry than usual
  • pain on the right side of your stomach area (abdomen)
  • bleeding or bruising more easily than normal
• Hormone gland problems (especially the thyroid, pituitary, and adrenal glands). Signs and symptoms that your hormone glands are not working properly may include:
  • rapid heart beat
  • weight loss
  • increased sweating
  • weight gain
  • 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

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 medicines and delay or completely stop treatment with KEYTRUDA, if you have severe side effects.

KEYTRUDA is a prescription medicine used to treat a kind of skin cancer called melanoma.

KEYTRUDA may be used when your melanoma:

• has spread or cannot be removed by surgery (advanced melanoma)

and,

• after you have tried a medicine called ipilimumab and it did not work or is no longer working

and,

• if your tumor has an abnormal “BRAF” gene, and you also have tried a different medicine
  called a BRAF inhibitor, and it did not work or is no longer working.

It is not known if KEYTRUDA is safe and effective in children less than 18 years of age.

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 may 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 last 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.

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.

• 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.

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

The most common side effects of KEYTRUDA include:

• feeling tired
• cough
• nausea
• itching
• rash
• decreased appetite
• constipation
• diarrhea
• joint pain

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

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

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

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.

Active ingredient: pembrolizumab
Inactive ingredients: L-histidine, polysorbate-80, sucrose. May contain hydrochloric acid/sodium hydroxide.

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