YERVOY- ipilimumab injection 
E.R. Squibb & Sons, L.L.C.

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MEDICATION GUIDE

YERVOY® (yur-voi)
(ipilimumab)
injection

Read this Medication Guide before you start receiving YERVOY and before each infusion. There may be new information. If your healthcare provider prescribes YERVOY in combination with nivolumab, also read the Medication Guide that comes with nivolumab. This Medication Guide does not take the place of talking with your healthcare provider about your medical condition or your treatment.

What is the most important information I should know about YERVOY?

YERVOY can cause serious side effects in many parts of your body which can lead to death. These problems may happen anytime during treatment with YERVOY or after you have completed treatment. Some of these problems may happen more often when YERVOY is used in combination with nivolumab.

Call your healthcare provider right away if you develop any of these signs or symptoms or they get worse. Do not try to treat symptoms yourself.

Intestinal problems (colitis) that can cause tears or holes (perforation) in the intestines. Signs and symptoms of colitis may include:

diarrhea (loose stools) or more bowel movements than usual
mucus or blood in your stools
dark, tarry, sticky stools
stomach pain (abdominal pain) or tenderness
you may or may not have fever

Liver problems (hepatitis) that can lead to liver failure. Signs and symptoms of hepatitis may include:

yellowing of your skin or the whites of your eyes
dark urine (tea colored)
nausea or vomiting
pain on the right side of your stomach
bleeding or bruise more easily than normal
decreased energy

Skin problems that can lead to severe skin reaction. Signs and symptoms of severe skin reactions may include:

skin rash with or without itching
sores in your mouth
your skin blisters or peels

Nerve problems that can lead to paralysis. Symptoms of nerve problems may include:

unusual weakness of legs, arms, or face
numbness or tingling in hands or feet

Hormone gland problems (especially the pituitary, adrenal, and thyroid glands). Signs and symptoms that your glands are not working properly may include:

persistent or unusual headaches
unusual sluggishness
feeling cold all the time
weight gain
changes in mood or behavior such as decreased sex drive, irritability, or forgetfulness
dizziness or fainting

Lung problems (pneumonitis). Symptoms of pneumonitis may include:

new or worsening cough
chest pain
shortness of breath

Kidney problems, including nephritis and kidney failure. Signs of kidney problems may include:

decrease in the amount of urine
blood in your urine
swelling in your ankles
loss of appetite

Inflammation of the brain (encephalitis). Signs and symptoms of encephalitis may include:

headache
fever
tiredness or weakness
confusion
memory problems
sleepiness
seeing or hearing things that are not really there (hallucinations)
seizures
stiff neck

Eye problems. Symptoms may include:

blurry vision, double vision, or other vision problems
eye pain or redness

Getting medical treatment right away may keep the problem from becoming more serious.

Your healthcare provider will check you for these problems during treatment with YERVOY. Your healthcare provider may treat you with corticosteroid medicines. Your healthcare provider may need to delay or completely stop treatment with YERVOY if you have severe side effects.

What is YERVOY?

YERVOY is a prescription medicine used:

to treat a kind of skin cancer called melanoma. YERVOY may be used:
o
in adults and children 12 years of age and older when melanoma has spread or cannot be removed by surgery
o
to help prevent melanoma from coming back after it and lymph nodes that contain cancer have been removed by surgery
in people with kidney cancer (renal cell carcinoma). YERVOY may be used in combination with nivolumab in certain people when their cancer has spread.
in adults and children 12 years of age and older, with a type of colon or rectal cancer (colorectal cancer). YERVOY in combination with nivolumab may be used when your colon or rectal cancer:
o
has spread to other parts of the body (metastatic).
o
is microsatellite stability-high (MSI-H) or mismatch repair deficient (dMMR), and
o
You have tried treatment with a fluoropyrimidine, oxaliplatin, and irinotecan, and it did not work or is no longer working.

It is not known if YERVOY is safe and effective in children younger than 12 years of age.

Before you receive YERVOY, tell your healthcare provider about all your medical conditions, including if you:

have immune system problems (autoimmune disease), such as ulcerative colitis, Crohn’s disease, lupus, or sarcoidosis
have had an organ transplant
have liver problems
are pregnant or plan to become pregnant. YERVOY can harm your unborn baby.
o
Females who are able to become pregnant should use effective birth control during treatment with YERVOY and for 3 months after the last dose of YERVOY.
o
If you become pregnant or think you are pregnant, tell your healthcare provider right away. You or your healthcare provider should contact Bristol-Myers Squibb at 1-800-721-5072 as soon as you become aware of the pregnancy.
o
Pregnancy Safety Surveillance Study: Females who become pregnant during treatment with YERVOY are encouraged to enroll in a Pregnancy Safety Surveillance Study. The purpose of this study is to collect information about the health of you and your baby. You or your healthcare provider can enroll you in the Pregnancy Safety Surveillance Study by calling 1-844-593-7869.
are breastfeeding or plan to breastfeed. It is not known if YERVOY passes into your breast milk.
o
Do not breastfeed during treatment with YERVOY and for 3 months after the last dose of YERVOY.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

How will I receive YERVOY?

YERVOY alone is given to you into your vein through an intravenous (IV) line over 90 minutes.
When YERVOY is used in combination with nivolumab, nivolumab is given to you into your vein through an IV line over 30 minutes. Then YERVOY is also given through an IV over 30 minutes on the same day.
YERVOY in combination with nivolumab is usually given every 3 weeks for 4 doses. After that, nivolumab alone is usually given every 2 or 4 weeks.
Your healthcare provider will decide how many treatments you will need.
Your healthcare provider will do blood tests before starting and during treatment with YERVOY.
It is important for you to keep all appointments with your healthcare provider. Call your healthcare provider if you miss an appointment. There may be special instructions for you.

What are the possible side effects of YERVOY?

YERVOY can cause serious side effects, including:

See What is the most important information I should know about YERVOY?
Severe infusion reactions. Tell your doctor or nurse right away if you get these symptoms during an infusion of YERVOY:
o
chills or shaking
o
itching or rash
o
flushing
o
difficulty breathing
o
dizziness
o
fever
o
feeling like passing out

Graft-versus-host disease, a complication that can happen after receiving a bone marrow (stem cell) transplant that uses donor stem cells (allogeneic), may be severe, and can lead to death, if you receive YERVOY either before or after transplant. Your healthcare provider will monitor you for the following signs and symptoms: skin rash, liver inflammation, stomach-area (abdominal) pain, and diarrhea.

The most common side effects of YERVOY when used alone include:

feeling tired
diarrhea
nausea
itching
rash
vomiting
headache
weight loss
fever
decreased appetite
difficulty falling or staying asleep

The most common side effects of YERVOY when used in combination with nivolumab include:

feeling tired
rash
diarrhea
nausea
fever
pain in muscles, bones, and joints
itching
abdominal pain
vomiting
cough
decreased appetite
shortness of breath

These are not all of the possible side effects of YERVOY.

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 YERVOY.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. You can ask your healthcare provider or pharmacist for information about YERVOY that is written for healthcare professionals.

What are the ingredients of YERVOY?

Active ingredient: ipilimumab

Inactive ingredients: diethylene triamine pentaacetic acid (DTPA), mannitol, polysorbate 80, sodium chloride, tris hydrochloride, and Water for Injection

Manufactured by: Bristol-Myers Squibb Company, Princeton, NJ 08543 USA
For more information, call 1-800-321-1335
U.S. License No. 1713

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YERVOY® and OPDIVO® are trademarks of Bristol-Myers Squibb Company.

This Medication Guide has been approved by the U.S. Food and Drug Administration.
Revised: May 2019

Revised: 9/2019
E.R. Squibb & Sons, L.L.C.