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

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MEDICATION GUIDE
YERVOY® (yur-voi)
(ipilimumab)

Read this Medication Guide before you start receiving YERVOY and before each infusion. There may be new information. 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 side effects are most likely to begin during treatment; however, side effects can show up months after your last infusion.

These side effects may include:

1.
Inflammation of the intestines (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
blood in your stools or dark, tarry, sticky stools
stomach pain (abdominal pain) or tenderness
2.
Inflammation of the liver (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
3.
Inflammation of the skin that can lead to severe skin reaction (toxic epidermal necrolysis). Signs and symptoms of severe skin reactions may include:
skin rash with or without itching
sores in your mouth
your skin blisters and/or peels
4.
Inflammation of the nerves 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
5.
Inflammation of hormone glands (especially the pituitary, adrenal, and thyroid glands) that may affect how these glands work. Signs and symptoms that your glands are not working properly may include:
persistent or unusual headaches
unusual sluggishness, feeling cold all the time, or weight gain
changes in mood or behavior such as decreased sex drive, irritability, or forgetfulness
dizziness or fainting
6.
Inflammation of the eyes. Symptoms may include:
blurry vision, double vision, or other vision problems
eye pain or redness

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

Getting medical treatment right away may keep the problem from becoming more serious. Your oncologist may decide to delay or stop YERVOY.

What is YERVOY?

YERVOY is a prescription medicine used in adults to treat melanoma (a kind of skin cancer) that has spread or cannot be removed by surgery.

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

What should I tell my healthcare provider before getting YERVOY?

Before you are given YERVOY, tell your healthcare provider about all your health problems if you:

have an active condition where your immune system attacks your body (autoimmune disease), such as ulcerative colitis, Crohn’s disease, lupus, or sarcoidosis
had an organ transplant, such as a kidney transplant
have liver damage from diseases or drugs
have any other medical conditions
are pregnant or plan to become pregnant. YERVOY may cause stillbirth, premature delivery, and/or death of your unborn baby
are breastfeeding

Tell your healthcare provider about all the medicines you take, including all prescription and non-prescription medicines, steroids or other medicines that lower your immune response, vitamins, and herbal supplements.

Know the medicines you take. Keep a list to show your doctors and pharmacists each time you get a new medicine.

You should not start a new medicine before you talk with the healthcare provider who prescribes you YERVOY.

How will I receive YERVOY?

You will get YERVOY through an intravenous line in your vein (infusion). It takes about 90 minutes to get a full dose.

YERVOY is usually given every 3 weeks for up to 4 doses. Your healthcare provider may change how often you receive YERVOY or how long the infusion may take.
Your healthcare provider should perform 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. See “What is the most important information I should know about YERVOY?

The most common side effects of YERVOY include:

tiredness
diarrhea
itching
rash

These are not all of the possible side effects of YERVOY. For more information, ask your healthcare provider.

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

You may also report side effects to Bristol-Myers Squibb at 1-800-721-5072.

General information about the safe and effective use of YERVOY.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide.

This Medication Guide summarizes the most important information about YERVOY. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider for information about YERVOY that is written for healthcare professionals.

For more information, call 1-800-321-1335.

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, USP


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

Revised: 12/2013
 
E.R. Squibb & Sons, L.L.C.