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 (OPDIVO®), 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 is a medicine that may treat certain cancers by working with your immune system. YERVOY 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 may have more than one of these problems at the same time. These problems may happen anytime during treatment or even after your treatment has ended. Some of these problems may happen more often when YERVOY is used in combination with nivolumab.

Call or see your healthcare provider right away if you develop any new or worse signs or symptoms, including:

Intestinal problems.

diarrhea (loose stools) or more frequent bowel movements than usual
stools that are black, tarry, sticky, or have blood or mucus
severe stomach-area (abdominal) 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)
bleeding or bruising more easily than normal

Skin problems.

rash
itching
skin blistering or peeling
painful sores in mouth or nose, throat, or genital area

Hormone gland problems.

headache 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

Lung problems.

new or worsening cough
shortness of breath
chest pain

Kidney problems.

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

Eye problems.

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

Problems can also happen in other organs and tissues. These are not all of the signs and symptoms of immune system problems that can happen with YERVOY. Call or see your healthcare provider right away for any new or worsening signs or symptoms.

Chest pain, irregular heartbeat, shortness of breath or 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 eye sight
Persistent or severe muscle pain or weakness, muscle cramps
Low red blood cells, bruising

Getting medical treatment right away may help keep these problems from becoming more serious. Your healthcare provider will check you for these problems during your treatment with YERVOY. Your healthcare provider may treat you with corticosteroid or hormone replacement medicines. Your healthcare provider may also 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.
o
YERVOY may be used alone in adults and children 12 years of age and older or in combination with nivolumab in adults when melanoma has spread or cannot be removed by surgery.
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YERVOY may be used alone 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).
o
YERVOY in combination with nivolumab may be used when your colon or rectal cancer:
has spread to other parts of the body (metastatic),
is microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR), and
you have tried treatment with a fluoropyrimidine, oxaliplatin, and irinotecan, and it did not work or is no longer working.
in people with liver cancer (hepatocellular carcinoma).
o
YERVOY may be used in combination with nivolumab if you have previously received treatment with sorafenib.
in adults with a type of lung cancer called non-small cell lung cancer (NSCLC).
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YERVOY may be used in combination with nivolumab as your first treatment for NSCLC:
when your lung cancer has spread to other parts of your body (metastatic), and
your tumors are positive for PD-L1, but do not have an abnormal EGFR or ALK gene.
o
YERVOY may be used in combination with nivolumab and 2 cycles of chemotherapy that contains platinum and another chemotherapy medicine, as the first treatment of your NSCLC when your lung cancer:
has spread or grown, or comes back, and
your tumor does not have an abnormal EGFR or ALK gene.
in adults with a type of cancer that affects the lining of the lungs and chest wall called malignant pleural mesothelioma.
o
YERVOY may be used in combination with nivolumab as your first treatment for malignant pleural mesothelioma that cannot be removed by surgery.

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 such as ulcerative colitis, Crohn’s disease, or lupus
have received an organ transplant
have received or plan to receive a stem cell transplant that uses donor stem cells (allogeneic)
have a condition that affects your nervous system, such as myasthenia gravis or Guillain-Barré syndrome
are pregnant or plan to become pregnant. YERVOY can harm your unborn baby.
 
Females who are able to become pregnant:
 
Your healthcare provider will give you a pregnancy test before you start treatment with YERVOY.
o
You should use an effective method of birth control during your treatment and for 3 months after the last dose of YERVOY. Talk to your healthcare provider about birth control methods that you can use during this time.
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Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with YERVOY. You or your healthcare provider should contact Bristol-Myers Squibb at 1-844-593-7869 as soon as you become aware of a pregnancy.
o
are breastfeeding or plan to breastfeed. It is not known if YERVOY passes into your breast milk.
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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 (except for treating unresectable or metastatic melanoma), 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.
For unresectable or metastatic melanoma, 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 90 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.
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For NSCLC that has spread to other parts of your body, YERVOY is given every 6 weeks and nivolumab is given either every 2 or 3 weeks for up to 2 years. Your healthcare provider will determine if you will also need to receive chemotherapy every 3 weeks for 2 cycles.
o
For malignant pleural mesothelioma that cannot be removed by surgery, YERVOY is given every 6 weeks and nivolumab is given every 3 weeks for up to 2 years.
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.
If you miss any appointments, call your healthcare provider as soon as possible to reschedule your appointment.

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-related reactions. Tell your healthcare provider or nurse right away if you get these symptoms during an infusion of YERVOY:
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chills or shaking
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itching or rash
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flushing
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shortness of breath or wheezing
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dizziness
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feel like passing out
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fever
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back or neck pain
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 severe and can lead to death. These complications may happen if you underwent transplantation either before or after being treated with YERVOY. Your healthcare provider will monitor you for these complications.

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
diarrhea
rash
itching
nausea
pain in muscles, bones, and joints
fever
cough
decreased appetite
vomiting
stomach-area (abdominal) pain
shortness of breath
upper respiratory tract infection
headache
low thyroid hormone levels (hypothyroidism)
decreased weight
dizziness

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

feeling tired
pain in muscles, bones, and joints
nausea
diarrhea
rash
decreased appetite
constipation
itching

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. If you would like more information about YERVOY, talk with your healthcare provider. 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. All other trademarks are the property of their respective owners.

This Medication Guide has been approved by the U.S. Food and Drug Administration.
Revised: May 2021

Revised: 5/2021
E.R. Squibb & Sons, L.L.C.