What Should I Know About Potential Side Effects?

Some of the side effects of the OPDIVO® + YERVOY® combination may be life-threatening and may need your doctor’s immediate attention. Be sure to tell your doctor about all side effects as soon as possible, including any changes in how you are feeling, so he or she can help
address them right away.

Lung Problems (pneumonitis)

  • new or worsening cough
  • chest pain
  • shortness of breath

Intestinal Problems (colitis) that can lead to tears or holes in your intestine

  • diarrhea (loose stools) or more bowel movements than usual
  • blood in your stools or dark, tarry, sticky stools
  • severe stomach area (abdomen) pain or tenderness

Liver Problems (hepatitis)

  • yellowing of your skin or the whites of your eyes
  • severe nausea or vomiting
  • pain on the right side of your stomach area (abdomen)
  • drowsiness
  • dark urine (tea colored)
  • bleeding or bruising more easily than normal
  • feeling less hungry than usual
  • decreased energy

Hormone Gland Problems (especially the thyroid, pituitary, adrenal glands, and pancreas)

  • headaches that will not go away or unusual headaches
  • extreme tiredness
  • weight gain or weight loss
  • dizziness or fainting
  • changes in mood or behavior such as decreased sex drive, irritability, or forgetfulness
  • hair loss
  • feeling cold
  • constipation
  • voice gets deeper
  • excessive thirst or lots of urine

Kidney Problems,
including nephritis and kidney failure

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

Skin Problems

  • rash
  • itching
  • skin blistering
  • ulcers in mouth or other mucous membranes

Inflammation of the
Brain (encephalitis)

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

Problems in Other Organs

  • changes in eyesight
  • severe or persistent muscle or joint pains
  • severe muscle weakness
  • chest pain

Severe Infusion Reactions

Tell your doctor or nurse right away if you get these symptoms during an infusion of OPDIVO:

  • chills or shaking
  • itching or rash
  • flushing
  • difficulty breathing
  • dizziness
  • fever
  • feeling like passing out

REPORTING SIDE EFFECTS EARLY IS IMPORTANT

Combining OPDIVO and YERVOY may increase the chances of side effects. Talking to your healthcare team about how you are feeling can help make them aware of side effects early. Treating side effects early may help keep them from becoming more serious.

It is also important to remember that you are not alone. Everyone’s support network is different, and support can come from many different people.


HOW CAN I PLAY A MORE ACTIVE ROLE IN COMMUNICATION WITH MY HEALTHCARE TEAM?

Your healthcare team will run routine tests to check for some signs of side effects, but tests can
only go so far. It’s important to play an active role, as many of the signs can only be noticed by
you, such as changes in the way you are feeling.

Here are some important things you can do to make your healthcare team aware of side effects as early as possible:

  • Pay close attention to how you are feeling, and be especially aware of any new discomfort that appears out of nowhere or any condition that suddenly gets worse. 
  • If you do notice a change in the way you are feeling—even if it seems small or irrelevant—contact your healthcare team immediately. Do not wait until your next clinic appointment.
  • Do not try to treat possible side effects yourself.

HERE ARE SOME STEPS YOU CAN TAKE WITH YOUR BROADER SUPPORT NETWORK

With busy schedules and so many important things to worry about, it can be hard to find time to
reach out to your healthcare team. Here are some tips for communicating with your team:

  • Figure out the best way to contact your doctor, and plan ahead
  • Report how you are feeling—it is an important thing you can do for your treatment
  • Remember that your healthcare team wants to hear about any concerns you are having
  • Use resources, like a journal, to help track how you are feeling

HOW CAN MY SUPPORT NETWORK HELP ME PLAY A MORE ACTIVE ROLE?

Not all patients have a caregiver, but those who do may have a helping hand. A caregiver—or
other community member—can help you:

  • Monitor and track how you are feeling
  • Call your healthcare team
  • Ask questions and help remember the answers
  • Keep track of appointments and treatment records

Sign up for the OPDIVO with You program for additional support for patients.


Call your oncologist if you have any of these signs or symptoms or if they get worse. Your healthcare provider may decide to delay or completely stop OPDIVO + YERVOY or give you other medicines (such as corticosteroids or hormone replacement medicines) to treat your symptoms.

Symptoms may occur anytime during treatment or even after your treatment has ended.

  • Getting medical treatment right away may keep the problem from becoming more serious
  • Do not treat symptoms yourself
  • Do not feel embarrassed or worry that you are bothering your oncologist

What are the most common side effects of OPDIVO when used in combination with YERVOY?

The most common side effects of OPDIVO, when used in combination with YERVOY, include: feeling tired; rash; diarrhea; nausea; fever; pain in muscles, bones, and joints; itching; abdominal pain; vomiting; cough; decreased appetite; and shortness of breath. The most common side effects of YERVOY include: feeling tired; diarrhea; nausea; itching; rash; vomiting; headache; weight loss; fever; decreased appetite; and difficulty falling or staying asleep.

What are the serious side effects of OPDIVO when used in combination with YERVOY?

OPDIVO can cause problems that can sometimes become serious or life-threatening and can lead to death. Serious side effects may include:

  • lung problems (pneumonitis)
  • intestinal problems (colitis) that can lead to tears or holes in your intestine
  • liver problems (hepatitis)
  • hormone gland problems (especially the thyroid, pituitary, adrenal glands, and pancreas )
  • kidney problems, including nephritis and kidney failure
  • skin problems
  • inflammation of the brain (encephalitis)
  • problems in other organs
  • severe infusion reactions

Additional serious side effects observed during a separate study of YERVOY alone include:

  • nerve problems that can lead to paralysis
  • eye problems

See Clinical Trial Results

See how OPDIVO + YERVOY performed in a
clinical trial in patients.

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SELECT IMPORTANT FACTS ABOUT OPDIVO AND YERVOY

OPDIVO is a medicine that may treat your melanoma by working with your immune system. OPDIVO 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 and can lead to death. These problems may happen anytime during treatment or even after your treatment has ended. Some of these problems may happen more often when OPDIVO is used in combination with 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.

Important Facts About
OPDIVO® (nivolumab) and OPDIVO + YERVOY® (ipilimumab)

This is a summary of important information that you need to know about OPDIVO and OPDIVO + YERVOY. Your healthcare team can work with you to help answer any questions you may have about these medications. Keep this information in a safe place so you can refer to it before and during your treatment.

Look out for the following icons as you read:

  • Talk to your
    healthcare team
  • Call a healthcare
    provider right away
  • Helpful information
    to remember

What are OPDIVO and OPDIVO + YERVOY?

OPDIVO is a prescription medicine used to treat people who have a type of skin cancer called melanoma, and who:

Have melanoma that has spread or cannot be removed by surgery (advanced melanoma).

OPDIVO can be used alone or in combination with YERVOY (OPDIVO + YERVOY).

OPDIVO is approved for both BRAF+ and BRAF- patients. OPDIVO was approved for BRAF+ metastatic melanoma patients based on the amount of time patients lived without their tumors worsening. There is ongoing evaluation of clinical benefit of OPDIVO for this use.

OPDIVO + YERVOY was approved based on the amount of time patients lived without their tumors worsening. There is ongoing evaluation of clinical benefit of OPDIVO + YERVOY for this use.

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


What are the serious side effects?

A serious side effect is a side effect that can sometimes become life-threatening and can lead to death. They may happen anytime during treatment or even after your treatment has ended.

OPDIVO is a medicine that may treat certain cancers by working with your immune system. OPDIVO can cause your immune system to attack normal organs and tissues in any area of your body and can affect the way they work. Some of these problems may happen more often when OPDIVO is used in combination with YERVOY.

YERVOY can also 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.

Get medical help immediately if you develop any of these symptoms or they get worse. It may keep these problems from becoming more serious. Your healthcare team will check you for side effects during treatment, and may treat you with corticosteroid or hormone replacement medicines. If you have a serious side effect, your healthcare team may need to delay or completely stop your treatment.

What are the serious side effects of OPDIVO and OPDIVO + YERVOY?

Lung problems (pneumonitis) — Things to look out for may include:

  • new or worsening cough
  • chest pain
  • shortness of breath

Intestinal problems (colitis) that can lead to tears or holes in your intestine — Things to look out for may include:

  • diarrhea (loose stools) or more
    bowel movements than usual
  • blood in your stools or dark,
    tarry, sticky stools
  • severe stomach area (abdomen)
    pain or tenderness

Liver problems (hepatitis) — Things to look out for may include:

  • yellowing of your skin or
    the whites of your eyes
  • severe nausea or vomiting
     
  • pain on the right side of your
    stomach area (abdomen)
  • drowsiness
  • dark urine (tea colored)
  • bleeding or bruising more easily
    than normal
  • feeling less hungry than usual
  • decreased energy

Hormone gland problems (especially the thyroid, pituitary, adrenal glands, and pancreas) — Things to look out for may include:

  • headaches that will not go away
    or unusual headaches
  • extreme tiredness
  • weight gain or weight loss
  • dizziness or fainting
  • changes in mood or behavior,
    such as decreased sex drive,
    irritability, or forgetfulness
  • hair loss

  • feeling cold
  • constipation
  • voice gets deeper
  • excessive thirst or lots of urine

Kidney problems, including nephritis and kidney failure — Things to look out for may include:

  • decrease in the amount of urine
  • blood in your urine
  • swelling in your ankles

  • loss of appetite

Skin problems — Things to look out for may include:

  • rash
  • itching
  • skin blistering
  • ulcers in the mouth or other
    mucous membranes

Inflammation of the brain (encephalitis) — Things to look out for may include:

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

Problems in other organs — Things to look out for may include:

  • changes in eyesight

  • severe or persistent
    muscle or joint pains
  • severe muscle weakness
  • chest pain

Additional serious side effects observed during a separate study of YERVOY alone include:

Nerve problems that can lead to paralysis — Things to look out for may include:

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

Eye problems — Things to look out for may include:

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

OPDIVO can cause serious side effects, including:

Severe infusion reactions — Things to look out for may include:

  • chills or shaking
  • itching or rash
  • flushing
  • difficulty breathing
  • dizziness

  • fever
  • feeling like passing out

Talk to your healthcare team right away if you get any of the symptoms of a severe infusion reaction during or after an infusion of OPDIVO.


What should I discuss with my healthcare team about pregnancy and nursing before starting treatment?

Tell your healthcare team if you are pregnant or plan to become pregnant. OPDIVO and YERVOY can harm your unborn baby. Females who are able to become pregnant should use an effective method of birth control during and for at least 5 months after the last dose of OPDIVO.

Talk to your healthcare team about birth control methods that you can use during this time. Tell your healthcare team right away if you become pregnant or think you are pregnant during treatment. You or your healthcare team should contact Bristol-Myers Squibb at as soon as you become aware of the pregnancy.

Enrolling in a Pregnancy Safety Surveillance Study is encouraged for females who become pregnant during treatment with YERVOY. The purpose of this study is to collect information about your health and the health of your baby. You or your healthcare provider can enroll in the Pregnancy Safety Surveillance Study by calling .

Tell your healthcare team if you are breastfeeding or plan to breastfeed. It is not known if either treatment passes into your breast milk. Do not breastfeed during treatment and for 3 months after the last dose of YERVOY.


What should I discuss with my healthcare team before starting treatment?

Talk to your healthcare team about all of your health problems or concerns, including if you:

  • have immune system
    problems such as autoimmune disease, Crohn’s disease, ulcerative colitis, lupus, or sarcoidosis
  • have had an organ transplant
  • have lung or breathing problems

  • have liver problems
  • have any other medical conditions

Talk to your healthcare team about all of the medicines you are taking, including:

  • prescription medicines
  • over‑the‑counter medicines
  • vitamins
  • herbal supplements

What are the most common side effects?

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

  • feeling tired
  • rash
  • pain in muscles, bones,
    and joints
  • itchy skin
  • diarrhea
  • nausea
  • weakness
  • cough
  • shortness of breath
  • constipation
  • decreased appetite
  • back pain
  • upper respiratory tract infection
  • fever
  • headache
  • abdominal pain

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

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

     

The most common side effects of YERVOY include:

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

These are not all of the possible side effects. Talk to your healthcare team for more information. Call your doctor 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 .

OPDIVO (10 mg/mL) and YERVOY (5 mg/mL) are injections for intravenous (IV) use.


For more information, please see U.S. Full Prescribing Information, including Boxed WARNING regarding immune-mediated side effects, and Medication Guide for YERVOY.

Please see U.S. Full Prescribing Information and Medication Guide for OPDIVO.

Talk to your healthcare team for more information about these medications.