What Should I Know About Potential Side Effects?

While everyone is different, you may find it helpful to learn what other patients have experienced during treatment with the OPDIVO® + YERVOY® combination. The chart below will give you an idea of what to look out for, in case you have any side effects.

It’s important to remember that this chart does not include all possible side effects of the OPDIVO + YERVOY combination. That’s why you need to report any discomfort or change in the way you are feeling to your healthcare team, even if your symptoms are not listed below. Some of the side effects of the OPDIVO + YERVOY combination may be life-threatening and may need your doctor's immediate attention.

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 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. This is why it is especially important to communicate regularly with your team about how you are feeling. 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:

  1. 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.
  2. If you do notice a change in the way you are feeling—even if it seems small or irrelevant—contact your Oncology Care Team immediately. Do not wait until your next clinic appointment.
  3. Do not try to treat possible side effects yourself.

TIPS FOR COMMUNICATING
WITH YOUR TEAM

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 Talk to your doctor or nurse about the best way to reach them. You might be able to get in touch with a direct call, email, or text.
  • Report how you are feeling—it is an important thing you can do for your treatment Frequent communication can help your healthcare team manage side effects right away, which may keep them from becoming more serious.
  • Remember that your healthcare team wants to hear about any concern you are having Don't feel like you’re bothering your healthcare team by getting in touch, even if you are not sure that what you are feeling is a side effect. It is best for your oncologist to make that decision.
  • Use resources to help track how you are feeling Sometimes it is difficult to remember everything you feel over time, which can make it tough to notice small changes. Using a journal or symptom tracker may help.

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

All of this information may seem overwhelming at first, but it is important to remember that you are not alone. You are part of a team that is working to help you be as healthy as possible.

Your healthcare team

This team includes your oncologist, nurses, and other clinic staff. When it comes to managing health and side effects, they are your most important source of information and support. Their role is to:

  • Answer questions about your treatment
  • Measure your health and track any changes
  • Respond to your calls about possible side effects you experience
  • Manage any side effects that you may have

Your broader support network

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

Advocacy and support groups can help you to meet other patients, share experiences, and access educational resources.
Learn more about how they can help.


Call your oncologist if you have any of these signs or symptoms or 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.

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

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performed in a clinical
trial in patients.

See the Results

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and educational resources
for anyone considering or currently taking OPDIVO + YERVOY.
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SELECT IMPORTANT FACTS ABOUT OPDIVO AND YERVOY

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. 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) + 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 is OPDIVO + YERVOY?

OPDIVO is a prescription medicine used in combination with YERVOY (OPDIVO + YERVOY) to treat kidney cancer (renal cell carcinoma) in certain people when their cancer has spread.

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 + 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
  • 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 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
  •  

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 two different prescription medicines that are given as intravenous (IV) infusions by your healthcare team.


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.