How Do OPDIVO® (nivolumab) + YERVOY® (ipilimumab) Team Up to Fight Metastatic Melanoma?

OPDIVO + YERVOY works by helping your immune system to fight cancer. It does this by combining 2 immunotherapy medications in different but complementary ways. Together, OPDIVO and YERVOY can help your immune system launch a response against cancer that’s greater than when either medication is used alone.

Learning more about this treatment can help you have better conversations with your healthcare team when discussing treatment decisions.

Watch this video to see how OPDIVO + YERVOY can work with your immune system to fight cancer.

Because OPDIVO + YERVOY works with your immune system, it 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.

SELECT IMPORTANT FACTS

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); and problems in other organs. Additional serious side effects observed during a separate study of YERVOY alone include nerve problems that can lead to paralysis; and eye problems. OPDIVO can cause serious side effects, including severe infusion reactions.


WHAT DOES MY IMMUNE SYSTEM HAVE TO DO WITH FIGHTING CANCER?

Active T cell

Your immune system is your body's
natural defense
against threats, including
cancer. Your immune system
has many
active T cells that search for these threats.

Once T cells recognize threats such as cancer cells, they
attack them in order to help protect your body.

Sometimes, cancer cells can
turn off or “inactivate” T cells
.
This means there will be fewer
active T cells in your body
available to attack cancer.

Cancer cells are also able to disguise themselves from your body's T cells. If T cells can't recognize cancer, they can't
attack it.

Inactive T cell Disguised cancer cells

OPDIVO and YERVOY WORK IN DIFFERENT BUT COMPLEMENTARY   
WAYS TO HELP YOUR T CELLS ATTACK CANCER AGAIN

How YERVOY Works

Like a power button, YERVOY may stimulate your immune system to
turn on more active T cells that
attack cancer cells.

plus sign
How OPDIVO Works

Like a radar, OPDIVO may help
more active T cells
to discover
cancer cells previously hidden.

While doing so, OPDIVO and YERVOY can also affect healthy cells.


OPDIVO + YERVOY COMBINATION THERAPY HELPS T CELLS ATTACK CANCER BY UNIQUELY   
COMBINING THE ACTIONS OF BOTH MEDICATIONS

Together, they can help your immune system launch a response against cancer that’s greater than when either medication is used alone. Here’s a closer look at how this works:

How YERVOY works How OPDIVO works OPDIVO + YERVOY works together to help your body attack cancer

Learn more about how OPDIVO and YERVOY work together to help your body attack cancer.

How OPDIVO + YERVOY estimulates your immune system

Together, OPDIVO and YERVOY may stimulate your immune system to have more active T cells that are able to discover and attack cancer cells, which may help destroy them. For more information about how OPDIVO and YERVOY may affect healthy cells, see below.

Initial studies suggest that after treatment with
YERVOY, your immune system may remember how to
attack cancer cells in the future.

When your active T cells respond to cancer, some active T cells may become memory T cells.* Memory T cells may help your immune system remember how to attack cancer in the future. The clinical significance of memory T cells (how well their response could treat cancer) is not yet known or understood.

YERVOY interaction with active T cell

*This is based on five studies that ranged in
population size from 22 to 115, and used a range of
YERVOY doses. In these studies, researchers
measured the amounts of protein markers
(antibodies called CD45RD+ or CD45RA-), which
can be found on T cells and memory T cells. By
measuring the protein markers, researchers can
estimate the amount of memory T cells.


select important facts about opdivo and yervoy

It is important to know that while helping your T cells attack cancer cells, OPDIVO + YERVOY combination therapy could also cause your active T cells to attack healthy cells in your body, and this could lead to side effects.

Because OPDIVO + YERVOY works with your immune system, it 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.

Your doctor will check you for these problems during treatment. Your healthcare provider should perform blood tests, such as liver and thyroid function tests, before starting and during treatment. Your doctor may treat you with corticosteroid or hormone replacement medicines. Your healthcare provider may also need to delay or completely stop treatment if you have severe side effects.

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.

See the Results

OPDIVO® with You Program


Complimentary support, tools, and educational resources for anyone considering or currently taking OPDIVO + YERVOY. Call 1-855-OPDIVO-1 or click to learn more.

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Frequently Asked Questions

Whether you are considering OPDIVO + YERVOY or are already on treatment, here are some frequently asked questions.

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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.