The First and Only
FDA-Approved Immunotherapy Combination for Certain People Whose Kidney Cancer
(Renal Cell Carcinoma) Has Spread

When treating kidney cancer, your first move could be one that lasts. OPDIVO + YERVOY is the first and only FDA-approved immunotherapy combination for certain people whose kidney cancer, or renal cell carcinoma (RCC), has spread. OPDIVO + YERVOY was studied versus SUTENT® (sunitinib malate) in several key areas including survival, how much tumors shrank, and how long patients responded to treatment. Results like these make it easy to see how OPDIVO + YERVOY may be able to help.

THE OPDIVO + YERVOY
CLINICAL TRIAL

About the Clinical Trial

Clinical Trial: 847 people with advanced kidney cancer, 425 took OPDIVO+YERVOY, 422 took Sutent, a standard treatment

Survival Results

For patients treated with

After 2 years (25.2 months) 60% OPDIVO+YERVOY patients were alive vs 50% with Sutent

Two years later, OPDIVO + YERVOY was proven to
lower the risk of dying by 37% compared to SUTENT.
Half of the patients on SUTENT were alive at 25.9 months compared to more than half being alive on
OPDIVO + YERVOY.


GETTING RESULTS. CHANGING EXPECTATIONS.

What does tumor response mean?

More patients achieved a response with OPDIVO + YERVOY (n=177) when compared to SUTENT (n=112),
and when they did they responded for a longer time.

More Tumor Shrinkage


Response For a Longer Time

Tumor Shrinkage Timeframe

There was no meaningful difference between the two treatments in the length of time that patients lived without their tumors worsening.


OPDIVO + YERVOY MAY BE RIGHT FOR YOU

While your doctor may perform a PD-L1* biomarker test, OPDIVO + YERVOY is FDA-approved
to treat this condition regardless of your test results.

*Programmed death-ligand 1.


Select Important Facts

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

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.

Talking With Your Doctor Is Key

Review a list of questions with your
oncologist about whether
OPDIVO + YERVOY is right for you.

Talk to Your Doctor

Complimentary support, tools,
and educational resources

for anyone considering or currently taking OPDIVO + YERVOY.
Call 1-855-OPDIVO-1 or click to
learn more.

Sign Up Now

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.