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For adults newly diagnosed with malignant pleural mesothelioma (MPM) that cannot be removed by surgery

OPDIVO® (nivolumab) is a prescription medicine used in combination with YERVOY® (ipilimumab) as a first treatment for adults with a type of cancer that affects the lining of the lungs and chest wall called malignant pleural mesothelioma which cannot be removed by surgery.

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

For adults newly diagnosed with malignant pleural mesothelioma (MPM) that cannot be removed by surgery

A Chance To Live Longer™

Today, there may be good news for some people with this rare condition: OPDIVO + YERVOY is now FDA-approved to treat it. See how this unique combination of 2 immunotherapies performed in a clinical trial.

THE OPDIVO + YERVOY + CLINICAL TRIAL


About the Clinical Trial

In the OPDIVO® (nivolumab) plus YERVOY® (ipilimumab) first-line malignant pleural mesothelioma (MPM) combination therapy clinical trial of 605 patients, 303 patients were given OPDIVO® (nivolumab) plus YERVOY® (ipilimumab), while 302 patients were given platinum-based chemotherapy

Clinical Trial Results

IN THE PRIMARY ANALYSIS
(MINIMUM FOLLOW-UP OF 22.1 MONTHS)

OPDIVO + YERVOY reduced the risk of
dying by 26% compared to
platinum-based chemotherapy.

At 18.1 months, half the patients
were alive on
OPDIVO + YERVOY.

At 14.1 months, half the patients were alive on platinum-based chemotherapy.


AT 2 YEARS

41% of patients were alive on OPDIVO + YERVOY and 27% of patients were alive on platinum-based chemotherapy

The analysis at this time point was not designed to show a difference between OPDIVO + YERVOY and platinum-based chemotherapy.

Ask your doctor if OPDIVO + YERVOY is
right for you

OPDIVO + YERVOY will not work for everyone. Individual results may vary.


SELECT IMPORTANT FACTS


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

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

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

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; and severe infusion-related reactions. Additional serious side effects of YERVOY alone include: nerve problems that can lead to paralysis; eye problems; and complications of stem-cell transplant that uses donor stem cells (allogeneic).

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 is OPDIVO + YERVOY?

OPDIVO is a prescription medicine used in combination with YERVOY (OPDIVO + YERVOY) to treat a type of cancer called malignant pleural mesothelioma, which affects the lining of the lungs and chest wall. OPDIVO + YERVOY is approved as a first treatment for adults with malignant pleural mesothelioma that cannot be removed by surgery.

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

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


What is the most important information I should know about OPDIVO + YERVOY?

OPDIVO and YERVOY are medicines that may treat certain cancers by working with your immune system. OPDIVO and 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. 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 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 also need to delay or completely stop your treatment.

What are the serious side effects of OPDIVO + YERVOY?

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.

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

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

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

  • diarrhea (loose stools) or more
    bowel movements than usual
  • mucus or blood in your stools or dark, tarry, sticky stools
  • stomach-area (abdomen)
    pain or tenderness
  • you may or may not have fever

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

  • yellowing of your skin or
    the whites of your eyes
  • 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
  • feeling more hungry or
    thirsty than usual
  • urinating more often than usual

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

Eye problems — Things to look out for may include:

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

Heart problems — Things to look out for may include:

  • shortness of breath
  • irregular heartbeat
  • feeling tired
  • chest pain

Muscle and joint problems — Things to look out for may include:

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

Additional serious side effects observed with YERVOY 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

What are the possible side effects of OPDIVO + YERVOY?

See the previous section, “What is the most important information I should know about OPDIVO + YERVOY?”

OPDIVO and OPDIVO + YERVOY can cause serious side effects, including:

Severe infusion-related 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-related reaction during an infusion.

Complications of stem cell transplant that uses donor stem cells (allogeneic). These complications, such as graft-versus-host disease, may be severe and can lead to death if you receive OPDIVO or YERVOY either before or after transplant. Your healthcare provider will monitor you for the following signs and symptoms: skin rash, liver inflammation, stomach-area (abdominal) pain, and diarrhea.


What are the most common side effects?

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

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 1-800-FDA-1088.


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

Tell your healthcare provider:

  • about all 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
  • if you are pregnant or plan to become pregnant. OPDIVO and YERVOY can harm your unborn baby. If you are a female who is able to become pregnant, your healthcare provider should do a pregnancy test before you start receiving OPDIVO and YERVOY. Females who are able to become pregnant should use an effective method of birth control during treatment and for at least 5 months after your last dose.
    • 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 1-844-593-7869 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 1-844-593-7869.
  • 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 5 months after your last dose.
  • about all the medicines you take, including
    • prescription medicines
    • over-the-counter medicines
    • vitamins
    • herbal supplements

For more information, please see U.S. Full Prescribing Information and Medication Guide for OPDIVO. Please see U.S. Full Prescribing Information and Medication Guide for YERVOY. Talk to your healthcare team for more information about these medications.