For questions about BMS medicines during this time, please call 1-800-721-8909.

For adults with newly diagnosed advanced non-small cell lung cancer

OPDIVO® (nivolumab) is a prescription medicine used in combination with YERVOY® (ipilimumab) and 2 cycles of chemotherapy that contains platinum and another chemotherapy medicine, as a first treatment for adults with a type of advanced stage lung cancer (called non-small cell lung cancer) when your lung cancer has spread or grown, or comes back, and your tumor does not have an abnormal EGFR or ALK gene.

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

For adults with advanced non-small cell lung cancer

A Chance To Live Longer™
The first and only approved combination of 2 immunotherapies with chemotherapy

A diagnosis of advanced non-small cell lung cancer can come as a shock. But, there is some good news: the approval of a unique treatment that combines 2 immunotherapies, OPDIVO + YERVOY, with 2 rounds of platinum-based chemotherapy.

THE OPDIVO + YERVOY + CHEMOTHERAPY CLINICAL TRIAL


About the Clinical Trial

In the OPDIVO® (nivolumab) plus YERVOY® (ipilimumab) with chemotherapy advanced NSCLC clinical trial of 719 patients, 361 patients were given OPDIVO® (nivolumab) plus YERVOY® (ipilimumab) plus chemotherapy, while 358 patients were given chemotherapy

Clinical Trial Results

Primary analysis at 8.1 months

At 14.1 months, half the people were alive on OPDIVO + YERVOY and platinum-based chemotherapy.

At 10.7 months, half the people were alive on platinum-based chemotherapy.


Follow-up analysis at 12.7 months

At 15.6 months, half the people were alive on OPDIVO + YERVOY and platinum-based chemotherapy.

At 10.9 months, half the people were alive on platinum-based chemotherapy.

This analysis was not designed to show a difference between OPDIVO + YERVOY and platinum-based chemotherapy, and platinum-based chemotherapy alone.


Shown to partially or completely shrink tumors

38%
in patients on OPDIVO + YERVOY and platinum-based therapy

vs

25%
in patients on platinum-based chemotherapy

The length of time that half of the patients lived without their tumors worsening was 6.8 months on OPDIVO + YERVOY and platinum-based chemotherapy and 5 months on platinum-based chemotherapy.

This analysis was conducted at a minimum follow-up of 8.1 months.

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


SELECT IMPORTANT FACTS


What are the serious side effects of OPDIVO and 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 (diarrhea or colitis) that can lead to tears or holes (perforation) 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)
  • eye problems
  • heart problems
  • muscle and joint problems
  • severe infusion-related reactions
  • complications of stem cell transplant that uses donor stem cells (allogeneic)

Additional serious side effects observed with YERVOY include:

  • nerve problems that can lead to paralysis

What are the most common side effects?

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

  • feeling tired
  • pain in muscles, bones, and joints
  • nausea
  • diarrhea
  • rash
  • decreased appetite
  • constipation
  • itching

These are not all the possible side effects. For more information, ask your healthcare provider or pharmacist. 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 .

Important Facts About OPDIVO® (nivolumab) + 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 reactions. Additional serious side effects of YERVOY alone include: nerve problems that can lead to paralysis; and eye problems.

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

This is a summary of important information that you need to know about OPDIVO. Your healthcare team can work with you to help answer any questions you may have about OPDIVO. 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 and 2 cycles of chemotherapy that contains platinum and another chemotherapy medicine (OPDIVO + YERVOY + chemo) to treat a type of advanced stage lung cancer called non-small cell lung cancer (NSCLC). OPDIVO + YERVOY + chemo is approved as a first treatment for adults:

Who have lung cancer that has spread or grown (metastatic) or comes back (recurrent) AND

Whose tumors do not have an abnormal EGFR or ALK gene.

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 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 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?

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 and OPDIVO + YERVOY 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.


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. If you are a female who is able to become pregnant, your healthcare provider should do a pregnancy test before you start receiving OPDIVO. 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.

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 1-800-721-5072 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.

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 5 months after the last dose.


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 the medicines you take, 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 and chemotherapy 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

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

  • feeling tired
  • pain in muscles, bones, and joints
  • nausea
  • diarrhea
  • rash
  • decreased appetite
  • constipation
  • itching

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.

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.

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