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.

What is OPDIVO?

OPDIVO is a prescription medicine used to treat:

People who have a type of skin cancer called melanoma, and:

Whose melanoma has spread or cannot be removed by surgery (advanced melanoma).

OPDIVO can be used alone or in combination with YERVOY (OPDIVO + YERVOY).

People who have a type of advanced stage lung cancer called non-small cell lung cancer, and who:

Have lung cancer that has spread or grown; AND

Have tried chemotherapy that contains platinum, and it did not work or is no longer working; AND

If their tumor has an abnormal EGFR or ALK gene, they have also tried an FDA-approved therapy for tumors with these abnormal genes and it did not work or is no longer working.

People who have kidney cancer (renal cell carcinoma):

OPDIVO is approved for people whose kidney cancer (RCC) has spread or grown after treatment with other cancer medications.

OPDIVO + YERVOY is approved for certain people whose kidney cancer (RCC) has spread.

People who have head and neck cancer called squamous cell carcinoma of the head and neck (SCCHN), and who:

Have been treated with chemotherapy that contains platinum, but their head and neck cancer has returned or spread after treatment.

People who have a type of skin cancer called melanoma, and who:

Have had surgery to remove it and the lymph nodes that contain cancer, to help prevent melanoma from coming back.

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

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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 also 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
•  
•  
•  
•  

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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 of OPDIVO.

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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 your 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.

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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

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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
• vomiting
• 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
• diarrhea
• rash
• itching
• nausea
• pain in muscles, bones,
  and joints
• fever
• cough
• decreased appetite
• vomiting
• abdominal pain
• shortness of breath
•  
• upper respiratory tract infection
• headache
• low thyroid hormone levels (hypothyroidism)
• decreased weight
• dizziness
   

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 1-800-FDA-1088.

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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.

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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.