Frequently Asked Questions About the
OPDIVO® + YERVOY® Regimen

Here are some frequently asked questions and answers that patients like you have had
about treatment with OPDIVO + YERVOY. Remember that this information is not a
substitute for talking with your healthcare professional. Your healthcare professional is the
best source of information about your condition.

HOW IS THE OPDIVO + YERVOY REGIMEN DIFFERENT FROM OTHER TREATMENTS?

The OPDIVO + YERVOY Regimen is not traditional chemotherapy. It is a powerful combination therapy that works with your immune system to fight cancer. The OPDIVO + YERVOY combination brings together 2 metastatic treatments that work together in complementary ways. It unites the breakthrough advancement of OPDIVO, a PD-1 (programmed death receptor-1) immunotherapy, with the established history of YERVOY. Chemotherapy, on the other hand, uses different drugs to kill or slow the growth of fast-growing cells, including cancer cells.

While doing so, OPDIVO and YERVOY could also affect non-tumor cells. Because of the way the OPDIVO + YERVOY Regimen works, it may cause your immune system to attack normal organs and tissues in 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 ends.


WHY SHOULD MY DOCTOR AND I CONSIDER THE OPDIVO + YERVOY REGIMEN?

Deciding on how you will fight metastatic melanoma is one of the most important decisions you and your oncologist will make. OPDIVO + YERVOY received approval from the FDA because of the percentage of patients with metastatic melanoma whose tumors shrank or disappeared during the clinical trial compared to those who received YERVOY alone. For more information, see Clinical Trial Results.

The OPDIVO + YERVOY combination reduced the risk of cancer spreading, growing, or getting worse by nearly 60% compared with YERVOY alone. Half of the patients on OPDIVO + YERVOY were alive at 11.5 months without their cancer spreading, growing or getting worse, compared to 2.9 months for patients on YERVOY alone. The OPDIVO + YERVOY Regimen will not work for every patient. Individual results may vary. So talk to your oncologist to see if the combination is right for you.


HOW MANY PEOPLE PARTICIPATED IN THIS CLINICAL TRIAL?

The clinical trial included 945 adult patients with unresectable or metastatic melanoma who were previously untreated. Patients were treated with either the combination of OPDIVO + YERVOY, OPDIVO alone, or YERVOY alone.


CAN I BE PRESCRIBED THE OPDIVO + YERVOY REGIMEN REGARDLESS OF BRAF  STATUS?

Yes. The OPDIVO + YERVOY Regimen was studied in both BRAF negative (normal BRAF gene) and BRAF positive (abnormal BRAF gene) patients, and results were seen in both patient types.


WHERE CAN I GO TO GET MY OPDIVO + YERVOY TREATMENTS?

You and your doctor should discuss the best place to get your infusions, whether it’s your doctor’s office, an infusion center, or a local hospital.


HOW DO I KNOW IF I’M RESPONDING TO THE OPDIVO + YERVOY REGIMEN?

While undergoing treatment with the OPDIVO + YERVOY Regimen, your doctor will likely order periodic scans to evaluate whether there are any changes in the size of your tumors.


WHAT SHOULD I KNOW ABOUT POTENTIAL SIDE EFFECTS?

Some of the side effects of the OPDIVO + YERVOY Regimen may be life-threatening and may need your doctor’s immediate attention. Be sure to tell your doctor about all side effects as soon as possible, including any changes in how you are feeling, so he or she can help address them right away. OPDIVO can cause severe infusion reactions. Tell your doctor or nurse right away if you get these symptoms during an infusion of OPDIVO: chills or shaking; itching or rash; flushing; difficulty breathing; dizziness; fever; feeling like passing out.

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; diarrhea; fever; shortness of breath; itching; decreased appetite; rash; nausea; vomiting; pain in muscles, bones, and joints; and cough. The most common side effects of YERVOY include: tiredness; diarrhea; itching; rash; nausea; vomiting; headache; weight loss; fever; decreased appetite; and difficulty falling or staying asleep.

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 of YERVOY alone include:

  • nerve problems that can lead to paralysis
  • eye problems

Getting medical treatment right away may keep these problems from becoming
more serious.


WHAT SHOULD I TELL MY
HEALTHCARE PROVIDER?

Before you receive the OPDIVO + YERVOY Regimen, tell your healthcare
provider if you:

  • Have immune system problems such as Crohn’s disease, ulcerative colitis, lupus, or sarcoidosis
  • Have had an organ transplant
  • Have lung or breathing problems
  • Have any other medical conditions
  • 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 provider about birth control methods that you can use during this time.
    • - Tell your healthcare provider right away if you become pregnant or think you are pregnant during treatment. You or your healthcare provider should contact Bristol-Myers Squibb at 1-800-721-5072 as soon as you become aware of the pregnancy.
    • - Pregnancy Safety Surveillance Study: Females who become pregnant during treatment with YERVOY are encouraged to enroll in a Pregnancy Safety Surveillance Study. The purpose of this study is to collect information about the health of you and your baby. You or your healthcare provider can enroll in the Pregnancy Safety Surveillance Study by calling 1-844-593-7869.
  • 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

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.


WHO CAN I TALK TO IF I NEED HELP OR HAVE QUESTIONS ABOUT OPDIVO + YERVOY?

Talk with your healthcare professional first if you have questions about this treatment option. You can also call a Care Navigator at 1-855-673-4861, 8 AM to 8 PM ET, Monday-Friday for general questions about the OPDIVO + YERVOY Regimen not specific to your health.


It can be helpful to review a list of questions you may want to ask
your doctor. Download Questions to Ask Your Doctor to help
answer your questions about whether OPDIVO + YERVOY may be
right for you.

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.

Sign Up Now

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

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 Safety Information
for OPDIVO® (nivolumab) and
the OPDIVO+YERVOY® (ipilimumab) Regimen

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.

Serious side effects may include:

  • Lung problems (pneumonitis). Symptoms of pneumonitis may include: new or worsening cough; chest pain; and shortness of breath.
  • Intestinal problems (colitis) that can lead to tears or holes in your intestine. Signs and symptoms of colitis may include: diarrhea (loose stools) or more bowel movements than usual; blood in your stools or dark, tarry, sticky stools; and severe stomach area (abdomen) pain or tenderness.
  • Liver problems (hepatitis). Signs and symptoms of hepatitis 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; and decreased energy.
  • Hormone gland problems (especially the thyroid, pituitary, adrenal glands, and pancreas). Signs and symptoms that your hormone glands are not working properly 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; and excessive thirst or lots of urine.
  • Kidney problems, including nephritis and kidney failure. Signs of kidney problems may include: decrease in the amount of urine; blood in your urine; swelling in your ankles; and loss of appetite.
  • Skin Problems. Signs of these problems may include: rash; itching; skin blistering; and ulcers in the mouth or other mucous membranes.
  • Inflammation of the brain (encephalitis). Signs and symptoms of encephalitis may include: headache; fever; tiredness or weakness; confusion; memory problems; sleepiness; seeing or hearing things that are not really there (hallucinations); seizures; and stiff neck.
  • Problems in other organs. Signs of these problems may include: changes in eyesight; severe or persistent muscle or joint pains; severe muscle weakness; and chest pain.

Additional serious side effects observed during a separate study of YERVOY alone include:

  • Nerve problems that can lead to paralysis. Symptoms of nerve problems may include: unusual weakness of legs, arms, or face; and numbness or tingling in hands or feet.
  • Eye problems. Symptoms may include: blurry vision, double vision, or other vision problems; and eye pain or redness.

Getting medical treatment right away may keep these problems from becoming more serious.

Your healthcare provider will check you for these problems during treatment. Your healthcare provider 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.

OPDIVO can cause serious side effects, including:

  • Severe infusion reactions. Tell your doctor or nurse right away if you get these symptoms during an infusion of OPDIVO: chills or shaking; itching or rash; flushing; difficulty breathing; dizziness; fever; and feeling like passing out.

Pregnancy and Nursing:

  • Pregnancy Safety Surveillance Study: Females who become pregnant during treatment with YERVOY are encouraged to enroll in a Pregnancy Safety Surveillance Study. The purpose of this study is to collect information about the health of you and your baby. You or your healthcare provider can enroll in the Pregnancy Safety Surveillance Study by calling 1-844-593-7869.
  • Before receiving treatment, tell your healthcare provider 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.

Tell your healthcare provider about:

  • Your health problems or concerns 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; or have any other medical conditions.
  • All the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

The most common side effects of OPDIVO when used alone include: feeling tired; pain in muscles, bones, and joints; diarrhea; weakness; shortness of breath; decreased appetite; upper respiratory tract infection; headache; rash; itchy skin; nausea; cough; constipation; back pain; fever; and stomach pain.

The most common side effects of OPDIVO, when used in combination with YERVOY, include: feeling tired; diarrhea; fever; shortness of breath; itching; decreased appetite; rash; nausea; vomiting; pain in muscles, bones, and joints; and cough. The most common side effects of YERVOY include: tiredness; diarrhea; itching; rash; nausea; vomiting; headache; weight loss; fever; decreased appetite; and difficulty falling or staying asleep.

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 . You may also report side effects to Bristol-Myers Squibb at .


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.