This is a summary of important information that you need to know about 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
- Call a healthcare
provider right away
- Helpful information
What is OPDIVO + YERVOY?
OPDIVO is a prescription medicine used in combination with YERVOY (OPDIVO + YERVOY) to treat liver cancer (hepatocellular carcinoma). OPDIVO + YERVOY is for adults who:
Have previously received treatment with sorafenib
OPDIVO + YERVOY was approved based on response rate and how long patients’ responses lasted. There is
ongoing evaluation of clinical benefit of OPDIVO + YERVOY for this use.
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 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 with OPDIVO 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)
- dark urine (tea colored)
- bleeding or bruising more easily
- 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
- 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:
- skin blistering
- ulcers in the mouth or other
Inflammation of the brain (encephalitis) — Things to look out for may include:
- tiredness or weakness
- memory problems
- seeing or hearing things that are not really there (hallucinations)
- 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 + YERVOY can cause serious side effects, including:
Severe infusion reactions — Things to look out for may include:
- chills or shaking
- itching or rash
- difficulty breathing
- 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. 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
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
- 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
- pain in muscles, bones,
- decreased appetite
- abdominal pain
- shortness of breath
- upper respiratory tract infection
- low thyroid hormone levels (hypothyroidism)
- decreased weight
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-10881-800-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.