For people with previously treated squamous cell carcinoma of the head and neck
OPDIVO® (nivolumab) is a prescription medicine used to treat people with head and neck cancer (squamous cell carcinoma) that has come back or spread and you have tried chemotherapy that contains platinum and it did not work or is no longer working.
It is not known if OPDIVO is safe and effective in children younger than
18 years of age.
For adults with squamous cell carcinoma of the head and neck
(SCCHN) that has returned or spread after previous treatment
in a Clinical Trial:
This OPDIVO study included 361 people with previously treated squamous cell carcinoma of the head and neck.
240 were
given OPDIVO
121 were given standard
therapy options*
At 1 Year
30% reduced risk of dying for patients receiving
OPDIVO versus patients receiving standard
therapy options.
At 7.5 months, half of the patients taking
OPDIVO were still alive
Compared with
5.1 months for patients taking standard
therapy options
OPDIVO will not work for everyone. Individual results may vary.
*Standard therapy options include cetuximab, methotrexate, or docetaxel.
See additional clinical trialinformation
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SELECT IMPORTANT FACTS ABOUT OPDIVO
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. 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; and abdominal pain.
Important Facts About OPDIVO® (nivolumab)
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
Look out for the following
icons as you read:
- Talk to your
healthcare team - Call a healthcare
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What is OPDIVO?
OPDIVO is a prescription medicine used to treat 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.
It is not known if OPDIVO is safe and effective in children younger than 18 years of age.
OPDIVO is a medicine that may treat certain cancers by working with your immune system. It can cause your immune system
to attack normal organs and tissues in any area of your body and can affect the way these organs work.
OPDIVO (10 mg/mL) is an injection for intravenous (IV) use.
What are the serious side effects of OPDIVO?
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.
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.
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
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.
What should I discuss with my healthcare team about pregnancy and nursing before starting OPDIVO?
Tell your healthcare team if you are pregnant or plan to become pregnant. OPDIVO 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
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 during treatment.
Tell your healthcare team if you are breastfeeding or plan to breastfeed. It is not known if OPDIVO 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 OPDIVO?
Talk to your healthcare team about all of your health problems or concerns, including if you:
- have immune system
problems such as Crohn’s disease, ulcerative colitis, or lupus - 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 of OPDIVO?
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
These are not all of the possible side effects of OPDIVO. 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
For more information, please see U.S. Full Prescribing Information and Medication Guide for OPDIVO, or talk to your
1506US1804265-05-01 06/20
Information provided on this website is not a substitute for talking with your healthcare professional.
Your healthcare professional is the best source of information about your disease.
All individuals depicted are models used for illustrative purposes only, unless otherwise noted.
