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
The OPDIVO Option: Scheduling Treatment Every 2 or 4 Weeks
These are general recommendations about treatment timing and dosing based on a clinical trial. Only your doctor
can make specific recommendations about your treatment with OPDIVO.
Here’s a quick look at the treatment schedule—including the flexible option of every 2 weeks or every 4 weeks.
The infusion takes
Your doctor will decide how many treatments are right for you. You may be on treatment until the cancer grows or you have unacceptable .
Frequent communication with your healthcare team is an important part of treatment. Use your appointment to let them know how you're feeling and ask any questions you may have. You may also be able to talk with others going through a similar situation.
Try to schedule your appointments for the same day of the week to make them easier to remember. It is important to keep all appointments with your healthcare team. If you miss one, call your healthcare team as soon as possible to reschedule your appointment.
A member of your healthcare team will do blood tests to check for side effects during your treatment with OPDIVO and may treat you with a corticosteroid or medicines. OPDIVO treatments may also need to be delayed or completely stopped if you have severe side effects. Be sure to talk to your healthcare team about side effects.
Before you receive OPDIVO, tell your healthcare team if you:
- •have immune system problems such as , ulcerative colitis, or lupus
- •have had an organ transplant
- •have lung or breathing problems
- •have liver problems
- •have any other medical conditions
- •are pregnant or plan to become pregnant. OPDIVO 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 team about birth control methods that you can use during this time
- -tell your healthcare team right away if you become pregnant during treatment with OPDIVO
- •are breastfeeding or plan to breastfeed. It is not known if OPDIVO passes into your breast milk. Do not breastfeed during treatment with OPDIVO
Tell your healthcare team about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
SELECT IMPORTANT FACTS ABOUT OPDIVO
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
- Call a healthcare
provider right away
- Helpful information
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.
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 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.
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
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.
Tell your healthcare team if you are pregnant or plan to become pregnant. OPDIVO 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
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.
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
- herbal supplements
The most common side effects of OPDIVO when used alone include:
- feeling tired
- pain in muscles, bones, and joints
- itchy skin
- shortness of breath
- decreased appetite
- back pain
- upper respiratory tract
- 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