FOR ADULTS WITH SQUAMOUS CELL
CARCINOMA OF THE HEAD AND NECK
(SCCHN)
THAT HAS RETURNED
OR SPREAD AFTER PREVIOUS TREATMENT

OPDIVO® MORE THAN
DOUBLED THE
ONE-YEAR SURVIVAL
RATE
COMPARED
WITH STANDARD
THERAPY OPTIONS*

In a Clinical Trial

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:

  • 36% of the people given OPDIVO were still alive
  • 17% of the people given standard therapy options were still alive

30% reduced risk of dying for patients receiving OPDIVO versus patients receiving standard therapy options. Half of the patients on OPDIVO were still alive at
7.5 months compared to 5.1 months with standard therapy options.

*Standard therapy options include cetuximab, methotrexate, or docetaxel.

Would You Like to Share
Your Story?

If you or a loved one is interested in sharing your experience on treatment, call 1-855-275-8222.

Patient Story

Terry is a real OPDIVO
patient diagnosed with a type
of head and neck cancer.

Hear His Story  

Frequently Asked Questions

Whether you are considering OPDIVO or are already on treatment, here are some frequently asked questions.

Get Answers

Helpful Information

Get useful tips, tools, and educational materials that can help you learn more about OPDIVO and may help support your care.

Support and Advocacy Groups

We can direct you to organizations that may be helpful for the challenges you may face.

A Care Counselor as Close as Your Phone

If you are prescribed OPDIVO and sign up for this additional resource, you’ll be able to speak with a registered nurse. This personal Care Counselor can answer questions about treatment and help you to be a more informed partner with your doctor. Care Counselors cannot provide medical advice. Your healthcare professional is the best source of information about your health.


If you’d like to sign up for the OPDIVO with You program or if you have general questions about OPDIVO, call 1-855-OPDIVO-1 (1-855-673-4861) 8 AM to 8 PM ET, Monday to Friday, or click the button to sign up.

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; pain in muscles, bones, and joints; diarrhea; cough; constipation; back pain; fever; rash; itchy skin; nausea; shortness of breath; decreased appetite; upper respiratory tract infection; and weakness.

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 your treatment.

Look out for the following icons as you read:

  • Talk to your
    healthcare team
  • Call a healthcare
    provider right away
  • Helpful information
    to remember

What is OPDIVO?

OPDIVO is a prescription medicine used to treat a type of head and neck cancer called squamous cell carcinoma of the head and neck (SCCHN). OPDIVO is for adult patients 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 less than 18 years of age.

OPDIVO is a medicine that may treat your head and neck cancer by working with your immune system. It can cause your immune system to attack normal organs and tissues in many areas of your body, and can affect the way these organs work.


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 can 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 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

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
  • 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

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. 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.

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.


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 conditons

Talk to your healthcare team about all of the medicines you are taking, 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 include:

  • feeling tired
  • pain in muscles, bones, and joints
  • diarrhea
  • cough
  • constipation
  • back pain
  • fever
  • rash
  • itchy skin
  • nausea
  • shortness of breath
  • decreased appetite
  • upper respiratory tract infection
  • weakness

These are not all of the possible side effects of OPDIVO. Talk to your healthcare team for more information.
You can report any side effects you experience to the FDA by calling
1-800-FDA-1088.


How will I receive OPDIVO?

OPDIVO is given as an intravenous (IV) infusion by your healthcare team.

An IV infusion is when medicine is given directly into the bloodstream through a needle placed in a vein by a healthcare professional - usually in the arm or hand.

60 minutes intravenous (IV) infusion time, though actual time in the clinic may vary.

OPDIVO is usually given every 2 weeks. Your doctor will decide how many treatment cycles you will receive, and do blood tests to check you for side effects.

Call your doctor right away to reschedule your appointment if you miss any of your appointments.


For more information, please see U.S. Full Prescribing Information and Medication Guide for OPDIVO, or talk to your healthcare team.