For Adults With Previously Treated
Advanced Bladder Cancer
(urothelial carcinoma)
Frequently Asked Questions

Frequently Asked Questions About OPDIVO®

Here are some frequently asked questions and answers that patients like you have had about treatment with OPDIVO. 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.


What Is OPDIVO?

OPDIVO® (nivolumab) is a prescription medicine used to treat bladder cancer (urothelial carcinoma) that has spread or grown and you have tried chemotherapy that contains platinum, and it did not work or is no longer working.

OPDIVO was approved based on response rate and how long patients' responses lasted. There is ongoing evaluation of clinical benefit of OPDIVO for this use.

It is not known if OPDIVO is safe and effective in children less than 18 years of age.


HOW IS OPDIVO DIFFERENT FROM CHEMOTHERAPY?

OPDIVO is an immunotherapy treatment. It’s a type of medicine that works with your immune system


WHAT IS THE DIFFERENCE BETWEEN UROTHELIAL CANCER AND BLADDER CANCER?

Urothelial carcinoma is a type of bladder cancer and accounts for 90% of cases. Urothelial cancers include cancers of certain parts of the urinary tract including the bladder, ureters, and renal pelvis. Bladder cancer is the fifth most common cancer in the United States.


DO I NEED TO TAKE A TREATMENT IN ADDITION TO OPDIVO FOR IT TO WORK?

OPDIVO is a monotherapy, that is, a medication that is taken alone rather than in combination with other treatments, such as radiation or chemotherapy.


HOW WILL I RECEIVE OPDIVO?

Your healthcare provider will give you OPDIVO into your vein through an intravenous (IV) line over 30 minutes. OPDIVO is usually given every 2 weeks or 4 weeks depending on the dose you are receiving. Your healthcare provider will decide how many treatments you need. Your healthcare provider will do blood tests to check you for side effects during treatment with OPDIVO and may treat you with a corticosteroid or hormone replacement medicines. OPDIVO treatments may also need to be delayed or completely stopped if you have severe side effects. If you miss any appointments, call your healthcare provider as soon as possible to reschedule your appointment.


Where can I go to get my OPDIVO 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 OPDIVO?

While undergoing treatment with OPDIVO, 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?

Although they may not be experienced by every patients, OPDIVO can cause serious side effects. 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.

What are the most common side effects of OPDIVO?

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 appetitie
  • upper respiratory tract infection
  • headache
  • rash
  • itchy skin
  • nausea
  • cough
  • constipation
  • back pain
  • fever
  • stomach pain

What are the serious side effects of OPDIVO?

A side effect is described as “serious” if it can sometimes become life-threatening and can lead to death. They may happen anytime during treatment or even after your treatment has ended.

  • lung problems (pneumonitis)
  • intestinal problems (colitis)
  • liver problems (hepatitis)
  • hormone gland problems (especially the thyroid, pituitary, adrenal glands, and pancreas)
  • kidney problems, including nephritis and kidney failure
  • inflammation of the brain (encephalitis)
  • skin problems
  • severe infusion reactions

Who can I talk to if I need help or have questions about OPDIVO?

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 OPDIVO not specific to your health.


Questions to Ask Your Doctor Brochure

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 may be right for you.

See Clinical Trial Results

See how OPDIVO performed in a clinical trial in patients.

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OPDIVO®  with You Program

Complimentary support, tools, and educational resources
for anyone considering or currently taking OPDIVO. Call
1-855-OPDIVO-1 or click to learn more.

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Talking With Your Doctor Is Key

Review a list of questions with your oncologist about whether OPDIVO is right for you.

Talk to Your Doctor

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; weakness; shortness of breath; decreased appetite; upper respiratory tract infection; headache; rash; itchy skin; nausea; cough; constipation; back pain; fever; and stomach 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 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 people who have bladder cancer (urothelial carcinoma), and who:

Have bladder cancer that has spread or grown; AND

Have tried chemotherapy that contains platinum, and it did not work or is no longer working.

OPDIVO was approved based on response rate and how long patients' responses lasted. There is ongoing evaluation of clinical benefit of OPDIVO for this use.

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 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.


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 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
  • 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
  • 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. 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 provider 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 conditions

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


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