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Potential OPDIVO® (nivolumab) user embracing her husband, outside their house.
Potential OPDIVO® (nivolumab) user embracing her husband, outside their house.

Clinical trial results for
bladder or urinary tract
cancer after surgery

To help prevent a type of bladder or urinary
tract cancer (urothelial carcinoma) from
coming back after it was removed by surgery

Actor portrayals.

An FDA-approved immunotherapy that helped reduce the risk of cancer coming back after surgery compared to placebo

Having surgery was an important step for you to take in treating your cancer, but to make sure your cancer doesn't return, your doctor may recommend adjuvant therapy. This is a type of treatment used after surgery to help prevent cancer from coming back by making sure no hidden or hard-to-see cells are left after surgery.

About the clinical trial

In a clinical trial of 709 people who had surgery to remove cancer in the lining of the bladder or urinary tract, 353 people were given OPDIVO and 356 people were given a placebo.

People given OPDIVO lived longer without their cancer coming back after
surgery compared to placebo

At 21 months, half the people given OPDIVO® did not have their cancer return.
OPDIVO

Half the people did not have their cancer return

At 11 months, half the people given a placebo did not have their cancer return.
Placebo

Half the people did not have their cancer return

People given OPDIVO had a 30% lower risk of their cancer returning after surgery than those given placebo.

Overall survival benefit data is not available at this time.

OPDIVO will not work for everyone. Individual results may vary.

Hands exploring how OPDIVO® (nivolumab) works and learning how this treatment may help fight cancer.

How treatment works

See how this treatment may help your body fight cancer

Learn more →

OPDIVO® (nivolumab) side effects.

Side effects

View side effects of treatment and learn how to manage them

See side effects →

Nurse monitoring a gentleman's infusion of OPDIVO® (nivolumab) immunotherapy treatment.

Getting an infusion

See your recommended treatment plan and what to expect from an infusion

Learn more →

For adults with a type of bladder or urinary tract cancer (urothelial carcinoma) to help prevent it from coming back after it was removed by surgery

OPDIVO® (nivolumab) is a prescription medicine used to treat adults with cancer of the lining of the urinary tract (including the bladder, ureters, or renal pelvis) [urothelial carcinoma] to help prevent cancer of the urinary tract from coming back after it was removed by surgery.

It is not known if OPDIVO is safe and effective in children younger than 12 years of age with melanoma or MSI-H or dMMR metastatic colorectal cancer.

It is not known if OPDIVO is safe and effective in children for the treatment of any other cancers.

Opdivo DTC ISI Contents

Important Facts About OPDIVO® (nivolumab) and OPDIVO + YERVOY® (ipilimumab)

This is a summary of important information that you need to know about OPDIVO and 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
healthcare team

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provider right away

Helpful information
to remember

What is the most important information I should know about OPDIVO + YERVOY?

OPDIVO and YERVOY are medicines that may treat certain cancers by working with your immune system. OPDIVO and YERVOY 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 another therapy.

Get medical help immediately if you develop any of these signs or symptoms or they get worse. It may keep these problems from becoming more serious. Your healthcare team will check you for these problems during treatment and may treat you with corticosteroid or hormone replacement medicines. If you have severe side effects, your healthcare team may also need to delay or completely stop your treatment.

What are the serious side effects of OPDIVO and OPDIVO + YERVOY?

A serious side effect is a side effect that can sometimes become severe or life-threatening and can lead to death. They may happen anytime during treatment or even after your treatment has ended. You may have more than one of these problems at the same time.

Call or see your healthcare provider right away if you develop any new or worse signs or symptoms, including:

Lung problems — Things to look out for may include:

  • new or worsening cough
  • shortness of breath
  • chest pain

Intestinal problems — Things to look out for may include:

  • diarrhea (loose stools) or more frequent bowel movements than usual
  • stools that are black, tarry, sticky, or have blood or mucus
  • severe stomach-area (abdominal) pain or tenderness

Liver problems — 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 than normal

Hormone gland problems — Things to look out for may include:

  • headaches that will not go away or unusual headaches
  • eye sensitivity to light
  • eye problems
  • rapid heartbeat
  • increased sweating
  • extreme tiredness
  • weight gain or weight loss
  • feeling more hungry or thirsty than usual
  • urinating more often than usual
  • hair loss
  • feeling cold
  • constipation
  • your voice gets deeper
  • dizziness or fainting
  • changes in mood or behavior, such as decreased sex drive, irritability, or forgetfulness

Kidney problems — Things to look out for may include:

  • decrease in your amount of urine
  • blood in your urine
  • swelling of your ankles
  • loss of appetite

Skin problems — Things to look out for may include:

  • rash
  • itching
  • skin blistering or peeling
  • painful sores or ulcers in the mouth or nose, throat, or genital area

Eye problems — Things to look out for may include:

  • blurry vision, double vision, or other vision problems
  • eye pain or redness

Problems can also happen in other organs and tissues. These are not all the signs and symptoms of immune system problems that can happen with OPDIVO and YERVOY. Call or see your healthcare provider right away for any new or worsening signs or symptoms, which may include:

  • Chest pain, irregular heartbeat, shortness of breath, swelling of ankles
  • Confusion, sleepiness, memory problems, changes in mood or behavior, stiff neck, balance problems, tingling or numbness of the arms or legs
  • Double vision, blurry vision, sensitivity to light, eye pain, changes in eyesight
  • Persistent or severe muscle pain or weakness, muscle cramps
  • Low red blood cells, bruising

What are the possible side effects of OPDIVO + YERVOY?

OPDIVO and OPDIVO + YERVOY can cause serious side effects, including:

See the previous section, “What is the most important information I should know about OPDIVO + YERVOY?”

Severe infusion reactions — Things to look out for may include:

  • chills or shaking
  • itching or rash
  • flushing
  • shortness of breath or wheezing
  • dizziness
  • feel like passing out
  • fever
  • back or neck pain

Tell your healthcare team right away if you get these symptoms during an infusion of OPDIVO or YERVOY.

Complications, including graft-versus-host disease (GVHD), of bone marrow (stem cell) transplant that uses donor stem cells (allogeneic). These complications can be severe and can lead to death. These complications may happen if you underwent transplantation either before or after being treated with OPDIVO or YERVOY. Your healthcare provider will monitor you for these complications.

What are the most common side effects?

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
  • stomach-area (abdominal) pain
  • urinary tract infection

The most common side effects of OPDIVO when used in combination with YERVOY include:

  • feeling tired
  • diarrhea
  • rash
  • itching
  • nausea
  • pain in muscles, bones, and joints
  • fever
  • cough
  • decreased appetite
  • vomiting
  • stomach-area (abdominal) pain
  • shortness of breath
  • upper respiratory tract infection
  • headache
  • low thyroid hormone levels (hypothyroidism)
  • constipation
  • decreased weight
  • dizziness

The most common side effects of OPDIVO when used in combination with YERVOY and chemotherapy include:

  • feeling tired
  • pain in muscles, bones, and joints
  • nausea
  • diarrhea
  • rash
  • decreased appetite
  • constipation
  • itching

The most common side effects of OPDIVO when used in combination with chemotherapy include:

  • nausea
  • constipation
  • feeling tired
  • decreased appetite
  • rash

The most common side effects of OPDIVO when used in combination with cabozantinib include:

  • diarrhea
  • feeling tired or weak
  • liver problems
  • rash, redness, pain, swelling, or blisters on the palms of your hands or soles of your feet
  • mouth sores
  • rash
  • high blood pressure
  • low thyroid hormone levels
  • pain in muscles, bones, and joints
  • decreased appetite
  • nausea
  • change in the sense of taste
  • stomach-area (abdominal) pain
  • cough
  • upper respiratory tract infection

The most common side effects of OPDIVO when used in combination with fluoropyrimidine and platinum-containing chemotherapy include:

  • nausea
  • numbness, pain, tingling, or burning in your hands or feet
  • decreased appetite
  • feeling tired
  • constipation
  • mouth sores
  • diarrhea
  • vomiting
  • stomach-area (abdominal) pain
  • pain in muscles, bones, and joints

These are not all the possible side effects. Talk to your healthcare team or pharmacist for more information. You are encouraged to report side effects of prescription drugs to the FDA. Call 1-800-FDA-1088.

What should I discuss with my healthcare team before receiving OPDIVO or YERVOY?

Tell your healthcare provider about all your medical conditions, including if you:

  • have immune system problems such as Crohn’s disease, ulcerative colitis, or lupus
  • have received an organ transplant
  • have received or plan to receive a stem cell transplant that uses donor stem cells (allogeneic)
  • have received radiation treatment to your chest area in the past and have received other medicines that are like OPDIVO
  • have a condition that affects your nervous system, such as myasthenia gravis or Guillain-Barré syndrome
  • are pregnant or plan to become pregnant. OPDIVO and YERVOY can harm your unborn baby.
  • are breastfeeding or plan to breastfeed. It is not known if OPDIVO or YERVOY passes into your breast milk. Do not breastfeed during treatment and for 5 months after your last dose of OPDIVO or YERVOY.

Females who are able to become pregnant:

Your healthcare provider should do a pregnancy test before you start receiving OPDIVO or YERVOY.

  • You should use an effective method of birth control during your treatment and for 5 months after the last dose of OPDIVO or YERVOY. Talk to your healthcare provider about birth control methods that you can use during this time.
  • Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with OPDIVO or YERVOY. You or your healthcare provider should contact Bristol Myers Squibb at 1-844-593-7869 as soon as you become aware of a pregnancy.

Tell your healthcare provider about all the medicines you take, including:

  • prescription medicines
  • over-the-counter medicines
  • vitamins
  • herbal supplements

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.

1506-US-2400108  03/24

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Bladder Submission Group

1506-US-2400131   04/24