For people with previously treated advanced bladder cancer (urothelial carcinoma)
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 younger than 18 years of age.
For adults with previously treated
bladder cancer (urothelial carcinoma)
in a Clinical Trial:
This trial enrolled 270 adults with previously treated advanced bladder cancer, all of whom received OPDIVO.
At 6 months
2.6% (7 of 270)
saw their tumors disappear completely (complete response)
17% (46 of 270)
saw their tumors shrink (partial response)
*Of the 270 adults in the trial, 53 had a response.
Of those who responded, half of them saw a
response in about 2 months
The shortest response lasted
The longest response lasted
OPDIVO will not work for everyone. Individual results may vary.
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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
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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 younger than
18 years of age.
OPDIVO is a medicine that may treat certain cancers by working with
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
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.
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