For people with previously treated advanced bladder cancer (urothelial carcinoma)
OPDIVO® (nivolumab) is a prescription medicine used to treat people with 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 (10 mg/mL) is an injection for intravenous (IV) use.
OPDIVO is a medicine that may treat certain cancers by working with
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.
A serious side effect is a side effect that can sometimes become severe or
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
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
- 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 in your ankles
- loss of appetite
Skin problems — Things to look out for may include:
- skin blistering or peeling
- painful sores or ulcers in the mouth or nose, throat, or genital area
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. 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
OPDIVO can cause serious side effects, including:
See the previous section, “What is the most important information I should know about OPDIVO?”
Severe infusion reactions — Things to look out for may include:
- chills or shaking
- itching or rash
- shortness of breath or wheezing
- feel like passing out
- back or neck pain
Tell your healthcare team right away if you get these symptoms during an infusion of OPDIVO.
Complications 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. Your healthcare provider will monitor you for these complications.
The most common side effects of OPDIVO when used alone include:
- feeling tired
- pain in muscles, bones,
- itchy skin
- shortness of breath
- decreased appetite
- back pain
- upper respiratory tract infection
- stomach-area (abdominal) pain
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
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 can harm your unborn baby.
- •are breastfeeding or plan to breastfeed. It is not known if OPDIVO passes into your breast milk. Do not breastfeed during treatment with OPDIVO and for 5 months after the last dose of OPDIVO.
Females who are able to become pregnant:
Your healthcare provider should do a pregnancy test before you start receiving OPDIVO.
- •You should use an effective method of birth control during your treatment and for at least 5 months after the last dose of OPDIVO. 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. You or your healthcare provider should contact Bristol Myers Squibb at
1-844-593-7869as 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
- herbal supplements