For adults with previously treated advanced bladder cancer (urothelial carcinoma)
OPDIVO® (nivolumab) is a prescription medicine used to treat adults with cancer of the lining of the urinary tract (including the bladder, urethra, ureters, or renal pelvis) [urothelial carcinoma] when it has spread or grown (locally advanced or metastatic) and you have tried chemotherapy that contains platinum, and it did not work or is no longer working or your cancer worsened within 12 months of treatment with chemotherapy that contains platinum, either before or after surgery to remove your cancer.
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.
For adults with previously treated
advanced
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
1.6 months
The longest response lasted
7.2 months
information
OPDIVO will not work for everyone. Individual results may vary.
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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; intestinal problems; liver problems; hormone gland problems; kidney problems; skin problems; problems in other organs and tissues; severe infusion reactions; and complications of stem cell transplant that uses donor stem cells (allogeneic). Call or see your healthcare provider right away for any new or worsening signs or symptoms.
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
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 adults who have cancer of the lining of the urinary tract (including the bladder, urethra, ureters, or renal pelvis) (urothelial carcinoma) and who have:
Urinary tract cancer that has spread or grown (locally advanced or metastatic) AND
Tried chemotherapy that contains platinum, and it did not work or is no longer working OR
Cancer that worsened within 12 months of treatment with chemotherapy that contains platinum, either before or after surgery to remove the cancer.
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 (10 mg/mL) is an injection for intravenous (IV) use.
What is the most important information I should know about OPDIVO?
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.
What are the serious side effects of OPDIVO?
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
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
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
What are the possible side effects of OPDIVO?
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
- 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.
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.
What are the most common side effects of OPDIVO?
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
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
What should I discuss with my healthcare team before receiving OPDIVO?
Tell your healthcare provider about all your medical conditions, including if you:
Females who are able to become pregnant:
Your healthcare provider should do a pregnancy test before you start receiving OPDIVO.
Tell your healthcare provider about all the medicines you take, including:
- prescription medicines
- over-the-counter medicines
- vitamins
- herbal supplements
For more information, please see accompanying U.S. Full Prescribing Information and Medication Guide for OPDIVO, or talk to your healthcare team.
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.
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