For people 12 years of age and older whose MSI-H/dMMR CRC has spread to other parts of the body (metastatic) and who have tried treatment with a fluoropyrimidine, oxaliplatin, and irinotecan, and it did not work or is no
longer working
OPDIVO® (nivolumab) is a prescription medicine used in combination with YERVOY® (ipilimumab) to treat adults and children 12 years of age and older, with a type of colon or rectal cancer (colorectal cancer) that has spread to other parts of the body (metastatic), is microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR), and you have tried treatment with a fluoropyrimidine, oxaliplatin, and irinotecan, and it did not work or is no longer working. OPDIVO in combination with YERVOY was approved based on response rate and how long patients’ responses lasted. There is ongoing evaluation of clinical benefit of OPDIVO in combination with YERVOY for this use.
OPDIVO® (nivolumab) is a prescription medicine used to treat adults and children 12 years of age and older with a type of colon or rectal cancer (colorectal cancer) that has spread to other parts of the body (metastatic), is microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR), and you have tried treatment with a fluoropyrimidine, oxaliplatin, and irinotecan, 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
For people 12 years of age and older whose MSI-H/dMMR CRC has spread to other parts of the body (metastatic) and who have tried treatment with a fluoropyrimidine, oxaliplatin, and irinotecan, and it did not work or is no longer working
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to see clinical trial information
OPDIVO and OPDIVO + YERVOY will not work for everyone. Individual results may vary.
ADDITIONAL RESOURCES FOR PATIENTS AND CAREGIVERS
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DIGITAL PATIENT BROCHURE YET?
Download this education brochure to learn more about OPDIVO and OPDIVO + YERVOY for people 12 years of age and older whose CRC has spread to other parts of the body (metastatic); has progressed after treatment with a fluoropyrimidine, oxaliplatin, and irinotecan; and is MSI-H or dMMR.
Important Facts About OPDIVO® (nivolumab) and OPDIVO + YERVOY® (ipilimumab)
OPDIVO and YERVOY 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; eye problems; problems in other organs and tissues; severe infusion reactions; and complications of stem cell transplant, including graft-versus-host disease (GVHD), 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) 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.
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What is OPDIVO?
OPDIVO is a prescription medicine used to treat:
Adults and children 12 years of age and older who have colorectal cancer (a type of colon or rectal cancer), and who:
Have colorectal cancer that has spread to other parts of the body (metastatic); AND
Have a tumor that is microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR); AND
Have tried treatment with a fluoropyrimidine, oxaliplatin, and irinotecan, and it did not work or is no longer working.
OPDIVO can be used alone or in combination with YERVOY (OPDIVO + YERVOY). OPDIVO and OPDIVO + YERVOY were approved based on response rate and how long patients’ responses lasted. There is ongoing evaluation of clinical benefit of OPDIVO and OPDIVO + YERVOY for this use.
It is not known if OPDIVO is safe and effective in children younger than 12 years of age with MSI-H or dMMR metastatic colorectal cancer.
OPDIVO (10 mg/mL) and YERVOY (5 mg/mL) are injections for intravenous (IV) use.
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
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 or YERVOY?
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 or YERVOY.
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 U.S. Full Prescribing Information and Medication Guide for OPDIVO or U.S. Full Prescribing Information and Medication Guide for YERVOY, 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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INDICATIONS
OPDIVO® (nivolumab) is a prescription medicine used to treat adults and children 12 years of age and older with a type of colon or rectal cancer (colorectal cancer) that has spread to other parts of the body (metastatic), is microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR), and you have tried treatment with a fluoropyrimidine, oxaliplatin, and irinotecan, 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.
OPDIVO® (nivolumab) is a prescription medicine used in combination with YERVOY® (ipilimumab) to treat adults and children 12 years of age and older, with a type of colon or rectal cancer (colorectal cancer) that has spread to other parts of the body (metastatic), is microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR), and you have tried treatment with a fluoropyrimidine, oxaliplatin, and irinotecan, and it did not work or is no longer working. OPDIVO in combination with YERVOY was approved based on response rate and how long patients’ responses lasted. There is ongoing evaluation of clinical benefit of OPDIVO in combination with YERVOY for this use.
It is not known if OPDIVO is safe and effective in children younger than 12 years of age with MSI-H or dMMR metastatic colorectal cancer.
Please see U.S. Full Prescribing Information and Medication Guide for YERVOY.
Please see U.S. Full Prescribing Information and Medication Guide for OPDIVO.
Important Safety Information for OPDIVO® (nivolumab) YERVOY® (ipilimumab)
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. These problems can sometimes become severe or life-threatening and can lead to death. These problems 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. Some of these problems may happen more often when OPDIVO is used in combination with another therapy.
Call or see your healthcare provider right away if you develop any new or worse signs or symptoms, including:
Problems can also happen in other organs and tissues. These are not all of 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
Getting medical help right away may help 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. Your healthcare team may also need to delay or completely stop your treatment if you have severe side effects.
Possible side effects of OPDIVO + YERVOY
OPDIVO and OPDIVO + YERVOY can cause serious side effects, including:
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; and 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); decreased weight; and dizziness.
These are not all the possible side effects. For more information, ask your healthcare provider or pharmacist. You are encouraged to report side effects of prescription drugs to the FDA. Call
Before receiving OPDIVO or YERVOY, tell your healthcare provider about all of 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 or YERVOY.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Please see U.S. Full Prescribing Information and Medication Guide for YERVOY.
Please see U.S. Full Prescribing Information and Medication Guide for OPDIVO.