For people whose liver cancer (hepatocellular carcinoma) has spread or grown after treatment with sorafenib
OPDIVO® (nivolumab) is a prescription medicine used to treat people with liver cancer (hepatocellular carcinoma) if you have previously received treatment with sorafenib. 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 people with liver cancer (hepatocellular carcinoma) if you have previously received treatment with sorafenib. 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 18 years of age.
patients younger than 18 years of age.
For people with liver cancer (hepatocellular carcinoma) previously treated with sorafenib
Discover a Different Choice With OPDIVO
and
OPDIVO + YERVOY® (ipilimumab)
How People Responded To OPDIVO
in a Clinical Trial
About the Clinical Trial
This OPDIVO study included 154 people
with HCC whose cancer spread or grew after
treatment with sorafenib or who could not tolerate sorafenib therapy.
The study was designed to look at overall overall response rate (ORR) and duration of responseresponse. This study is ongoing.
ORR is the percentage of people who responded to treatment. These people saw their tumors either shrink
(complete response).
DoR is the measure of how long the response lasts.
Clinical Trial Results
12% (19 of 154)
saw their tumors shrink (partial response)
2% (3 of 154)
saw their tumors disappear completely (complete response)
*The disappearance of any measureable tumors in response to treatment. This does not necessarily mean the cancer has been cured.
HCC=hepatocellular carcinoma.
How Long Did People Respond To OPDIVO in the Clinical Trial?
When the data were collected, more than half of the people who responded to OPDIVO were still responding
Of the 22 people who responded, the shortest response lasted
3.2 months
The longest response lasted at least
51.1 months
91% of people
had a response for 6 months or longer
59% of people
had a response for 12 months or longer
32% of people
had a response for 24 months or longer
For OPDIVO + YERVOY clinical trial results, click here.
OPDIVO will not work for everyone. Individual results may vary.
SELECT IMPORTANT FACTS
What are the serious side effects of OPDIVO?
OPDIVO can cause problems that can sometimes become serious or
- lung problems (pneumonitis)
- intestinal problems (colitis) that can lead to tears or holes in your intestine
- liver problems (hepatitis)
- hormone gland problems (especially the thyroid, pituitary, adrenal glands, and pancreas)
- kidney problems, including nephritis and kidney failure
- skin problems
- inflammation of the brain (encephalitis)
- problems in other organs
- severe infusion reactions
What are the most common side effects of OPDIVO?
The most common side effects of OPDIVO when used alone include:
- feeling tired
- rash
- diarrhea
- nausea
- fever
- pain in muscles, bones, and joints
- upper respiratory tract infection
- headache
- decreased weight
- itching
- abdominal pain
- vomiting
- cough
- decreased appetite
- shortness of breath
- hypothyroidism
These are not all of the possible side effects. 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
Important Facts About OPDIVO® (nivolumab) and OPDIVO + YERVOY® (ipilimumab)
OPDIVO can cause problems that can sometimes become serious or life threatening and can lead to death. Serious side effects may include lung problems (pneumonitis); intestinal problems (colitis) that can lead to tears or holes in your intestine; liver problems (hepatitis); hormone gland problems (especially the thyroid, pituitary, adrenal glands, and pancreas); kidney problems, including nephritis and kidney failure; skin problems; inflammation of the brain (encephalitis); problems in other organs; and severe infusion reactions. Additional serious side effects of YERVOY alone include: nerve problems that can lead to paralysis; and eye problems.
Important Facts About OPDIVO® (nivolumab) and OPDIVO + YERVOY® (ipilimumab)
This is a summary of important information that you need to know about 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 - Call a healthcare
provider right away - Helpful information
to remember
What is OPDIVO + YERVOY?
People who have liver cancer (hepatocellular carcinoma), and who:
Have previously received treatment with sorafenib
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
OPDIVO (10 mg/mL) and YERVOY
What are the serious side effects?
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.
OPDIVO is a medicine that may treat certain cancers by working with your immune system. OPDIVO 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 YERVOY.
YERVOY can also cause serious side effects in many parts of your body which can lead to death. These problems may happen anytime during treatment with YERVOY or after you have completed treatment.
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.
What are the serious side effects of OPDIVO and OPDIVO + YERVOY?
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) - drowsiness
- dark urine (tea colored)
- bleeding or bruising more easily
than normal - 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
- constipation
- 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:
- rash
- itching
- skin blistering
- ulcers in the mouth or other
mucous membranes
Inflammation of the brain (encephalitis) — Things to look out for may include:
- headache
- fever
- tiredness or weakness
- confusion
- memory problems
- sleepiness
- seeing or hearing things that are not really there (hallucinations)
- seizures
- 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
Additional serious side effects observed during a separate study of YERVOY alone include:
Nerve problems that can lead to paralysis — Things to look out for may include:
- unusual weakness of legs, arms, or face
- numbness or tingling in hands or feet
Eye problems — Things to look out for may include:
- blurry vision, double vision, or other vision problems
- eye pain or redness
OPDIVO and OPDIVO + YERVOY can cause serious side effects, including:
Severe infusion reactions — Things to look out for may include:
- chills or shaking
- itching or rash
- flushing
- difficulty breathing
- dizziness
- fever
- 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.
What should I discuss with my healthcare team about pregnancy and nursing before starting treatment?
Tell your healthcare team if you are pregnant or plan to become pregnant. OPDIVO and YERVOY can harm
your unborn baby. If you are a female who is able to become pregnant, your healthcare provider should do a pregnancy test before you start receiving OPDIVO. Females who are able to become pregnant should use an effective method of birth control
during and for at least
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 or think you are pregnant during
treatment. You or your healthcare team should contact
Enrolling in a Pregnancy Safety Surveillance Study is encouraged for females who become
pregnant during treatment with YERVOY. The purpose of this study is to collect information
about your health and the health of your baby. You or your healthcare provider can enroll in the
Pregnancy Safety Surveillance Study by calling 1-844-593-7869.
Tell your healthcare team if you are breastfeeding or plan to breastfeed. It is not known if either treatment passes into your breast milk. Do not breastfeed during treatment and for 5 months after the last dose.
What should I discuss with my healthcare team before starting treatment?
Talk to your healthcare team about all of your health problems or concerns, including if you:
- have immune system
problems such as autoimmune disease, Crohn’s disease, ulcerative colitis, lupus, or sarcoidosis - 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
- vitamins
- herbal supplements
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
- abdominal pain
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
- abdominal pain
- shortness of breath
- upper respiratory tract infection
- headache
- low thyroid hormone levels (hypothyroidism)
- decreased weight
- dizziness
These are not all of the possible side effects. 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
For more information, please see U.S. Full Prescribing Information, including Boxed WARNING regarding
immune-mediated side effects, and Medication Guide for YERVOY.
Please see U.S. Full Prescribing Information and Medication Guide for OPDIVO.
Talk to your healthcare team for more information about these medications.
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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Please see U.S. Full Prescribing Information, including Boxed WARNING regarding immune-mediated side effects, and
Medication Guide for YERVOY.
Please see U.S. Full Prescribing Information and Medication Guide for OPDIVO.
INDICATIONS AND IMPORTANT SAFETY INFORMATION
Important Safety Information for OPDIVO® (nivolumab) and OPDIVO + YERVOY® (ipilimumab)
OPDIVO is a medicine that may treat certain cancers by working with your immune system. OPDIVO 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 serious or life-threatening and can lead to death. These problems may happen anytime during treatment or even after your treatment has ended. Some of these problems may happen more often when OPDIVO is used in combination with YERVOY.
YERVOY can cause serious side effects in many parts of your body which can lead to death. These problems may happen anytime during treatment with YERVOY or after you have completed treatment.
Serious side effects may include:
Additional serious side effects observed during a separate study of YERVOY alone include:
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 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.
OPDIVO and OPDIVO + YERVOY can cause serious side effects, including:
Pregnancy and Nursing:
Tell your healthcare provider about:
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; shortness of breath; constipation; decreased appetite; back pain; upper respiratory tract infection; fever; headache; stomach-area (abdominal) pain; and vomiting.
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. The most common side effects of YERVOY include: feeling tired; diarrhea; nausea; itching; rash; vomiting; headache; weight loss; fever; decreased appetite; and difficulty falling or staying asleep
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; and itching.
These are not all the possible side effects. For more information, ask your healthcare provider or pharmacist. 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 1-800-FDA-1088.
Please see U.S. Full Prescribing Information, including Boxed WARNING regarding immune-mediated side effects, and Medication Guide for YERVOY.
Please see U.S. Full Prescribing Information and Medication Guide for OPDIVO.
INDICATIONS
OPDIVO® (nivolumab) is a prescription medicine used to treat people with a type of skin cancer called melanoma that has spread or cannot be removed by surgery (advanced melanoma).
OPDIVO® (nivolumab) is a prescription medicine used in combination with YERVOY®: (ipilimumab) to treat people with a type of skin cancer called melanoma that has spread or cannot be removed by surgery (advanced melanoma).
OPDIVO® (nivolumab) is a prescription medicine used in combination with YERVOY® (ipilimumab) as a first treatment for adults with a type of advanced stage lung cancer (called non-small cell lung cancer) when your lung cancer has spread to other parts of your body (metastatic) and your tumors are positive for PD-L1, but do not have an abnormal EGFR or ALK gene.
OPDIVO® (nivolumab) is a prescription medicine used in combination with YERVOY® (ipilimumab) and 2 cycles of chemotherapy that contains platinum and another chemotherapy medicine, as a first treatment for adults with a type of advanced stage lung cancer (called non-small cell lung cancer) when your lung cancer has spread or grown, or comes back, and your tumor does not have an abnormal EGFR or ALK gene.
OPDIVO® (nivolumab) is a prescription medicine used to treat people with a type of advanced stage lung cancer (called non-small cell lung cancer) that has spread or grown and you have tried chemotherapy that contains platinum, and it did not work or is no longer working. If your tumor has an abnormal EGFR or ALK gene, you should have also tried an FDA-approved therapy for tumors with these abnormal genes, and it did not work or is no longer working.
OPDIVO® (nivolumab) is a prescription medicine used to treat people with a type of advanced stage lung cancer (called small cell lung cancer) that has spread or grown and you have tried at least two different types of chemotherapy, including one 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.
OPDIVO® (nivolumab) is a prescription medicine used to treat people with kidney cancer (renal cell carcinoma) when your cancer has spread or grown after treatment with other cancer medications.
OPDIVO® (nivolumab) is a prescription medicine used in combination with YERVOY® (ipilimumab) to treat people with kidney cancer (renal cell carcinoma) in certain people when their cancer has spread.
OPDIVO® (nivolumab) is a prescription medicine used to treat adults with a type of blood cancer called classical Hodgkin lymphoma if your cancer has come back or spread after a type of stem cell transplant that uses your own stem cells (autologous), and you used the drug brentuximab vedotin before or after your stem cell transplant, or if you received at least 3 kinds of treatment including an autologous stem cell transplant. OPDIVO was approved based on response rate. There is ongoing evaluation of clinical benefit of OPDIVO for this use.
OPDIVO® (nivolumab) is a prescription medicine used to treat people with head and neck cancer (squamous cell carcinoma) that has come back or spread and you have tried chemotherapy that contains platinum and it did not work or is no longer working.
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.
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.
OPDIVO® (nivolumab) is a prescription medicine used to treat people with liver cancer (hepatocellular carcinoma) if you have previously received treatment with sorafenib. 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 to treat people with a type of skin cancer called melanoma to help prevent melanoma from coming back after it and lymph nodes that contain cancer have been removed by surgery.
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, or in children younger than 18 years of age for the treatment of any other cancers.
INDICATIONS
OPDIVO® (nivolumab) is a prescription medicine used to treat people with liver cancer (hepatocellular carcinoma) if you have previously received treatment with sorafenib. 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 people with liver cancer (hepatocellular carcinoma) if you have previously received treatment with sorafenib. 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 18 years of age.
Please see U.S. Full Prescribing Information, including Boxed WARNING regarding immune-mediated side effects and Medication Guide for YERVOY.
Please see U.S. Full Prescribing Information and Medication Guide for OPDIVO.
Important Safety Information for OPDIVO® (nivolumab) and OPDIVO + YERVOY® (ipilimumab)
OPDIVO is a medicine that may treat certain cancers by working with your immune system. OPDIVO 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 serious or life-threatening and can lead to death. These problems may happen anytime during treatment or even after your treatment has ended. Some of these problems may happen more often when OPDIVO is used in combination with YERVOY.
YERVOY can cause serious side effects in many parts of your body which can lead to death. These problems may happen anytime during treatment with YERVOY or after you have completed treatment.
Serious side effects may include:
Additional serious side effects observed during a separate study of YERVOY alone include:
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 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.
OPDIVO and OPDIVO + YERVOY can cause serious side effects, including:
Pregnancy and Nursing:
Tell your healthcare provider about:
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; and abdominal pain.
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; 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. 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
1-800-FDA-1088.
Please see U.S. Full Prescribing Information, including Boxed WARNING regarding immune-mediated side effects, and Medication Guide for YERVOY.
Please see U.S. Full Prescribing Information and Medication Guide for OPDIVO.