For people with advanced melanoma
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 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).
It is not known if OPDIVO is safe and effective in children younger than 18 years of age.
For adults with advanced melanoma
are approved for advanced melanoma
regardless of BRAF biomarker status
In an analysis of 945 previously untreated advanced melanoma patients, 314 received a combination of OPDIVO + YERVOY, 316 received OPDIVO alone, and 315 received YERVOY alone.
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OPDIVO + YERVOY TRIAL RESULTS
IN A FOLLOW-UP ANALYSIS FOR THIS STUDY
5 YEARS
The follow-up analysis at 5 years is consistent with the earlier
(primary) analysis at 28 months. At 28 months,
A
separate analysis looking at results by BRAF status
OPDIVO TRIAL RESULTS
IN A FOLLOW-UP ANALYSIS FOR
THIS STUDY
The follow-up analysis at 5 years is consistent with the earlier (primary) analysis at 28 months. At 28 months, OPDIVO reduced the risk of dying by 37% compared to YERVOY alone. Half of the patients on OPDIVO were alive at 36.9 months, compared to 19.9 months with YERVOY.
A
separate analysis looking at results by BRAF status
OPDIVO and OPDIVO + YERVOY will not work for everyone. Individual results may vary.
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to
see additional clinical trial information
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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 observed during a separate study of YERVOY alone include: nerve problems that can lead to paralysis; and eye problems.
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 observed during a separate study of YERVOY alone include: nerve problems that can lead to paralysis; and eye problems.
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 and OPDIVO + YERVOY?
OPDIVO is a prescription medicine used to treat people who have a type of skin cancer called melanoma, and:
Whose melanoma has spread or cannot be removed by surgery (advanced melanoma).
OPDIVO can be used alone or in combination with YERVOY (OPDIVO + YERVOY).
It is not known if OPDIVO is safe and effective in children younger than 18 years of age.
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 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 5 months after the last dose.
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
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
The most common side effects of YERVOY include:
- feeling tired
- diarrhea
- nausea
- itching
- rash
- vomiting
- headache
- weight loss
- fever
- decreased appetite
- difficulty falling or staying asleep
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.
7356US1804780-08-01 06/20
Information provided on this website is not a substitute for talking with your healthcare professional.
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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 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).
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. 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.
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.
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.