Full Indications
Select an Indication
For certain adults with advanced non-small cell lung cancer (NSCLC)
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.
It is not known if OPDIVO is safe and effective in children younger than 18 years of age.
OPDIVO (10 mg/mL) and YERVOY
For people with previously treated advanced non-small cell lung cancer
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
It is not known if OPDIVO is safe and effective in children younger than 18 years of age.
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® (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.
OPDIVO (10 mg/mL) and YERVOY
For people with melanoma after it and the affected lymph nodes have been removed by surgery to prevent it from coming back
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 18 years of age.
For certain people with advanced kidney cancer (renal cell carcinoma)
OPDIVO® (nivolumab) is a prescription medicine used in combination with YERVOY® (ipilimumab) to treat people with kidney cancer in certain people when their cancer has spread (advanced renal cell carcinoma) and you have not already had treatment for your advanced RCC.
It is not known if OPDIVO is safe and effective in children younger than 18 years of age.
OPDIVO (10 mg/mL) and YERVOY
For newly diagnosed adults whose kidney cancer (renal cell carcinoma) has spread
OPDIVO® (nivolumab) is a prescription medicine used in combination with cabozantinib to treat people with kidney cancer when your cancer has spread (advanced renal cell carcinoma) and you have not already had treatment for your advanced RCC. Please read the Patient Information that comes with cabozantinib.
It is not known if OPDIVO is safe and effective in children younger than 18 years of age.
For people with previously treated advanced kidney cancer (renal cell carcinoma)
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.
It is not known if OPDIVO is safe and effective in children younger than 18 years of age.
For people with previously treated squamous cell carcinoma of the head and neck
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.
It is not known if OPDIVO is safe and effective in children younger than 18 years of age.
For people with liver cancer (hepatocellular carcinoma) that have received treatment with sorafenib
OPDIVO® (nivolumab) is a prescription medicine used to treat people with liver cancer (hepatocellular carcinoma) after you have 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.
OPDIVO (10 mg/mL) and YERVOY
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 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
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 (MSl-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 (10 mg/mL) and YERVOY
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 miscrosatellite 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 adults with previously treated classical Hodgkin lymphoma including an autologous stem cell transplant whose cancer has come back or 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 medicine 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.
It is not known if OPDIVO is safe and effective in children younger than 18 years of age.
For people with previously treated advanced esophageal squamous cell cancer
OPDIVO® (nivolumab) is a prescription medicine used to treat people with cancer of the tube that connects your throat to your stomach (esophageal cancer) if your esophageal cancer is a type called squamous cell carcinoma and cannot be removed with surgery and has come back or spread to other parts of the body after you have received chemotherapy that contains fluoropyrimidine and platinum.
It is not known if OPDIVO is safe and effective in children younger than 18 years of age.
For adults newly diagnosed with malignant pleural mesothelioma (MPM)
OPDIVO® (nivolumab) is a prescription medicine used in combination with YERVOY® (ipilimumab) as a first treatment for adults with a type of cancer that affects the lining of the lungs and chest wall called malignant pleural mesothelioma which cannot be removed by surgery.
It is not known if OPDIVO is safe and effective in children younger than 18 years of age.
OPDIVO (10 mg/mL) and YERVOY
For people with esophageal or gastroesophageal junction (GEJ) cancer who have been treated with chemoradiation followed by surgery to help prevent it from coming back
OPDIVO® (nivolumab) is a prescription medicine that may be used to help prevent cancer of the tube that connects your throat to your stomach (esophageal cancer) or cancer where the esophagus joins the stomach (gastroesophageal junction cancer) from coming back after it has been treated with chemoradiation followed by surgery to remove the cancer, but some cancer cells were still present in the removed tumor or lymph nodes.
It is not known if OPDIVO is safe and effective in children younger than 18 years of age.
For certain previously untreated adults with advanced gastric, gastroesophageal junction, and esophageal adenocarcinomas
OPDIVO® (nivolumab) is a prescription medicine used to treat people with cancer of the stomach (gastric), cancer where the esophagus joins the stomach (gastroesophageal junction), and in people with esophageal adenocarcinoma. OPDIVO may be used in combination with chemotherapy that contains fluoropyrimidine and platinum when your cancer cannot be removed with surgery or has spread to other parts of the body.
It is not known if OPDIVO is safe and effective in children younger than 18 years of age.
FULL INDICATIONS
For certain adults with advanced non-small cell lung cancer (NSCLC)
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 (10 mg/mL) and YERVOY
(IV) use.
For people with previously treated advanced non-small cell lung cancer
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
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® (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 (10 mg/mL) and YERVOY
(IV) use.
For people with melanoma after it and the affected lymph nodes have been removed by surgery to prevent it from coming back
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.
For certain people with advanced kidney cancer (renal cell carcinoma)
OPDIVO® (nivolumab) is a prescription medicine used in combination with YERVOY® (ipilimumab) to treat people with kidney cancer in certain people when their cancer has spread (advanced renal cell carcinoma) and you have not already had treatment for your advanced RCC.
OPDIVO (10 mg/mL) and YERVOY
(IV) use.
For newly diagnosed adults whose kidney cancer (renal cell carcinoma) has spread
OPDIVO® (nivolumab) is a prescription medicine used in combination with cabozantinib to treat people with kidney cancer when your cancer has spread (advanced renal cell carcinoma) and you have not already had treatment for your advanced RCC. Please read the Patient Information that comes with cabozantinib.
For people with previously treated advanced kidney cancer (renal cell carcinoma)
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.
For people with previously treated squamous cell carcinoma of the head and neck
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.
For people with liver cancer (hepatocellular carcinoma) that have received 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.
OPDIVO (10 mg/mL) and YERVOY
(IV) use.
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.
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
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 (10 mg/mL) and YERVOY
(IV) 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.
For adults with previously treated classical Hodgkin lymphoma including an autologous stem cell transplant whose cancer has come back or 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.
For people with previously treated advanced esophageal squamous cell cancer
OPDIVO® (nivolumab) is a prescription medicine used to treat people with cancer of the tube that connects your throat to your stomach (esophageal cancer) if your esophageal cancer is a type called squamous cell carcinoma, and cannot be removed with surgery, and has come back or spread to other parts of the body after you have received chemotherapy that contains fluoropyrimidine and platinum.
For adults newly diagnosed with malignant pleural mesothelioma (MPM)
OPDIVO® (nivolumab) is a prescription medicine used in combination with YERVOY® (ipilimumab) as a first treatment for adults with a type of cancer that affects the lining of the lungs and chest wall called malignant pleural mesothelioma which cannot be removed by surgery.
OPDIVO (10 mg/mL) and YERVOY
(IV) use.
For people with esophageal or gastroesophageal junction (GEJ) cancer who have been treated with chemoradiation followed by surgery to help prevent it from coming back
OPDIVO® (nivolumab) is a prescription medicine that may be used to help prevent cancer of the tube that connects your throat to your stomach (esophageal cancer) or cancer where the esophagus joins the stomach (gastroesophageal junction cancer) from coming back after it has been treated with chemoradiation followed by surgery to remove the cancer, but some cancer cells were still present in the removed tumor or lymph nodes.
For people with advanced gastric cancer, gastroesophageal junction (GEJ) cancer, and esophageal adenocarcinoma (EAC)
OPDIVO® (nivolumab) is a prescription medicine used to treat people with cancer of the stomach (gastric), cancer where the esophagus joins the stomach (gastroesophageal junction), and in people with esophageal adenocarcinoma. OPDIVO may be used in combination with chemotherapy that contains fluoropyrimidine and platinum when your cancer cannot be removed with surgery or has spread to other parts of the body.
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.
OPDIVO (10 mg/mL) and YERVOY
(IV) use.
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.
Look out for the following icons as you read:
Talk to your
healthcare team
Call a healthcare
provider right away
Helpful information
to remember
- Talk to your
healthcare team - Call a healthcare
provider right away - Helpful information
to remember
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
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
- 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
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
- itching
The most common side effects of OPDIVO when used in combination with cabozantinib include:
- diarrhea
- feeling tired or weak
- liver problems
- rash, redness, pain, swelling, or blisters on the palms of your hands or soles of your feet
- mouth sores
- rash
- high blood pressure
- low thyroid hormone levels
- pain in muscles, bones, and joints
- decreased appetite
- nausea
- change in the sense of taste
- stomach-area (abdominal) pain
- cough
- upper respiratory tract infection
The most common side effects of OPDIVO when used in combination with fluoropyrimidine and platinum-containing chemotherapy include:
- numbness, pain, tingling, or burning in your hands or feet
- nausea
- feeling tired
- diarrhea
- vomiting
- decreased appetite
- stomach-area (abdominal) pain
- constipation
- pain in muscles, bones, and joints
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:
- 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 and YERVOY can harm your unborn baby.
- are breastfeeding or plan to breastfeed. It is not known if OPDIVO or YERVOY passes into your breast milk. Do not breastfeed during treatment with OPDIVO or YERVOY and for 5 months after the last dose of OPDIVO or YERVOY.
Females who are able to become pregnant:
Your healthcare provider should do a pregnancy test before you start receiving OPDIVO or YERVOY.
- You should use an effective method of birth control during your treatment and for at least 5 months after the last dose of OPDIVO or YERVOY. 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 or YERVOY. You or your healthcare provider should contact Bristol Myers Squibb at 1-844-593-7869 as 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
- vitamins
- herbal supplements
For more information, please see U.S. Full Prescribing Information and Medication Guide for OPDIVO,
and 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.
Please see U.S. Full Prescribing Information and Medication Guide for OPDIVO.
Please see U.S. Full Prescribing Information and Medication Guide for YERVOY.
INDICATIONS AND IMPORTANT SAFETY INFORMATION
Important Safety Information for OPDIVO® (nivolumab) and OPDIVO + 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; and stomach-area (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; 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.
The most common side effects of OPDIVO, when used in combination with cabozantinib, include: diarrhea; feeling tired or weak; liver problems; rash, redness, pain, swelling or blisters on the palms of your hands or soles of your feet; mouth sores; rash; high blood pressure; low thyroid hormone levels; pain in muscles, bones, and joints; decreased appetite; nausea; change in the sense of taste; stomach-area (abdominal) pain; cough; upper respiratory tract infection.
The most common side effects of OPDIVO when used in combination with fluoropyrimidine and platinum-containing chemotherapy include: numbness, pain, tingling, or burning in your hands or feet; nausea; feeling tired; diarrhea; vomiting; decreased appetite; stomach-area (abdominal) pain; constipation; pain in muscles, bones and joints.
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 1-800-FDA-1088.
Before receiving OPDIVO or YERVOY, tell your healthcare provider about all of your
medical conditions, including
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 OPDIVO.
Please see U.S. Full Prescribing Information and Medication Guide for YERVOY.
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 in combination with YERVOY® (ipilimumab) as a first treatment for adults with a type of cancer that affects the lining of the lungs and chest wall called malignant pleural mesothelioma which cannot be removed by surgery.
OPDIVO® (nivolumab) is a prescription medicine used in combination with YERVOY® (ipilimumab) to treat people with kidney cancer in certain people when their cancer has spread (advanced renal cell carcinoma) and you have not already had treatment for your advanced RCC.
OPDIVO® (nivolumab) is a prescription medicine used in combination with cabozantinib to treat people with kidney cancer when your cancer has spread (advanced renal cell carcinoma) and you have not already had treatment for your advanced RCC. Please read the Patient Information that comes with cabozantinib.
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 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 medicine 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 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.
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.
OPDIVO® (nivolumab) is a prescription medicine used to treat people with cancer of the tube that connects your throat to your stomach (esophageal cancer) if your esophageal cancer is a type called squamous cell carcinoma, and cannot be removed with surgery, and has come back or spread to other parts of the body after you have received chemotherapy that contains fluoropyrimidine and platinum.
OPDIVO® (nivolumab) is a prescription medicine that may be used to help prevent cancer of the tube that connects your throat to your stomach (esophageal cancer) or cancer where the esophagus joins the stomach (gastroesophageal junction cancer) from coming back after it has been treated with chemoradiation followed by surgery to remove the cancer, but some cancer cells were still present in the removed tumor or lymph nodes.
OPDIVO® (nivolumab) is a prescription medicine used to treat people with cancer of the stomach (gastric), cancer where the esophagus joins the stomach (gastroesophageal junction), and in people with esophageal adenocarcinoma. OPDIVO may be used in combination with chemotherapy that contains fluoropyrimidine and platinum when your cancer cannot be removed with surgery or has spread to other parts of the body.
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.
You are now leaving this Bristol Myers Squibb site.
This internet site may provide links or references to other sites.
Bristol Myers Squibb has no responsibility for the content of such other sites and
is not liable for any damages or injury arising from that content.
Any links to other sites are provided merely as a convenience to the users of this internet site.
Would you like to leave this site?
You are about to leave this Bristol-Myers Squibb Company site. You are being redirected to another Bristol-Myers Squibb Company site.
Would you like to leave this site?
This link is currently not available. Please check back at a later time.