
—The adrenal glands are 2 triangle-shaped glands located on the top of each kidney, and they produce many of the hormones the body needs to function properly.
Common search terms: BRAF Gene, Complete Response, Immunotherapy, Metastatic, Side Effects
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—An abbreviation for deficient mismatch repair. Cells in your body have a mismatch repair (MMR) system, which can fix inconsistencies in their DNA when DNA is being copied within the cell. d !. M !. M !. R means that this system is deficient, or not functioning properly. This can result in tumors with microsatellite instability (MSI-H).
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—Many different types of cancer can occur in the head and neck. The most common is squamous cell carcinoma of the head and neck (SCCHN). Most SCCHN begins in the layer of cells that line the moist surfaces inside the head and neck, for example, the mouth—including the tongue, lips, and cheeks—throat, sinuses, and voice box.
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—PD-1 is an acronym for programmed death receptor-1. PD-1 is a checkpoint protein on immune cells called T cells. It normally acts as a type of “off switch” that helps keep the T cells from attacking other cells in the body. It does this when it attaches to PD-L1, a protein on some normal (and cancer) cells. When PD-1 binds to PD-L1, it basically tells the T cell to leave the other cell alone. Some cancer cells have large amounts of PD-L1, which helps them evade immune attack.
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FULL INDICATIONS
For certain adults with advanced
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 adults with early-stage non-small cell lung cancer (NSCLC) before surgery
OPDIVO® (nivolumab) is a prescription medicine used in combination with chemotherapy that contains platinum and another chemotherapy medicine, before you have surgery, for adults with early-stage lung cancer (called non-small cell lung cancer).
For adults with previously treated advanced non-small cell lung cancer
OPDIVO® (nivolumab) is a prescription medicine used to treat adults 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.
For adults and children 12 years of age and older with advanced melanoma
OPDIVO® (nivolumab) is a prescription medicine used to treat adults and children 12 years of age and older 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 adults and children 12 years of age and older 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 adults and children 12 years of age and older 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 adults and children 12 years of age and older 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 adults with advanced kidney cancer (renal cell carcinoma)
OPDIVO® (nivolumab) is a prescription medicine used in combination with YERVOY® (ipilimumab) to treat adults with kidney cancer in certain people when your 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 adults 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 adults with previously treated advanced kidney cancer (renal cell carcinoma)
OPDIVO® (nivolumab) is a prescription medicine used to treat adults with kidney cancer (renal cell carcinoma) when your cancer has spread or grown after treatment with other cancer medications.
For adults with previously treated squamous cell carcinoma of the head and neck
OPDIVO® (nivolumab) is a prescription medicine used to treat adults 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 adults with liver cancer (hepatocellular carcinoma) who have received treatment with sorafenib
OPDIVO® (nivolumab) is a prescription medicine used in combination with YERVOY® (ipilimumab) to treat adults 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 adults with previously treated advanced cancer in the bladder or urinary tract (urothelial carcinoma)
OPDIVO® (nivolumab) is a prescription medicine used to treat adults with cancer of the lining of the urinary tract (including the bladder, urethra, ureters, or renal pelvis) [urothelial carcinoma] when it has spread or grown (locally advanced or metastatic) and you have tried chemotherapy that contains platinum, and it did not work or is no longer working or your cancer worsened within 12 months of treatment with chemotherapy that contains platinum, either before or after surgery to remove your cancer.
For adults with a type of bladder or urinary tract cancer (urothelial carcinoma) to help prevent it from coming back after it was removed by surgery
OPDIVO® (nivolumab) is a prescription medicine used to treat adults with cancer of the lining of the urinary tract (including the bladder, ureters, or renal pelvis) [urothelial carcinoma] to help prevent cancer of the urinary tract from coming back after it was removed by surgery.
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 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 adults with previously treated advanced esophageal squamous cell cancer
OPDIVO® (nivolumab) is a prescription medicine used to treat adults 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 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 in adults 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 previously untreated adults with advanced or metastatic esophageal squamous cell cancer (ESCC)
OPDIVO® (nivolumab) is a prescription medicine used in combination with chemotherapy that contains fluoropyrimidine and platinum to treat adults with cancer of the tube that connects your throat to your stomach (esophageal cancer) when your cancer is a type called squamous cell carcinoma and cannot be removed with surgery (advanced) or has spread to other parts of the body (metastatic) and you have not already had treatment for your advanced or metastatic esophageal cancer.
OPDIVO® (nivolumab) is a prescription medicine used in combination with YERVOY® (ipilimumab) to treat adults with cancer of the tube that connects your throat to your stomach (esophageal cancer) when your cancer is a type called squamous cell carcinoma and cannot be removed with surgery (advanced) or has spread to other parts of the body (metastatic), and you have not already had treatment for your advanced or metastatic esophageal cancer.
OPDIVO (10 mg/mL) and YERVOY (5 mg/mL) are injections for intravenous (IV) use.
For certain previously untreated adults with advanced gastric, gastroesophageal junction, and esophageal adenocarcinomas
OPDIVO® (nivolumab) is a prescription medicine used in combination with chemotherapy that contains fluoropyrimidine and platinum to treat adults with cancer of the stomach (gastric), junction between the stomach and esophagus (gastroesophageal junction), and esophagus that is a type called adenocarcinoma and 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 melanoma or MSI-H or dMMR metastatic colorectal cancer.
It is not known if OPDIVO is safe and effective in children for the treatment of any other cancers.
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 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:
Intestinal problems — Things to look out for may include:
Liver problems — Things to look out for may include:
Hormone gland problems — Things to look out for may include:
Kidney problems — Things to look out for may include:
Skin problems — Things to look out for may include:
Eye problems — Things to look out for may include:
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:
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:
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:
The most common side effects of OPDIVO when used in combination with YERVOY include:
The most common side effects of OPDIVO when used in combination with YERVOY and chemotherapy include:
The most common side effects of OPDIVO when used in combination with chemotherapy include:
The most common side effects of OPDIVO when used in combination with cabozantinib include:
The most common side effects of OPDIVO when used in combination with fluoropyrimidine and platinum-containing chemotherapy include:
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:
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.