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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.

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.

OPDIVO (10 mg/mL) and YERVOY (5 mg/mL) are injections for intravenous (IV) use.

Click below to view more indications.

For adults with early-stage non-small cell lung cancer (NSCLC) before and after surgery

OPDIVO^® (nivolumab) is a prescription medicine used in combination with chemotherapy that contains platinum and another chemotherapy medicine before you have surgery for early-stage NSCLC that does not have an abnormal EGFR or ALK gene, and then may be continued alone after surgery to help prevent your lung cancer from coming back.

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.

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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).

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.

Click below to view more indications.

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.

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.

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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).

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.

OPDIVO (10 mg/mL) and YERVOY (5 mg/mL) are injections for intravenous (IV) use.

Click below to view more indications.

For adults and children 12 years of age and older to help prevent Stage IIB, Stage IIC, Stage III or Stage IV melanoma from coming back after it has been completely removed by surgery

OPDIVO^® (nivolumab) is a prescription medicine used to treat a kind of skin cancer called melanoma. It may be used alone in adults and children 12 years and older with Stage IIB, Stage IIC, Stage III or Stage IV melanoma to help prevent melanoma from coming back after it has been completely removed by surgery.

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.

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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.

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.

OPDIVO (10 mg/mL) and YERVOY (5 mg/mL) are injections for intravenous (IV) use.

Click below to view more indications.

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.

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.

Click below to view more indications.

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.

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.

Click below to view more indications.

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.

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.

Click below to view more indications.

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.

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.

OPDIVO (10 mg/mL) and YERVOY (5 mg/mL) are injections for intravenous (IV) use.

Click below to view more indications.

For previously untreated adults with urinary tract cancer (urothelial carcinoma) that has spread or cannot be removed by surgery

OPDIVO^® (nivolumab) may be used in combination with chemotherapy medicines cisplatin and gemcitabine as the first treatment when urinary tract cancer has spread (metastatic) or cannot be removed by surgery.

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.

Click below to view more indications.

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.

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.

Click below to view more indications.

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.

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.

Click below to view more indications.

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 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 (5 mg/mL) are injections for intravenous (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.

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.

Click below to view more indications.

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 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.

Click below to view more indications.

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 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.

OPDIVO (10 mg/mL) and YERVOY (5 mg/mL) are injections for intravenous (IV) use.

Click below to view more indications.

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.

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.

Click below to view more indications.

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.

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.

Click below to view more indications.

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.

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.

OPDIVO (10 mg/mL) and YERVOY (5 mg/mL) are injections for intravenous (IV) use.

Click below to view more indications.

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.

Click below to view more indications.

Prescribing Information

Medication Guide

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