Indications
For certain adults with advanced non-small cell lung cancer (NSCLC)
As an intravenous infusion
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.
As a subcutaneous injection
OPDIVO Qvantig™ (nivolumab + hyaluronidase-nvhy) 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) 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 Qvantig is safe and effective in children.
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).
OPDIVO Qvantig™ (nivolumab + hyaluronidase-nvhy) 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 and you have received 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 received an EGFR or ALK inhibitor medicine and it did not work or is no longer working.
OPDIVO Qvantig™ (nivolumab + hyaluronidase-nvhy) is a prescription medicine used alone to treat adults with a type of advanced stage lung cancer (called non-small cell lung cancer) that has spread and you have received 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 received a FDA-approved therapy for tumors with these abnormal genes, and it did not work or is no longer working.
For certain people with advanced melanoma
OPDIVO® (nivolumab) is a prescription medicine used to treat adults and children 12 years of age or 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 or older with a type of skin cancer called melanoma that has spread or cannot be removed by surgery (advanced melanoma).
OPDIVO Qvantig™ (nivolumab + hyaluronidase-nvhy) is a prescription medicine used alone to treat adults with a type of skin cancer called melanoma that has spread or cannot be removed by surgery (advanced melanoma).
OPDIVO Qvantig™ (nivolumab + hyaluronidase-nvhy) is a prescription medicine used alone to treat adults with a type of skin cancer called melanoma that has spread or cannot be removed by surgery (advanced melanoma), after completing combination treatment with intravenous nivolumab and ipilimumab.
It is not known if OPDIVO Qvantig is safe and effective in children. OPDIVO Qvantig cannot be used in combination with ipilimumab.
For certain people 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.
OPDIVO Qvantig™ (nivolumab + hyaluronidase-nvhy) is a prescription medicine used to treat a kind of skin cancer called melanoma. It may be used alone in adults 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.
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 Qvantig™ (nivolumab + hyaluronidase-nvhy) is a prescription medicine used alone as a first treatment for certain adults with kidney cancer that has spread (advanced renal cell carcinoma), after completing combination treatment with intravenous nivolumab and ipilimumab.
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.
OPDIVO Qvantig™ (nivolumab + hyaluronidase-nvhy) is a prescription medicine used in combination with cabozantinib as a first treatment for adults with kidney cancer that has spread (advanced renal cell carcinoma). 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 after treatment with other cancer medications.
OPDIVO Qvantig™ (nivolumab + hyaluronidase-nvhy) is a prescription medicine used to treat adults with kidney cancer (renal cell carcinoma) when your cancer has spread 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.
OPDIVO Qvantig™ (nivolumab + hyaluronidase-nvhy) is a prescription medicine used alone to treat adults with head and neck cancer (squamous cell carcinoma) that has come back or spread and you have received chemotherapy that contains platinum and it did not work or is no longer working.
For adults with liver cancer (hepatocellular carcinoma)
OPDIVO® (nivolumab) is a prescription medicine used in combination with YERVOY® (ipilimumab) as a first treatment for adults with a type of liver cancer called hepatocellular carcinoma that cannot be removed by surgery or has spread.
OPDIVO Qvantig™ (nivolumab and hyaluronidase-nvhy) is a prescription medicine used alone as a first treatment for adults with a type of liver cancer called hepatocellular carcinoma (HCC) after completing combination treatment with intravenous nivolumab and ipilimumab, when your cancer cannot be removed with surgery or has spread.
OPDIVO Qvantig (120 mg/2,000 units per mL) is an injection for subcutaneous use.
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 a type of liver cancer called hepatocellular carcinoma (HCC) when your liver cancer cannot be removed by surgery or has spread, and you have received prior treatment with sorafenib.
OPDIVO Qvantig™ (nivolumab and hyaluronidase-nvhy) is a prescription medicine used alone to treat adults with a type of liver cancer called hepatocellular carcinoma (HCC) after completing combination treatment with intravenous nivolumab and ipilimumab when your cancer cannot be removed with surgery or has spread, and you have received prior treatment with sorafenib.
For previously untreated adults with urinary tract cancer (urothelial carcinoma) that has spread or cannot be removed by surgery
OPDIVO® (nivolumab) is a prescription medicine used in combination with chemotherapy medicines cisplatin and gemcitabine, as a first line treatment when your urinary tract cancer has spread (metastatic) or cannot be removed by surgery.
OPDIVO Qvantig™ (nivolumab + hyaluronidase-nvhy) is a prescription medicine used in combination with chemotherapy medicines cisplatin and gemcitabine, as a first line treatment for adults whose urinary tract cancer has spread (metastatic) or cannot be removed by surgery.
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.
OPDIVO Qvantig™ (nivolumab + hyaluronidase-nvhy) is a prescription medicine used alone 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 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 (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.
OPDIVO Qvantig™ (nivolumab + hyaluronidase-nvhy) is a prescription medicine used alone 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 (locally advanced or metastatic) and you have received 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 and children 12 years of age and older with advanced MSI-H/dMMR CRC
OPDIVO® (nivolumab) is a prescription medicine that may be 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 cannot be removed with surgery, or has spread, and is microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR).
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.
OPDIVO Qvantig™ (nivolumab and hyaluronidase-nvhy) is a prescription medicine used alone to treat adults and children 12 years of age and older who weigh 66 pounds (30 kg) or more with a type of colon or rectal cancer (colorectal cancer or CRC), after completing combination treatment with intravenous nivolumab and ipilimumab, when your cancer cannot be removed with surgery, or has spread, and is microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR).
It is not known if OPDIVO Qvantig is safe and effective in children younger than 12 years of age with MSI-H or dMMR metastatic colorectal cancer.
For people 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 that may be used alone to treat adults and children 12 years of age and older with a type of colon or rectal cancer (colorectal cancer) that has spread, and 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 Qvantig™ (nivolumab and hyaluronidase-nvhy) is a prescription medicine that may be used alone to treat adults and children 12 years of age and older who weigh 66 pounds (30 kg) or more with a type of colon or rectal cancer (colorectal cancer or CRC) that has spread, is microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR), and you have received treatment with a fluoropyrimidine, oxaliplatin, and irinotecan, and it did not work or is no longer working.
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.
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.
OPDIVO Qvantig™ (nivolumab + hyaluronidase-nvhy) is a prescription medicine used alone 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 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.
OPDIVO Qvantig™ (nivolumab + hyaluronidase-nvhy) is a prescription medicine used alone 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 completely 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 as a first treatment for 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 or has spread, and your tumors are positive for PD-L1.
OPDIVO® (nivolumab) is a prescription medicine used in combination with YERVOY® (ipilimumab) as a first treatment for 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 or has spread, and your tumors are positive for PD-L1.
OPDIVO Qvantig™ (nivolumab + hyaluronidase-nvhy) is prescription medicine used in combination with chemotherapy that contains fluoropyrimidine and platinum as a first treatment 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 or has spread and your tumors are positive for PD-L1.
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 cancer), cancer where the esophagus joins the stomach (gastroesophageal junction cancer), and with esophageal adenocarcinoma when your cancer cannot be removed with surgery or has spread, and your tumors are positive for PD-L1.
OPDIVO Qvantig™ (nivolumab + hyaluronidase-nvhy) 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 esophageal adenocarcinoma and cannot be removed with surgery or has spread and your tumors are positive for PD-L1.
Prescribing Information
OPDIVO
YERVOY
OPDIVO Qvantig
Medication Guide
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