Nivolumab (intravenous route)

Opdivo

Nivolumab injection is used alone or together with other medicines (eg, ipilimumab) to treat melanoma (skin cancer) that has spread throughout the body (metastatic) or that cannot be removed by surgery. It is also used to help prevent Stage IIB, Stage IIC, Stage III, or Stage IV melanoma from coming back after it has been completely removed by surgery. Nivolumab injection is also used with chemo medicines containing platinum before having surgery for non-small cell lung cancer (NSCLC). Nivolumab injection is also used with ipilimumab as first-line treatment for metastatic (cancer that has already spread) non-small cell lung cancer (NSCLC) in patients whose tumors express PD-L1 and do not have an abnormal EGFR or ALK gene. Your doctor will perform a test to check for the PD-L1 tumor before you receive this medicine. It is also used with ipilimumab and 2 cycles of chemo medicines containing platinum as first-line treatment for non-small cell lung cancer that has come back or spread in patients whose tumors do not have an abnormal EGFR or ALK gene. Nivolumab injection is also used to treat non-small cell lung cancer that has spread throughout the body and after other cancer medicines (eg, medicines containing platinum). It is given to patients whose tumors have an abnormal EGFR or ALK gene and have disease progression during treatment. Nivolumab injection is also used with ipilimumab as first-line treatment for malignant pleural mesothelioma (cancer that affects the inside lining of the lungs and chest wall) that cannot be removed by surgery. Nivolumab injection is used alone to treat kidney cancer that has spread throughout the body in patients who have received other medicines. It is also used together with other medicines (eg, ipilimumab or cabozatinib) to treat kidney cancer that has spread throughout the body in patients who have not received other medicines. It is also used to treat classical Hodgkin lymphoma (white blood cell cancer) that has come back or spread after autologous hematopoietic stem cell transplantation (HSCT) and used brentuximab vedotin after stem cell transplant, or after you received at least 3 kinds of treatment including autologous HSCT. This medicine is also used to treat squamous cell cancer of the head and neck (SCCHN) that has come back or spread throughout the body after receiving medicines containing platinum but did not work well. Nivolumab injection is also used to treat urothelial carcinoma (bladder cancer) that has spread throughout the body (metastatic) or cannot be removed by surgery (locally advanced). This medicine is given to patients who have received other cancer medicines (eg, platinum) that did not work well or whose cancer has worsened within 12 months of treatment containing platinum, either before or after surgery to remove your cancer. It is also used to help prevent urothelial carcinoma from coming back after it has been removed by surgery. This medicine is also used in combination with cisplatin and gemcitabine as first-line treatment of urothelial carcinoma that has spread throughout the body or cannot be removed by surgery. Nivolumab injection is also used alone or together with other medicines (eg, ipilimumab) to treat microsatellite instability high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer (cancer of the colon or rectum) that has spread. It is given to patients who have received other cancer treatments (eg, fluoropyrimidine, oxaliplatin, irinotecan) that did not work well. Nivolumab injection is also used together with other medicines (eg, ipilimumab) to treat hepatocellular cancer (liver cancer) in patients who have previously received treatment with sorafenib. Nivolumab injection is also used to treat esophageal or gastroesophageal junction cancer in patients who have received combination of chemotherapy and radiation followed by surgery to remove the cancer. It is given to patients who still have some cancer cells in the removed tumor or lymph nodes. Nivolumab injection is also used together with other medicines (eg, fluoropyrimidine and platinum, or ipilimumab) as first-line treatment for squamous cell carcinoma of the esophagus that has spread or cannot be removed by surgery. This medicine is also used to treat squamous cell carcinoma of the esophagus that has returned, spread, or cannot be removed by surgery in patients who have received other medicines (eg, fluoropyrimidine and platinum). Nivolumab injection is also used together with other medicines (eg, fluoropyrimidine and platinum) to treat cancer of the stomach (gastric cancer), gastroesophageal junction, or esophagus (esophageal adenocarcinoma) that has spread or cannot be removed by surgery. Nivolumab is a monoclonal antibody that affects the immune system and helps control the growth of cancer cells. This medicine is to be given only by or under the supervision of your doctor. This product is available in the following dosage forms:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered: Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully. Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of nivolumab injection to treatcolon and rectal cancerandmelanomain children 12 years of age and older. Safety and efficacy have not been establishedin children younger than 12 years of age to treat colon and rectal cancer and melanomaorin children to treat other approved conditions. Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of nivolumab injection in the elderly. There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding. Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive. Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines. Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco. The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially: