Opdivo (Nivolumab)

Nivolumab Injection (nye vol' ue mab) Opdivo®

Nivolumab injection is used alone or in combination with ipilimumab (Yervoy) to treat certain types of melanoma (a type of skin cancer) that has spread to other parts of the body or cannot be removed by surgery, to treat a type of lung cancer (non-small cell lung cancer; NSCLC) that has spread to other parts of the body that worsened either during or after treatment with other chemotherapy medications, to treat advanced renal cell carcinoma (RCC, a type of cancer that begins in the cells of the kidneys) that worsened after treatment with other chemotherapy medications, to treat Hodgkin's lymphoma (Hodgkin's disease) in adults who worsened or did not respond to autologous stem cell transplant (procedure in which certain blood cells are removed from the body and then returned to the body after chemotherapy and/or radiation treatment) and brentuximab vedotin (Adcetris) treatment or at least three other treatments including the stem cell transplant, to treat a certain type of head and neck cancer that keeps coming back or that has spread to other parts of the body or worsened during or after treatment with other chemotherapy medications, to treat urothelial cancer (cancer of the lining of the bladder and other parts of the urinary tract) that has spread to other parts of the body and has worsened during or after treatment with other chemotherapy medications, to treat a certain type of colorectal cancer (cancer that begins in the large intestine) in adults and children 12 years of age and older that has spread to other parts of the body and has worsened after treatment with other chemotherapy medications. Nivolumab is in a class of medications called monoclonal antibodies. It works by helping your immune system to slow or stop the growth of cancer cells.

Nivolumab comes as a liquid to be injected into a vein over 60 minutes by a doctor or nurse in a hospital or medical facility. When nivolumab is given alone to treat melanoma, lung cancer, advanced RCC, Hodgkin lymphoma, head and neck cancer, urothelial cancer, or colorectal cancer, it is usually given once every 2 weeks for as long as your doctor recommends that you receive treatment. When nivolumab is given with ipilimumab to treat melanoma, it is usually given once every 3 weeks for 4 doses, and then once every 2 weeks for as long as your doctor recommends that you receive treatment. Nivolumab may cause serious or life-threatening reactions during an infusion. A doctor or nurse will watch you closely while you are receiving the infusion and shortly after the infusion to be sure you are not having a serious reaction to the medication. Tell your doctor or nurse immediately if you experience any of the following symptoms that may occur during the infusion: chills or shaking, itching, rash, flushing, difficulty breathing, dizziness, fever, and feeling faint. Your doctor may slow down your infusion, delay, or stop your treatment with nivolumab injection, or treat you with additional medications depending on your response to the medication and any side effects that you experience. Talk to your doctor about how you are feeling during your treatment. Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with nivolumab injection. Read the information carefully and ask your doctor or pharmacist if you have any questions.

Before receiving nivolumab injection, tell your doctor and pharmacist if you are allergic to nivolumab, any other medications, or any of the ingredients in nivolumab injection. Ask your pharmacist or check the Medication Guide for a list of the ingredients. tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Your doctor may need to change the doses of your medications or monitor you carefully for side effects. tell your doctor if you have ever had an organ transplant, Also tell your doctor if you have or have ever had an autoimmune disease (condition in which the immune system attacks a healthy part of the body) such as Crohn's disease (condition in which the immune system attacks the lining of the digestive tract causing pain, diarrhea, weight loss, and fever), ulcerative colitis (condition that causes swelling and sores in the lining of the colon [large intestine] and rectum), or lupus (condition in which the immune system attacks many tissues and organs including the skin, joints, blood, and kidneys); any type of lung disease or breathing problems; or liver disease. tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while you are receiving nivolumab injection. You should use effective birth control to prevent pregnancy during your treatment with nivolumab injection and for at least 5 months after your final dose. Talk to your doctor about birth control methods that will work for you. If you become pregnant while receiving nivolumab injection, call your doctor immediately. Nivolumab injection may harm the fetus. tell your doctor if you are breastfeeding or plan to breastfeed. You should not breastfeed while receiving nivolumab injection.

Unless your doctor tells you otherwise, continue your normal diet.

If you miss an appointment to receive nivolumab injection, call your doctor as soon as possible.

Nivolumab injection may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away: joint, back, jaw, or bone pain muscle pain or weakness dry, cracked, scaly skin redness, swelling, or pain on the palms of your hand or soles of your feet mouth sores dry eyes or mouth Some side effects can be serious. If you experience any of these symptoms, tell your doctor immediately: shortness of breath new or worsening cough coughing up blood chest pain diarrhea stomach area pain or tenderness stools that are black, tarry, sticky, or contain blood tiredness or weakness feeling cold deepening of voice or hoarseness changes in weight (gain or loss) changes in mood or behavior (decreased sex drive, irritability, or forgetfulness) neck stiffness pain, burning, tingling, or numbness in the hands or feet headaches, including those that are unusual or will not go away hallucinations (seeing things or hearing voices that do not exist) seizures confusion fever hair loss itching, rash, hives, or blisters on your skin constipation nausea vomiting drowsiness dizziness or fainting yellowing of skin or eyes dark-colored urine bleeding or bruising more easily than normal loss of appetite increased thirst decreased or increased urination swelling of face, arms, legs, feet or ankles blood in urine changes in vision breath that smells fruity Nivolumab injection may cause other side effects. Call your doctor if you have any unusual problems while receiving this medication. If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to nivolumab injection. It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.