• Opdivo is a brand (trade) name for nivolumab which is a type of injected immunotherapy medicine that may be used to treat many different types of cancer including advanced skin cancer (melanoma), liver cancer, and lung cancer.
• Opdivo (nivolumab) works by blocking the PD-1 (programmed death receptor-1) pathway to help prevent cancer cells from hiding from the immune system. Nivolumab helps boost the immune system's response against cancer. PD-1 receptors are found on T-cells (also called T-lymphocytes) which are a type of white blood cell. Some cancer cells avoid detection by attaching to these PD-1 receptors. This prevents the activation of the T-cell which normally would target and destroy cancer. The cancer cells can then multiply and spread.
• When Opdivo (nivolumab) binds to the PD-1 receptor on the T-cell, this helps to block the cancer cells from linking to and inactivating the T-cells. Nivolumab can allow re-activation of the immune system T-cells to help fight off cancer. While affecting the tumor, this could also affect normal healthy cells.
• Opdivo belongs to the class of medicines known as checkpoint inhibitors. It may also be called a programmed death receptor-1 (PD-1) blocking antibody.

• Approved to treat many different types of cancers including advanced melanoma, advanced or metastatic gastrointestinal or esophageal cancer, lung cancer, kidney cancer, classical Hodgkin lymphoma, squamous cell cancer of the esophagus or squamous cell cancer of the head or neck, bladder cancer, advanced renal cell carcinoma, and liver cancer
• Also approved to treat a type of metastatic colorectal cancer in adults and children over the age of 12 that has progressed despite treatment.
• In combination with ipilimumab, it is the preferred treatment for adult patients with unresectable malignant pleural mesothelioma.
• Opdivo in combination with chemotherapy or Opdivo in combination with Yervoy may be used as first-line treatments for unresectable advanced or metastatic esophageal qquamous cell carcinoma.
• Can be used for adjuvant treatment of completely resected esophageal or gastroesophageal junction cancer in patients with residual pathologic disease who have received neoadjuvant chemoradiotherapy.
• May be used as adjuvant treatment of patients with urothelial carcinoma (UC) who are at high risk of recurrence after undergoing radical resection, regardless of prior neoadjuvant chemotherapy, nodal involvement or PD-L1 status.
• Usually given when cancer has spread, cannot be surgically removed, or has come back after prior treatment.
• May be used alone or in combination with other anti-cancer medications, depending on the cancer.
• Opdivo is a targeted drug treatment that works by helping the immune system block the growth and spread of cancer cells in the body. It is not a chemotherapy treatment.
• The dosage of Opdivo varies depending on the type of cancer being treated but the usual dosage for adults is 240 mg given by intravenous infusion over 30 minutes every 2 weeks. Alternative dosages include 480 mg given by intravenous infusion over 30 minutes every 4 weeks. For children aged 12 years and older and weighing less than 40 kg with metastatic colorectal cancer, the dosage is 3 mg/kg by intravenous infusion over 30 minutes every 2 weeks.

If you are between the ages of 18 and 60, take no other medication or have no other medical conditions, side effects you are more likely to experience include:

• Fatigue, a rash, itchy skin, a cough, upper respiratory tract infections, musculoskeletal pain, edema, vitiligo (skin discoloration), and gastrointestinal side effects (such as nausea, vomiting, and diarrhea) are the most common side effects reported. Other side effects include ventricular arrhythmia, iridocyclitis (inflammation of the colored part of the eye), infusion-related reactions, dizziness, neuropathy, and other skin conditions. Weight loss has also been reported, possibly related to a decreased appetite.
• The dosage of Opdivo may need to be withheld or permanently discontinued in people who develop severe side effects, for example, grade 2 or higher diarrhea or colitis, grade 3 or higher rash, or grade 2 pneumonitis.
• Laboratory tests may show increased levels of amylase and lipase; hyponatremia (low sodium); increased bilirubin, AST, alkaline phosphatase, and ALT; hyperglycemia (high blood sugars), hypocalcemia (low calcium), and hyperkalemia (high potassium). Hypothyroidism and hyperthyroidism may also occur.
• Opdivo is a type of immunotherapy, and uncommonly, this can cause the immune system to attack healthy organs and tissues leading to side effects. These side effects may be serious or life-threatening and can occur anytime during or after treatment with Opdivo. If these symptoms occur, Opdivo may need to be stopped temporarily or permanently and other treatments, such as corticosteroids (such as prednisone) or hormone replacement therapy, initiated.
• Lung problems (pneumonitis, swelling in the lungs) may occur in people taking Opdivo. Symptoms include shortness of breath, chest pain, new or worsening cough.
• Other significant immune system-related side effects include colitis, hepatitis, hormone gland problems, kidney problems, skin reactions, mouth ulcers, confusion, and a change in eyesight.
• Regular laboratory testing and imaging studies are usually required to monitor for side effects, liver and kidney function, or disease progression. Anemia and lymphopenia have also been reported.
• Opdivo may not be suitable for some people such as those with immune system problems such as Crohn’s disease, ulcerative colitis, or lupus, with lung or breathing problems, with liver disease, or who have had an organ transplant.
• Opdivo should not be given to pregnant women or those intending to become pregnant. Women who are taking Opdivo should also not breastfeed during treatment and for five months after their last dose.
• Opdivo does not need to be reconstituted before administration but does need to be diluted with either 0.9% sodium chloride Injection, USP or 5% dextrose Injection, USP to prepare an infusion with a final concentration ranging from 1 mg/mL to 10 mg/mL.
• Opdivo is expensive. The cost for Opdivo intravenous solution (10 mg/mL) is around $1,154 for a supply of 4 milliliters. For a 240mg infusion, this works out at $6,924 per dose.
• Use of Opdivo for certain types of cancer may be restricted to those people with a specific genetic marker (an abnormal "EGFR" or "ALK" gene).
• It is not yet clear what the optimum duration of therapy with Opdivo, but it is not a type of medication that patients continue to take indefinitely. When given for the adjuvant treatment of melanoma, Opdivo is given for up to a year. For other types of cancers, it may be given until disease progression occurs or unacceptable toxicity occurs. When used in combination with other treatments it is usually given for up to two years.
• No generic version of Opdivo is available.

Note: In general, seniors or children, people with certain medical conditions (such as liver or kidney problems, heart disease, diabetes, seizures) or people who take other medications are more at risk of developing a wider range of side effects. View complete list of side effects

• Opdivo can uncommonly cause your immune system to attack healthy organs and glands in your body. Ask your doctor or pharmacist for the Medication Guide, which lists side effects that may occur if your immune system is affected by pembrolizumab. Contact your doctor immediately if you experience any of these side effects to help keep them from becoming more serious.
• Tell your doctor immediately if you develop any severe side effects while taking Opdivo, such as shortness of breath; diarrhea; stools that are black, tarry, sticky, or contain blood or mucus; severe pain or tenderness in the stomach area; yellowing of your skin or the whites of your eyes; nausea or vomiting; dark urine; bleeding or bruising more easily than normal; rapid heartbeat; headaches; weight loss or weight gain; a skin rash; changes in eyesight; or any other side effects that you are concerned about.
• Tell your doctor about any medicines or supplements you take, including those brought from a drug store or grocery because some of these may interact with Opdivo. If you have any other medical conditions, make sure you let your doctor know about them.
• You may need to have a negative pregnancy test before starting Opdivo and use effective birth control to prevent pregnancy while taking Opdivo and for five months after your last dose. Opdivo can harm a developing baby. Tell your doctor right away if you inadvertently become pregnant.
• Do not breastfeed while you are being administered Opdivo and for five months after your last dose.
• You will need frequent medical tests while you are being treated with Opdivo. Do not miss any follow-up visits.
• If you are caring for somebody who is being given Opdivo, be aware that it can pass into body fluids (such as urine, feces, or vomit) for at least 48 hours after a dose. Wear rubber gloves when handling body fluids, handling contaminated trash or laundry. Wash hands before and after removing gloves. Wash soiled clothing and linens separately from other laundry.
• If you have any concerns about your cancer treatment talk with your doctor who knows your medical history and can recommend the best available treatment options for you.

• How effective Opdivo is depends on the type of cancer and how much it has spread, the age of the patient and what other comorbidities they have, and a few other variables. In general, PD-1 immune checkpoint inhibitors such as Opdivo have been shown to significantly prolong overall survival (OS) in certain patients over a wide range of cancer types. In some types of cancer, it provides no survival benefit over existing therapies, but patients may be more likely to respond to Opdivo than to other treatments. Opdivo does not work for everyone. Examples of survival rates include:
• Melanoma (unresectable or metastatic): 87% had ongoing responses ranging from 2.6+ to 10+ months; 13/38 had ongoing responses of ≥ 6 months; median duration of overall survival with Opdivo was 15.7 months vs dacarbazine or paclitaxel + carboplatin at 14.4 months.
• Non-small cell lung cancer - metastatic with PD-L1 expression level of ≥ 1%; median duration of overall survival Opdivo + Yervoy was 17.1 months vs chemotherapy at 14.9 months; overall survival rate for Opdivo was 40% at 2 years vs chemotherapy at 32.8%.
• Malignant pleural mesothelioma: median duration of overall survival for Opdivo + Yervoy was 18.1 months vs chemotherapy at 14.1 months; median progression-free survival for Opdivo + Yervoy was 6.8 months vs chemotherapy at 7.2 months.
• Renal cell carcinoma - advanced: median duration of overall survival Opdivo was 25.8 months vs Everolimus at 19.7 months. Progression-free survival was also improved in the Opdivo group
• For a detailed analysis of survival rates and the percentage of people who had a complete or partial response to treatment see How long does Opdivo prolong life and what’s its success rate?

Medicines that interact with Opdivo may either decrease its effect, affect how long it works for, increase side effects, or have less of an effect when taken with Opdivo. An interaction between two medications does not always mean that you must stop taking one of the medications; however, sometimes it does. Speak to your doctor about how drug interactions should be managed.

Common medications that may interact with Opdivo include:

• corticosteroids, such as betamethasone, budesonide, cortisone, dexamethasone, hydrocortisone, or prednisone
• idelalisib
• lenalidomide, pomalidomide, or thalidomide.

Increased mortality was reported when Opdivo was added to a thalidomide analog (such as lenalidomide) plus dexamethasone.

Note that this list is not all-inclusive and includes only common medications that may interact with Opdivo. You should refer to the prescribing information for Opdivo for a complete list of interactions.