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Indications

For Patients With Metastatic Non-Small Cell Lung Cancer (1 of 11)

OPDIVO^® (nivolumab), in combination with YERVOY^® (ipilimumab), is indicated for the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L1 (≥1%) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations.

OPDIVO, in combination with YERVOY and 2 cycles of platinum-doublet chemotherapy, is indicated for the first-line treatment of adult patients with metastatic or recurrent non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations.

OPDIVO is indicated for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving OPDIVO.

For Patients With Melanoma (2 of 11)

OPDIVO^® (nivolumab), as a single agent, is indicated for the treatment of patients with unresectable or metastatic melanoma.

OPDIVO, in combination with YERVOY^® (ipilimumab), is indicated for the treatment of patients with unresectable or metastatic melanoma.

OPDIVO is indicated for the adjuvant treatment of patients with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection.

For Patients With Advanced Renal Cell Carcinoma (3 of 11)

OPDIVO^® (nivolumab), in combination with YERVOY^® (ipilimumab), is indicated for the first-line treatment of patients with intermediate or poor risk advanced renal cell carcinoma (RCC).

OPDIVO, in combination with cabozantinib, is indicated for the first-line treatment of patients with advanced renal cell carcinoma (RCC).

OPDIVO is indicated for the treatment of patients with advanced renal cell carcinoma (RCC) who have received prior anti-angiogenic therapy.

For Patients With Unresectable Malignant Pleural Mesothelioma (4 of 11)

OPDIVO^® (nivolumab), in combination with YERVOY^® (ipilimumab), is indicated for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma (MPM).

For Patients With Gastric, Gastroesophageal Junction, and Esophageal Cancers (5 of 11)

OPDIVO^® (nivolumab) is indicated for the treatment of patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) after prior fluoropyrimidine- and platinum-based chemotherapy.

OPDIVO is indicated for the adjuvant treatment of completely resected esophageal or gastroesophageal junction cancer with residual pathologic disease in patients who have received neoadjuvant chemoradiotherapy (CRT).

OPDIVO, in combination with fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the treatment of patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma.

Squamous Cell Carcinoma of the Head (SCCHN) & Neck Icon

For Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck on or After Platinum-Based Therapy (6 of 11)

OPDIVO^® (nivolumab) is indicated for the treatment of patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) with disease progression on or after platinum-based therapy.

For Patients With Hepatocellular Carcinoma (HCC) Previously Treated With Sorafenib (7 of 11)

OPDIVO^® (nivolumab), in combination with YERVOY^® (ipilimumab), is indicated for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

For Patients With Urothelial Carcinoma (8 of 11)

OPDIVO^® (nivolumab) is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.

OPDIVO, as a single agent, is indicated for the adjuvant treatment of patients with urothelial carcinoma (UC) who are at high risk of recurrence after undergoing radical resection of UC.

For Adult Patients With MSI-H/dMMR Metastatic Colorectal Cancer That Has Progressed Following Treatment With a Fluoropyrimidine, Oxaliplatin, and Irinotecan (9 of 11)

For Patients (≥12 years) With MSI-H/dMMR Metastatic Colorectal Cancer That Has Progressed Following Treatment With a Fluoropyrimidine, Oxaliplatin, and Irinotecan (10 of 11)

OPDIVO^® (nivolumab), as a single agent, is indicated for the treatment of adult and pediatric (12 years and older) patients with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (CRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

For Adults With Relapsed or Progressed cHL After Autologous HSCT and Brentuximab Vedotin, or After 3 or More Lines of Therapy Including Autologous HSCT (11 of 11)

OPDIVO^® (nivolumab) is indicated for the treatment of adult patients with classical Hodgkin lymphoma (cHL) that has relapsed or progressed after autologous hematopoietic stem cell transplantation (HSCT) and brentuximab vedotin or after 3 or more lines of systemic therapy that includes autologous HSCT. This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

Important safety information

Severe and Fatal Immune-Mediated Adverse Reactions

Immune-mediated adverse reactions listed herein may not include all possible severe and fatal immune-mediated adverse reactions.

Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue. While immune-mediated adverse reactions usually manifest during treatment, they can also occur after discontinuation of OPDIVO or YERVOY. Early identification and management are essential to ensure safe use of OPDIVO and YERVOY. Monitor for signs and symptoms that may be clinical manifestations of underlying immune-mediated adverse reactions. Evaluate clinical chemistries including liver enzymes, creatinine, adrenocorticotropic hormone (ACTH) level, and thyroid function at baseline and periodically during treatment with OPDIVO and before each dose of YERVOY. In cases of suspected immune-mediated adverse reactions, initiate appropriate workup to exclude alternative etiologies, including infection. Institute medical management promptly, including specialty consultation as appropriate.

Withhold or permanently discontinue OPDIVO and YERVOY depending on severity (please see section 2 Dosage and Administration in the accompanying Full Prescribing Information). In general, if OPDIVO or YERVOY interruption or discontinuation is required, administer systemic corticosteroid therapy (1 to 2 mg/kg/day prednisone or equivalent) until improvement to Grade 1 or less. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Consider administration of other systemic immunosuppressants in patients whose immune-mediated adverse reactions are not controlled with corticosteroid therapy. Toxicity management guidelines for adverse reactions that do not necessarily require systemic steroids (e.g., endocrinopathies and dermatologic reactions) are discussed below.

Immune-Mediated Pneumonitis

OPDIVO and YERVOY can cause immune-mediated pneumonitis. The incidence of pneumonitis is higher in patients who have received prior thoracic radiation. In patients receiving OPDIVO monotherapy, immune-mediated pneumonitis occurred in 3.1% (61/1994) of patients, including Grade 4 (<0.1%), Grade 3 (0.9%), and Grade 2 (2.1%). In patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg every 3 weeks, immune-mediated pneumonitis occurred in 7% (31/456) of patients, including Grade 4 (0.2%), Grade 3 (2.0%), and Grade 2 (4.4%). In patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg every 3 weeks, immune-mediated pneumonitis occurred in 3.9% (26/666) of patients, including Grade 3 (1.4%) and Grade 2 (2.6%). In NSCLC patients receiving OPDIVO 3 mg/kg every 2 weeks with YERVOY 1 mg/kg every 6 weeks, immune-mediated pneumonitis occurred in 9% (50/576) of patients, including Grade 4 (0.5%), Grade 3 (3.5%), and Grade 2 (4.0%). Four patients (0.7%) died due to pneumonitis.

In Checkmate 205 and 039, pneumonitis, including interstitial lung disease, occurred in 6.0% (16/266) of patients receiving OPDIVO. Immune-mediated pneumonitis occurred in 4.9% (13/266) of patients receiving OPDIVO, including Grade 3 (n=1) and Grade 2 (n=12).

Immune-Mediated Colitis

OPDIVO and YERVOY can cause immune-mediated colitis, which may be fatal. A common symptom included in the definition of colitis was diarrhea. Cytomegalovirus (CMV) infection/reactivation has been reported in patients with corticosteroid-refractory immune-mediated colitis. In cases of corticosteroid-refractory colitis, consider repeating infectious workup to exclude alternative etiologies. In patients receiving OPDIVO monotherapy, immune-mediated colitis occurred in 2.9% (58/1994) of patients, including Grade 3 (1.7%) and Grade 2 (1%). In patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg every 3 weeks, immune-mediated colitis occurred in 25% (115/456) of patients, including Grade 4 (0.4%), Grade 3 (14%), and Grade 2 (8%). In patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg every 3 weeks, immune-mediated colitis occurred in 9% (60/666) of patients, including Grade 3 (4.4%) and Grade 2 (3.7%).

Immune-Mediated Hepatitis and Hepatotoxicity

OPDIVO and YERVOY can cause immune-mediated hepatitis. In patients receiving OPDIVO monotherapy, immune-mediated hepatitis occurred in 1.8% (35/1994) of patients, including Grade 4 (0.2%), Grade 3 (1.3%), and Grade 2 (0.4%). In patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg every 3 weeks, immune-mediated hepatitis occurred in 15% (70/456) of patients, including Grade 4 (2.4%), Grade 3 (11%), and Grade 2 (1.8%). In patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg every 3 weeks, immune-mediated hepatitis occurred in 7% (48/666) of patients, including Grade 4 (1.2%), Grade 3 (4.9%), and Grade 2 (0.4%).

OPDIVO in combination with cabozantinib can cause hepatic toxicity with higher frequencies of Grade 3 and 4 ALT and AST elevations compared to OPDIVO alone. Consider more frequent monitoring of liver enzymes as compared to when the drugs are administered as single agents. In patients receiving OPDIVO and cabozantinib, Grades 3 and 4 increased ALT or AST were seen in 11% of patients.

Immune-Mediated Endocrinopathies

OPDIVO and YERVOY can cause primary or secondary adrenal insufficiency, immune-mediated hypophysitis, immune-mediated thyroid disorders, and Type 1 diabetes mellitus, which can present with diabetic ketoacidosis. Withhold OPDIVO and YERVOY depending on severity (please see section 2 Dosage and Administration in the accompanying Full Prescribing Information). For Grade 2 or higher adrenal insufficiency, initiate symptomatic treatment, including hormone replacement as clinically indicated. Hypophysitis can present with acute symptoms associated with mass effect such as headache, photophobia, or visual field defects. Hypophysitis can cause hypopituitarism; initiate hormone replacement as clinically indicated. Thyroiditis can present with or without endocrinopathy. Hypothyroidism can follow hyperthyroidism; initiate hormone replacement or medical management as clinically indicated. Monitor patients for hyperglycemia or other signs and symptoms of diabetes; initiate treatment with insulin as clinically indicated.

In patients receiving OPDIVO monotherapy, adrenal insufficiency occurred in 1% (20/1994), including Grade 3 (0.4%) and Grade 2 (0.6%). In patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg every 3 weeks, adrenal insufficiency occurred in 8% (35/456), including Grade 4 (0.2%), Grade 3 (2.4%), and Grade 2 (4.2%). In patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg every 3 weeks, adrenal insufficiency occurred in 7% (48/666) of patients, including Grade 4 (0.3%), Grade 3 (2.5%), and Grade 2 (4.1%). In patients receiving OPDIVO and cabozantinib, adrenal insufficiency occurred in 4.7% (15/320) of patients, including Grade 3 (2.2%) and Grade 2 (1.9%).

In patients receiving OPDIVO monotherapy, hypophysitis occurred in 0.6% (12/1994) of patients, including Grade 3 (0.2%) and Grade 2 (0.3%). In patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg every 3 weeks, hypophysitis occurred in 9% (42/456), including Grade 3 (2.4%) and Grade 2 (6%). In patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg every 3 weeks, hypophysitis occurred in 4.4% (29/666) of patients, including Grade 4 (0.3%), Grade 3 (2.4%), and Grade 2 (0.9%).

In patients receiving OPDIVO monotherapy, thyroiditis occurred in 0.6% (12/1994) of patients, including Grade 2 (0.2%). In patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg every 3 weeks, thyroiditis occurred in 2.7% (22/666) of patients, including Grade 3 (4.5%) and Grade 2 (2.2%).

In patients receiving OPDIVO monotherapy, hyperthyroidism occurred in 2.7% (54/1994) of patients, including Grade 3 (<0.1%) and Grade 2 (1.2%). In patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg every 3 weeks, hyperthyroidism occurred in 9% (42/456) of patients, including Grade 3 (0.9%) and Grade 2 (4.2%). In patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg every 3 weeks, hyperthyroidism occurred in 12% (80/666) of patients, including Grade 3 (0.6%) and Grade 2 (4.5%).

In patients receiving OPDIVO monotherapy, hypothyroidism occurred in 8% (163/1994) of patients, including Grade 3 (0.2%) and Grade 2 (4.8%). In patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg every 3 weeks, hypothyroidism occurred in 20% (91/456) of patients, including Grade 3 (0.4%) and Grade 2 (11%). In patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg every 3 weeks, hypothyroidism occurred in 18% (122/666) of patients, including Grade 3 (0.6%) and Grade 2 (11%).

In patients receiving OPDIVO monotherapy, diabetes occurred in 0.9% (17/1994) of patients, including Grade 3 (0.4%) and Grade 2 (0.3%), and 2 cases of diabetic ketoacidosis. In patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg every 3 weeks, diabetes occurred in 2.7% (15/666) of patients, including Grade 4 (0.6%), Grade 3 (0.3%), and Grade 2 (0.9%).

Immune-Mediated Nephritis with Renal Dysfunction

OPDIVO and YERVOY can cause immune-mediated nephritis. In patients receiving OPDIVO monotherapy, immune-mediated nephritis and renal dysfunction occurred in 1.2% (23/1994) of patients, including Grade 4 (<0.1%), Grade 3 (0.5%), and Grade 2 (0.6%). In patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg every 3 weeks, immune-mediated nephritis with renal dysfunction occurred in 4.1% (27/666) of patients, including Grade 4 (0.6%), Grade 3 (1.1%), and Grade 2 (2.2%).

Immune-Mediated Dermatologic Adverse Reactions

OPDIVO can cause immune-mediated rash or dermatitis. Exfoliative dermatitis, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug rash with eosinophilia and systemic symptoms (DRESS) has occurred with PD-1/PD-L1 blocking antibodies. Topical emollients and/or topical corticosteroids may be adequate to treat mild to moderate nonexfoliative rashes.

YERVOY can cause immune-mediated rash or dermatitis, including bullous and exfoliative dermatitis, SJS, TEN, and DRESS. Topical emollients and/or topical corticosteroids may be adequate to treat mild to moderate non-bullous/exfoliative rashes.

Withhold or permanently discontinue OPDIVO and YERVOY depending on severity (please see section 2 Dosage and Administration in the accompanying Full Prescribing Information).

In patients receiving OPDIVO monotherapy, immune-mediated rash occurred in 9% (171/1994) of patients, including Grade 3 (1.1%) and Grade 2 (2.2%). In patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg every 3 weeks, immune-mediated rash occurred in 28% (127/456) of patients, including Grade 3 (4.8%) and Grade 2 (10%). In patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg every 3 weeks, immune-mediated rash occurred in 16% (108/666) of patients, including Grade 3 (3.5%) and Grade 2 (4.2%).

Other Immune-Mediated Adverse Reactions

The following clinically significant immune-mediated adverse reactions occurred at an incidence of <1% (unless otherwise noted) in patients who received OPDIVO monotherapy or OPDIVO in combination with YERVOY or were reported with the use of other PD-1/PD-L1 blocking antibodies. Severe or fatal cases have been reported for some of these adverse reactions: cardiac/vascular: myocarditis, pericarditis, vasculitis; nervous system: meningitis, encephalitis, myelitis and demyelination, myasthenic syndrome/myasthenia gravis (including exacerbation), Guillain-Barré syndrome, nerve paresis, autoimmune neuropathy; ocular: uveitis, iritis, and other ocular inflammatory toxicities can occur; gastrointestinal: pancreatitis to include increases in serum amylase and lipase levels, gastritis, duodenitis; musculoskeletal and connective tissue: myositis/polymyositis, rhabdomyolysis, and associated sequelae including renal failure, arthritis, polymyalgia rheumatica; endocrine: hypoparathyroidism; other (hematologic/immune): hemolytic anemia, aplastic anemia, hemophagocytic lymphohistiocytosis (HLH), systemic inflammatory response syndrome, histiocytic necrotizing lymphadenitis (Kikuchi lymphadenitis), sarcoidosis, immune thrombocytopenic purpura, solid organ transplant rejection.

In addition to the immune-mediated adverse reactions listed above, across clinical trials of YERVOY monotherapy or in combination with OPDIVO, the following clinically significant immune-mediated adverse reactions, some with fatal outcome, occurred in <1% of patients unless otherwise specified: nervous system: autoimmune neuropathy (2%), myasthenic syndrome/myasthenia gravis, motor dysfunction; cardiovascular: angiopathy, temporal arteritis; ocular: blepharitis, episcleritis, orbital myositis, scleritis; gastrointestinal: pancreatitis (1.3%); other (hematologic/immune): conjunctivitis, cytopenias (2.5%), eosinophilia (2.1%), erythema multiforme, hypersensitivity vasculitis, neurosensory hypoacusis, psoriasis.

Some ocular IMAR cases can be associated with retinal detachment. Various grades of visual impairment, including blindness, can occur. If uveitis occurs in combination with other immune-mediated adverse reactions, consider a Vogt-Koyanagi-Harada–like syndrome, which has been observed in patients receiving OPDIVO and YERVOY, as this may require treatment with systemic corticosteroids to reduce the risk of permanent vision loss.

Infusion-Related Reactions

OPDIVO and YERVOY can cause severe infusion-related reactions. Discontinue OPDIVO and YERVOY in patients with severe (Grade 3) or life-threatening (Grade 4) infusion-related reactions. Interrupt or slow the rate of infusion in patients with mild (Grade 1) or moderate (Grade 2) infusion-related reactions. In patients receiving OPDIVO monotherapy as a 60-minute infusion, infusion-related reactions occurred in 6.4% (127/1994) of patients. In a separate trial in which patients received OPDIVO monotherapy as a 60-minute infusion or a 30-minute infusion, infusion-related reactions occurred in 2.2% (8/368) and 2.7% (10/369) of patients, respectively. Additionally, 0.5% (2/368) and 1.4% (5/369) of patients, respectively, experienced adverse reactions within 48 hours of infusion that led to dose delay, permanent discontinuation or withholding of OPDIVO. In melanoma patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg every 3 weeks, infusion-related reactions occurred in 2.5% (10/407) of patients. In HCC patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg every 3 weeks, infusion-related reactions occurred in 8% (4/49) of patients. In RCC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg every 3 weeks, infusion-related reactions occurred in 5.1% (28/547) of patients. In MSI-H/dMMR mCRC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg every 3 weeks, infusion-related reactions occurred in 4.2% (5/119) of patients. In MPM patients receiving OPDIVO 3 mg/kg every 2 weeks with YERVOY 1 mg/kg every 6 weeks, infusion-related reactions occurred in 12% (37/300) of patients.

Complications of Allogeneic Hematopoietic Stem Cell Transplantation

Fatal and other serious complications can occur in patients who receive allogeneic hematopoietic stem cell transplantation (HSCT) before or after being treated with OPDIVO or YERVOY. Transplant-related complications include hyperacute graft-versus-host-disease (GVHD), acute GVHD, chronic GVHD, hepatic veno-occlusive disease (VOD) after reduced intensity conditioning, and steroid-requiring febrile syndrome (without an identified infectious cause). These complications may occur despite intervening therapy between OPDIVO or YERVOY and allogeneic HSCT.

Follow patients closely for evidence of transplant-related complications and intervene promptly. Consider the benefit versus risks of treatment with OPDIVO and YERVOY prior to or after an allogeneic HSCT.

Embryo-Fetal Toxicity

Based on its mechanism of action and findings from animal studies, OPDIVO and YERVOY can cause fetal harm when administered to a pregnant woman. The effects of YERVOY are likely to be greater during the second and third trimesters of pregnancy. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with OPDIVO and YERVOY and for at least 5 months after the last dose.

Increased Mortality in Patients with Multiple Myeloma when OPDIVO is Added to a Thalidomide Analogue and Dexamethasone

In randomized clinical trials in patients with multiple myeloma, the addition of OPDIVO to a thalidomide analogue plus dexamethasone resulted in increased mortality. Treatment of patients with multiple myeloma with a PD-1 or PD-L1 blocking antibody in combination with a thalidomide analogue plus dexamethasone is not recommended outside of controlled clinical trials.

Lactation

There are no data on the presence of OPDIVO or YERVOY in human milk, the effects on the breastfed child, or the effects on milk production. Because of the potential for serious adverse reactions in breastfed children, advise women not to breastfeed during treatment and for 5 months after the last dose.

Serious Adverse Reactions

In Checkmate 037, serious adverse reactions occurred in 41% of patients receiving OPDIVO (n=268). Grade 3 and 4 adverse reactions occurred in 42% of patients receiving OPDIVO. The most frequent Grade 3 and 4 adverse drug reactions reported in 2% to <5% of patients receiving OPDIVO were abdominal pain, hyponatremia, increased aspartate aminotransferase, and increased lipase. In Checkmate 066, serious adverse reactions occurred in 36% of patients receiving OPDIVO (n=206). Grade 3 and 4 adverse reactions occurred in 41% of patients receiving OPDIVO. The most frequent Grade 3 and 4 adverse reactions reported in ≥2% of patients receiving OPDIVO were gamma-glutamyltransferase increase (3.9%) and diarrhea (3.4%). In Checkmate 067, serious adverse reactions (74% and 44%), adverse reactions leading to permanent discontinuation (47% and 18%) or to dosing delays (58% and 36%), and Grade 3 or 4 adverse reactions (72% and 51%) all occurred more frequently in the OPDIVO plus YERVOY arm (n=313) relative to the OPDIVO arm (n=313). The most frequent (≥10%) serious adverse reactions in the OPDIVO plus YERVOY arm and the OPDIVO arm, respectively, were diarrhea (13% and 2.2%), colitis (10% and 1.9%), and pyrexia (10% and 1.0%). In Checkmate 227, serious adverse reactions occurred in 58% of patients (n=576). The most frequent (≥2%) serious adverse reactions were pneumonia, diarrhea/colitis, pneumonitis, hepatitis, pulmonary embolism, adrenal insufficiency, and hypophysitis. Fatal adverse reactions occurred in 1.7% of patients; these included events of pneumonitis (4 patients), myocarditis, acute kidney injury, shock, hyperglycemia, multi-system organ failure, and renal failure. In Checkmate 9LA, serious adverse reactions occurred in 57% of patients (n=358). The most frequent (>2%) serious adverse reactions were pneumonia, diarrhea, febrile neutropenia, anemia, acute kidney injury, musculoskeletal pain, dyspnea, pneumonitis, and respiratory failure. Fatal adverse reactions occurred in 7 (2%) patients, and included hepatic toxicity, acute renal failure, sepsis, pneumonitis, diarrhea with hypokalemia, and massive hemoptysis in the setting of thrombocytopenia. In Checkmate 017 and 057, serious adverse reactions occurred in 46% of patients receiving OPDIVO (n=418). The most frequent serious adverse reactions reported in ≥2% of patients receiving OPDIVO were pneumonia, pulmonary embolism, dyspnea, pyrexia, pleural effusion, pneumonitis, and respiratory failure. In Checkmate 057, fatal adverse reactions occurred; these included events of infection (7 patients, including one case of Pneumocystis jirovecii pneumonia), pulmonary embolism (4 patients), and limbic encephalitis (1 patient). In Checkmate 743, serious adverse reactions occurred in 54% of patients receiving OPDIVO plus YERVOY. The most frequent serious adverse reactions reported in ≥2% of patients were pneumonia, pyrexia, diarrhea, pneumonitis, pleural effusion, dyspnea, acute kidney injury, infusion-related reaction, musculoskeletal pain, and pulmonary embolism. Fatal adverse reactions occurred in 4 (1.3%) patients and included pneumonitis, acute heart failure, sepsis, and encephalitis. In Checkmate 214, serious adverse reactions occurred in 59% of patients receiving OPDIVO plus YERVOY (n=547). The most frequent serious adverse reactions reported in ≥2% of patients were diarrhea, pyrexia, pneumonia, pneumonitis, hypophysitis, acute kidney injury, dyspnea, adrenal insufficiency, and colitis. In Checkmate 9ER, serious adverse reactions occurred in 48% of patients receiving OPDIVO and cabozantinib (n=320). The most frequent serious adverse reactions reported in ≥2% of patients were diarrhea, pneumonia, pneumonitis, pulmonary embolism, urinary tract infection, and hyponatremia. Fatal intestinal perforations occurred in 3 (0.9%) patients. In Checkmate 025, serious adverse reactions occurred in 47% of patients receiving OPDIVO (n=406). The most frequent serious adverse reactions reported in ≥2% of patients were acute kidney injury, pleural effusion, pneumonia, diarrhea, and hypercalcemia. In Checkmate 205 and 039, adverse reactions leading to discontinuation occurred in 7% and dose delays due to adverse reactions occurred in 34% of patients (n=266). Serious adverse reactions occurred in 26% of patients. The most frequent serious adverse reactions reported in ≥1% of patients were pneumonia, infusion-related reaction, pyrexia, colitis or diarrhea, pleural effusion, pneumonitis, and rash. Eleven patients died from causes other than disease progression: 3 from adverse reactions within 30 days of the last OPDIVO dose, 2 from infection 8 to 9 months after completing OPDIVO, and 6 from complications of allogeneic HSCT. In Checkmate 141, serious adverse reactions occurred in 49% of patients receiving OPDIVO (n=236). The most frequent serious adverse reactions reported in ≥2% of patients receiving OPDIVO were pneumonia, dyspnea, respiratory failure, respiratory tract infection, and sepsis. In Checkmate 275, serious adverse reactions occurred in 54% of patients receiving OPDIVO (n=270). The most frequent serious adverse reactions reported in ≥2% of patients receiving OPDIVO were urinary tract infection, sepsis, diarrhea, small intestine obstruction, and general physical health deterioration. In Checkmate 274, serious adverse reactions occurred in 30% of patients receiving OPDIVO (n=351). The most frequent serious adverse reaction reported in ≥2% of patients receiving OPDIVO was urinary tract infection. Fatal adverse reactions occurred in 1% of patients; these included events of pneumonitis (0.6%). In Checkmate 142 in MSI-H/dMMR mCRC patients receiving OPDIVO with YERVOY (n=119), serious adverse reactions occurred in 47% of patients. The most frequent serious adverse reactions reported in ≥2% of patients were colitis/diarrhea, hepatic events, abdominal pain, acute kidney injury, pyrexia, and dehydration. In Checkmate 040, serious adverse reactions occurred in 59% of patients receiving OPDIVO with YERVOY (n=49). Serious adverse reactions reported in ≥4% of patients were pyrexia, diarrhea, anemia, increased AST, adrenal insufficiency, ascites, esophageal varices hemorrhage, hyponatremia, increased blood bilirubin, and pneumonitis. In Checkmate 238, serious adverse reactions occurred in 18% of patients receiving OPDIVO (n=452). Grade 3 or 4 adverse reactions occurred in 25% of OPDIVO-treated patients (n=452). The most frequent Grade 3 and 4 adverse reactions reported in ≥2% of OPDIVO-treated patients were diarrhea and increased lipase and amylase. In Attraction-3, serious adverse reactions occurred in 38% of patients receiving OPDIVO (n=209). Serious adverse reactions reported in ≥2% of patients who received OPDIVO were pneumonia, esophageal fistula, interstitial lung disease, and pyrexia. The following fatal adverse reactions occurred in patients who received OPDIVO: interstitial lung disease or pneumonitis (1.4%), pneumonia (1.0%), septic shock (0.5%), esophageal fistula (0.5%), gastrointestinal hemorrhage (0.5%), pulmonary embolism (0.5%), and sudden death (0.5%). In Checkmate 577, serious adverse reactions occurred in 33% of patients receiving OPDIVO (n=532). A serious adverse reaction reported in ≥2% of patients who received OPDIVO was pneumonitis. A fatal reaction of myocardial infarction occurred in one patient who received OPDIVO. In Checkmate 649, serious adverse reactions occurred in 52% of patients treated with OPDIVO in combination with chemotherapy (n=782). The most frequent serious adverse reactions reported in ≥2% of patients treated with OPDIVO in combination with chemotherapy were vomiting (3.7%), pneumonia (3.6%), anemia (3.6%), pyrexia (2.8%), diarrhea (2.7%), febrile neutropenia (2.6%), and pneumonitis (2.4%). Fatal adverse reactions occurred in 16 (2.0%) patients who were treated with OPDIVO in combination with chemotherapy; these included pneumonitis (4 patients), febrile neutropenia (2 patients), stroke (2 patients), gastrointestinal toxicity, intestinal mucositis, septic shock, pneumonia, infection, gastrointestinal bleeding, mesenteric vessel thrombosis, and disseminated intravascular coagulation.

Common Adverse Reactions

In Checkmate 037, the most common adverse reaction (≥20%) reported with OPDIVO (n=268) was rash (21%). In Checkmate 066, the most common adverse reactions (≥20%) reported with OPDIVO (n=206) vs dacarbazine (n=205) were fatigue (49% vs 39%), musculoskeletal pain (32% vs 25%), rash (28% vs 12%), and pruritus (23% vs 12%). In Checkmate 067, the most common (≥20%) adverse reactions in the OPDIVO plus YERVOY arm (n=313) were fatigue (62%), diarrhea (54%), rash (53%), nausea (44%), pyrexia (40%), pruritus (39%), musculoskeletal pain (32%), vomiting (31%), decreased appetite (29%), cough (27%), headache (26%), dyspnea (24%), upper respiratory tract infection (23%), arthralgia (21%), and increased transaminases (25%). In Checkmate 067, the most common (≥20%) adverse reactions in the OPDIVO arm (n=313) were fatigue (59%), rash (40%), musculoskeletal pain (42%), diarrhea (36%), nausea (30%), cough (28%), pruritus (27%), upper respiratory tract infection (22%), decreased appetite (22%), headache (22%), constipation (21%), arthralgia (21%), and vomiting (20%). In Checkmate 227, the most common (≥20%) adverse reactions were fatigue (44%), rash (34%), decreased appetite (31%), musculoskeletal pain (27%), diarrhea/colitis (26%), dyspnea (26%), cough (23%), hepatitis (21%), nausea (21%), and pruritus (21%). In Checkmate 9LA, the most common (>20%) adverse reactions were fatigue (49%), musculoskeletal pain (39%), nausea (32%), diarrhea (31%), rash (30%), decreased appetite (28%), constipation (21%), and pruritus (21%). In Checkmate 017 and 057, the most common adverse reactions (≥20%) in patients receiving OPDIVO (n=418) were fatigue, musculoskeletal pain, cough, dyspnea, and decreased appetite. In Checkmate 743, the most common adverse reactions (≥20%) in patients receiving OPDIVO plus YERVOY were fatigue (43%), musculoskeletal pain (38%), rash (34%), diarrhea (32%), dyspnea (27%), nausea (24%), decreased appetite (24%), cough (23%), and pruritus (21%). In Checkmate 214, the most common adverse reactions (≥20%) reported in patients treated with OPDIVO plus YERVOY (n=547) were fatigue (58%), rash (39%), diarrhea (38%), musculoskeletal pain (37%), pruritus (33%), nausea (30%), cough (28%), pyrexia (25%), arthralgia (23%), decreased appetite (21%), dyspnea (20%), and vomiting (20%). In Checkmate 9ER, the most common adverse reactions (≥20%) in patients receiving OPDIVO and cabozantinib (n=320) were diarrhea (64%), fatigue (51%), hepatotoxicity (44%), palmar-plantar erythrodysaesthesia syndrome (40%), stomatitis (37%), rash (36%), hypertension (36%), hypothyroidism (34%), musculoskeletal pain (33%), decreased appetite (28%), nausea (27%), dysgeusia (24%), abdominal pain (22%), cough (20%) and upper respiratory tract infection (20%). In Checkmate 025, the most common adverse reactions (≥20%) reported in patients receiving OPDIVO (n=406) vs everolimus (n=397) were fatigue (56% vs 57%), cough (34% vs 38%), nausea (28% vs 29%), rash (28% vs 36%), dyspnea (27% vs 31%), diarrhea (25% vs 32%), constipation (23% vs 18%), decreased appetite (23% vs 30%), back pain (21% vs 16%), and arthralgia (20% vs 14%). In Checkmate 205 and 039, the most common adverse reactions (≥20%) reported in patients receiving OPDIVO (n=266) were upper respiratory tract infection (44%), fatigue (39%), cough (36%), diarrhea (33%), pyrexia (29%), musculoskeletal pain (26%), rash (24%), nausea (20%) and pruritus (20%). In Checkmate 141, the most common adverse reactions (≥10%) in patients receiving OPDIVO (n=236) were cough (14%) and dyspnea (14%) at a higher incidence than investigator’s choice. In Checkmate 275, the most common adverse reactions (≥20%) reported in patients receiving OPDIVO (n=270) were fatigue (46%), musculoskeletal pain (30%), nausea (22%), and decreased appetite (22%). In Checkmate 274, the most common adverse reactions (≥20%) reported in patients receiving OPDIVO (n=351) were rash (36%), fatigue (36%), diarrhea (30%), pruritus (30%), musculoskeletal pain (28%), and urinary tract infection (22%). In Checkmate 142 in MSI-H/dMMR mCRC patients receiving OPDIVO as a single agent (n=74), the most common adverse reactions (≥20%) were fatigue (54%), diarrhea (43%), abdominal pain (34%), nausea (34%), vomiting (28%), musculoskeletal pain (28%), cough (26%), pyrexia (24%), rash (23%), constipation (20%), and upper respiratory tract infection (20%). In Checkmate 142 in MSI-H/dMMR mCRC patients receiving OPDIVO with YERVOY (n=119), the most common adverse reactions (≥20%) were fatigue (49%), diarrhea (45%), pyrexia (36%), musculoskeletal pain (36%), abdominal pain (30%), pruritus (28%), nausea (26%), rash (25%), decreased appetite (20%), and vomiting (20%). In Checkmate 040, the most common adverse reactions (≥20%) in patients receiving OPDIVO with YERVOY (n=49), were rash (53%), pruritus (53%), musculoskeletal pain (41%), diarrhea (39%), cough (37%), decreased appetite (35%), fatigue (27%), pyrexia (27%), abdominal pain (22%), headache (22%), nausea (20%), dizziness (20%), hypothyroidism (20%), and weight decreased (20%). In Checkmate 238, the most common adverse reactions (≥20%) reported in OPDIVO-treated patients (n=452) vs ipilimumab-treated patients (n=453) were fatigue (57% vs 55%), diarrhea (37% vs 55%), rash (35% vs 47%), musculoskeletal pain (32% vs 27%), pruritus (28% vs 37%), headache (23% vs 31%), nausea (23% vs 28%), upper respiratory infection (22% vs 15%), and abdominal pain (21% vs 23%). The most common immune-mediated adverse reactions were rash (16%), diarrhea/colitis (6%), and hepatitis (3%). In Attraction-3, the most common adverse reactions (≥20%) in OPDIVO-treated patients (n=209) were rash (22%) and decreased appetite (21%). In Checkmate 577, the most common adverse reactions (≥20%) in patients receiving OPDIVO (n=532) were fatigue (34%), diarrhea (29%), nausea (23%), rash (21%), musculoskeletal pain (21%), and cough (20%). In Checkmate 649, the most common adverse reactions (≥20%) in patients treated with OPDIVO in combination with chemotherapy (n=782) were peripheral neuropathy (53%), nausea (48%), fatigue (44%), diarrhea (39%), vomiting (31%), decreased appetite (29%), abdominal pain (27%), constipation (25%), and musculoskeletal pain (20%).

Please see US Full Prescribing Information for OPDIVO and YERVOY.

Clinical Trials and Patient Populations

Checkmate 037–previously treated metastatic melanoma; Checkmate 066–previously untreated metastatic melanoma; Checkmate 067–previously untreated metastatic melanoma, as a single agent or in combination with YERVOY; Checkmate 227–previously untreated metastatic non-small cell lung cancer, in combination with YERVOY; Checkmate 9LA–previously untreated recurrent or metastatic non-small cell lung cancer in combination with YERVOY and 2 cycles of platinum-doublet chemotherapy by histology; Checkmate 017–second-line treatment of metastatic squamous non-small cell lung cancer; Checkmate 057–second-line treatment of metastatic non-squamous non-small cell lung cancer; Checkmate 743–previously untreated unresectable malignant pleural mesothelioma, in combination with YERVOY; Checkmate 214–previously untreated renal cell carcinoma, in combination with YERVOY; Checkmate 9ER–previously untreated renal cell carcinoma, in combination with cabozantinib; Checkmate 025–previously treated renal cell carcinoma; Checkmate 205/039–classical Hodgkin lymphoma; Checkmate 141–recurrent or metastatic squamous cell carcinoma of the head and neck; Checkmate 275–previously treated advanced or metastatic urothelial carcinoma; Checkmate 274-adjuvant treatment of urothelial carcinoma; Checkmate 142–MSI-H or dMMR metastatic colorectal cancer, as a single agent or in combination with YERVOY; Checkmate 040–hepatocellular carcinoma, in combination with YERVOY; Checkmate 238–adjuvant treatment of melanoma; Attraction-3–esophageal squamous cell carcinoma; Checkmate 577–adjuvant treatment of esophageal or gastroesophageal junction cancer; Checkmate 649–previously untreated advanced or metastatic gastric or gastroesophageal junction or esophageal adenocarcinoma

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OPDIVO Prescribing Information
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YERVOY Medication Guide

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DOSING SCHEDULES

OPDIVO® offers a choice of dosing schedules for certain indications.
Please refer to the approved recommendations by indication for specific
details.

Select an Indication

Please see full indications below. If viewing on a mobile device, tap “Indications” at the top of this page.

Dosing Guide

Learn about dosing for OPDIVO and OPDIVO-based combinations across all indications.

Download the Guide

1L Metastatic Non-Small Cell Lung Cancer (PD-L1 ≥1%)¹

OPDIVO + YERVOY

Dosing and Schedule

Duration


Weight-based dosing^†‡ 3 mg/kg of OPDIVO IV infusion over 30 minutes q2w with 1 mg/kg of YERVOY IV infusion over 30 minutes q6w	In combination with ipilimumab, until disease progression, unacceptable toxicity, or up to 2 years in patients without disease progression

1L Metastatic or Recurrent Non-Small Cell Lung Cancer¹

OPDIVO + YERVOY with 2 cycles of histology-based platinum-doublet chemotherapy

Dosing and Schedule^†‡

Duration


OPDIVO + YERVOY 360 mg of OPDIVO IV infusion over 30 minutes q3w with 1 mg/kg of YERVOY IV infusion over 30 minutes q6w AND	In combination with ipilimumab, until disease progression, unacceptable toxicity, or up to 2 years in patients without disease progression

Platinum-doublet
chemotherapy

Histology-based platinum-
doublet chemotherapy q3w

2 cycles of histology-based
platinum-doublet chemotherapy

Histology-based chemo; SQ patients: carboplatin AUC 6 + paclitaxel 200 mg/m² q3w; NSQ patients: carboplatin AUC 5 or 6 or cisplatin 75 mg/m² + pemetrexed 500 mg/m² q3w with optional pemetrexed maintenance therapy.

For the r/m NSCLC dosing regimen in combination with chemo: on the first week, 4 agents will be administered (OPDIVO 360 mg + YERVOY 1 mg/kg + histology-based chemo), followed by 3 agents (OPDIVO + histology-based chemo) on the third week, 2 agents (OPDIVO + YERVOY) on the sixth week, and OPDIVO monotherapy on the ninth week, followed by maintenance therapy of OPDIVO + YERVOY.

2L Metastatic Non-Small Cell Lung Cancer

OPDIVO Monotherapy


OPDIVO 240 mg IV infusion q2w or OPDIVO 480 mg IV infusion q4w^§	Treat until disease progression OR unacceptable toxicity

No premedications are required with OPDIVO and YERVOY. *Information on FDA-approved tests for the determination of PD-L1 expression in NSCLC is available at http://www.fda.gov/CompanionDiagnostics. ^†When OPDIVO is administered in combination with YERVOY, if OPDIVO is withheld or discontinued, YERVOY should also be withheld or discontinued.¹ ^‡Interrupt or slow the rate of infusion in patients with mild or moderate infusion-related reactions. Discontinue OPDIVO or OPDIVO + YERVOY in patients with severe or life-threatening infusion-related reactions.¹ ^§Based on exploratory dose–exposure–response relationships for efficacy and safety, OPDIVO 240 mg q2w and 480 mg q4w are predicted to be similar.³ Review the U.S. Full Prescribing Information for OPDIVO and YERVOY. 1L=first-line; 2L=second-line; AUC=area under the curve; IV=intravenous; NSQ=non-squamous; q2w=every 2 weeks; q3w=every 3 weeks; q4w=every 4 weeks; q6w=every 6 weeks; r/m NSCLC=recurrent or metastatic non-small cell lung cancer; SQ=squamous.

1L Metastatic Non-Small Cell Lung Cancer (PD-L1 ≥1%)¹

OPDIVO + YERVOY

Dosing and Schedule

Weight-based dosing^†‡
3 mg/kg of OPDIVO IV infusion over 30 minutes q2w WITH 1 mg/kg of YERVOY IV infusion over 30 minutes q6w

Duration

Weight-based dosing^†‡
In combination with ipilimumab, until disease progression, unacceptable toxicity, or up to 2 years in patients without disease progression

1L Metastatic or Recurrent Non-Small Cell Lung Cancer¹

OPDIVO + YERVOY with 2 cycles of
histology-based platinum-doublet
chemotherapy

Dosing and Schedule^†‡

OPDIVO + YERVOY
360 mg of OPDIVO IV infusion over 30 minutes q3w WITH 1 mg/kg of YERVOY IV infusion over 30 minutes q6w AND
Platinum-doublet chemotherapy
Histology-based platinum-doublet chemotherapy q3w

Duration

OPDIVO + YERVOY
In combination with ipilimumab, until disease progression, unacceptable toxicity, or up to 2 years in patients without disease progression
Platinum-doublet chemotherapy
2 cycles of histology-based platinum-doublet chemotherapy
Histology-based chemo; SQ patients: carboplatin AUC 6 + paclitaxel 200 mg/m² q3w; NSQ patients: carboplatin AUC 5 or 6 or cisplatin 75 mg/m² + pemetrexed 500 mg/m² q3w with optional pemetrexed maintenance therapy. For the r/m NSCLC dosing regimen in combination with chemo: on the first week, 4 agents will be administered (OPDIVO 360 mg + YERVOY 1 mg/kg + histology-based chemo), followed by 3 agents (OPDIVO + histology-based chemo) on the third week, 2 agents (OPDIVO + YERVOY) on the sixth week, and OPDIVO monotherapy on the ninth week, followed by maintenance therapy of OPDIVO + YERVOY.

2L Metastatic Non-Small Cell Lung Cancer

OPDIVO Monotherapy

Dosing and Schedule^†‡

OPDIVO 240 mg IV infusion q2w
or
OPDIVO 480 mg IV infusion q4w^§

Duration

Treat until disease progression
or
unacceptable toxicity

OPDIVO^® (nivolumab), as a single agent, is indicated for the treatment of patients with unresectable or metastatic melanoma.

OPDIVO, in combination with YERVOY^® (ipilimumab), is indicated for the treatment of patients with unresectable or metastatic melanoma.

Unresectable or Metastatic Melanoma¹

OPDIVO + YERVOY

Dosing and Schedule

Duration


Induction phase*^† (weight-based) 1 mg/kg of OPDIVO IV infusion over 30 minutes followed on the same day by 3 mg/kg of YERVOY IV infusion over 90 minutes	q3w for a maximum of 4 doses OR until disease progression OR unacceptable toxicity, whichever occurs earlier

Maintenance phase OPDIVO 240 mg IV infusion q2w or OPDIVO 480 mg IV infusion q4w^‡	Treat until disease progression OR unacceptable toxicity
After completing 4 doses of the combination in the induction phase, administer OPDIVO as a single agent.

OPDIVO Monotherapy


OPDIVO 240 mg IV infusion q2w or OPDIVO 480 mg IV infusion q4w^‡	Treat until disease progression OR unacceptable toxicity

No premedications are required. *When OPDIVO is administered in combination with YERVOY, if OPDIVO is withheld or discontinued, YERVOY should also be withheld or discontinued.¹ ^†Interrupt or slow the rate of infusion in patients with mild or moderate infusion-related reactions. Discontinue OPDIVO or OPDIVO + YERVOY in patients with severe or life-threatening infusion-related reactions.¹ ^‡Based on exploratory dose–exposure–response relationships for efficacy and safety, OPDIVO 240 mg q2w and 480 mg q4w are predicted to be similar.³ Review the U.S. Full Prescribing Information for OPDIVO and YERVOY. IV=intravenous; q2w=every 2 weeks; q3w=every 3 weeks; q4w=every 4 weeks.

Unresectable or Metastatic Melanoma¹

OPDIVO + YERVOY

Dosing and Schedule

Induction phase*^† (weight-based)
1 mg/kg of OPDIVO IV infusion over 30 minutes followed on the same day by 3 mg/kg of YERVOY IV infusion over 90 minutes
Maintenance phase
OPDIVO 240 mg IV infusion q2w or OPDIVO 480 mg IV infusion q4w^‡
After completing 4 doses of the combination in the induction phase, administer OPDIVO as a single agent.

Duration

Induction phase*^† (weight-based)
q3w for a maximum of 4 doses OR until disease progression OR unacceptable toxicity, whichever occurs earlier
Maintenance phase
Treat until disease progression or unacceptable toxicity
After completing 4 doses of the combination in the induction phase, administer OPDIVO as a single agent.

OPDIVO Monotherapy

Dosing and Schedule

OPDIVO 240 mg IV infusion q2w
or
OPDIVO 480 mg IV infusion q4w^‡

Duration

Treat until disease progression
or
unacceptable toxicity

OPDIVO^® (nivolumab) is indicated for the adjuvant treatment of patients with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection.

Adjuvant Treatment of Melanoma¹

OPDIVO Monotherapy

Dosing and Schedule

Duration


OPDIVO 240 mg IV infusion q2w or OPDIVO 480 mg IV infusion q4w*	Treat until disease recurrence OR unacceptable toxicity for up to 1 year

No premedications are required. *Based on exploratory dose–exposure–response relationships for efficacy and safety, OPDIVO 240 mg q2w and 480 mg q4w are predicted to be similar.³ ^†Interrupt or slow the rate of infusion in patients with mild or moderate infusion-related reactions. Discontinue OPDIVO in patients with severe or life-threatening infusion-related reactions.¹ IV=intravenous; q2w=every 2 weeks; q4w=every 4 weeks.

Adjuvant Treatment of Melanoma¹

OPDIVO Monotherapy

Dosing and Schedule

OPDIVO 240 mg IV
infusion q2w
or
OPDIVO 480 mg IV
infusion q4w*

Duration

Treat until disease recurrence
or
unacceptable toxicity
for up to 1 year

OPDIVO^® (nivolumab), in combination with YERVOY^® (ipilimumab), is indicated for the first-line treatment of patients with intermediate or poor risk advanced renal cell carcinoma (RCC).

OPDIVO, in combination with cabozantinib, is indicated for the first-line treatment of patients with advanced renal cell carcinoma (RCC).

OPDIVO is indicated for the treatment of patients with advanced renal cell carcinoma (RCC) who have received prior anti-angiogenic therapy.

Advanced Renal Cell Carcinoma¹

OPDIVO + YERVOY

Dosing and Schedule

Duration


Induction phase* ^† (weight-based) 3 mg/kg of OPDIVO IV infusion over 30 minutes followed on the same day by 1 mg/kg of YERVOY IV infusion over 30 minutes	q3w for 4 doses of combination therapy OR until disease progression OR unacceptable toxicity

Maintenance phase OPDIVO 240 mg IV infusion q2w or OPDIVO 480 mg IV infusion q4w^‡	Treat until disease progression OR unacceptable toxicity
After completing 4 doses of combination therapy with YERVOY, administer OPDIVO as a single agent.

OPDIVO + Cabozantinib

OPDIVO

OPDIVO 240 mg IV infusion q2w
or
OPDIVO 480 mg IV infusion q4w^‡

Cabozantinib

Administer OPDIVO in combination with
cabozantinib 40 mg orally once daily
without food

OPDIVO: Until disease
progression, unacceptable
toxicity, or up to 2 years

Cabozantinib: Until disease
progression or unacceptable
toxicity

OPDIVO Monotherapy


OPDIVO 240 mg IV infusion q2w or OPDIVO 480 mg IV infusion q4w^‡	Treat until disease progression OR unacceptable toxicity

No premedications are required. *When OPDIVO is administered in combination with YERVOY, if OPDIVO is withheld or discontinued, YERVOY should also be withheld or discontinued.¹ ^†Interrupt or slow the rate of infusion in patients with mild or moderate infusion-related reactions. Discontinue OPDIVO or OPDIVO + YERVOY in patients with severe or life-threatening infusion-related reactions.¹ ^‡Based on exploratory dose–exposure–response relationships for efficacy and safety, OPDIVO 240 mg q2w and 480 mg q4w are predicted to be similar.³ Review the U.S. Full Prescribing Information for OPDIVO, YERVOY, and cabozantinib. IV=intravenous; q2w=every 2 weeks; q3w=every 3 weeks; q4w=every 4 weeks.

Advanced Renal Cell Carcinoma¹

OPDIVO + YERVOY

Dosing and Schedule

Induction phase*^† (weight-based)
3 mg/kg of OPDIVO IV infusion over 30 minutes followed on the same day by 1 mg/kg of YERVOY IV infusion over 30 minutes
Maintenance phase
OPDIVO 240 mg IV infusion q2w or OPDIVO 480 mg IV infusion q4w^‡
After completing 4 doses of the combination in the induction phase, administer OPDIVO as a single agent.

Duration

Induction phase*^† (weight-based)
q3w for 4 doses of combination therapy OR until disease progression OR unacceptable toxicity
Maintenance phase
Treat until disease progression or unacceptable toxicity
After completing 4 doses of combination therapy with YERVOY, administer OPDIVO as a single agent.

OPDIVO + Cabozantinib

Dosing and Schedule

OPDIVO 240 mg IV
infusion q2w
or
OPDIVO 480 mg IV
infusion q4w^‡
Administer OPDIVO in combination with
cabozantinib 40 mg orally once daily without food

Duration

OPDIVO: Until disease
progression, unacceptable toxicity,
or up to 2 years

Cabozantinib: Until disease
progression or unacceptable
toxicity

OPDIVO Monotherapy

Dosing and Schedule

OPDIVO 240 mg IV infusion q2w
or
OPDIVO 480 mg IV infusion q4w^‡

Duration

Treat until disease progression
or
unacceptable toxicity

No premedications are required. *When OPDIVO is administered in combination with YERVOY, if OPDIVO is withheld or discontinued, YERVOY should also be withheld or discontinued.¹ ^†Interrupt or slow the rate of infusion in patients with mild or moderate infusion-related reactions. Discontinue OPDIVO or OPDIVO + YERVOY in patients with severe or life-threatening infusion-related reactions.¹ ^‡Based on exploratory dose–exposure–response relationships for efficacy and safety, OPDIVO 240 mg q2w and 480 mg q4w are predicted to be similar.³ Review the U.S. Full Prescribing Information for OPDIVO, YERVOY, and cabozantinib. IV=intravenous; q2w=every 2 weeks; q3w=every 3 weeks; q4w=every 4 weeks.

OPDIVO^® (nivolumab), in combination with YERVOY^® (ipilimumab), is indicated for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma (MPM).

1L Unresectable Malignant Pleural Mesothelioma¹

OPDIVO + YERVOY

Dosing and Schedule

Duration


OPDIVO + YERVOY*^† 360 mg of OPDIVO IV infusion over 30 minutes q3w WITH 1 mg/kg of YERVOY IV infusion over 30 minutes q6w	In combination with ipilimumab until disease progression, unacceptable toxicity, or up to 2 years in patients without disease progression

No premedications are required. *When OPDIVO is administered in combination with YERVOY, if OPDIVO is withheld or discontinued, YERVOY should also be withheld or discontinued.¹ ^†Interrupt or slow the rate of infusion in patients with mild or moderate infusion-related reactions. Discontinue OPDIVO or OPDIVO + YERVOY in patients with severe or life-threatening infusion-related reactions.¹ Review the U.S. Full Prescribing Information for OPDIVO and YERVOY. 1L=first-line; IV=intravenous; q3w=every 3 weeks; q6w=every 6 weeks.

1L Unresectable Malignant Pleural Mesothelioma¹

OPDIVO + YERVOY

Dosing and Schedule

OPDIVO + YERVOY*^†
360 mg of OPDIVO IV infusion over 30 minutes q3w WITH 1 mg/kg of YERVOY IV infusion over 30 minutes q6w

Duration

OPDIVO + YERVOY*^†

In combination with ipilimumab until disease progression, unacceptable toxicity, or up to 2 years in patients without disease progression

No premedications are required. *When OPDIVO is administered in combination with YERVOY, if OPDIVO is withheld or discontinued, YERVOY should also be withheld or discontinued.¹ ^†Interrupt or slow the rate of infusion in patients with mild or moderate infusion-related reactions. Discontinue OPDIVO or OPDIVO + YERVOY in patients with severe or life-threatening infusion-related reactions.¹ Review the U.S. Full Prescribing Information for OPDIVO and YERVOY. IV=intravenous; q2w=every 2 weeks; q3w=every 3 weeks; q4w=every 4 weeks.

Advanced Esophageal Squamous Cell Carcinoma¹

OPDIVO Monotherapy

Dosing and Schedule

Duration


OPDIVO 240 mg IV infusion q2w or OPDIVO 480 mg IV infusion q4w*	Treat until disease progression OR unacceptable toxicity

Advanced Esophageal Squamous Cell Carcinoma¹

OPDIVO Monotherapy

Dosing and Schedule

OPDIVO 240 mg IV infusion q2w
or
OPDIVO 480 mg IV infusion q4w*

Duration

Treat until disease progression
or
unacceptable toxicity

No premedications are required. *Based on exploratory dose–exposure-response relationships for efficacy and safety, OPDIVO 240 mg q2w and 480 mg q4w are predicted to be similar.³ ^†Interrupt or slow the rate of infusion in patients with mild or moderate infusion-related reactions. Discontinue OPDIVO in patients with severe or life-threatening infusion-related reactions. IV=intravenous; q2w=every 2 weeks; q4w=every 4 weeks.

OPDIVO^® (nivolumab), in combination with fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the
treatment of patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer, or esophageal
adenocarcinoma.

OPDIVO is indicated for the treatment of patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) after prior fluoropyrimidine- and platinum-based chemotherapy.

Advanced or Metastatic Gastric, GEJ, or
Esophageal Adenocarcinoma¹

OPDIVO with fluoropyrimidine- and platinum-containing chemotherapy

Dosing and Schedule

Duration


OPDIVO 240 mg with fluoropyrimidine- and platinum-containing chemotherapy q2w OR OPDIVO 360 mg with fluoropyrimidine- and platinum-containing chemotherapy q3w	Continue treatment until disease progression, unacceptable toxicity, or up to 2 years

•The recommended dose of OPDIVO is: – 360 mg (30-minute IV infusion) with fluoropyrimidine- and platinum-containing chemotherapy q3w, or – 240 mg (30-minute IV infusion) with fluoropyrimidine- and platinum-containing chemotherapy q2w – Continue treatment until disease progression, unacceptable toxicity, or up to 2 years •Refer to the respective Prescribing Information for each therapeutic agent administered in combination with OPDIVO for the recommended dosage and administration information, as appropriate •Administer OPDIVO first followed by fluoropyrimidine- and platinum-containing chemotherapy on the same day *Interrupt or slow the rate of infusion in patients with mild or moderate infusion-related reactions. Discontinue OPDIVO in patients with severe or life-threatening infusion-related reactions.¹

GEJ=gastroesophageal junction; q2w=every 2 weeks; q3w=every 3 weeks.

Advanced or Metastatic
Gastric Cancer, GEJ Cancer, or Esophageal Adenocarcinoma¹

OPDIVO with fluoropyrimidine- and
platinum-containing chemotherapy

Dosing and Schedule

OPDIVO
240 mg with
fluoropyrimidine- and
platinum-containing
chemotherapy q2w
OR
OPDIVO
360 mg with
fluoropyrimidine- and
platinum-containing
chemotherapy q3w

Duration

Continue treatment until disease
progression, unacceptable
toxicity, or up to 2 years

GEJ=gastroesophageal junction; q2w=every 2 weeks; q3w=every 3 weeks.

OPDIVO^® (nivolumab) is indicated for the adjuvant treatment of completely resected esophageal or gastroesophageal junction cancer with residual pathologic disease in patients who have received neoadjuvant chemoradiotherapy (CRT).

Adjuvant treatment of EC or GEJC¹

OPDIVO Monotherapy

Dosing and Schedule

Duration


OPDIVO 240 mg IV infusion q2w OR OPDIVO 480 mg IV infusion q4w*	Until disease progression or unacceptable toxicity for a total treatment duration of 1 year

No premedications are required. *Based on exploratory dose-exposure–response relationships for efficacy and safety, OPDIVO 240 mg q2w and 480 mg q4w are predicted to be similar.³ ^†Interrupt or slow the rate of infusion in patients with mild or moderate infusion-related reactions. Discontinue OPDIVO in patients with severe or life-threatening infusion-related reactions.¹

EC=esophageal cancer; GEJC=gastroesophageal junction cancer; q2w=every 2 weeks; q4w=every 4 weeks.

Adjuvant Treatment of EC or GEJC¹

OPDIVO Monotherapy

Dosing and Schedule

OPDIVO 240 mg IV
infusion q2w
OR
OPDIVO 480 mg IV
infusion q4w*

Duration

Until disease progression or
unacceptable toxicity for a total
treatment duration of 1 year

EC=esophageal cancer; GEJC=gastroesophageal junction cancer; q2w=every 2 weeks; q4w=every 4 weeks.

Recurrent or Metastatic Squamous Cell Carcinoma
of the Head and Neck¹

OPDIVO Monotherapy

Dosing and Schedule

Duration


OPDIVO 240 mg IV infusion q2w or OPDIVO 480 mg IV infusion q4w*	Treat until disease progression OR unacceptable toxicity

Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck¹

OPDIVO Monotherapy

Dosing and Schedule

OPDIVO 240 mg IV infusion q2w
or
OPDIVO 480 mg IV infusion q4w*

Duration

Treat until disease progression
or
unacceptable toxicity

Advanced Hepatocellular Carcinoma¹

OPDIVO + YERVOY

Dosing and Schedule

Duration


Induction phase* ^† (weight-based) 1 mg/kg of OPDIVO IV infusion over 30 minutes followed on the same day by 3 mg/kg of YERVOY IV infusion over 30 minutes	q3w for 4 doses of combination therapy OR until disease progression OR unacceptable toxicity

Maintenance phase OPDIVO 240 mg IV infusion q2w or OPDIVO 480 mg IV infusion q4w^‡	Treat until disease progression OR unacceptable toxicity
After completing 4 doses of the combination in the induction phase, administer OPDIVO as a single agent.

Advanced Hepatocellular Carcinoma¹

OPDIVO + YERVOY

Dosing and Schedule

Induction phase*^† (weight-based)
1 mg/kg of OPDIVO IV infusion over 30 minutes followed on the same day by 3 mg/kg of YERVOY IV infusion over 30 minutes
Maintenance phase
OPDIVO 240 mg IV infusion q2w or OPDIVO 480 mg IV infusion q4w^‡
After completing 4 doses of the combination in the induction phase, administer OPDIVO as a single agent.

Duration

Induction phase*^† (weight-based)
q3w for 4 doses of combination therapy OR until disease progression OR unacceptable toxicity
Maintenance phase
Treat until disease progression or unacceptable toxicity
After completing 4 doses of the combination in the induction phase, administer OPDIVO as a single agent.

Locally Advanced or Metastatic Urothelial Carcinoma¹

OPDIVO Monotherapy

Dosing and Schedule

Duration


OPDIVO 240 mg IV infusion q2w OR OPDIVO 480 mg IV infusion q4w*	Treat until disease progression OR unacceptable toxicity

Locally Advanced or Metastatic Urothelial Carcinoma¹

OPDIVO Monotherapy

Dosing and Schedule

OPDIVO 240 mg IV infusion q2w
or
OPDIVO 480 mg IV infusion q4w*

Duration

Treat until disease progression
or
unacceptable toxicity

OPDIVO^® (nivolumab) is indicated for the adjuvant treatment of patients with urothelial carcinoma (UC) who are at high risk of recurrence after undergoing radical resection of UC.

Adjuvant Treatment of Urothelial Carcinoma¹

OPDIVO Monotherapy

Dosing and Schedule

Duration


OPDIVO 240 mg IV infusion q2w OR OPDIVO 480 mg IV infusion q4w*	Treat until disease recurrence OR unacceptable toxicity for up to 1 year

Adjuvant Treatment of Urothelial Carcinoma¹

OPDIVO Monotherapy

Dosing and Schedule

OPDIVO 240 mg IV infusion q2w
or
OPDIVO 480 mg IV infusion q4w*

Duration

Treat until disease recurrence
or
unacceptable toxicity for up to 1 year

OPDIVO^® (nivolumab), in combination with YERVOY^® (ipilimumab), is indicated for the treatment of adults and pediatric patients 12 years and older with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (CRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

OPDIVO, as a single agent, is indicated for the treatment of adult and pediatric (12 years and older) patients with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (CRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

MSI-H/dMMR Metastatic Colorectal Cancer¹

Dosing for adult and pediatric patients age 12 and older and weighing 40 kg or more:

OPDIVO + YERVOY

Dosing and Schedule

Duration


Induction phase* ^† (weight-based) 3 mg/kg of OPDIVO IV infusion over 30 minutes followed on the same day by 1 mg/kg of YERVOY IV infusion over 30 minutes	q3w for 4 doses of combination therapy OR until disease progression OR unacceptable toxicity

Maintenance phase OPDIVO 240 mg IV infusion q2w OR OPDIVO 480 mg IV infusion q4w^‡	Treat until disease progression OR unacceptable toxicity
After completing 4 doses of the combination in the induction phase, administer OPDIVO as a single agent.

OPDIVO Monotherapy


OPDIVO 240 mg IV infusion q2w OR OPDIVO 480 mg IV infusion q4w^‡	Treat until disease progression OR unacceptable toxicity

Dosing for pediatric patients age 12 and older and weighing less than 40 kg: The recommended dose of OPDIVO in combination with YERVOY for pediatric patients age 12 years and older and weighing less than 40 kg is OPDIVO 3 mg/kg administered as an intravenous infusion over 30 minutes, followed by YERVOY 1 mg/kg administered as an intravenous infusion over 30 minutes on the same day, every 3 weeks for 4 doses. After completing 4 doses of the combination, administer OPDIVO 3 mg/kg as a single agent every 2 weeks as an intravenous infusion over 30 minutes until disease progression or unacceptable toxicity.¹ The recommended dose of OPDIVO monotherapy for pediatric patients age 12 years and older and weighing less than 40 kg is OPDIVO 3 mg/kg as a single agent every 2 weeks administered as an intravenous infusion over 30 minutes until disease progression or unacceptable toxicity.¹ No premedications are required. *When OPDIVO is administered in combination with YERVOY, if OPDIVO is withheld or discontinued, YERVOY should also be withheld or discontinued.¹ ^†Interrupt or slow the rate of infusion in patients with mild or moderate infusion-related reactions. Discontinue OPDIVO or OPDIVO + YERVOY in patients with severe or life-threatening infusion-related reactions.¹ ^‡Based on exploratory dose–exposure–response relationships for efficacy and safety, OPDIVO 240 mg q2w and 480 mg q4w are predicted to be similar.³ Review the U.S. Full Prescribing Information for OPDIVO and YERVOY. IV=intravenous; MSI-H/dMMR=microsatellite instability-high or mismatch repair deficient; q2w=every 2 weeks; q3w=every 3 weeks; q4w=every 4 weeks.

MSI-H/dMMR Metastatic Colorectal Cancer¹

Dosing for adult and pediatric patients age 12 and older and weighing 40 kg or more:

OPDIVO + YERVOY

Dosing and Schedule

Induction phase*^† (weight-based)
3 mg/kg of OPDIVO IV infusion over 30 minutes followed on the same day by 1 mg/kg of YERVOY IV infusion over 30 minutes
Maintenance phase
OPDIVO 240 mg IV infusion q2w OR OPDIVO 480 mg IV infusion q4w^‡
After completing 4 doses of the combination in the induction phase, administer OPDIVO as a single agent.

Duration

Induction phase*^† (weight-based)
q3w for 4 doses of combination therapy OR until disease progression OR unacceptable toxicity
Maintenance phase
Treat until disease progression or unacceptable toxicity
After completing 4 doses of the combination in the induction phase, administer OPDIVO as a single agent.

OPDIVO Monotherapy

Dosing and Schedule

OPDIVO 240 mg IV infusion q2w
OR
OPDIVO 480 mg IV infusion q4w^‡

Duration

Treat until disease progression
or
unacceptable toxicity

Relapsed or Progressed Classical Hodgkin Lymphoma¹

OPDIVO Monotherapy

Dosing and Schedule

Duration


OPDIVO 240 mg IV infusion q2w or OPDIVO 480 mg IV infusion q4w*	Treat until disease progression OR unacceptable toxicity

Relapsed or Progressed Classical Hodgkin Lymphoma¹

OPDIVO Monotherapy

Dosing and Schedule

OPDIVO 240 mg IV infusion q2w
or
OPDIVO 480 mg IV infusion q4w*

Duration

Treat until disease progression
or
unacceptable toxicity

No premedications are required. *Based on exploratory dose–exposure-response relationships for efficacy and safety, OPDIVO 240 mg q2w and 480 mg q4w are predicted to be similar.³ ^†Interrupt or slow the rate of infusion in patients with mild or moderate infusion-related reactions. Discontinue OPDIVO in patients with severe or life-threatening infusion-related reactions.¹ IV=intravenous; q2w=every 2 weeks; q4w=every 4 weeks.

Please scroll down for full indications for OPDIVO^® and OPDIVO-based combinations.
If viewing on a mobile device, tap “Indications” at the top of this page.

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Dosing Schedules for OPDIVO Monotherapy¹

Indication

Dose and
Schedule

Intravenous
Infusion Time

Duration of
Therapy

Unresectable or Metastatic Melanoma

Metastatic Non-Small Cell Lung Cancer

Advanced Renal Cell Carcinoma

Relapsed or Progressed Classical Hodgkin Lymphoma

Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck

Locally Advanced or Metastatic Urothelial Carcinoma

Advanced Esophageal Squamous Cell Carcinoma

OPDIVO
240 mg every 2 weeks
or
OPDIVO
480 mg every 4 weeks*

30 minutes^†

Treat until disease
progression or
unacceptable toxicity

Adjuvant Treatment of Melanoma

Adjuvant Treatment of Urothelial Carcinoma

OPDIVO
240 mg every 2 weeks
or
OPDIVO
480 mg every 4 weeks*

30 minutes^†

Treat until disease
recurrence or
unacceptable toxicity
for up to 1 year

MSI-H/dMMR Metastatic Colorectal Cancer for adult and pediatric patients 12 years and older and weighing 40 kg or more

OPDIVO
240 mg every 2 weeks
or
OPDIVO
480 mg every 4 weeks*

30 minutes^†

Treat until disease
progression or
unacceptable toxicity

MSI-H/dMMR Metastatic Colorectal Cancer for pediatric patients 12 years and older weighing less than 40 kg

OPDIVO
3 mg/kg every 2 weeks

30 minutes^†

Treat until disease
progression or
unacceptable toxicity

Adjuvant Treatment of completely
resected Esophageal or
Gastroesophageal Junction Cancer in
patients who have received neoadjuvant
chemoradiotherapy (CRT)

OPDIVO
240 mg every 2 weeks
or
OPDIVO
480 mg every 4 weeks*

30 minutes^†

Until disease
progression or
unacceptable toxicity
for a total treatment
duration of 1 year

No premedications are required. *Based on exploratory dose–exposure–response relationships for efficacy and safety, OPDIVO 240 mg q2w and 480 mg q4w
are predicted to be similar.³ ^†Interrupt or slow the rate of infusion in patients with mild or moderate infusion-related reactions. Discontinue OPDIVO in patients with
severe or life-threatening infusion-related reactions.¹

OPDIVO in Combination with Other Therapeutic Agents¹

Indication

Dose and
Schedule

Intravenous
Infusion Time

Duration of
Therapy

Metastatic Non-Small Cell Lung Cancer (PD-L1 ≥1%)^¶

OPDIVO 3 mg/kg
every 2 weeks^‡
with
YERVOY 1 mg/kg
every 6 weeks^‡
(weight-based)

OPDIVO:
30 minutes ^§

YERVOY:
30 minutes^§

In combination with ipilimumab,
treat until
disease progression,
unacceptable toxicity,
or up to 2 years in
patients without
disease progression

Metastatic or Recurrent Non-Small Cell Lung Cancer (OPDIVO + YERVOY with limited chemo)

360 mg of OPDIVO
every 3 weeks^‡
with
1 mg/kg of YERVOY
every 6 weeks^‡
and
Histology-based
platinum-doublet
chemotherapy every
3 weeks

OPDIVO:
30 minutes ^§

YERVOY:
30 minutes^§

In combination with
ipilimumab, until
disease progression,
unacceptable toxicity,
or for up to 2 years in
patients without
disease progression

2 cycles of
histology-based
platinum-doublet
chemotherapy

Unresectable or Metastatic Melanoma

OPDIVO 1 mg/kg
followed by
YERVOY 3 mg/kg
on the same day
every 3 weeks^‡
(weight-based)

OPDIVO:
30 minutes ^§

YERVOY:
90 minutes^§

Maximum 4 doses of combination therapy or until unacceptable toxicity, whichever occurs earlier

After completing 4 doses of the combination,
administer OPDIVO as a single agent:

Either
OPDIVO 240 mg
every 2 weeks
or
OPDIVO 480 mg
every 4 weeks^||

OPDIVO:
30 minutes ^§

Treat until disease
progression or
unacceptable toxicity

Advanced Renal Cell Carcinoma
(OPDIVO + YERVOY)

OPDIVO 3 mg/kg
followed by
YERVOY 1 mg/kg
on the same day
every 3 weeks^‡
(weight-based)

OPDIVO:
30 minutes ^§

YERVOY:
30 minutes ^§

For 4 doses of combination therapy
or until disease progression
or unacceptable toxicity

After completing 4 doses of the combination, administer OPDIVO
as a single agent:

Either
OPDIVO 240 mg
every 2 weeks
or
OPDIVO 480 mg
every 4 weeks^||

OPDIVO:
30 minutes ^§

Treat until disease
progression or
unacceptable toxicity

Advanced Renal Cell Carcinoma (OPDIVO + cabozantinib)

Either OPDIVO 240 mg every 2 weeks
or
OPDIVO 480 mg every 4 weeks^||

Administer OPDIVO in combination with cabozantinib 40 mg orally once daily without food

OPDIVO:
30 minutes^§

OPDIVO: Until disease
progression, unacceptable toxicity, or up to 2 years

Cabozantinib:
Until disease progression or unacceptable toxicity

Malignant Pleural Mesothelioma

OPDIVO 360 mg
every 3 weeks^‡
with
YERVOY 1 mg/kg
every 6 weeks^‡

OPDIVO:
30 minutes ^§

YERVOY:
30 minutes^§

In combination with ipilimumab until disease progression, unacceptable toxicity, or up to 2 years in patients without disease progression

Advanced Hepatocellular Carcinoma

OPDIVO 1 mg/kg
followed by
YERVOY 3 mg/kg
on the same day
every 3 weeks^‡

OPDIVO:
30 minutes ^§

YERVOY:
30 minutes ^§

4 doses of
combination therapy
or until
unacceptable toxicity

After completing 4 doses of the combination, administer OPDIVO
as a single agent:

Either
OPDIVO 240 mg
every 2 weeks
or
OPDIVO 480 mg
every 4 weeks^||

OPDIVO:
30 minutes ^§

Treat until disease
progression or
unacceptable toxicity

MSI-H/dMMR Metastatic Colorectal
Cancer for adult and pediatric patients 12 years and older and weighing 40 kg or more

OPDIVO 3 mg/kg
followed by
YERVOY 1 mg/kg
on the same day
every 3 weeks^‡

(weight-based)

OPDIVO:
30 minutes ^§

YERVOY:
30 minutes ^§

For 4 doses of combination therapy
or until disease progression
or unacceptable toxicity

After completing 4 doses of the combination, administer OPDIVO
as a single agent:

Either
OPDIVO 240 mg
every 2 weeks
or
OPDIVO 480 mg
every 4 weeks^||

OPDIVO:
30 minutes ^§

Treat until disease
progression or
unacceptable toxicity

MSI-H/dMMR Metastatic Colorectal
Cancer for pediatric patients
12 years and older weighing less than 40 kg

OPDIVO 3 mg/kg
followed by
YERVOY 1 mg/kg
on the same day
every 3 weeks^‡

(weight-based)

OPDIVO:
30 minutes ^§

YERVOY:
30 minutes ^§

For 4 doses of combination therapy
or until disease progression
or unacceptable toxicity

After completing 4 doses of the combination, administer OPDIVO
as a single agent:

OPDIVO
3 mg/kg
every 2 weeks

OPDIVO:
30 minutes ^§

Treat until disease
progression or
unacceptable toxicity

Advanced or Metastatic Gastric Cancer, GEJ Cancer, or Esophageal Adenocarcinoma

OPDIVO
240 mg with
fluoropyrimidine- and
platinum-containing
chemotherapy^# on the
same day every 2 weeks
or
OPDIVO
360 mg with
fluoropyrimidine- and
platinum-containing
chemotherapy^# on the
same day every
3 weeks

OPDIVO:
30 minutes ^§

Continue treatment
until disease
progression,
unacceptable toxicity,
or up to 2 years

No premedications are required with OPDIVO and YERVOY. ^‡When OPDIVO is administered in combination with YERVOY, if OPDIVO is withheld or discontinued, YERVOY should also be withheld or discontinued.¹ ^§Interrupt or slow the rate of infusion in patients with mild or moderate infusion-related reactions. Discontinue OPDIVO or OPDIVO + YERVOY in patients with
severe or life-threatening infusion-related reactions.¹ ^||Based on exploratory dose–exposure–response relationships for efficacy and safety, OPDIVO 240 mg q2w and 480 mg q4w
are predicted to be similar.³ ^¶Information on FDA-approved tests for the determination of PD-L1 expression in NSCLC is available at http://www.fda.gov/CompanionDiagnostics. ^#Refer to the respective Prescribing Information for each therapeutic agent administered in combination with OPDIVO for the recommended dosage and administration information, as appropriate. Review the U.S. Full Prescribing Information for OPDIVO, YERVOY, and cabozantinib IV=intravenous; MSI-H/dMMR=microsatellite instability-high or mismatch repair deficient; PI=Prescribing Information; q2w=every 2 weeks; q3w=every 3 weeks; q4w=every 4 weeks.

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Dosing Schedules for
OPDIVO Monotherapy¹

Indication
Unresectable or Metastatic Melanoma
Metastatic Non-Small Cell Lung Cancer
Advanced Renal Cell Carcinoma
Relapsed or Progressed Classical Hodgkin Lymphoma
Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck
Locally Advanced or Metastatic Urothelial Carcinoma
Advanced Esophageal Squamous Cell Carcinoma
Dose and Schedule	Intravenous Infusion Time
OPDIVO 240 mg every 2 weeks or OPDIVO 480 mg every 4 weeks*	30 minutes^†
Duration of Therapy
Treat until disease progression or unacceptable toxicity

Indication
Adjuvant Treatment of Melanoma
Adjuvant Treatment of Urothelial Carcinoma
Dose and Schedule	Intravenous Infusion Time
OPDIVO 240 mg every 2 weeks or OPDIVO 480 mg every 4 weeks*	30 minutes^†
Duration of Therapy
Treat until disease recurrence or unacceptable toxicity for up to 1 year

Indication
Metastatic Small Cell Lung Cancer
Dose and Schedule	Intravenous Infusion Time
OPDIVO 240 mg every 2 weeks	30 minutes^†
Duration of Therapy
Treat until disease progression or unacceptable toxicity

Indication
MSI-H/dMMR Metastatic Colorectal Cancer for adult and pediatric patients 12 years and older and weighing 40 kg or more
Dose and Schedule	Intravenous Infusion Time
OPDIVO 240 mg every 2 weeks or OPDIVO 480 mg every 4 weeks*	30 minutes^†
Duration of Therapy
Treat until disease progression or unacceptable toxicity

Indication
MSI-H/dMMR Metastatic Colorectal Cancer for pediatric patients 12 years and older weighing less than 40 kg
Dose and Schedule	Intravenous Infusion Time
OPDIVO 3 mg/kg every 2 weeks	30 minutes^†
Duration of Therapy
Treat until disease progression or unacceptable toxicity

Indication
Adjuvant Treatment of completely resected Esophageal or Gastroesophageal Junction Cancer in patients who have received neoadjuvant chemoradiotherapy (CRT)
Dose and Schedule	Intravenous Infusion Time
OPDIVO 240 mg every 2 weeks or OPDIVO 480 mg every 4 weeks*	OPDIVO: 30 minutes^†
Duration of Therapy
Until disease progression or unacceptable toxicity for a total treatment duration of 1 year

OPDIVO in Combination with Other Therapeutic Agents¹

Indication
Metastatic Non-Small Cell Lung Cancer (PD-L1 ≥1%)^¶
Dose and Schedule	Intravenous Infusion Time
OPDIVO 3 mg/kg every 2 weeks^‡ with YERVOY 1 mg/kg every 6 weeks^‡ (weight-based)	OPDIVO: 30 minutes ^§
	YERVOY: 30 minutes^§
Duration of Therapy
In combination with ipilimumab, treat until disease progression, unacceptable toxicity, or up to 2 years in patients without disease progression

Indication
Metastatic or Recurrent Non-Small Cell Lung Cancer (OPDIVO + YERVOY with limited chemo)
OPDIVO + YERVOY Dose and Schedule	Intravenous Infusion Time
360 mg of OPDIVO every 3 weeks^‡ with 1 mg/kg of YERVOY every 6 weeks^‡	OPDIVO: 30 minutes ^§
	YERVOY: 30 minutes^§
Duration of Therapy
In combination with ipilimumab, until disease progression, unacceptable toxicity, or for up to 2 years in patients without disease progression
Chemotherapy Dose and Schedule
Histology-based platinum-doublet chemotherapy every 3 weeks
Duration of Therapy
2 cycles of histology-based platinum-doublet chemotherapy

Indication
Unresectable or Metastatic Melanoma
Dose and Schedule	Intravenous Infusion Time
OPDIVO 1 mg/kg followed by YERVOY 3 mg/kg on the same day every 3 weeks^‡ (weight-based)	OPDIVO: 30 minutes^§
	YERVOY: 90 minutes^§
Duration of Therapy
Maximum 4 doses of combination therapy or until unacceptable toxicity, whichever occurs earlier
After completing 4 doses of the combination, administer OPDIVO as a single agent:
Dose and Schedule	Intravenous Infusion Time
Either OPDIVO 240 mg every 2 weeks or OPDIVO 480 mg every 4 weeks^\|\|	OPDIVO: 30 minutes^§
Duration of Therapy
Treat until disease progression or unacceptable toxicity

Indication
Advanced Renal Cell Carcinoma (OPDIVO + YERVOY)
Dose and Schedule	Intravenous Infusion Time
OPDIVO 3 mg/kg followed by YERVOY 1 mg/kg on the same day every 3 weeks^‡ (weight-based)	OPDIVO: 30 minutes^§
	YERVOY: 30 minutes^§
Duration of Therapy
For 4 doses of combination therapy or until disease progression or unacceptable toxicity
After completing 4 doses of the combination, administer OPDIVO as a single agent:
Dose and Schedule	Intravenous Infusion Time
Either OPDIVO 240 mg every 2 weeks or OPDIVO 480 mg every 4 weeks^\|\|	OPDIVO: 30 minutes^§
Duration of Therapy
Treat until disease progression or unacceptable toxicity

Indication
Advanced Renal Cell Carcinoma (OPDIVO + cabozantinib)
Dose and Schedule	Intravenous Infusion Time
Either OPDIVO 240 mg every 2 weeks or OPDIVO 480 mg every 4 weeks^\|\| Administer OPDIVO in combination with cabozantinib 40 mg orally once daily without food	OPDIVO: 30 minutes ^§
Duration of Therapy
OPDIVO: Until disease progression, unacceptable toxicity, or up to 2 years Cabozantinib: Until disease progression or unacceptable toxicity

Indication
Malignant Pleural Mesothelioma
Dose and Schedule	Intravenous Infusion Time
OPDIVO 360 mg every 3 weeks^‡ with YERVOY 1 mg/kg every 6 weeks^‡	OPDIVO: 30 minutes ^§
	YERVOY: 30 minutes^§
Duration of Therapy
In combination with ipilimumab, until disease progression, unacceptable toxicity, or up to 2 years in patients without disease progression

Indication
Advanced Hepatocellular Carcinoma
Dose and Schedule	Intravenous Infusion Time
OPDIVO 1 mg/kg followed by YERVOY 3 mg/kg on the same day every 3 weeks^‡	OPDIVO: 30 minutes^§
	YERVOY: 30 minutes^§
Duration of Therapy
4 doses of combination therapy or until unacceptable toxicity
After completing 4 doses of the combination, administer OPDIVO as a single agent:
Dose and Schedule	Intravenous Infusion Time
Either OPDIVO 240 mg every 2 weeks or OPDIVO 480 mg every 4 weeks^\|\|	OPDIVO: 30 minutes^§
Duration of Therapy
Treat until disease progression or unacceptable toxicity

Indication
MSI-H/dMMR Metastatic Colorectal Cancer for adult and pediatric patients 12 years and older and weighing 40 kg or more
Dose and Schedule	Intravenous Infusion Time
OPDIVO 3 mg/kg followed by YERVOY 1 mg/kg on the same day every 3 weeks^‡ (weight-based)	OPDIVO: 30 minutes^§
	YERVOY: 30 minutes^§
Duration of Therapy
For 4 doses of combination therapy or until disease progression or unacceptable toxicity
After completing 4 doses of the combination, administer OPDIVO as a single agent:
Dose and Schedule	Intravenous Infusion Time
Either OPDIVO 240 mg every 2 weeks or OPDIVO 480 mg every 4 weeks^\|\|	OPDIVO: 30 minutes^§
Duration of Therapy
Treat until disease progression or unacceptable toxicity

Indication
MSI-H/dMMR Metastatic Colorectal Cancer for pediatric patients 12 years and older weighing less than 40 kg
Dose and Schedule	Intravenous Infusion Time
OPDIVO 3 mg/kg followed by YERVOY 1 mg/kg on the same day every 3 weeks^‡ (weight-based)	OPDIVO: 30 minutes^§
	YERVOY: 30 minutes^§
Duration of Therapy
For 4 doses of combination therapy or until disease progression or unacceptable toxicity
After completing 4 doses of the combination, administer OPDIVO as a single agent:
Dose and Schedule	Intravenous Infusion Time
OPDIVO 3 mg/kg every 2 weeks	OPDIVO: 30 minutes^§
Duration of Therapy
Treat until disease progression or unacceptable toxicity

Indication
Advanced or Metastatic Gastric Cancer, GEJ Cancer, or Esophageal Adenocarcinoma
Dose and Schedule	Intravenous Infusion Time
OPDIVO 240 mg with fluoropyrimidine- and platinum-containing chemotherapy^# on the same day every 2 weeks or OPDIVO 360 mg with fluoropyrimidine- and platinum-containing chemotherapy^# on the same day every 3 weeks	OPDIVO: 30 minutes ^§
Duration of Therapy
Continue treatment until disease progression, unacceptable toxicity, or up to 2 years

No premedications are required with OPDIVO and YERVOY. ^‡When OPDIVO is administered in combination with YERVOY, if OPDIVO is withheld or discontinued, YERVOY should also be withheld or discontinued.¹ ^§Interrupt or slow the rate of infusion in patients with mild or moderate infusion-related reactions. Discontinue OPDIVO or OPDIVO + YERVOY in patients with severe or life-threatening infusion-related reactions.¹ ^||Based on exploratory dose–exposure–response relationships for efficacy and safety, OPDIVO 240 mg q2w and 480 mg q4w are predicted to be similar.³ ^¶Information on FDA-approved tests for the determination of PD-L1 expression in NSCLC is available at http://www.fda.gov/CompanionDiagnostics. ^#Refer to the respective Prescribing Information for each therapeutic agent administered in combination with OPDIVO for the recommended dosage and administration information, as appropriate. Review the U.S. Full Prescribing Information for OPDIVO, YERVOY, and cabozantinib IV=intravenous; MSI-H/dMMR=microsatellite instability-high or mismatch repair deficient; PI=Prescribing Information; q2w=every 2 weeks; q3w=every 3 weeks; q4w=every 4 weeks.

Treatment modifications

Recommended dosing modifications for adverse reactions.

See More Details

Preparation and administration

Preparation and administration information, including storage recommendations and infusion instructions.

Learn More

Indications

Important safety information

Please verify that you are a U.S. Healthcare Professional

DOSING SCHEDULES

1L Metastatic Non-Small Cell Lung Cancer (PD-L1 ≥1%)1

OPDIVO + YERVOY

1L Metastatic or Recurrent Non-Small Cell Lung Cancer1

OPDIVO + YERVOY with 2 cycles of histology-based platinum-doublet chemotherapy

2L Metastatic Non-Small Cell Lung Cancer

OPDIVO Monotherapy

1L Metastatic Non-Small Cell Lung Cancer (PD-L1 ≥1%)1

OPDIVO + YERVOY

1L Metastatic or Recurrent Non-Small Cell Lung Cancer1

OPDIVO + YERVOY with 2 cycles of histology-based platinum-doublet chemotherapy

2L Metastatic Non-Small Cell Lung Cancer

OPDIVO Monotherapy

Unresectable or Metastatic Melanoma1

OPDIVO + YERVOY

OPDIVO Monotherapy

Unresectable or Metastatic Melanoma1

OPDIVO + YERVOY

OPDIVO Monotherapy

Adjuvant Treatment of Melanoma1

OPDIVO Monotherapy

Adjuvant Treatment of Melanoma1

OPDIVO Monotherapy

Advanced Renal Cell Carcinoma1

OPDIVO + YERVOY

OPDIVO + Cabozantinib

OPDIVO Monotherapy

Advanced Renal Cell Carcinoma1

OPDIVO + YERVOY

OPDIVO + Cabozantinib

OPDIVO Monotherapy

1L Unresectable Malignant Pleural Mesothelioma1

OPDIVO + YERVOY

1L Unresectable Malignant Pleural Mesothelioma1

OPDIVO + YERVOY

Advanced Esophageal Squamous Cell Carcinoma1

OPDIVO Monotherapy

Advanced Esophageal Squamous Cell Carcinoma1

OPDIVO Monotherapy

Advanced or Metastatic Gastric, GEJ, or Esophageal Adenocarcinoma1

OPDIVO with fluoropyrimidine- and platinum-containing chemotherapy

Advanced or Metastatic Gastric Cancer, GEJ Cancer, or Esophageal Adenocarcinoma1

OPDIVO with fluoropyrimidine- and platinum-containing chemotherapy

Adjuvant treatment of EC or GEJC1

OPDIVO Monotherapy

Adjuvant Treatment of EC or GEJC1

OPDIVO Monotherapy

Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck1

OPDIVO Monotherapy

Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck1

OPDIVO Monotherapy

Advanced Hepatocellular Carcinoma1

OPDIVO + YERVOY

Advanced Hepatocellular Carcinoma1

OPDIVO + YERVOY

Locally Advanced or Metastatic Urothelial Carcinoma1

OPDIVO Monotherapy

Locally Advanced or Metastatic Urothelial Carcinoma1

OPDIVO Monotherapy

Adjuvant Treatment of Urothelial Carcinoma1

OPDIVO Monotherapy

Adjuvant Treatment of Urothelial Carcinoma1

OPDIVO Monotherapy

MSI-H/dMMR Metastatic Colorectal Cancer1

OPDIVO + YERVOY

OPDIVO Monotherapy

MSI-H/dMMR Metastatic Colorectal Cancer1

OPDIVO + YERVOY

OPDIVO Monotherapy

Relapsed or Progressed Classical Hodgkin Lymphoma1

OPDIVO Monotherapy

Relapsed or Progressed Classical Hodgkin Lymphoma1

OPDIVO Monotherapy

Dosing Schedules for OPDIVO Monotherapy1

OPDIVO in Combination with Other Therapeutic Agents1

Dosing Schedules for OPDIVO Monotherapy1

OPDIVO in Combination with Other Therapeutic Agents1

1L Metastatic Non-Small Cell Lung Cancer (PD-L1 ≥1%)¹

1L Metastatic or Recurrent Non-Small Cell Lung Cancer¹

1L Metastatic Non-Small Cell Lung Cancer (PD-L1 ≥1%)¹

1L Metastatic or Recurrent Non-Small Cell Lung Cancer¹

OPDIVO + YERVOY with 2 cycles of
histology-based platinum-doublet
chemotherapy

Unresectable or Metastatic Melanoma¹

Unresectable or Metastatic Melanoma¹

Adjuvant Treatment of Melanoma¹

Adjuvant Treatment of Melanoma¹

Advanced Renal Cell Carcinoma¹

Advanced Renal Cell Carcinoma¹

1L Unresectable Malignant Pleural Mesothelioma¹

1L Unresectable Malignant Pleural Mesothelioma¹

Advanced Esophageal Squamous Cell Carcinoma¹

Advanced Esophageal Squamous Cell Carcinoma¹

Advanced or Metastatic Gastric, GEJ, or
Esophageal Adenocarcinoma¹

Advanced or Metastatic
Gastric Cancer, GEJ Cancer, or Esophageal Adenocarcinoma¹

OPDIVO with fluoropyrimidine- and
platinum-containing chemotherapy

Adjuvant treatment of EC or GEJC¹

Adjuvant Treatment of EC or GEJC¹

Recurrent or Metastatic Squamous Cell Carcinoma
of the Head and Neck¹

Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck¹

Advanced Hepatocellular Carcinoma¹

Advanced Hepatocellular Carcinoma¹

Locally Advanced or Metastatic Urothelial Carcinoma¹

Locally Advanced or Metastatic Urothelial Carcinoma¹

Adjuvant Treatment of Urothelial Carcinoma¹

Adjuvant Treatment of Urothelial Carcinoma¹

MSI-H/dMMR Metastatic Colorectal Cancer¹

MSI-H/dMMR Metastatic Colorectal Cancer¹

Relapsed or Progressed Classical Hodgkin Lymphoma¹

Relapsed or Progressed Classical Hodgkin Lymphoma¹

Dosing Schedules for OPDIVO Monotherapy¹

OPDIVO in Combination with Other Therapeutic Agents¹

Dosing Schedules for
OPDIVO Monotherapy¹

OPDIVO in Combination with Other Therapeutic Agents¹