Indicated for:

Unresectable or Metastatic Melanoma:

• The treatment of unresectable or metastatic melanoma in adults and pediatric patients 12 years and older.

• YERVOY, in combination with nivolumab, is indicated for the treatment of unresectable or metastatic melanoma in adult patients.

Adjuvant Treatment of Melanoma:

• Adjuvant treatment of patients with cutaneous melanoma with pathologic involvement of regional lymph nodes of more than 1 mm who have undergone complete resection, including total lymphadenectomy.

Advanced Renal Cell Carcinoma:

• YERVOY, in combination with nivolumab, is indicated for the treatment of patients with intermediate or poor risk, previously untreated advanced renal cell carcinoma (RCC).

Microsatellite Instability-High or Mismatch Repair Deficient Metastatic Colorectal Cancer:

• YERVOY, in combination with nivolumab, is indicated for the treatment of adult 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.

Hepatocellular Carcinoma:

• YERVOY, in combination with nivolumab, 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.

Metastatic Non-Small Cell Lung Cancer:

• YERVOY, in combination with nivolumab, 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.

• YERVOY, in combination with nivolumab and 2 cycles of platinum-doublet chemotherapy, is indicated for the first-line treatment of adult patients with metastatic or recurrent NSCLC, with no EGFR or ALK genomic tumor aberrations.

Malignant Pleural Mesothelioma:

• YERVOY, in combination with nivolumab, is indicated for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma.

YERVOY is a fully human monoclonal antibody that blocks T-cell inhibitory signals induced by the CTLA-4 pathway, thereby removing inhibition of the immune response with the potential for induction of immune-mediated adverse reactions.

Select patients with metastatic NSCLC for treatment with YERVOY in combination with nivolumab based on PD-L1 expression.

No dose reduction for YERVOY is recommended. In general, withhold YERVOY for severe (Grade 3) immune-mediated adverse reactions. Permanently discontinue YERVOY for life-threatening (Grade 4) immune-mediated adverse reactions, recurrent severe (Grade 3) immune-mediated reactions that require systemic immunosuppressive treatment, persistent moderate (Grade 2) or severe (Grade 3) reactions lasting 12 weeks or longer after last YERVOY dose (excluding endocrinopathy), or an inability to reduce corticosteroid dose to 10 mg or less of prednisone or equivalent per day within 12 weeks of initiating steroids.

Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue. Immune-mediated adverse reactions can occur at any time after starting YERVOY. While immune-mediated adverse reactions usually manifest during treatment, immune-mediated adverse reactions can also manifest after discontinuation of YERVOY.

YERVOY can cause immune-mediated diarrhea/colitis, which may be fatal.

Cytomegalovirus (CMV) infection/reactivation has been reported in patients with corticosteroid-refractory immune-mediated diarrhea/colitis. In cases of corticosteroid-refractory diarrhea/colitis, consider repeating infectious workup to exclude alternative etiologies.

Immune-mediated enterocolitis/colitis including fatal cases, can occur with YERVOY.

Immune-mediated hepatitis, including fatal cases, can occur with YERVOY.

YERVOY can cause immune-mediated rash or dermatitis, including bullous and exfoliative dermatitis, Stevens Johnson Syndrome and toxic epidermal necrolysis (TEN).

Immune-mediated neuropathies, including fatal cases, can occur with YERVOY.

Immune-mediated endocrinopathies, including life-threatening cases, can occur with YERVOY.

Immune-mediated pneumonitis, including fatal cases, can occur with nivolumab with YERVOY.

Immune-mediated nephritis with renal dysfunction can occur with nivolumab with YERVOY.

Immune-mediated encephalitis can occur with YERVOY.

Reports of hypophysitis, adrenal insufficiency, hyperthyroidism, hypothyroidism, thyroiditis, type 1 diabetes mellitus, and severe infusion reactions.

Fatal or serious graft-versus-host disease (GVHD) can occur in patients who receive YERVOY either before or after allogeneic hematopoietic stem cell transplantation (HSCT).

Monitor patients for signs or symptoms of ocular toxicity, which may include blurred vision and reduced visual acuity. Immune-mediated ocular toxicity may be associated with retinal detachment or permanent vision loss. Administer corticosteroid eye drops to patients who develop uveitis, iritis, or episcleritis.

Permanently discontinue YERVOY for immune-mediated ocular disease that is unresponsive to local immunosuppressive therapy.

Permanently discontinue YERVOY for symptomatic endocrinopathy reactions lasting 6 weeks or longer or inability to reduce corticosteroid dose to 7.5 mg prednisone or equivalent per day.

Permanently discontinue YERVOY for ophthalmologic reactions grade 2 through 4 or for ophthalmologic reactions not improving to Grade 1 within 2 weeks while receiving topical therapy or requiring systemic treatment.

Permanently discontinue YERVOY for for SJS, TEN, or DRESS.

Permanently discontinue YERVOY for Grade 3 or 4 pneumonitis.

Permanently discontinue YERVOY Grade 3 or 4 colitis/diarrhea.

Permanently discontinue YERVOY for Grade 4 increased blood creatinine.

Permanently discontinue YERVOY for life-threatening (Grade 4) immune-mediated adverse reactions.

Permanently discontinue YERVOY for Grade 3 or 4 neurological toxicities.

Permanently discontinue YERVOY for Grade 3 or 4 myocarditis.

Permanently discontinue YERVOY for recurrent severe (Grade 3) immune-mediated reactions that require systemic immunosuppressive treatment.

Permanently discontinue YERVOY depending on severity Grades 3 or 4 endocrinopathies.

Permanently discontinue YERVOY for hepatitis with tumor involvement of the liver/non-HCC with AST or ALT more than 5 times the ULN or total bilirubin more than 3 times the ULN.

Permanently discontinue YERVOY for hepatitis with tumor involvement of the liver/HCC with AST/ALT increases to more than 10 times ULN or total bilirubin increases to more than 3 times ULN.

Permanently discontinue YERVOY for Grade 3 or 4 exfoliative or bullous dermatologic conditions.

Permanently discontinue YERVOY for immune-mediated encephalitis.

Permanently discontinue YERVOY and initiate systemic high-dose corticosteroid therapy for severe immune-mediated reactions.

Permanently discontinue YERVOY in patients with severe enterocolitis and initiate systemic corticosteroids at a dose of 1 to 2 mg/kg/day of prednisone or equivalent.

Discontinue YERVOY in for Grade 3 or 4 infusion-related reactions.

Permanently discontinue YERVOY for all other Grade 2 reactions lasting 6 weeks or longer or all other Grade 3 or 4 reactions.

Based on animal studies, YERVOY can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with a YERVOY-containing regimen and for 3 months after the last dose of YERVOY.

Discontinue nursing during treatment with YERVOY. Advise women to discontinue nursing during treatment with YERVOY and for 3 months following the final dose.

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• Use in patients under the age of 12. GoToSource 

• Advanced prostate cancer. GoToSource

Enterocolitis (inflammation of small intestine and the colon), hepatitis (inflammation of the liver), dermatitis (including potentially fatal toxic epidermal necrolysis), neuropathy (nerve damage), endocrinopathy (endocrine gland dysfunction), intestinal perforation, guillain-barré syndrome (autoimmune disorder), peripheral motor neuropathy, hypothyroidism (low thyroid), adrenal insufficiency (adrenal glands not producing adequate steroid hormones), hypopituitarism (diminished activity of pituitary gland), nephritis (inflammation of kidneys), pneumonitis (inflammation of lung tissue), meningitis (inflammation of membranes surrounding brain and spinal cord), pericarditis (inflammation of tissue surrounding the heart), uveitis (eye inflammation), iritis (inflammation of iris of the eye), hemolytic anemia (red blood cells are destroyed faster than they can be made), myocarditis (inflammation of heart muscle), angiopathy (disease of blood vessels), temporal arteritis (inflammation of temporal arteries which supply blood to the head and brain), vasculitis (inflammation of blood vessels), polymyalgia rheumatica (inflammatory disorder causing muscle pain and stiffness), conjunctivitis (inflammation of membrane covering surface of eyeball), episcleritis (inflammation of episcleral tissues in eye), scleritis (inflammation of white of the eye), leukocytoclastic vasculitis (inflammation of small blood vessels), erythema multiforme (skin disorder), psoriasis (inflammatory skin disease), pancreatitis (inflammation of the pancreas), arthritis (joint inflammation), autoimmune thyroiditis (disease of the thyroid gland), thrombocytopenia (low blood platelet count), pulmonary sarcoidosis (lung disease) and hemophilia A (blood does not clot normally). GoToSource 

Hypophysitis (inflammation of the pituitary gland). GoToSource

Kidney failure, hearing loss and vision loss. GoToSource

Inflammatory myopathy (skeletal muscle disease) and myositis (inflammation of muscle tissue). GoToSource

Polymyositis (inflammatory muscle disease). GoToSource

Ocular myositis (inflammation of muscles that control eye movement). GoToSource

Lawsuits filed for gastrointestinal perforation, hepatitis due to liver damage, paralysis from nerve damage and inflamed pancreas, kidneys, lungs and heart.