HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use YERVOY safely and effectively. See full prescribing information for YERVOY.

YERVOYTM (ipilimumab)
Injection, for intravenous infusion
Initial U.S. Approval: 2011

 
WARNING: IMMUNE-MEDIATED ADVERSE REACTIONS
See full prescribing information for complete boxed warning.

YERVOY can result in severe and fatal immune-mediated adverse reactions due to T-cell activation and proliferation. These immune-mediated reactions may involve any organ system; however, the most common severe immune-mediated adverse reactions are enterocolitis, hepatitis, dermatitis (including toxic epidermal necrolysis), neuropathy, and endocrinopathy. The majority of these immune-mediated reactions initially manifested during treatment; however, a minority occurred weeks to months after discontinuation of YERVOY.

Permanently discontinue YERVOY and initiate systemic high-dose corticosteroid therapy for severe immune-mediated reactions. (2.2)

Assess patients for signs and symptoms of enterocolitis, dermatitis, neuropathy, and endocrinopathy and eva luate clinical chemistries including liver function tests and thyroid function tests at baseline and before each dose. (5.1, 5.2, 5.3, 5.4, 5.5)
 
INDICATIONS AND USAGE
YERVOY is a human cytotoxic T-lymphocyte antigen 4 (CTLA-4)-blocking antibody indicated for the treatment of unresectable or metastatic melanoma. (1)
 
DOSAGE AND ADMINISTRATION
YERVOY 3 mg/kg administered intravenously over 90 minutes every 3 weeks for a total of four doses. (2.1)
Permanently discontinue for severe adverse reactions. (2.2)

 
DOSAGE FORMS AND STRENGTHS
50 mg/10 mL (5 mg/mL) (3)
200 mg/40 mL (5 mg/mL) (3)

 
CONTRAINDICATIONS
None. (4)

 
WARNINGS AND PRECAUTIONS
Immune-mediated adverse reactions: Permanently discontinue for severe reactions. Withhold dose for moderate immune-mediated adverse reactions until return to baseline, improvement to mild severity, or complete resolution, and patient is receiving less than 7.5 mg prednisone or equivalent per day. Administer systemic high-dose corticosteroids for severe, persistent, or recurring immune-mediated reactions. (5.1, 5.2, 5.3, 5.4, 5.5)

Immune-mediated hepatitis: eva luate liver function tests before each dose of YERVOY.
Immune-mediated endocrinopathies: Monitor thyroid function tests and clinical chemistries prior to each dose. eva luate at each visit for signs and symptoms of endocrinopathy. Institute hormone replacement therapy as needed.

 
ADVERSE REACTIONS
Most common adverse reactions (≥5%) are fatigue, diarrhea, pruritus, rash, and colitis. (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Bristol-Myers Squibb at 1-800-721-5072 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

 
USE IN SPECIFIC POPULATIONS
Pregnancy: Based on animal data, YERVOY may cause fetal harm. (8.1)
Nursing mothers: Discontinue nursing or discontinue YERVOY. (8.3)

See 17 for PATIENT COUNSELING INFORMATION and Medication Guide 

Revised: 03/2011
 

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