is, neuropathy, and endocrinopathy and eva luate clinical chemistries including liver function tests and thyroid function tests at baseline and before each dose. [See Warnings and Precautions (5.1, 5.2, 5.3, 5.4, 5.5).]
INDICATIONS AND USAGE
Yervoy (ipilimumab) is indicated for the treatment of unresectable or metastatic melanoma.
DOSAGE AND ADMINISTRATION
Recommended Dosing
The recommended dose of Yervoy is 3 mg/kg administered intravenously over 90 minutes every 3 weeks for a total of 4 doses.
Recommended Dose Modifications
Withhold scheduled dose of Yervoy for any moderate immune-mediated adverse reactions or for symptomatic endocrinopathy. For patients with complete or partial resolution of adverse reactions (Grade 0–1), and who are receiving less than 7.5 mg prednisone or equivalent per day, resume Yervoy at a dose of 3 mg/kg every 3 weeks until administration of all 4 planned doses or 16 weeks from first dose, whichever occurs earlier.
Permanently discontinue Yervoy for any of the following:
Persistent moderate adverse reactions or inability to reduce corticosteroid dose to 7.5 mg prednisone or equivalent per day.
Failure to complete full treatment course within 16 weeks from administration of first dose.
Severe or life-threatening adverse reactions, including any of the following:
Colitis with abdominal pain, fever, ileus, or peritoneal signs; increase in stool frequency (7 or more over baseline), stool incontinence, need for intravenous hydration for more than 24 hours, gastrointestinal hemorrhage, and gastrointestinal perforation
Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >5 times the upper limit of normal or total bilirubin >3 times the upper limit of normal
Stevens-Johnson syndrome, toxic epidermal necrolysis, or rash complicated by full thickness dermal ulceration, or necrotic, bullous, or hemorrhagic manifestations
Severe motor or sensory neuropathy, Guillain-Barré syndrome, or myasthenia gravis
Severe immune-mediated reactions involving any organ system (eg, nephritis, pneumonitis, pancreatitis, non-infectious myocarditis)
Immune-mediated ocular disease that is unresponsive to topical immunosuppressive therapy
Preparation and Administration
Do not shake product.
Inspect parenteral drug products visually for particulate matter and discoloration prior to administration. Discard vial if solution is cloudy, there is pronounced discoloration (solution may have pale-yellow color), or there is foreign particulate matter other than translucent-to-white, amorphous particles.
Preparation of Solution
Allow the vials to stand at room temperature for approximately 5 minutes prior to preparation of infusion.
Withdraw the required volume of Yervoy and transfer into an intravenous bag.
Dilute with 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP to prepare a diluted solution with a final concentration ranging from 1 mg/mL to 2 mg/mL. Mix diluted solution by gentle inversion.
Store the diluted solution for no more than 24 hours under refrigeration (2°C to 8°C, 36°F to 46°F) or at room temperature (20°C to 25°C, 68°F to 77°F).
Discard partially used vials or empty vials of Yervoy.
Administration Instructions
Do not mix Yervoy with, or administer as an infusion with, other medicinal products.
Flush th |
