YERVOY INJECTION CONCENTRATE 5MG/ML [SIN14598P]

Product Info

YERVOY INJECTION CONCENTRATE 5MG/ML

[SIN14598P]

1 INDICATIONS AND USAGE

YERVOY (ipilimumab) is indicated for the treatment of unresectable or metastatic melanoma.

2 DOSAGE AND ADMINISTRATION

2.1 Recommended Dosing

The recommended dose of YERVOY is 3 mg/kg administered intravenously over 30–90 minutes every 3 weeks for a total of 4 doses.

Liver function tests (LFTs) and thyroid function tests should be evaluated at baseline and before each dose of YERVOY. In addition, any signs or symptoms of immune-related adverse reactions, including diarrhoea and colitis, must be assessed during treatment with YERVOY.

2.2 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

2.3 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) or at room temperature (20°C to 25°C).

• 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 the intravenous line with 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP after each dose.

• Administer diluted solution over 30–90 minutes through an intravenous line containing a sterile, non-pyrogenic, low-protein-binding in-line filter.

4 CONTRAINDICATIONS

YERVOY is contraindicated in patients who are hypersensitive to ipilimumab or to any ingredient in the formulation. [See Description (10) – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.]