Figure 5: To remove the Gliadel® Wafer, gently grasp the wafer with the aid of forceps and place it onto a designated sterile field.

Once the tumor is resected, tumor pathology is confirmed, and hemostasis is obtained, up to eight Gliadel® Wafers (polifeprosan 20 with carmustine implant) may be placed to cover as much of the resection cavity as possible. Slight overlapping of the wafers is acceptable. Wafers broken in half may be used, but wafers broken in more than two pieces should be discarded in a biohazard container. Oxidized regenerated cellulose (Surgicel®) may be placed over the wafers to secure them against the cavity surface. After placement of the wafers, the resection cavity should be irrigated and the dura closed in a water tight fashion.
Unopened foil pouches may be kept at ambient room temperature for a maximum of six hours at a time.
HOW SUPPLIED
Gliadel® Wafer is available in a single dose treatment box containing eight individually pouched wafers. Each wafer contains 7.7 mg of carmustine and is packaged in two aluminum foil laminate pouches. The inner pouch is sterile and is designed to maintain product sterility and protect the product from moisture. The outer pouch is a peelable overwrap. The outside surface of the outer pouch is not sterile.
Gliadel® Wafer must be stored at or below -20°C (-4°F).
REFERENCES
Recommendations for the Safe Handling of Parenteral Antineoplastic Drugs, NIH Publication No. 83-2621. For sale by the Superintendent of Documents, U.S. Government Printing Office, Washington, DC 20402.
AMA Council Report, Guidelines for Handling Parenteral Antineoplastics. JAMA, 1985; 253(11):1590-1592.
National Study Commission on Cytotoxic Exposure -- Recommendations for Handling Cytotoxic Agents. Available from Louis P. Jeffrey, ScD., Chairman, National Study Commission on Cytotoxic Exposure, Massachusetts College of Pharmacy and Allied Health Sciences, 179 Longwood Avenue, Boston, Massachusetts 02115.
Clinical Oncological Society of Australia, Guidelines and Recommendations for Safe Handling of Antineoplastic Agents. Med J Australia, 1983; 1:426-428.
Jones RB, et al: Safe Handling of Chemotherapeutic Agents: A Report from the Mount Sinai Medical Center. CA -- A Cancer Journal for Clinicians, 1983; (Sept/Oct) 258-263.
American Society of Hospital Pharmacists Technical Assistance Bulletin on Handling Cytotoxic and Hazardous Drugs. Am J. Hosp Pharm, 1990; 47:1033-1049.
OSHA Work-Practice Guidelines for Personnel Dealing with Cytotoxic (Antineoplastic) Drugs. Am J Hosp Pharm, 1986; 43:1193-1204.
NDC: 62856-177-08
CAUTION: FEDERAL LAW PROHIBITS DISPENSING WITHOUT PRESCRIPTION.

Manufactured by
Eisai Inc.
Woodcliff Lake, NJ 07677

Rev. 04/2010

201241

PRINCIPAL DISPLAY PANEL
NDC 62856-177-08

Caution Card:

Pouch Label:

Box Label:

Gliadel
polifeprosan 20 with carmustine implant wafer
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:62856-177
Route of Administration INTRACAVITARY DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CARMUSTINE (CARMUSTINE) CARMUSTINE 7.7 mg
Inactive Ingredients
Ingredient Name Strength
POLI