HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use GLIADEL WAFER safely and effectively. See full prescribing information for GLIADEL WAFER. GLIADEL - ® WAFER ...
These highlights do not include all the information needed to use GLIADEL WAFER safely and effectively. See full prescribing information for GLIADEL WAFER.
GLIADEL ® WAFER (carmustine implant) for intracranial use
Initial U.S. Approval: 1996
INDICATIONS AND USAGE
GLIADEL Wafer is an alkylating drug indicated for the treatment of:
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newly-diagnosed high-grade-malignant glioma as an adjunct to surgery and radiation (1) and
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recurrent glioblastoma multiforme as an adjunct to surgery (1)
DOSAGE AND ADMINISTRATION
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Recommended dose: Eight 7.7 mg wafers (61.6 mg total dose) implanted intracranially (2.1, 2.2)
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Follow preparation and handling recommendations (2.3).
DOSAGE FORMS AND STRENGTHS
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Each GLIADEL Wafer contains 7.7 mg of carmustine (3).
CONTRAINDICATIONS
None (4)
WARNINGS AND PRECAUTIONS
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Seizures: Monitor patients for seizures following implantation (5.1).
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Intracranial hypertension: Monitor patients for signs of increased intracranial pressure (5.2).
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Impaired neurosurgical wound healing: Monitor patients for complications of craniotomy (5.3).
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Meningitis: Monitor patients for signs of bacterial or chemical meningitis (5.4).
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Wafer migration: Monitor patients for signs of obstructive hydrocephalus (5.5).
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Embryo-fetal toxicity: Can cause fetal harm (5.6)
ADVERSE REACTIONS
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Newly-Diagnosed High-Grade Malignant Glioma: Most common adverse reactions (incidence >10% and between arm difference ≥4%) are cerebral edema, asthenia, nausea, vomiting, constipation, wound healing abnormalities and depression (6.1).
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Recurrent High-Grade Malignant Glioma: Most common adverse reactions (incidence >10% and between arm difference ≥4%) are urinary tract infection, wound healing abnormalities and fever (6.1).
To report SUSPECTED ADVERSE REACTIONS, contact Arbor Pharmaceuticals, LLC at 1-866-516-4950 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
USE IN SPECIFIC POPULATIONS
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Pediatric use: Safety and effectiveness not established (8.4)
See 17 for PATIENT COUNSELING INFORMATION.
Revised: 11/2014
FULL PRESCRIBING INFORMATION: CONTENTS*
Table of Contents
1 INDICATIONS AND USAGE
GLIADEL Wafer is indicated for the treatment of patients with: newly-diagnosed high-grade malignant glioma as an adjunct to surgery and radiation, and - recurrent glioblastoma ...
GLIADEL Wafer is indicated for the treatment of patients with:
-
newly-diagnosed high-grade malignant glioma as an adjunct to surgery and radiation, and
-
recurrent glioblastoma multiforme as an adjunct to surgery.
2 DOSAGE AND ADMINISTRATION
2.1 Recommended Dose - The recommended dose of GLIADEL Wafer is eight 7.7 mg wafers for a total of 61.6 mg implanted intracranially. The safety and effectiveness of ...
2.1 Recommended Dose
The recommended dose of GLIADEL Wafer is eight 7.7 mg wafers for a total of 61.6 mg implanted intracranially. The safety and effectiveness of repeat administration have not been studied.
2.2 Insertion Instructions
Following maximal tumor resection, confirmation of tumor pathology and establishment of hemostasis, place up to a maximum of eight GLIADEL Wafers to cover as much of the resection cavity as possible. Should the size and shape of the resected cavity not accommodate eight wafers, place the maximum number of wafers feasible within the cavity. Slight overlapping of the wafers is acceptable. Wafers broken in half may be used, but discard wafers broken in more than two pieces. Oxidized regenerated cellulose (Surgicel®) may be placed over the wafers to secure them against the cavity surface. After placement of the wafers, irrigate the resection cavity and close the dura in a water-tight fashion.
2.3 Preparation and Safe Handling
GLIADEL Wafers contain a cytotoxic drug. Follow applicable special handling and disposal procedures.1
Each wafer is packaged within two nested aluminum foil laminate pouches. The inner pouch is sterile and is designed to maintain product sterility and protect the product from moisture. The outside surface of the outer laminated aluminum foil pouch is a peelable overwrap and is not sterile.
Deliver GLIADEL Wafers to the operating room in their outer aluminum foil pouch, unopened. Do not open the pouch until the wafers are ready to be implanted. GLIADEL Wafers in unopened outer foil pouches are stable at room temperature for six hours at a time for up to three cycles within a 30-day period.
Exposure to carmustine can cause severe burning and hyperpigmentation of the skin. Use double gloves when handling GLIADEL Wafers. Discard the outer gloves into a biohazard waste container after use. Use a dedicated surgical instrument for wafer implantation. If repeat neurosurgical intervention is indicated, handle residual wafers or wafer remnants as potential cytotoxic agents.
Instructions for Opening Pouch Containing GLIADEL Wafer
Read all steps of the instructions prior to opening the pouch.
Instructions for opening the pouch containing GLIADEL Wafer can be viewed at the following website: http://gliadel.com/hcp/pouch-opening-instructions. Illustrations are also pictured below.
Figure 1: To remove the sterile inner pouch from the outer pouch, locate the folded corner and slowly pull in an outward motion.
Figure 2: Do NOT pull in a downward motion rolling knuckles over the pouch. This may exert pressure on the wafer and cause it to break.
Figure 3: The inner pouch is a multi-layered, silver colored, foil laminate. Remove the inner pouch by grabbing hold of the crimped edge of the inner pouch using a sterile instrument and pulling upward.
Figure 4: To open the inner pouch, gently hold the crimped edge and cut in an arc-like fashion around the wafer.
Figure 5: To remove the GLIADEL Wafer, gently grasp the wafer with th
