Uses
1 INDICATIONS AND USAGE
GLIADEL Wafer is indicated for the treatment of patients with: newly-diagnosed high-grade glioma as an adjunct to surgery and radiation, and recurrent glioblastoma as an adjunct to surgery.
4 CONTRAINDICATIONS
None.
Gliadel
- Manufacturer
- Azurity Pharmaceuticals, Inc.
- Effective date
- 2024-12-05
- Label type
- HUMAN PRESCRIPTION DRUG LABEL
- Version
- 8
- Source
- full-release
- Hydrated at
- 2026-05-31 21:18:57
Key Label Information#
Warnings
4 CONTRAINDICATIONS
None.
5 WARNINGS AND PRECAUTIONS
Directions And Dosage
2 DOSAGE AND ADMINISTRATION
3 DOSAGE FORMS AND STRENGTHS
GLIADEL Wafer is an off-white to pale yellow round wafer. Each GLIADEL Wafer contains 7.7 mg of carmustine.
Other Label Information
16 HOW SUPPLIED/STORAGE AND HANDLING
GLIADEL Wafer is supplied 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. NDC for single dose treatment box: 24338-050-08
PRINCIPAL DISPLAY PANEL - 8 Wafer Box
NDC 24338-050-08 GLIADEL ® WAFER (carmustine implant) 7.7 mg carmustine/wafer For intracranial use. Each sterile wafer contains 192.3 mg polifeprosan 20 and 7.7 mg carmustine. Contents: 8 wafers, individually packaged Store at or below -20°C (-4°F). Rx only Warning: Cytotoxic agent See package insert for full prescribing information. Keep out of the reach of children. Azurity PHARMACEUTICALS, Inc.
Label Images#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 309013 | carmustine 7.7 MG Intracavitary Drug Implant | PSN | 8 |
| 212994 | GLIADEL Wafer 7.7 MG Intracavitary Drug Implant | PSN | 8 |
| 212994 | carmustine 7.7 MG Drug Implant [Gliadel] | SBD | 8 |
| 309013 | carmustine 7.7 MG Drug Implant | SCD | 8 |
| 309013 | BCNU 7.7 MG Drug Implant | SY | 8 |
| 212994 | BCNU 7.7 MG Drug Implant [Gliadel] | SY | 8 |
| 309013 | carmustine 7.7 MG Wafer | SY | 8 |
| 212994 | Gliadel Wafer 7.7 MG Intracavitary Drug Implant | SY | 8 |
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| CARMUSTINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| bae01308-1b8b-469d-b5f8-5f7855ef8376 | Product name | 7 | 20250716 |
| 8f5e4eb6-eb6b-45c2-b18a-1d6819bcb788 | Product name | 1 | 20230125 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 24338-050-08 | Gliadel | 1 in 1 POUCH | WAFER | 1 | 8 | |
| 24338-050-08 | Gliadel | 8 in 1 BOX | WAFER | 8 | 8 |
DailyMed Dashboard NDC Coverage#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 24338-050-08 | EA - Each | 24338-050 | 78c17940-1707-44b1-8880-813aa28dacda | 1 | 2014-09-03 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| carmustine | ACTIVE INGREDIENT | U68WG3173Y | 5 | |
| carmustine | ACTIVE MOIETY | U68WG3173Y | 5 | |
| polifeprosan 20 | INACTIVE INGREDIENT | S40C40DA21 | 5 |
Products#
- Gliadel
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 24338-050 | 24338-050-08 |
Ingredients#
| Name | UNII | Kind |
|---|---|---|
| POLIFEPROSAN 20 | S40C40DA21 | IACT |
| CARMUSTINE | U68WG3173Y | ACTIB |
Complete SPL Sections#
1 INDICATIONS AND USAGE
GLIADEL Wafer is indicated for the treatment of patients with: newly-diagnosed high-grade glioma as an adjunct to surgery and radiation, and recurrent glioblastoma as an adjunct to surgery.
2 DOSAGE AND ADMINISTRATION
3 DOSAGE FORMS AND STRENGTHS
GLIADEL Wafer is an off-white to pale yellow round wafer. Each GLIADEL Wafer contains 7.7 mg of carmustine.
4 CONTRAINDICATIONS
None.
5 WARNINGS AND PRECAUTIONS
6 ADVERSE REACTIONS
The following serious adverse reactions are discussed elsewhere in the labeling: Seizures [ see Warnings and Precautions (5.1) ] Intracranial Hypertension [ see Warnings and Precautions (5.2) ] Impaired Neurosurgical Wound Healing [ see Warnings and Precautions (5.3) ] Meningitis [ see Warnings and Precautions (5.4) ]
8 USE IN SPECIFIC POPULATIONS
11 DESCRIPTION
GLIADEL Wafer is an implant for intracranial use, containing carmustine, a nitrosourea alkylating agent, and polifeprosan, a biodegradable copolymer used to control the release of carmustine. It is a sterile, off-white to pale yellow wafer approximately 1.45 cm in diameter and 1 mm thick. Each wafer contains 7.7 mg of carmustine [1, 3-bis (2-chloroethyl)-1-nitrosourea, or BCNU] and 192.3 mg of a biodegradable polyanhydride copolymer. The copolymer, polifeprosan 20, consists of poly [bis (p-carboxyphenoxy)] propane and sebacic acid in a 20:80 molar ratio. Carmustine is homogeneously distributed in the copolymer matrix. The structural formula for polifeprosan 20 is: The structural formula for carmustine is:
12 CLINICAL PHARMACOLOGY
13 NONCLINICAL TOXICOLOGY
14 CLINICAL STUDIES
15 REFERENCES
"OSHA Hazardous Drugs". OSHA. http://www.osha.gov/SLTC/hazardousdrugs/index.html
16 HOW SUPPLIED/STORAGE AND HANDLING
GLIADEL Wafer is supplied 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. NDC for single dose treatment box: 24338-050-08
17 PATIENT COUNSELING INFORMATION
SPL UNCLASSIFIED SECTION
Manufactured by Eisai Inc. Nutley, NJ 07110 Distributed by Azurity Pharmaceuticals, Inc. Woburn, MA 01801 Patent: https://azurity.com/patents GLIADEL ® is a registered trademark of Eisai Inc. GL-PI-05
PRINCIPAL DISPLAY PANEL - 8 Wafer Box
NDC 24338-050-08 GLIADEL ® WAFER (carmustine implant) 7.7 mg carmustine/wafer For intracranial use. Each sterile wafer contains 192.3 mg polifeprosan 20 and 7.7 mg carmustine. Contents: 8 wafers, individually packaged Store at or below -20°C (-4°F). Rx only Warning: Cytotoxic agent See package insert for full prescribing information. Keep out of the reach of children. Azurity PHARMACEUTICALS, Inc.