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Brand Name

Gliadel

Generic Name

Carmustine

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FDA approval date: December 13, 2012

Classification: Alkylating Drug

Form: Kit, Wafer

What is Gliadel (Carmustine)?

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. GLIADEL Wafer is an alkylating drug indicated for the treatment of: newly-diagnosed high-grade glioma as an adjunct to surgery and radiation and recurrent glioblastoma as an adjunct to surgery

Approved To Treat

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Brand Information

Gliadel (carmustine)

1INDICATIONS 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.

2DOSAGE FORMS AND STRENGTHS

GLIADEL Wafer is an off-white to pale yellow round wafer. Each GLIADEL Wafer contains 7.7 mg of carmustine.

3CONTRAINDICATIONS

None.

4ADVERSE REACTIONS

The following serious adverse reactions are discussed elsewhere in the labeling:

Seizures
Intracranial Hypertension
Impaired Neurosurgical Wound Healing
Meningitis

4.1Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

5DESCRIPTION

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:

6REFERENCES

"OSHA Hazardous Drugs".

7HOW 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

8PRINCIPAL DISPLAY PANEL - 8 Wafer Box

NDC 24338-050-08

GLIADEL
(carmustine implant)

7.7 mg carmustine/wafer

For intracranial use.

Each sterile wafer contains

Contents:

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.