Gliadel 7.7 mg/1
carmustine · WAFER · Azurity Pharmaceuticals, Inc.
Gliadel is a wafer containing carmustine at 7.7 mg/1, taken intracavitary. Manufactured by Azurity Pharmaceuticals, Inc..
Key Facts
- Brand Name
- Gliadel
- Generic Name
- carmustine
- NDC Code (Product)
24338-050- Manufacturer
- Azurity Pharmaceuticals, Inc.
- Strength
- 7.7 mg/1
- Dosage Form
- WAFER
- Route
- INTRACAVITARY
- Marketing Status
- Application #
- NDA020637
- Drug Class
- Alkylating Drug [EPC]
- Marketing Start
- 12/13/2012
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
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. GLIADEL Wafer is an alkylating drug indicated for the treatment of: newly-diagnosed high-grade glioma as an adjunct to surgery and radiation ( 1 ) and recurrent glioblastoma as an adjunct to surgery ( 1 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Recommended dose: Eight 7.7 mg wafers (61.6 mg total dose) implanted intracranially ( 2.1 , 2.2 ) Follow preparation and handling recommendations ( 2.3 ). 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 …
Contraindications
4 CONTRAINDICATIONS None. None ( 4 )
Adverse Reactions
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) ] Newly-Diagnosed High-Grade 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 ). Recurrent High-Grade 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 Azurity Pharmaceuticals, Inc. at 1-800-461-7449 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical 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. Newly-Dia…
Frequently Asked Questions
What is Gliadel used for?
Gliadel contains carmustine. It is a wafer taken intracavitary. Consult your doctor for specific uses.
Is Gliadel a controlled substance?
Gliadel is not classified as a controlled substance by the DEA.
What is the generic name for Gliadel?
The generic name for Gliadel is carmustine. There are 11 other brand versions of carmustine.
What is the NDC code for Gliadel 7.7 mg/1?
The NDC (National Drug Code) for Gliadel 7.7 mg/1 is 24338-050, listed by Azurity Pharmaceuticals, Inc..