Drug Description

Presentation

Indications

GLIADEL Implant is indicated in newly-diagnosed high-grade malignant glioma patients as an adjunct to surgery and radiation.

GLIADEL Implant is indicated for use as an adjunct to surgery in patients with recurrent histologically proved glioblastoma multiforme for whom surgical resection is indicated.

Adult Dosage

For intralesional use in adults only.

Each GLIADEL Implant contains 7.7 mg of carmustine, resulting in a dose of 61.6 mg when eight implants are placed in the tumour resection cavity.

It is recommended that a maximum of eight implants be placed if the size and shape of the resection cavity allows it. Implants broken in half may be used, but implants broken in more than two pieces should be discarded in the dedicated biohazard waste containers.

It is recommended that the placement of the implants should be directly from the product's inner sterile packaging into the resection cavity. Oxidised regenerated cellulose may be placed over the implants to secure them to the cavity surface .

Contra Indications

Hypersensitivity to the active substance carmustine or to any of the excipients of GLIADEL Implant.

Special Precautions

Patients undergoing craniotomy for glioblastoma and implantation of GLIADEL Implant should be monitored closely in view of known complications of craniotomy which includes convulsions, intracranial infections, abnormal wound healing, and brain oedema. Cases of intracerebral mass effect unresponsive to corticosteroids have been described in patients treated with GLIADEL Implant, including one case leading to brain herniation. Careful monitoring of GLIADEL Implant-treated patients for cerebral oedema/intracranial hypertension with consequent steroid use is warranted. CSF leak was more common in GLIADEL Implant-treated patients. Attention to a water-tight dural closure and local wound care is indicated.

Development of brain oedema with mass effect (due to tumour recurrence, intracranial infection, or necrosis) may necessitate re-operation and, in some cases, removal of GLIADEL Implant or its remnants.

Communication between the surgical resection cavity and the ventricular system should be avoided to prevent the implants from migrating into the ventricular system and possibly causing obstructive hydrocephalus. If a communication larger than the diameter of the implant exists, it should be closed prior to GLIADEL Implant implantation.

Computed tomography and magnetic resonance imaging may demonstrate enhancement in the brain tissue surrounding the resection cavity after placement of GLIADEL Implants. This enhancement may represent oedema and inflammation caused by GLIADEL Implants or tumour progression.

Interactions

Interactions of GLIADEL Implant with other drugs or chemotherapy have not been formally eva luated.

Adverse Reactions

The spectrum of undesirable effects observed in patients with newly-diagnosed high-grade malignant glioma and recurrent malignant gliomas was generally consistent with that encountered in patients undergoing craniotomy for malignant gliomas.

Very common ( 1/10), common ( 1/100 to < 1/10) and uncommon ( 1/1,000 to < 1/100) adverse reactions reported in patients receiving GLIADEL Implant during the clinical trials are listed below.

Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

Primary Surgery

The following data are the most frequently occurring adverse events observed in 5% or more of the 120 newly-diagnosed malignant glioma patients receiving GLIADEL Implant during the trial.

Common Adverse Events Observed in 5% of Patients Receiving GLIADEL Implant at Initial Surgery