Since 1997, over 20,000 procedures have been performed with GLIADEL.4
How to Use GLIADEL® Wafer
Six Steps to Using GLIADEL® Wafer
1. Preparation for Use
- Maximize resection of tumor
- Send tumor specimen to pathologist to confirm malignant glioma
- Achieve hemostasis before implantation to eliminate bleeding
- Obtain clear irrigation fluid
2. Handle Wafers carefully due to fragility and toxicity of carmustine
- Use double surgical gloves
- Use a surgical instrument dedicated to wafer handling
- Keep wafer pouches unopened until implantation
3. Opening the GLIADEL pouch (outer surface of foil pouch is not sterile)
- Open outer pouch: peel folded corner in outward motion
- Do not pull downward this may break wafer
- Remove inner pouch: with forceps, grab crimped edge, pull upwards
- Open inner pouch: gently hold crimped edge, cut around wafer
- Remove wafer: gently grasp with forceps, place onto sterile field
4. Implanting GLIADEL
- Line resection cavity surface with wafers
- Cover entire surface of cavity using mosaic pattern, using up to eight wafers (7.7
mg carmustine each)
- Pack wafers close without stacking; slight overlap and halving wafers are acceptable
- If necessary, stretch surface area to maximize exposure to wafers
- Prevent wafer migration into ventricular system and obstructive hydrocephalus by
closing any communication larger than a wafer before implantation
- Dispose of unused wafers
5. Securing the Wafers
- Anchor wafers with ½-inch-wide strips of Surgicel® (oxidized cellulose),
starting at bottom of cavity and moving up
- Keep Surgicel® strips 1 layer deep: do not create large mass
6. Ensure watertight dural closure
- Take extra care to decrease risk of CSF leaks and infection
- Suction to ensure no blood in cavity
- Irrigate resection cavity before closure
- If necessary, use a graft of autologous, nonsynthetic or synthetic dura patch or
substitute
- Treat CSF leaks aggressively
- Manage edema with aggressive and prolonged corticosteroid treatment
- Begin anticonvulsants before surgery (recommended for all patients)
The information described above is a general example intended to help educate individuals
on GLIADEL® Wafer. The information provided is neither a substitute
for professional medical advice nor intended to provide treatment options. The text
and graphics depicted do not replace the services of a physician or doctor-patient
relationship. The use of the information is at the discretion of the reader. The
reader should always consult a qualified medical expert in the use of GLIADEL®
Wafer. MGI PHARMA makes no representations or warranties with respect to any information
provided on this graphic and is not liable for any direct or indirect claim, loss
or damage resulting from the use of this information.
Surgicel is a registered trademark of Johnson & Johnson.
References
Prescribing Information
Important Safety Information
Indications:
GLIADEL® Wafer is indicated in patients with newly diagnosed high-grade
malignant glioma as an adjunct to surgery and radiation. GLIADEL is also indicated
in patients with recurrent glioblastoma multiforme as an adjunct to surgery.
Contraindication:
GLIADEL® Wafer should not be given to patients who have demonstrated
a previous hypersensitivity to carmustine or any of the components of GLIADEL.
Warnings:
Patients undergoing craniotomy for malignant glioma and implantation of GLIADEL
should be monitored closely for known complications of craniotomy, including seizures,
intracranial infections, abnormal wound healing, and brain edema.
Cases of intracerebral mass effect unresponsive to corticosteroids have been described
in patients treated with GLIADEL, including one case leading to brain herniation.
Precautions:
Communication between the surgical resection cavity and the ventricular system should
be avoided to prevent the wafers from migrating into the ventricular system and
causing obstructive hydrocephalus. If a communication larger than the diameter of
a wafer exists, it should be closed prior to wafer implantation.
Computed tomography and magnetic resonance imaging of the head may demonstrate enhancement
in the brain tissue surrounding the resection cavity after implantation of GLIADEL.
This enhancement may represent edema and inflammation caused by GLIADEL or tumor
progression.
The short-term and long-term toxicity profiles of GLIADEL when given in conjunction
with chemotherapy have not been fully explored.
Pregnancy and Nursing:
There are no studies assessing the reproductive toxicity of GLIADEL. Carmustine,
the active component of GLIADEL, can cause fetal harm when administered to a pregnant
woman.
It is recommended that patients receiving GLIADEL discontinue nursing.
Adverse Events:
Seizures:
In the initial surgery trial, the incidence of seizures was 33.3% in patients receiving
GLIADEL and 37.5% in patients receiving placebo. Grand mal seizures occurred in
5% of GLIADEL-treated patients and 4.2% of placebo-treated patients. The incidence
of seizures within the first 5 days after wafer implantation was 2.5% in the GLIADEL
group and 4.2% in the placebo group.
In the surgery for recurrent disease trial, the incidence of post-operative seizures
was 19% in both patients receiving GLIADEL and placebo. In this study, 12/22 (54%)
of patients treated with GLIADEL and 2/22 (9%) of placebo patients experienced the
first new or worsened seizure within the first five post-operative days. The median
time to onset of the first new or worsened post-operative seizure was 3.5 days in
patients treated with GLIADEL and 61 days in placebo patients.
Brain Edema:
In the initial surgery trial, brain edema was noted in 22.5% of patients treated
with GLIADEL and in 19.2% of patients treated with placebo. Development of brain
edema with mass effect (due to tumor recurrences, intracranial infection, or necrosis)
may necessitate re-operation and, in some cases, removal of GLIADEL or its remnants.
Healing Abnormalities:
The following healing abnormalities have been reported in clinical trials of GLIADEL:
wound dehiscence, delayed wound healing, subdural, subgaleal or wound effusions,
and cerebrospinal fluid leak. In the initial surgery trial, healing abnormalities
occurred in 15.8% of GLIADEL-treated patients and in 11.7% of placebo recipients.
Cerebrospinal fluid leaks occurred in 5% of GLIADEL recipients and 0.8% of those
given placebo. During surgery, a water-tight dural closure should be obtained to
minimize the risk of cerebrospinal fluid leak.
In the surgery for recurrent disease trial, the incidence of healing abnormalities
was the 14% of GLIADEL treated patients and 5% in patients receiving placebo wafers.
Intracranial Infection:
In the initial surgery trial, the incidence of brain abscess or meningitis was 5%
in patients treated with GLIADEL and 6% in patients receiving placebo. In the recurrent
setting, the incidence of brain abscess or meningitis was 4% in patients treated
with GLIADEL and 1% in patients receiving placebo.
Please see the Prescribing Information for more information.
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