Gliadel Generic Name & Formulations
Legal Class
Rx
General Description
Carmustine 7.7mg, polifeprosan 20; per wafer.
Pharmacological Class
Nitrosurea.
How Supplied
Single-dose treatment box (8 wafers)—1
Manufacturer
Gliadel Indications
Indications
Newly-diagnosed high-grade malignant glioma as an adjunct to surgery and radiation. Recurrent glioblastoma multiforme as an adjunct to surgery.
Gliadel Dosage and Administration
Adult
See literature. Place 8 wafers (61.6mg) in the resection cavity if the size and shape of it allows; max 8 wafers per surgical procedure.
Children
Not recommended.
Gliadel Contraindications
Not Applicable
Gliadel Boxed Warnings
Not Applicable
Gliadel Warnings/Precautions
Warnings/Precautions
Avoid communication between surgical resection cavity and ventricular system to prevent wafer from migrating and causing obstructive hydrocephalus. If communication larger than diameter of wafer exists, it should be closed prior to wafer implantation. Pregnancy (Cat.D). Nursing mothers: not recommended.
Gliadel Pharmacokinetics
See Literature
Gliadel Interactions
Not Applicable
Gliadel Adverse Reactions
Adverse Reactions
Abdominal pain, back pain, chest pain, intracranial hypertension, abnormal healing, brain edema, meningitis or abscess; intracerebral mass effect.
Gliadel Clinical Trials
See Literature
Gliadel Note
Not Applicable
Gliadel Patient Counseling
See Literature