• Guidelines
  • BCNU Wafer (Gliadel®)
    Recommendations for Patients with:
  •  
  • Newly Diagnosed (HGG/GBM)
  • Progressive GBM
  • AANS/CNS
  • NCCN®*

American Association of Neurological Surgeons/Congress of Neurological Surgeons (AANS/CNS) Joint Tumor Section

•  BCNU-impregnated biodegradable polymers are recommended for both newly diagnosed and progressive GBM patients for whom craniotomy is indicated (level II recommendations).1,2,3,4

NCCN Clinical Practice Guidelines In Oncology (NCCN Guidelines®) for Central Nervous System Cancers V.1.20215

•  Consider Carmustine (BCNU) Wafer implant in newly diagnosed anaplastic gliomaa (HGGs)/glioblastoma (GBM) in patients where maximal safe resection is feasible and frozen-section diagnosis supports high-grade glioma (category 2B recommendationi)a,b

•  Consider Carmustine (BCNU) Wafer implant in recurrent anaplastic glioma/glioblastoma patients during resection for local recurrence (category 2A recommendationii)b

INDICATIONS

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

GLIADEL® Wafer is also indicated in patients with recurrent glioblastoma multiforme as an adjunct to surgery.

INDICATIONS

GLIADEL Wafer is indicated for the treatment of patients with newly-diagnosed high-grade glioma as an adjunct to surgery and radiation.

GLIADEL Wafer is also indicated for the treatment of patients with recurrent glioblastoma as an adjunct to surgery.

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

Seizures: Seizures occurred in 37% of patients treated with GLIADEL Wafers for recurrent glioma in the recurrent high-grade glioma trial. New or worsening (treatment emergent) seizures occurred in 20% of patients; 54% of treatment emergent seizures occurred within the first 5 post-operative days. The median time to onset of the first new or worsened post-operative seizure was four days. Institute optimal anti-seizure therapy prior to surgery. Monitor patients for seizures postoperatively.

Intracranial Hypertension: Brain edema occurred in 23% of patients with newly diagnosed glioma treated with GLIADEL Wafers in the newly-diagnosed high-grade glioma trial. Additionally, one GLIADEL-treated patient experienced intracerebral mass effect unresponsive to corticosteroids which led to brain herniation. Monitor patients closely for intracranial hypertension related to brain edema, inflammation, or necrosis of the brain tissue surrounding the resection. In refractory cases, consider re-operation and removal of GLIADEL Wafers or Wafer remnants.

Impaired Neurosurgical Wound Healing: Impaired neurosurgical wound healing including wound dehiscence, delayed wound healing, and subdural, subgaleal, or wound effusions occur with GLIADEL Wafer treatment. In the newly-diagnosed high-grade glioma trial, 16% of GLIADEL Wafer-treated patients with newly diagnosed glioma experienced impaired intracranial wound healing and 5% had cerebrospinal fluid leaks. In the recurrent high-grade glioma trial, 14% of GLIADEL Wafer-treated patients with recurrent high-grade glioma experienced wound healing abnormalities. Monitor patients post-operatively for impaired neurosurgical wound healing.

Meningitis: Meningitis occurred in 4% of patients with recurrent glioma receiving GLIADEL Wafers in the recurrent high-grade glioma trial. Two cases of meningitis were bacterial; one patient required removal of the Wafers four days after implantation; the other developed meningitis following reoperation for recurrent tumor. One case was diagnosed as chemical meningitis and resolved following steroid treatment. In one case the cause was unspecified, but meningitis resolved following antibiotic treatment. Monitor postoperatively for signs of meningitis and central nervous system infection.

Wafer Migration: GLIADEL Wafer migration can occur. To reduce the risk of obstructive hydrocephalus due to wafer migration into the ventricular system, close any communication larger than the diameter of a Wafer between the surgical resection cavity and the ventricular system prior to Wafer implantation. Monitor patients for signs of obstructive hydrocephalus.

Embryo-Fetal Toxicity: GLIADEL Wafers can cause fetal harm when administered to a pregnant woman. Carmustine, the active component of GLIADEL Wafer, is embryotoxic and teratogenic in rats at exposures less than the exposure at the recommended human dose based on body surface area (BSA) and embryotoxic in rabbits at exposures similar to the exposure at the recommended human dose based on BSA. Advise patients of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception for 6 months after implantation of GLIADEL Wafer. Advise males with female partners of reproductive potential to use effective contraception for 3 months following implantation of Gliadel Wafers.

ADVERSE REACTIONS

The most common adverse reactions in newly-diagnosed high-grade glioma patients (incidence >10% and between arm difference ≥4%) are cerebral edema, asthenia, nausea, vomiting, constipation, wound healing abnormalities and depression.

The most common adverse reactions in recurrent high-grade glioma patients (incidence >10% and between arm difference ≥4%) are urinary tract infection, wound healing abnormalities and fever.

For additional safety information, please consult the GLIADEL full Prescribing Information.

You are encouraged to report side effects of prescription drugs to Arbor Pharmaceuticals, LLC Medical Information at 1-866-516-4950 or to the FDA at www.fda.gov/medwatch or call 1-800-FDA-1088.

  1. REFERENCES
  2. Olson, J. J., & Ryken, T. (2008). Guidelines for the treatment of newly diagnosed glioblastoma: introduction. Journal of Neuro-Oncology, 89(3), 255–258. https://doi.org/10.1007/s11060-008-9595-4
  3. Fadul, C. E., Wen, P. Y., Kim, L., & Olson, J. J. (2008). Cytotoxic chemotherapeutic management of newly diagnosed glioblastoma multiforme. Journal of NeuroOncology, 89(3), 339–357. https://doi.org/10.1007/
  4. Olson, J. J., Ryken, T. C., & Kalkanis, S. N. (2014). Introduction, rationale, and methodology. Journal of Neuro-Oncology, 118(3), 429–434. https://doi.org/10.1007/s11060-013-1329-6
  5. Olson, J. J., Nayak, L., Ormond, D. R., Wen, P. Y., & Kalkanis, S. N. (2014). The role of cytotoxic chemotherapy in the management of progressive glioblastoma: A systematic review and evidence-based clinical practice guideline. Journal of NeuroOncology, 118(3), 501–555. https://doi.org/10.1007/s11060-013-1338-5
  6. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Central Nervous System Cancers V.1.2021. © National Comprehensive Cancer Network, Inc 2021. All rights reserved. Accessed 06/25/2021. To view the most recent and complete version of the guideline, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.

For US Healthcare Professionals Only.