Malignant gliomas may be treated with surgery, radiation, chemotherapy, or any combination of these treatment options. The treatment your doctor recommends depends on various factors including the type of tumor, its location, and its size.

  • SURGERY
  • If possible, surgery is usually the first step in treating most brain tumors. The surgeon will remove as much tumor as possible without damaging healthy tissue, either to provide tissue for diagnosis, relieve symptoms caused by the tumor or to reduce the amount of tumor left to be treated with radiation and/or chemotherapy.
  • GLIADEL® Wafer
  • Gliadel Wafer is a locally delivered chemotherapy that can only be given during surgery. For patients who meet the appropriate criteria, up to 8 wafers can be applied to the tissue in the area of the brain where the tumor was located. The goals of local delivery are to avoid delivering chemotherapy throughout the body and to increase its chemotherapy at the tumor site.
  • CHEMOTHERAPY
  • Chemotherapy is a cancer treatment that works by killing cancer cells, stopping their growth or slowing their growth. Chemotherapy drugs are delivered orally, injected into an artery, vein, muscle or the skin, or delivered locally at the tumor site after surgery.
  • RADIATION THERAPY
  • Radiation therapy uses beams of intense energy to destroy, slow the growth of or stop the growth of cancer cells. Doctors typically give radiation therapy after surgery and possibly along with chemotherapy.
  • TUMOR TREATING FIELDS
  • This treatment uses alternating, low-intensity electrical fields that are delivered by placing electrodes on the outside of a person’s head. The electromagnetic fields interfere with the parts of a tumor cell that are needed for the cells to grow and spread.

GLIADEL Wafer (carmustine, BCNU Wafer) is included in national treatment guidelines.*

*The American Association of Neurosurgeons/Congress of Neurological Surgeons (AANS/CNS) Joint Tumor Section includes carmustine (BCNU) wafer as a recommended therapy for both newly diagnosed and progressive glioblastoma patients for whom craniotomy is indicated.

EXPLORE THE BRAIN

INDICATIONS

GLIADEL Wafer (carmustine implant) 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.

IMPORTANT SAFETY INFORMATION

You should not be given GLIADEL Wafer if you are allergic to carmustine or any of the components of GLIADEL Wafer.

If you are undergoing surgery for malignant glioma and implantation of GLIADEL Wafer, you should be monitored closely for known complications, including convulsions, infections, abnormal wound healing, and swelling of the brain.

If you are pregnant or are planning to become pregnant, you should understand that carmustine, the active component of GLIADEL Wafer, can cause harm to the fetus if given to a pregnant woman. It is not known if either carmustine, or other components of GLIADEL Wafer are excreted in human milk. Many drugs are excreted in human milk and there is a risk for serious side effects from carmustine in nursing infants; therefore discontinuation of nursing is recommended if you will be receiving GLIADEL Wafer.

It is possible that if GLIADEL Wafers are not implanted properly, they could block the flow of cerebrospinal fluid and might cause abnormal accumulation of fluid in the brain (obstructive hydrocephalus).

The short-term and long-term safety of GLIADEL Wafer when given together with chemotherapy is not fully known.

Following surgery to remove a brain tumor and implantation of GLIADEL Wafer, the following side effects have been reported in clinical studies:

Seizures (convulsions): In clinical studies, seizures have occurred within days or several weeks following implantation of GLIADEL Wafer. Both new seizures and worsening of seizures have been reported.

Brain Swelling: Brain swelling has occurred in clinical studies. In some cases, brain swelling may require another surgery, and removal of GLIADEL Wafers or remnants of the wafers may be required.

Abnormal wound healing: In clinical studies, abnormal healing of the surgical wound has occurred following implantation of GLIADEL Wafer. These abnormalities included reopening of the surgical area, leaking of brain or spinal fluid, delays in healing, or other abnormalities in how the wound heals.

Brain Infections: In clinical studies, brain infections, including meningitis, have occurred following implantation of GLIADEL Wafer.

ADVERSE REACTIONS

The most common adverse reactions in Newly-Diagnosed High Grade Malignant Glioma patients are cerebral edema, asthenia, nausea, vomiting, constipation, wound healing abnormalities and depression.

The most common adverse reactions in Recurrent Glioblastoma Multiforme patients are urinary tract infection, wound healing abnormalities and fever.

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.

For more information, ask your healthcare provider or pharmacist, or consult the full Prescribing Information.