A malignant brain tumor is usually rapidly growing, invasive, and life-threatening. The World Health Organization assigns grades to brain tumors to aid communication, to plan treatment and to predict outcome. The grade of a tumor reflects the degree of malignancy. GLIADEL Wafer is intended to treat malignant brain tumors that fall into the grade III and grade IV categories.

  • GRADE I
  • Used to describe tumor cells that look like healthy cells and grow slowly.
  • GRADE II
  • Used to describe tumors that also grow slowly, but may spread into nearby tissues or progress to higher grades.
  • GRADE III
  • Used to describe tumors that look different from healthy cells, grow quickly, and are likely to spread into surrounding tissues.
  • GRADE IV
  • Used to describe tumors that look very different from healthy cells, grow at an aggressive rate, and will generally spread into surrounding tissues.

GLIADEL Wafer is only approved for use in newly diagnosed grade III or IV gliomas and recurrent grade IV gliomas.

SYMPTOMS

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

Please read the full Prescribing Information and discuss it with your doctor or healthcare professional. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.FDA.gov/medwatch or call 1-800-FDA-1088.

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