Tools used to diagnose brain tumors and monitor your progress and treatment include

  • MRI
  • A procedure in which radio waves and a powerful magnet linked to a computer are used to create detailed pictures of areas inside the body. MRI is especially useful for imaging the brain, the spine, the soft tissue of joints, and the inside of bones.
  • Additional related procedures include Magnetic Resonance Angiography (MRA) and Functional Magnetic Resonance Imaging (fMRI).
  • CT SCAN
  • A series of detailed pictures of areas inside the body taken from different angles. The pictures are created by a computer linked to an x-ray machine. Also called CAT scan, computed tomography scan, computerized axial tomography scan, and computerized tomography.
  • PET SCAN
  • A Positron Emission Tomography (PET) scan is a procedure in which a small amount of radioactive glucose (sugar) is injected into a vein, and a scanner is used to make detailed, computerized pictures of areas inside the body where the glucose is used.
  • BIOPSY
  • The removal of cell or tissue samples for examination by a pathologist. The pathologist may study the tissue under a microscope or perform other tests on the cell or tissue samples to help make or confirm a diagnosis.

TREATMENT OPTIONS

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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