A brain tumor is an abnormal growth of cells in the brain and there are many different types of them. In general, they are described as benign or malignant, and as primary or metastatic.

Benign Versus Malignant Brain Tumors

A benign tumor contains noncancerous cells, is typically not life threatening, and is treated primarily with surgery. A malignant tumor contains cancerous cells, often grows rapidly, and is life-threatening.

Primary Versus Metastatic Brain Tumors

A brain tumor can start in the brain or in other parts of the body. If the tumor starts in the brain, it is called a primary brain tumor. Primary tumors can be benign or malignant. If cancer cells that originate in other parts of the body (such as the breast, lung, or kidney) travel to the brain, they are called metastatic brain tumors. All metastatic brain tumors are malignant.

GLIADEL Wafer is not indicated in patients with metastatic brain tumors.

Types of Gliomas

Glioma is a general term used to describe a tumor that grows out of the brain’s supportive cells called glial cells. Gliomas are the most common type of primary malignant brain tumor.

Astrocytomas are the most common type of glioma found in adults. These tumors originate from astrocytes – the star-shaped cells that create the supportive tissue of the brain.

Low-grade astrocytomas are slow-growing tumors that may be located in the cerebrum or the cerebellum parts of the brain with a low risk of spreading. Diffuse astrocytomas (grade II) are slow growing and still considered low grade, but may infiltrate the surrounding tissue.

Anaplastic astrocytomas are faster-growing tumors that are characterized by tentacle-like projections that spread into surrounding brain tissue.

Glioblastoma multiforme (GBM) is the most malignant type of astrocytoma. These tumors have the ability to form new blood vessels that help maintain their growth even after treatment.

GLIADEL Wafer is not indicated FOR USE IN LOW-GRADE ASTROCYTOMAS.

Oligodendrogliomas are tumors that originate as oligodenrocytes, another one of the types of cells found in the supportive tissue of the brain. Under the microscope, these cells have short arms and a definitive “fried-egg” appearance that stands out from the more common star-shaped astrocytomas.

Anaplastic oligodendrogliomas are aggressive tumors that arise in oligodendrocytes that grow quickly. They are characterized by excessive growth of blood vessels that form clusters or branches in the brain tissue and areas of dead cells and tissue.

Anaplastic oligoastrocytomas are gliomas that contain both oligodendrocytes and astrocytes. Like anaplastic oligodendrogliomas, they have rapid growth of blood vessels and areas of dead cells and tissue.

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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