- What are the potential benefits of treatment with GLIADEL Wafer?
- For newly diagnosed high-grade glioma patients, overall survival, the primary outcome measure, in a study of 240 patients was prolonged in the GLIADEL arm. Median overall survival in the GLIADEL arm was 13.9 months while the placebo arm was 11.6 months.1
- In a study of 222 patients with recurrent high-grade glioma, 6 month survival rate in patients with Glioblastoma was 56% in the GLIADEL arm and 36% in the placebo arm. Median overall survival for the GLIADEL arm was 6.51 months while survival in the placebo arm was 4.63 months.1
- What are the potential risks of treatment with GLIADEL Wafer?
- 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.
- Please read the full Prescribing Information and discuss it with your doctor or healthcare professional. 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.
- Is GLIADEL Wafer radioactive?
- No, GLIADEL Wafer is not radioactive.
- Can I still be treated with other types of cancer treatments if I am treated with GLIADEL Wafer?
- The short-term and long-term side effects of GLIADEL Wafer when given with other chemotherapies have not been fully explored.
- You and your doctor will decide whether other therapies should be used to treat your malignant glioma.
- What if I cannot afford my medications, or if I have insurance or coverage questions?
- For questions on coverage and assistance, contact the Arbor Assistance Program:
- Phone: (866) 516-4950, Option 4
- Hours: Monday – Friday, 8:00 AM to 5:00 PM CST
- Fax: (866) 448-1960
For more information about your treatment please talk to your doctor
- GLIADEL® Wafer (carmustine implant) for intracranial use [Prescribing Information]. Atlanta, GA: Arbor Pharmaceuticals, LLC; 2018.