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Gliadel Warnings and Precautions

Complications like infections, seizures, and increased pressure on the brain could occur in some people who receive Gliadel. These and other safety precautions should be reviewed to help minimize complications with this chemotherapy drug. Warnings with Gliadel also apply to women who are pregnant or nursing. Also, people who are taking certain medications or have certain medical conditions may not be able to receive this drug.

What Should I Tell My Healthcare Provider?

You should talk with your healthcare provider prior to receiving Gliadel® (carmustine implant) if you have:
 
 
Also, let your healthcare provider know if you are:
 
  • Pregnant or thinking of becoming pregnant
  • Breastfeeding.
 
You should also tell your healthcare provider about all other medications you are taking, including prescription and nonprescription medicines, vitamins, and herbal supplements.
 

Specific Precautions and Warnings With Gliadel

Some warnings and precautions to be aware of prior to receiving this medication include the following:
 
  • People who undergo surgery for glioma (a type of brain tumor) and implantation of Gliadel are at risk for potentially serious complications, including seizures, brain infections, swelling of the brain, and abnormal wound healing. Your healthcare provider will monitor you closely for these problems.
 
  • If Gliadel is not implanted properly, the wafers could block the flow of cerebrospinal fluid (the clear fluid that surrounds the brain and spinal cord). If this happens, the fluid could accumulate and cause pressure on the brain (known medically as obstructive hydrocephalus). Let your healthcare provider know if you have any symptoms of increased pressure on the brain, such as:
 
    • Headaches
    • Nausea
    • Vomiting
    • Problems with coordination, balance, vision, concentration, or memory.
 
  • In clinical studies, there were reports of seizures occurring days and weeks after Gliadel was implanted, even in people who had never had a seizure before.
 
  • Brain swelling has been reported to occur in people given Gliadel. If you develop brain swelling, you may need to have another surgery. In some cases, the wafers may need to be removed.
 
  • Abnormal wound healing has been reported in people who received Gliadel in clinical trials. Examples of abnormal wound healing include:
 
    • Reopening of the surgical wound
    • Delayed healing of the surgical wound
    • Leakage of cerebrospinal fluid.
 
  • Brain infections, such as meningitis, have occurred in people who received Gliadel implants. Contact your healthcare provider right away if you develop any signs of meningitis, such as:
 
    • Fever
    • A severe headache
    • Nausea and vomiting
    • A stiff neck.
 
  • Carmustine, the active ingredient in Gliadel, has been reported to cause other types of cancer in animal studies. It is unknown whether Gliadel is associated with the same risks.
 
 
  • Gliadel is a pregnancy Category D medication, which means it may harm an unborn child if used during pregnancy (see Gliadel and Pregnancy).
 
  • It is unknown whether Gliadel passes through breast milk. Therefore, if you are breastfeeding or plan to start, discuss this with your healthcare provider prior to receiving the drug (see Gliadel and Breastfeeding).
 
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