Frequently Asked Questions about Gliadel® Wafer (carmustine implant)
Generic Name: carmustine implant (kar-MUS-teen), prolifeprospan 20 with carmustine implant
Trade Name: Gliadel® Wafer
For which conditions is Gliadel® Wafer approved for? Gliadel® Wafer implant is approved for the treatment of high-grade glioma and recurrent glioblastoma multiforme.
What is the mechanism of action? Gliadel® Wafer belongs to a group of drugs referred to as nitrosoureas. Gliadel® Wafer produces its anti-cancer effects by causing chemical reactions that result in damage to both DNA and amino acids in a cell. The DNA and amino acid damage caused by Gliadel® Wafer ultimately result in cellular death.
How is Gliadel® Wafer implant typically given (administered)? Gliadel® Wafer implants are dime-sized “wafers” that are placed in the cavity in the brain that remains following the surgical removal of the cancer.The wafers slowly dissolve, allowing Gliadel® Wafer to be continuously delivered to the area of the brain that was directly surrounding the cancer in order to kill any cancer cells left behind after surgery. The amount of wafers placed during surgery depends upon the size of the surgical cavity and the ability to appropriately place the wafers in the cavity.
How are patients typically monitored? Patients will usually have scheduled meetings with their healthcare provider while they are being treated with Gliadel® Wafer implants. Patients may also undergo physical examinations, scans or other measures to assess side effects and response to therapy. Patients will have their surgical wound assessed to check for normal healing and infection.
What are the common (occur in 30% or more of patients) side effects of treatment with Gliadel® Wafer implant?
- Abnormal healing of the surgical wound
- Brain edema (swelling)
These side effects may occur as a result of brain surgery alone but may occur more frequently when the Gliadel® Wafer implant is used.
This is not a complete list of side effects. Some patients may experience other side effects that are not listed here. Patients may wish to discuss with their physician the other less common side effects of this drug, some of which may be serious.
Some side effects may require medical attention. Other side effects do not require medical attention and may go away during treatment. Patients should check with their physician about any side effects that continue or are bothersome.
What can patients do to help alleviate or prevent discomfort and side effects?
- Pay careful attention to the physician’s instructions and inform the physician of any side effects.
- Maintain adequate rest and nutrition.
- Wear sunscreen and protective clothing and try to minimize sun exposure.
- Drink plenty of fluids. (Patients should ask their physician about the amount of liquid to consume during a day.)
Are there any special precautions patients should be aware of before starting treatment?
- Patients should inform their physician if they are pregnant, breastfeeding or planning a family in the near future. This drug may cause birth defects. It is important to use some kind of birth control while undergoing treatment. Also, patients may want to talk to their physician if they are considering having children in the future, since some drugs may cause fertility problems.
- It is important that patients inform their physician of any pre-existing conditions (chicken pox, heart disease, kidney disease, liver disease, lung disease, etc.) as they may worsen with this drug.
- Patients should inform their physician of any other medication they are taking (whether prescription or over-the-counter, including vitamins, herbs, etc.) as they may interfere with treatment.
- Patients should check with their physician before starting any new drug or nutritional supplement.
- Patients should inform their physician of any known drug or food allergies or any reactions to medications they have experienced in the past.
When should patients notify their physician?
- Signs of infection at the site of surgery – pus, increasing tenderness, swelling or redness
- Drainage from the site of surgery
What is a package insert?
A package insert is required by the FDA and contains a summary of the essential scientific information needed for the safe and effective use of the drug for healthcare providers and consumers. A package insert typically includes information regarding specific indications, administration schedules, dosing, side effects, contraindications, results from some clinical trials, chemical structure, pharmacokinetics and metabolism of the specific drug. By carefully reviewing the package insert, you will get the most complete and current information about how to safely use this drug. If you do not have the package insert for the drug you are using, your pharmacist or physician may be able to provide you with a copy.
Important Limitations of Use
The information provided above on the drug you have selected is provided for your information only and is not a substitute for consultation with an appropriate medical doctor. We are providing this information solely as a courtesy and, as such, it is in no way a recommendation as to the safety, efficacy or appropriateness of any particular drug, regimen, dosing schedule for any particular cancer, condition or patient nor is it in any way to be considered medical advice. Patients should discuss the appropriateness of a particular drug or chemotherapy regimen with their physician.
As with any printed reference, the use of particular drugs, regimens and drug dosages may become out-of-date over time, since new information may have been published and become generally accepted after the latest update to this printed information. Please keep in mind that health care professionals are fully responsible for practicing within current standards, avoiding use of outdated regimens, employing good clinical judgment kin selecting drugs and/or regimens, in calculating doses for individual patients, and verifying all dosage calculations.
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The prescribing physician is solely responsible for making all decisions relating to appropriate patient care including, but not limited to, drugs, regimens, dose, schedule, and any supportive care.