Gliadel Wafer: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

• GLIADEL Wafer is used with surgery, in the treatment of

  glioblastoma multiforme (a form of brain cancer) if it comes back.

• GLIADEL Wafer may be used with surgery and radiation

  therapy to treat newly diagnosed malignant glioma (a form of brain cancer) in some patients.

What it does:

Carmustine helps to kill any leftover tumor cells that are not taken out by the surgery. Polifeprosan 20 works by controlling the release of carmustine into the area where the brain tumor was taken out.

When it should not be used:

You should not be given GLIADEL Wafer if you are allergic to carmustine or any of the other ingredients in GLIADEL Wafer.

What the medicinal ingredient is:

Carmustine

What the important nonmedicinal ingredients are:

Polifeprosan 20 (a copolymer of carboxyphenoxypropane and sebacic acid).

What dosage forms it comes in:

GLIADEL Wafer is an implant in the form of a sterile, off-white to pale yellow wafer approximately 1.45 cm in diameter and 1 mm thick. Each wafer contains 7.7 mg of carmustine.

WARNINGS AND PRECAUTIONS

Serious Warnings and Precautions

GLIADEL Wafer should only be placed by a qualified surgeon during brain surgery.

There is little information on the use of GLIADEL Wafer together with temozolomide. The combined treatment may result in increased risk of harm (toxicity).

Possible serious side effects with GLIADEL Wafer implant include the following:

• Obstructive hydrocephalus (an abnormal accumulation of cerebrospinal fluid in the brain), especially if GLIADEL Wafers are not properly implanted.
• New seizures and worsening of seizures
• Brain infections, including meningitis
• Abnormal wound healing
• Brain swelling (edema)

BEFORE you have treatment with GLIADEL Wafer talk to your doctor or pharmacist if any of the conditions apply to you:

• Are pregnant or planning to get pregnant. GLIADEL can cause harm to an unborn baby, therefore pregnancy should be avoided while receiving GLIADEL treatment.

• Are breastfeeding. Breastfeeding should be discontinued while receiving GLIADEL treatment.
• You have any allergies to this drug or its ingredients or components of the container.

GLIADEL should not be used in patients under 18 years of age.

INTERACTIONS WITH THIS MEDICATION

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use. During your treatment with GLIADEL Wafer, do not start taking a new medicine before checking with your doctor or pharmacist.

The safety of GLIADEL Wafer when given with other cancer treatments has not been fully studied.

PROPER USE OF THIS MEDICATION

GLIADEL Wafer is placed by a surgeon during brain surgery into the area where the brain tumor was taken out. The implant will dissolve slowly, releasing the medication to the surrounding area. Follow all your doctor’s instructions on what to do before and after surgery.

Usual dose:

The number of implants placed is based on the size of the area to cover. The maximum recommended dose is 8 implants placed at each surgery.

Since this drug can be absorbed through the skin, women who are pregnant or who may become pregnant should not handle this medication.

Overdose:

In case of a suspected drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

Missed Dose:

Not applicable

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

Very common side effects (>4%):

• nausea, vomiting
• fever (signs of an infection), pain

• swelling/redness/warmth at surgery site, wound at surgery

  site that is opening or not healing properly

• seizures, severe headache

• extreme tiredness/weakness, confusion, weakness on one

  side of the body, slurred speech, stiff neck, fainting

• rash
• mental/mood changes (e.g., depression, anxiety)

Common side effects (1%):

• constipation
• bleeding in the stomach
• chest pain

Seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice any other effects not listed above, contact your doctor or pharmacist.

This is not a complete list of side effects. For any unexpected effects while taking GLIADEL Wafer, contact your doctor or pharmacist.

HOW TO STORE IT

Store in a freezer at or below -15ºC (5ºF). Unopened foil pouches may be kept at room temperature for up to 6 hours. Consult your pharmacist for details. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain

unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

REPORTING SUSPECTED SIDE EFFECTS

You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:

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• Report online at www.healthcanada.gc.ca/medeffect
• Call toll-free at 1-866-234-2345

• Complete a Canada Vigilance Reporting Form and:

  • Fax toll-free to 1-866-678-6789, or

  • Mail to: Canada Vigilance Program Health Canada

    Postal Locator 0701D

    Ottawa, Ontario

    K1A 0K9

Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect^™ Canada Web site at

www.healthcanada.gc.ca/medeffect.

NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.

MORE INFORMATION

This document plus the full product monograph, prepared for health professionals can be obtained by contacting the sponsor, Eisai Limited, at: 1-877-873-4724

Last revised: August 17, 2012.