Gliadel Wafer 7.7 mg implant

Generic name:
Carmustine/polifeprosan 20 - implant

Pronunciation
(kar-MUS-teen/POL-ee-FEP-roe-san)

Brand name(s)
Gliadel

This medication is an implant used to treat certain types of brain tumors (such as malignant glioma). The implant is a combination product (wafer) made of carmustine and polifeprosan 20. Carmustine belongs to a class of drugs known as alkylating agents. It works by slowing or stopping the growth of cancer cells. Polifeprosan 20 helps control the release of carmustine in the brain.

This implant is placed in the space left after surgery to remove a brain tumor. The implant will slowly dissolve and release the medication in your brain.

The number of implants (wafers) placed is based on the amount of space in the brain. Usually, up to 8 wafers may be placed at one time during surgery.

Nausea, vomiting, constipation, or abdominal/back pain may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

People using this medication may have serious side effects. However, you have been prescribed this drug because your doctor has judged that the benefit to you is greater than the risk of side effects. Careful monitoring by your doctor may decrease your risk.

Tell your doctor right away if you have any serious side effects, including:

• swelling/redness/warmth or poor healing at surgery site
• signs of infection (such as fever, stiff neck)
• chest pain
• mental/mood changes (such as depression, anxiety)
• weakness

Get medical help right away if you have any very serious side effects, including:

• seizure
• signs of increased pressure around the brain (such as severe headache, confusion, vision changes)

A very serious allergic reaction to this drug is rare. However, get medical help right away 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.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before receiving carmustine/polifeprosan 20, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using carmustine. Carmustine may harm an unborn baby. Women should ask about reliable forms of birth control for at least 6 months after the implant is placed. Men should ask about reliable forms of birth control for at least 3 months after the implant is placed. If you or your partner becomes pregnant, talk to your doctor right away about the risks and benefits of this medication.

It is unknown if this medication passes into breast milk. Because of the possible risk to the infant, breastfeeding is not recommended for at least 7 days after the implant is placed. Consult your doctor before breastfeeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

This medication may be harmful if swallowed. If someone has swallowed it and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669.

Lab and/or medical tests should be done while you are using this medication. Keep all medical and lab appointments.

Not applicable.

Not applicable. This product is used in a hospital and will not be stored at home.

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.