Gliadel (Implantation)

Carmustine implant is used along with surgery and radiation to treat newly-diagnosed high-grade glioma. It is also used with surgery to treat glioblastoma that has returned (recurrent). These are forms of brain cancer.

Carmustine is part of a group of cancer medicines called alkylating agents. It disrupts the growth of cancer cells, which are eventually killed.

This medicine is to be given only by your doctor.

It is important that your doctor check your progress closely while you are receiving this medicine. This will allow your doctor to see if the medicine is working properly and to check for unwanted effects.

Receiving this medicine while you are pregnant can harm your unborn baby. It may also cause birth defects if the father is receiving it when his sexual partner becomes pregnant. Female patients should use an effective form of birth control for 6 months to prevent getting pregnant after receiving the medicine. Male patients who have female partners should use effective birth control for 3 months after implantation with this medicine. If you think you have become pregnant following implantation of this medicine, tell your doctor right away.

This medicine may cause seizures after the surgical procedure. Call your doctor if you have symptoms of seizures after receiving this medicine.

This medicine may cause increased pressure in the head (intracranial hypertension). Tell your doctor right away if you have a severe headache, nausea, vomiting, blurred vision, or any change in vision after receiving the implant.

This medicine may cause a brain infection called meningitis. Tell your doctor right away if you have a severe headache, confusion, drowsiness, nausea, a general feeling of illness, or a stiff neck.

Some men receiving this medicine have become infertile (unable to have children). If you plan to have children, talk to your doctor before receiving this medicine.

In deciding to use a medicine, you and your doctor need to consider the risks of taking the medicine against the benefits it may provide.

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also, let your health care professional know if you have any other allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

There have not been appropriate studies on how age affects the effects of carmustine implant in children. Safety and effectiveness have not been established.

Geriatric

While appropriate studies on how age affects the effects of carmustine implant have not been conducted in older adults, no specific problems related to older adults have been documented so far.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication during breastfeeding. Consider the potential benefits and risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together, while in other cases, two different medicines may be used together even if an interaction could occur. If you are receiving this medicine, it is very important for your healthcare professional to know if you are taking any of the following medicines. The following interactions have been chosen based on their potential significance and may not include all possible interactions.

Using this medicine with any of the following medicines is not recommended. Your doctor may choose not to treat you with this medication or may change some of your other medicines.

• Measles Virus Vaccine, Live
• Mumps Virus Vaccine, Live
• Rotavirus Vaccine, Live
• Rubella Virus Vaccine, Live
• Varicella Virus Vaccine, Live
• Zoster Vaccine, Live

Using this medicine with any of the following medicines is usually not recommended, but may be necessary in some cases. If both medicines are prescribed together, your doctor may adjust the dose or how often you take one or both of the medicines.

• Adenovirus Vaccine
• Bacillus of Calmette and Guerin Vaccine, Live
• Cholera Vaccine, Live
• Cimetidine
• Dengue Tetravalent Vaccine, Live
• Influenza Virus Vaccine, Live
• Melphalan
• Phenobarbital
• Poliovirus Vaccine, Live
• Smallpox Vaccine
• Typhoid Vaccine, Live
• Yellow Fever Vaccine

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken at the same time as eating food or certain types of food because interactions might happen. Using alcohol or tobacco with certain medicines can also cause interactions. Talk to your healthcare professional about the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

Other medical problems may affect how you can use this medicine. Make sure to tell your doctor if you have any other medical issues, especially:

• Intracranial hypertension (increased pressure in the head) or
• Seizures—Use with caution. This may worsen these conditions.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do happen they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common

• Blurred vision
• Change in ability to see colors, especially blue or yellow
• Confusion
• Fever
• Headache
• Nausea
• Problems with movement, walking, or speech
• Seizures
• Trouble healing
• Vomiting

Less common

• Change in personality
• Drowsiness
• General feeling of illness
• Severe headache
• Stiff neck or back
• Weakness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue, are bothersome, or if you have any questions about them:

More common

• Back pain
• Bladder pain
• Bloody or cloudy urine
• Difficult, burning, or painful urination
• Difficulty having a bowel movement
• Discouragement
• Feeling sad or empty
• Frequent urge to urinate
• Irritability
• Lack of appetite
• Lack or loss of strength
• Loss of interest or pleasure
• Lower back or side pain
• Stomach pain
• Trouble concentrating
• Trouble sleeping

Less common

• Chest pain

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Gliadel

Available Dosage Forms:

• Implant

Therapeutic Class: Antineoplastic Agent

Pharmacologic Class: Alkylating Agent

Chemical Class: Nitrosourea

Medicines used to treat cancer are very strong and can have many side effects. Before receiving this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.

Your doctor will place this medicine in your brain during a surgical procedure. It is in the form of a small, round wafer. The wafer will dissolve and slowly release the medicine in the tumor.