Pronunciation:

kar-MUS-teen

Brand Names:

• Gliadel

Dosage Forms:

• Implant

Classifications:

Therapeutic—

Antineoplastic Agent

Pharmacologic—

Alkylating Agent

Chemical—

Nitrosourea

Uses of This Medicine:

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

Carmustine belongs to the group of cancer medicines known as alkylating agents. It interferes with the growth of cancer cells, which are eventually destroyed.

This medicine is to be given only by your doctor.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

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

Children—

Appropriate studies have not been performed on the relationship of age to the effects of carmustine implant in the pediatric population. Safety and efficacy have not been established.

Older adults—

Although appropriate studies on the relationship of age to the effects of carmustine implant have not been performed in the geriatric population, no geriatric-specific problems have been documented to date.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

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

• 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 required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use 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

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Intracranial hypertension (increased pressure in the head) or
• Seizures—Use with caution. May make these conditions worse.

Proper Use of This Medicine:

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.

Precautions While Using This Medicine:

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 keep from 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 an 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.

Side Effects of This Medicine:

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