Gliadel

Gliadel is used together with surgery and radiation therapy to treat malignant glioma and glioblastoma multiforme. 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 or under the direct supervision of your doctor. This product is available in the implant form.

Before using DRUG, you must know all about the risks and complications associated with it.

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 healthcare 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.
• Pediatric Population: 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.
• Geriatric Population: 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.
• Pregnancy: All Trimesters: Category D: Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease may outweigh the potential risk.
• Breastfeeding: 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.
• Drug Interactions: 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.

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 this medicines:

• • Rotavirus Vaccine, Live
  • Adenovirus Vaccine Type 4, Live
  • Adenovirus Vaccine Type 7, Live
  • Bacillus of Calmette and Guerin Vaccine, Live
  • Cimetidine
  • Influenza Virus Vaccine, Live
  • Measles Virus Vaccine, Live
  • Mumps Virus Vaccine, Live
  • Poliovirus Vaccine, Live
  • Rubella Virus Vaccine, Live
  • Smallpox Vaccine
  • Typhoid Vaccine
  • Varicella Virus Vaccine
  • 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).
• Seizures—Use with caution. May make these conditions worse.

In order to understand the proper usage and administration of Gliadel, speak with your doctor.

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.

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

To use Gliadel correctly, you must follow all instructions given by your doctor. Your doctor will see if the medicine is working properly and will check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant after receiving the medicine.

If you think you have become pregnant while using 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 using this medicine have become infertile (unable to have children). If you plan to have children, talk to your doctor before receiving this medicine.

Along with its needed effects, Gliadel may cause some unwanted side 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 and vomiting
• problems with movement, walking, or speech
• seizures
• trouble healing

Less common:

• drowsiness
• the general feeling of illness
• severe headache
• stiff neck or back

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:

• abdominal or stomach pain
• back pain
• bladder pain
• bloody or cloudy urine
• difficult, burning, or painful urination
• difficulty having a bowel movement (stool)
• 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
• tiredness
• 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.