Carmustine implant

What is Carmustine implant?

• Carmustine implant (Gliadel Wafer) is an alkylating drug used for the treatment of malignant glioma that is high grade and has not already been treated. It is also used with surgery to treat glioblastoma multiforme that has recurred (come back).

Carmustine

Carmustine ball-and-stick

What are the uses of this medicine?

Carmustine implant (Gliadel Wafer) for the treatment of:

• newly-diagnosed high-grade glioma as an adjunct to surgery and radiation and
• recurrent glioblastoma as an adjunct to surgery

How does this medicine work?

• Carmustine (kar mus' teen), is a nitrosourea that acts as an alkylating agent and is used in the therapy of several forms of leukemia, lymphoma and solid organ cancer.
• Like cyclophosphamide, carmustine requires activation in the liver to form its active intermediates which act by modifying and cross linking purine bases in DNA, thus inhibiting DNA, RNA and protein synthesis and leading to cell death in rapidly dividing cells.
• Carmustine also forms adducts with intracellular proteins.

Who Should Not Use this medicine ?

• This medicine have no usage limitations.

What drug interactions can this medicine cause?

• No formal drug interaction studies have been conducted with Gliadel Wafer.

Is this medicine FDA approved?

• Carmustine was approved for use in the United States in 1977, and its current uses include treatment of breast, gastric, liver, pancreatic, lung, brain, ovarian and testicular cancer, malignant melanoma, Hodgkin and non-Hodgkin lymphoma and multiple myeloma.

How should this medicine be used?

Recommended dosage:

• The recommended dose of Gliadel Wafer is eight 7.7 mg wafers for a total of 61.6 mg implanted intracranially. The safety and effectiveness of repeat administration have not been studied.

Administration:

• Following maximal tumor resection, confirmation of tumor pathology and establishment of hemostasis, place up to a maximum of eight GLIADEL Wafers to cover as much of the resection cavity as possible.
• Should the size and shape of the resected cavity not accommodate eight wafers, place the maximum number of wafers feasible within the cavity.
• Oxidized regenerated cellulose (Surgicel®) may be placed over the wafers to secure them against the cavity surface.
• After placement of the wafers, irrigate the resection cavity and close the dura in a water-tight fashion.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Gliadel Wafer containing 7.7 mg of carmustine

This medicine is available in fallowing brand namesː

• Gliadel Wafer

What side effects can this medication cause?

The most common side effects of this medicine include: In Newly-Diagnosed High-Grade Glioma:

• cerebral edema
• asthenia
• nausea
• vomiting
• constipation
• wound healing abnormalities
• depression

In Recurrent High-Grade Glioma:

• urinary tract infection
• wound healing abnormalities
• fever

What special precautions should I follow?

• Seizures occurred in patients treated with GLIADEL Wafers. Monitor patients for seizures following implantation.
• Brain edema occurred in patients with newly diagnosed glioma treated with GLIADEL Wafers. Monitor patients for signs of increased intracranial pressure.
• Impaired neurosurgical wound healing including wound dehiscence, delayed wound healing, and subdural, subgleal, or wound effusions occur with Gliadel Wafer treatment. Monitor patients for complications of craniotomy.
• Meningitis occurred in patients with recurrent glioma receiving GLIADEL Wafers. Monitor patients for signs of bacterial or chemical meningitis.
• Gliadel Wafer migration can occur. Monitor patients for signs of obstructive hydrocephalus.
• Gliadel Wafer Can cause fetal harm. Advise patients of the potential risk to a fetus. Advise males and females of reproductive potential to use an effective method of contraception.
• GLIADEL Wafers contain a cytotoxic drug. Follow applicable special handling and disposal procedures.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• Gliadel Wafer can cause fetal harm when administered to a pregnant woman.
• There are no available data on GLIADEL use in pregnant women.

Can this medicine be used in children?

• The safety and effectiveness of Gliadel Wafer in pediatric patients have not been established.

What are the active and inactive ingredients in this medicine?

Active ingredient:

• carmustine

Inactive ingredients:

• polifeprosan 20

Who manufactures and distributes this medicine?

Manufactured by

• Eisai Inc.
• Woodcliff Lake, NJ

Distributed by

• Arbor Pharmaceuticals, LLC
• Atlanta, GA

• GLIADEL® is a registered trademark of Eisai Inc.

What should I know about storage and disposal of this medication?

• Store Gliadel Wafer at or below -20ºC (-4ºF).
• Do not keep unopened foil pouches at ambient room temperature for more than six hours at a time for up to three cycles within a 30-day period.
• Gliadel Wafer is a cytotoxic drug and special handling and disposal procedures should be considered

• Dailymed label info on Carmustine implant
• FDA Carmustine implant

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