Carmustine

What is Carmustine?

• Carmustine (BiCNU) is a nitrosourea used alone and in combination with other antineoplastic agents in the treatment of several forms of cancer including leukemias, lymphomas, and breast, testicular, ovarian, gastric and pancreatic cancer.

Carmustine

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Carmustine ball-and-stick

What are the uses of this medicine?

Carmustine (BiCNU) is used as palliative therapy as a single agent or in established combination therapy in the following:

• Brain tumors glioblastoma, brainstem glioma, medulloblastoma, astrocytoma, ependymoma, and metastatic brain tumors.
• Multiple myeloma in combination with prednisone.
• Relapsed or refractory Hodgkin's lymphoma in combination with other approved drugs.
• Relapsed or refractory Non-Hodgkin's lymphomas in combination with other approved drugs.

How does this medicine work?

• Carmustine (kar mus' teen), which is also known as BICNU, 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 cannot be used in patients with:

• previous hypersensitivity to BiCNU or its components.

What drug interactions can this medicine cause?

• Greater myelosuppression (e.g., leukopenia and neutropenia) has been reported when oral cimetidine has been coadministered with carmustine. Consider alternative drugs to cimetidine.
• Phenobarbital induces the metabolism of carmustine and may compromise antitumor activity of BiCNU.
• BiCNU when coadministered with phenytoin may reduce phenytoin serum concentrations. Consider alternative drugs to phenytoin.

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.
• Carmustine is given intravenously and is available in liquid formulations (100 mg vials) in generic forms and under the trade names Gliadel or BiCNU.

How should this medicine be used?

Recommended dosage:

• As a single agent, 150 to 200 mg/m2BiCNU intravenously every 6 weeks as a single dose or divided into daily injections such as 75 to 100 mg/m2on 2 successive days.
• Adjust dose for combination therapy or in patients with reduced bone marrow reserve.

Administration:

• Administer reconstituted solution only as a slow intravenous infusion over at least 2 hours.

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

This medicine is available in fallowing doasage form:

• As injection: 100 mg of carmustine lyophilized powder in a single-dose vial for reconstitution and a vial containing 3mL sterile diluent (Dehydrated Alcohol Injection, USP).

This medicine is available in fallowing brand namesː

• BiCNU ; Gliadel

What side effects can this medication cause?

The most common side effects of this medicine include:

• nausea
• vomiting
• renal toxicity
• pneumonitis
• pulmonary toxicity
• myelosuppression

What special precautions should I follow?

• A serious and frequent toxicity of BiCNU is delayed myelosuppression and usually occurs 4 to 6 weeks after drug administration. Hence, patients should be advised to get blood counts monitored weekly for at least 6 weeks. The bone marrow toxicity of BiCNU is cumulative.
• Advise patients to contact a health care professional immediately for any of the following: shortness of breath, particularly during exercise, dry, hacking cough, fast, shallow breathing, gradual unintended weight loss, tiredness, aching joints and muscles, clubbing (widening and rounding) of the tips of the fingers or toes.
• Injection site reactions may occur during the administration of BiCNU. Rapid intravenous infusion of BiCNU may produce intensive flushing of the skin and suffusion of the conjunctiva within 2 hours, lasting about 4 hours. Extravasation may occur; monitor infusion site closely during administration.
• Long-term use of nitrosoureas, such as BiCNU, has been reported to be associated with the development of secondary malignancies. Monitor patient periodically for such signs and apprise the patient of the symptoms for which they need to seek medical help.
• Ocular toxicity has occurred when administered via unapproved intraarterial intracarotid route. Safety and effectiveness of the intra-arterial route have not been established.
• There are no adequate and well- controlled studies in pregnant women. Advise pregnant women of the potential risk to the fetus. Advise females of reproductive potential to use highly effective contraception during and after treatment with BiCNU for at least 6 months after therapy.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• myeloablation

Management of overdosage:

• No proven antidotes have been established for BiCNU overdosage.

Can this medicine be used in pregnancy?

• BiCNU (carmustine for injection) can cause fetal harm when administered to a pregnant woman based on the mechanism of action.
• Limited available data with BiCNU use in pregnant women are insufficient to inform a drug-associated risk of major birth defects and miscarriage.

Can this medicine be used in children?

• Safety and effectiveness in children have not been established.

What are the active and inactive ingredients in this medicine?

Active ingredient:

• CARMUSTINE

Inactive ingredients:

• ALCOHOL

Who manufactures and distributes this medicine?

Manufactured by:

• Gland Pharma Limited
• Visakhapatnam,
• Andhra Pradesh, India.

Manufactured for:

• Avet Pharmaceuticals Inc.
• East Brunswick, NJ

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

• Store product and diluent in a refrigerator (2°-8°C, 36°-46°F).

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• Dailymed label info on Carmustine
• FDA Carmustine

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