Lomustine

What is Lomustine?

• Lomustine (Gleostine) also known as CCNU is an alkylating drug used for the treatment of patients with Brain tumors, Hodgkin lymphoma.

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Lomustine

What are the uses of this medicine?

Lomustine (Gleostine) is used alone or with other drugs to treat:

Brain tumors:

• It is used in patients who have already been treated with surgery or radiation therapy.

Hodgkin lymphoma:

• It is used with chemotherapy in patients whose disease got worse after other types of treatment.

How does this medicine work?

• Lomustine (loe mus' teen: also known as CCNU) is a nitrosourea similar to carmustine (BCNU), which acts as an alkylating agent and is used in the therapy of several forms of lymphoma and solid organ cancer.
• Like cyclophosphamide, lomustine requires activation in the liver to form its active intermediaries which act by modifying and cross linking purine bases in DNA, thus inhibiting DNA, RNA and protein synthesis and leading to programmed cell death (apoptosis) in rapidly dividing cells.
• Lomustine also forms adducts with cellular proteins.

Who Should Not Use this medicine ?

• This medicine have no usage limitations.

What drug interactions can this medicine cause?

• Tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.

Is this medicine FDA approved?

• Lomustine was approved for use in the United States in 1977.

How should this medicine be used?

Recommended dosage:

• The recommended dose of Gleostine in adult and pediatric patients is 130 mg/m 2 taken as a single oral dose every 6 weeks.
• Round doses to the nearest 10 mg.

Administration:

• Lomustine comes as a capsule to take by mouth.
• It is usually taken once every 6 weeks on an empty stomach.
• Reduce dose to 100 mg/m 2 every 6 weeks in patients with compromised bone marrow function.

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

This medicine is available in fallowing doasage form:

• As Capsules: 10 mg, 40 mg, and 100 mg

This medicine is available in fallowing brand namesː

• Gleostine

What side effects can this medication cause?

The most common side effects of this medicine include:

• delayed myelosupression
• nausea
• vomiting
• stomatitis
• alopecia
• nephrotoxicity
• oral ulcers
• diarrhea

What special precautions should I follow?

• Pulmonary infiltrates and/or fibrosis occurs with Gleostine. Perform pulmonary function tests prior to treatment and repeat frequently. Permanently discontinue Gleostine in patients diagnosed with pulmonary fibrosis.
• Acute leukemia and myelodysplasia can occur with long-term use.
• Increased levels of transaminases, alkaline phosphatase and bilirubin can occur with Gleostine. Monitor liver function.
• GLEOSTINE can cause renal failure. Monitor renal function.
• GLEOSTINE can cause fetal harm. Advise males and females of reproductive potential of the potential risk to a fetus and to use effective contraception.
• Gleostine causes myelosuppression that can result in fatal infections and bleeding. Monitor blood counts for at least 6 weeks after each dose. Do not give Gleostine more frequently than every 6 weeks.
• Lomustine therapy is associated with minor transient serum enzyme elevations and has been linked to rare cases of clinically apparent acute liver injury.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• Overdosage with Gleostine has occurred, including fatal cases.
• myelosuppression
• abdominal pain
• diarrhea
• vomiting
• anorexia
• lethargy
• dizziness
• abnormal hepatic function
• cough
• shortness of breath

Management of overdosage:

• No antidotes exist for Gleostine overdosage.
• In the event of an overdose, appropriate supportive treatment should be initiated.

Can this medicine be used in pregnancy?

• Based on animal data and its mechanism of action, Gleostine can cause fetal harm when administered to a pregnant woman.
• Advise pregnant women of the potential risk to a fetus.

Can this medicine be used in children?

• Pediatric use, including dose, is not based on adequate and well-controlled clinical studies.

What are the active and inactive ingredients in this medicine?

Active ingredient:

• LOMUSTINE

Inactive ingredients:

• MAGNESIUM STEARATE
• MANNITOL

Who manufactures and distributes this medicine?

Manufactured by Corden Pharma Latina S.p.A., Sermoneta (LT), Italy for:

• NextSource Biotechnology, LLC
• Miami, FL USA

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

• Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F).
• Avoid temperatures over 40°C (104°F).
• Gleostine is a cytotoxic drug.
• Follow applicable special handling and disposal procedures.

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• Dailymed label info on Lomustine
• FDA Lomustine

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