Chlorambucil

What is Chlorambucil?

• Chlorambucil (Leukeran) is a bifunctional alkylating agent of the nitrogen mustard type used to treat chronic lymphocytic leukemia (CLL), Hodgkin lymphoma, and non-Hodgkin lymphoma.

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Chlorambucil

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Chlorambucil ball-and-stick

What are the uses of this medicine?

Chlorambucil (Leukeran) is approved for palliative treatment of:

• Chronic lymphocytic leukemia
• Hodgkin lymphoma
• Non-Hodgkin lymphoma (certain types).

How does this medicine work?

• Chlorambucil (klor am' bue sil) is an orally available, alkylating agent similar to mechlorethamine, cyclophosphamide and melphalan (nitrogen mustard-like).
• The alkylating agents act by causing modification and cross linking of DNA, thus inhibiting DNA, RNA and protein synthesis and causing cell death in rapidly dividing cells.
• Alkylating agents also have immunosuppressive activity, and chlorambucil has also been used in the therapy of autoimmune diseases and allograft rejection.

Who Should Not Use this medicine ?

This medicine cannot be used in patients with:

• hypersensitivity to chlorambucil

What drug interactions can this medicine cause?

• There are no known drug/drug interactions with chlorambucil.

Is this medicine FDA approved?

• Chlorambucil was approved for use in the United States in 1957.

How should this medicine be used?

Recommended dosage:

• The usual oral dosage is 0.1 to 0.2 mg/kg body weight daily for 3 to 6 weeks as required.
• This usually amounts to 4 to 10 mg per day for the average patient.

Administration:

• Chlorambucil comes as a tablet to take by mouth.
• It is usually taken once a day for 3 to 6 weeks, but sometimes may be taken intermittently, as a single dose once every 2 weeks, or as a single dose once a month.
• The length of treatment depends on the types of drugs you are taking, how well your body responds to them, and the type of cancer you have.
• Take chlorambucil at around the same time every day.
• Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand.
• Take chlorambucil exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

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

This medicine is available in fallowing doasage form:

• As film-coated tablet containing 2 mg chlorambucil

This medicine is available in fallowing brand namesː

• Leukeran

What side effects can this medication cause?

The most common side effects of this medicine include:

• nausea
• vomiting
• sores in the mouth and throat
• tiredness
• missed menstrual periods (in girls and women)

Chlorambucil may cause some serious side effects:

• skin rash
• unusual bruising or bleeding
• black, tarry stools
• red urine
• cough
• sore throat
• congestion
• fever
• difficulty breathing
• seizures
• yellowing of the skin or eyes
• pain in the upper right part of the stomach
• dark colored urine
• frequent urination
• unusual lumps or masses

What special precautions should I follow?

• LEUKERAN (chlorambucil) can severely suppress bone marrow function. Chlorambucil is a carcinogen in humans.
• Chlorambucil can cause fetal harm when administered to a pregnant woman. Women of childbearing potential should be advised to avoid becoming pregnant.
• Rare instances of skin rash progressing to erythema multiforme, toxic epidermal necrolysis, or Stevens-Johnson syndrome have been reported. Chlorambucil should be discontinued promptly in patients who develop skin reactions.
• Chlorambucil produces human infertility.
• Administration of live vaccines to immunocompromised patients should be avoided.
• Patients should be informed that the major toxicities of chlorambucil are related to hypersensitivity, drug fever, myelosuppression, hepatotoxicity, infertility, seizures, gastrointestinal toxicity, and secondary malignancies.
• Chlorambucil therapy has been associated with low rates of serum enzyme elevations during therapy and to rare instances of acute, clinically apparent injury.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• Reversible pancytopenia
• agitated behavior
• ataxia
• grand mal seizures

Management of overdosage:

• There is no known antidote, the blood picture should be closely monitored and general supportive measures should be instituted, together with appropriate blood transfusions, if necessary.
• Chlorambucil is not dialyzable.

Can this medicine be used in pregnancy?

• Chlorambucil can cause fetal harm when administered to a pregnant woman.
• Women of childbearing potential should be advised to avoid becoming pregnant.

Can this medicine be used in children?

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

What are the active and inactive ingredients in this medicine?

Active ingredients include:

• chlorambucil

Inactive ingredients include:

• silicon dioxide
• hypromelloses
• anhydrous lactose
• polyethylene glycol, unspecified
• cellulose, microcrystalline
• ferric oxide red
• stearic acid
• titanium dioxide
• ferric oxide yellow

Who manufactures and distributes this medicine?

Mfd. by:

• Excella GmbH & Co. KG, Feucht, Germany

Distributed by:

• Prasco Laboratories
• Mason, OH USA

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

• Store in a refrigerator, 2° to 8°C (36° to 46°F).

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• Dailymed label info on Chlorambucil
• FDA Chlorambucil

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