LEUKERAN

CHLORAMBUCIL

Manufacturer: Waylis Therapeutics LLC

Score: 144.0

Quick Summary

LEUKERAN (chlorambucil) is an alkylating agent used in the treatment of chronic lymphatic leukemia, malignant lymphomas, and Hodgkin's disease. It works by interfering with DNA replication and inducing apoptosis. The usual oral dosage is 0.1 to 0.2 mg/kg body weight daily for 3 to 6 weeks, with careful adjustment according to patient response. Chlorambucil has several warnings, including its potential to cause bone marrow suppression, infertility, and secondary malignancies. It is contraindicated in patients with prior resistance to the agent or hypersensitivity. Special population considerations include use during pregnancy, nursing, pediatric, and geriatric use.

Key Clinical Findings and Indications

Chronic lymphatic leukemia
Malignant lymphomas
Hodgkin's disease

Important Safety Information

Warning

LEUKERAN can severely suppress bone marrow function and is a carcinogen in humans.

Contraindications

Prior resistance to the agent
Hypersensitivity to chlorambucil

Adverse Reactions

Bone marrow suppression
Anemia
Leukopenia
Neutropenia
Thrombocytopenia
Pancytopenia
Nausea and vomiting
Diarrhea
Oral ulceration
Tremors
Muscular twitching
Myoclonia
Confusion
Agitation
Ataxia
Flaccid paresis
Hallucinations

Dosing Recommendations

General Guidance

Dose reduction may be necessary in patients with hepatic impairment.

Chronic lymphatic leukemia

Adult Dose

0.1 to 0.2 mg/kg body weight daily for 3 to 6 weeks

Pediatric Dose

Malignant lymphomas

Adult Dose

0.2 mg/kg daily

Pediatric Dose

Hodgkin's disease

Adult Dose

0.2 mg/kg daily

Pediatric Dose

Special Population Considerations

Pregnancy

Chlorambucil can cause fetal harm when administered to a pregnant woman.
Unilateral renal agenesis has been observed in offspring whose mothers received chlorambucil during the first trimester.

Nursing Mothers

It is not known whether chlorambucil is excreted in human milk.
A decision should be made whether to discontinue nursing or to discontinue the drug.

Pediatric Use

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

Geriatric Use

Clinical studies did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.
Dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range.

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