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Manufacturer Aspen Pharmacare
Distributor Hong Kong: Primal
Contents Chlorambucil
Indications Hodgkin's disease. Certain forms of non-Hodgkin's lymphoma. Chronic lymphocytic leukaemia, Waldenstrom's macroglobulinaemia, advanced ovarian adenocarcinoma, breast cancer in a proportion of patients.
Dosage Hodgkin's disease Monotherapy: 0.2 mg/kg/day for 4-8 wk. Non-Hodgkin's lymphoma Monotherapy: 0.1-0.2 mg/kg/day for 4-8 wk initially. Chronic lymphocytic leukaemia 0.15 mg/kg/day until the total leucocyte count has fallen to 10,000/microlitre. Treatment may be resumed 4 wk after the end of the 1st course & continued at 0.1 mg/kg/day. Waldenstrom's macroglobulinaemia Starting dose: 6-12 mg daily until leucopenia occurs; followed by 2-8 mg daily indefinitely. Ovarian carcinoma Monotherapy: 0.2 mg/kg/day for 4-6 wk, Maintenance course: 0.2 mg/kg/day for 2-4 wk w/ 2-6 wk intervals between each course. Advanced breast cancer Monotherapy 0.2 mg/kg/day for 6 wk. Combination therapy w/ prednisolone, methotrexate or 5-fluorouracil 5-7.5 mg/m2/day.
Administration Should be taken on an empty stomach (Take on an empty stomach. Ensure adequate hydration. Swallow whole, do not chew/crush.).
Contraindications Pregnancy (1st trimester) & lactation.
Special Precautions Immunisation using a live organism vaccine has the potential to cause infection in immunocompromised host. Monitor blood counts closely; should not be given to patients who have recently undergone radiotoxic or chemotherapy. In lymphocytic infiltration of bone marrow, daily dose should not >0.1 mg/kg body wt. Renal or hepatic impairment. Childn w/ nephrotic syndrome, patients prescribed high pulse dosing regimens & patients w/ history of seizure disorder. Acute secondary haematologic malignancies. Ensure adequate contraceptive precautions.
Adverse Drug Reactions Acute secondary haematologic malignancies esp leukaemia & myelodysplastic syndrome; leucopenia, neutropenia, thrombocytopenia, pancytopenia, bone marrow suppression, anaemia; seizures in childn w/ nephrotic syndrome; nausea, vomiting, diarrhoea, oral ulceration; rash. Rarely, irreversible bone marrow failure, allergic reactions, Stevens-Johnson syndrome, toxic epidermal necrolysis, seizures, movement disorders, peripheral neuropathy, interstitial pulmonary fibrosis, interstitial pneumonia, hepatotoxicity, jaundice, sterile cystitis, drug fever.
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Drug Interactions Live organism vaccines, phenylbutazone.
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Pregnancy Category (US FDA)
Category D: There is positive evidence of human foetal risk, but the benefits from use in pregnant women may be acceptable despite the risk (e.g., if the drug is needed in a life-threatening situation or for a serious disease for which safer drugs cannot be used or are ineffective).
ATC Classification L01AA02 - chlorambucil ; Belongs to the class of alkylating agents, nitrogen mustard analogues. Used in the treatment of cancer.
Presentation/Packing
Form Packing Photo
Leukeran film-coated tablet Leukeran 2 mg x 25's
Manufacturer: Aspen Pharmacare
Distributor: Hong Kong: Primal