Monograph: |
ACLARUBICIN
ACLARUBICIN OR ACLACINOMYCIN A IS USED TO TREAT ACUTE NON LYMPHOCYTIC LEUKEMIA, A CANCER OF THE BLOOD AND BONE MARROW. IT IS AN OLIGOSACCHARIDE ANTHRACYCLINE AGENT PRODUCED BY A SOIL BACTERIUM CALLED STREPTOMYCES GALILAEUS AND HAS POWERFUL ANTICANCER
ACLARUBICIN IS DISCONTINUED WORLD-WIDE FOR THE TREATMENT OF CANCER, EXCEPT IN ASSOCIATION WITH CYTARABINE IN JAPAN, INDIA AND CHINA.
DOSAGE/DIRECTION FOR USE ADULT: IV INITIAL: 175-300 MG/M2, DIVIDED OVER 3-7 CONSECUTIVE DAYS. MAINTENANCE: 25-100 MG/M2 3-4 WKLY.
CONTRAINDICATIONS PREGNANCY, LACTATION; CV DISEASE.
SPECIAL PRECAUTIONS MYOCARDIAL IRRADIATION AND USE OF RADIOTHERAPY. HEPATIC OR RENAL IMPAIRMENT. ELDERLY.
ADVERSE REACTIONS NAUSEA, VOMITING, MUCOSITIS, IRRITANT TO TISSUE, SORE MOUTH, BONE-MARROW SUPPRESSION, HYPERURICAEMIA. ALOPOECIA (RARE). POTENTIALLY FATAL: CARDIOTOXICITY (RARE), MYELOSUPPRESSION IN PATIENTS WHO RECEIVED MITOMYCIN OR A NITROSOUREA, LEUCOPENIA.
DRUG INTERACTIONS OTHER CARDIOTOXIC DRUGS E.G. DAUNORUBICIN OR CYCLOPHOSPHAMIDE, LIVE VACCINES; DECREASES EFFECTS OF DIGOXIN, ORAL ANTICOAGULANTS, PHENYTOIN AND SUXAMETHONIUM.
CIMS CLASS CYTOTOXIC CHEMOTHERAPY
ATC CLASSIFICATION L01DB04 - ACLARUBICIN ; BELONGS TO THE CLASS OF CYTOTOXIC ANTIBIOTICS, ANTHRACYCLINES AND RELATED SUBSTANCES. USED IN THE TREATMENT OF CANCER.
IT IS ONE OF THE ANTHRACYCLINES WITH THE LOWEST CARDIOTOXICITY, IT IS NOT MUTAGENIC AND IT STIMULATES DIFFERENTIATION OF TUMOUR CELLS. THE THERAPEUTIC INDEX OF ACLARUBICIN (EFFICACY RELATED TO TOXICITY) IS HIGHER THAN THAT OF DOXORUBICIN AND DAUNORUBICIN, USING A PROPER DOSE SCHEDULE. SINGLE DOSE THERAPY OF ACLARUBICIN SHOWS ONLY MARGINAL EFFICACY, WHEREAS MULTIPLE DIVIDED DOSE THERAPY EXHIBITS EFFICACY COMPARABLE TO THAT OF DOXORUBICIN AND DAUNORUBICIN. THUS FOR CLINICAL TRIALS TWO DOSE SCHEDULES WERE DESIGNED: 25 MG/M2/DAY, DAYS 1-7 FOR ACUTE LEUKAEMIA; AND 30 MG/M2/DAY, DAYS 1-4 FOR SOLID TUMOURS.
ACLARUBICIN WAS SHOWN TO BE HIGHLY ACTIVE IN ACUTE LEUKAEMIA WITH 58% COMPLETE REMISSIONS IN FIRST RELAPSE OF AML. GOOD RESULTS WERE ALSO SEEN IN ACUTE LEUKAEMIA IN COMBINATION WITH CYTOSINE ARABINOSIDE AND THIOGUANINE. IN CLINICAL TRIALS WITH BREAST CANCER AND THYROID CANCER THE EFFICACY WAS IN THE SAME RANGE AS WOULD BE EXPECTED FOR DOXORUBICIN, BUT SIDE-EFFECTS WERE MARKEDLY REDUCED. ANOREXIA, MILD NAUSEA AND INFREQUENT VOMITING WERE OBSERVED. MYELOSUPPRESSION WAS COMMON BUT DOSE REDUCTION WAS NOT NECESSARY. THERE WAS NO ALOPECIA AND NO CONGESTIVE HEART FAILURE.
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