EPIRUBICIN INJECTION IS ADMINISTERED TO PATIENTS BY INTRAVENOUS INFUSION. EPIRUBICIN IS GIVEN IN REPEATED 3- TO 4-WEEK CYCLES. THE TOTAL DOSE OF EPIRUBICIN MAY BE GIVEN ON DAY 1 OF EACH CYCLE OR DIVIDED EQUALLY AND GIVEN ON DAYS 1 AND 8 OF EACH CYCLE. THE RECOMMENDED DOSAGES OF EPIRUBICIN ARE AS FOLLOWS:
STARTING DOSES
THE RECOMMENDED STARTING DOSE OF EPIRUBICIN IS 100 TO 120 MG/M 2 . THE FOLLOWING REGIMENS WERE USED IN THE TRIALS SUPPORTING USE OF EPIRUBICIN AS A COMPONENT OF ADJUVANT THERAPY IN PATIENTS WITH AXILLARY-NODE POSITIVE BREAST CANCER:
CEF-120: CYCLOPHOSPHAMIDE 75 MG/M 2 PO D 1-14
EPIRUBICIN 60 MG/M 2 IV D 1, 8
5-FLUOROURACIL 500 MG/M 2 IV D 1, 8
REPEATED EVERY 28 DAYS FOR 6 CYCLES
FEC-100: 5-FLUOROURACIL 500 MG/M 2
EPIRUBICIN 100 MG/M 2
CYCLOPHOSPHAMIDE 500 MG/M 2
ALL DRUGS ADMINISTERED INTRAVENOUSLY ON DAY 1 AND REPEATED EVERY 21 DAYS FOR 6 CYCLES
EPIRUBICIN HYDROCHLORIDE IS GIVEN BY INTRAVENOUS INJECTION OF A SOLUTION IN SODIUM CHLORIDE 0.9% OR WATER FOR INJECTIONS INTO A FAST-RUNNING INFUSION OF SODIUM CHLORIDE 0.9% OR GLUCOSE 5% OVER 3 TO 5 MINUTES, OR BY INFUSION OVER UP TO 30 MINUTES. IT IS GIVEN AS A SINGLE AGENT IN USUAL DOSES OF 60 TO 90 MG/M2 AS A SINGLE DOSE EVERY 3 WEEKS; THIS DOSE MAY BE DIVIDED OVER 2 OR 3 DAYS IF DESIRED. A REGIMEN OF 12.5 TO 25 MG/M2 ONCE A WEEK HAS ALSO BEEN TRIED IN PALLIATIVE CARE. HIGH-DOSE REGIMENS, OF 120 MG/M2 OR MORE EVERY 3 WEEKS, OR 45 MG/M2 FOR 3 CONSECUTIVE DAYS EVERY 3 WEEKS HAVE BEEN USED.
DOSES MAY NEED TO BE REDUCED IF EPIRUBICIN IS GIVEN WITH OTHER ANTINEOPLASTICS. DOSES SHOULD ALSO BE REDUCED IN PATIENTS WITH LIVER IMPAIRMENT (SEE ) AND IN THOSE WHOSE BONE-MARROW FUNCTION IS IMPAIRED BY AGE OR PREVIOUS CHEMOTHERAPY OR RADIOTHERAPY.
A TOTAL CUMULATIVE DOSE OF 0.9 TO 1 G/M2 SHOULD NOT GENERALLY BE EXCEEDED, BECAUSE OF THE RISK OF CARDIOTOXICITY.
EPIRUBICIN HAS ALSO BEEN GIVEN BY INTRAVESICAL INSTILLATION IN THE LOCAL TREATMENT OF BLADDER CANCER. INSTILLATION OF 50 MG WEEKLY AS A 0.1% SOLUTION (IN SODIUM CHLORIDE 0.9% OR STERILE WATER) FOR 8 WEEKS HAS BEEN SUGGESTED, REDUCED TO 30 MG IN 50 ML WEEKLY IF CHEMICAL CYSTITIS DEVELOPS; FOR CARCINOMA IN-SITU, THE DOSE MAY BE INCREASED, IF TOLERATED, TO 80 MG IN 50 ML WEEKLY. FOR THE PROPHYLAXIS OF RECURRENCE IN PATIENTS WHO HAVE UNDERGONE TRANSURETHRAL RESECTION, 50 MG WEEKLY FOR 4 WEEKS, FOLLOWED BY 50 MG INSTILLED ONCE A MONTH FOR 11 MONTHS IS THE SUGGESTED REGIMEN. THE SOLUTION SHOULD BE RETAINED IN THE BLADDER FOR 1 HOUR.
BLOOD COUNTS SHOULD BE MADE ROUTINELY DURING TREATMENT WITH EPIRUBICIN (SEE ALSO BONE-MARROW DEPRESSION, ) AND CARDIAC FUNCTION SHOULD BE CAREFULLY MONITORED. LIVER FUNCTION SHOULD BE ASSESSED BEFORE AND IF POSSIBLE DURING THERAPY.