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Ellence
epirubicin
Black Box Warnings .
Cardiotoxicity
myocardial damage, incl. acute left ventricular failure, fatal CHF, may occur during tx or months to years after D/C tx; incr. risk w/ higher cumulative dose, w/ incidence rates from 0.9% at a cumulative dose of 550 mg/m^2, 1.6% at 700 mg/m^2, and 3.3% at 900 mg/m^2; give cumulative dose >900 mg/m^2 only w/ extreme caution; incr. risk if active/dormant cardiovascular disease, prior or concomitant XRT to mediastinal/pericardial area, prior anthracycline or anthracenedione tx, or concomitant cardiotoxic drug tx; cardiac toxicity may occur at lower cumulative doses w/ or w/o cardiac risk factors; assess LVEF before and regularly during and after tx
Secondary AML or Myelodysplastic Syndrome
occur at a higher incidence in patients treated w/ anthracyclines, incl. epirubicin; refractory secondary leukemia more common in patients who receive combo regimens w/ DNA-damaging antineoplastics, heavy pre-treatment w/ cytotoxic drugs, or escalation of anthracycline dose; cumulative risk estimated as 0.27% at 3 years, 0.46% at 5 years, and 0.55% at 8 years
Extravasation
can result in severe local tissue injury and necrosis requiring wide excision of affected area and skin grafting; immediately D/C tx and apply ice to affected area if extravasation suspected; do not give IM or SC
Myelosuppression
severe cases resulting in serious infection, septic shock, requirement for transfusion, hospitalization, and death may occur
Adult Dosing .
Dosage forms: INJ
Special Note
- [uses, dosing may vary]
- Info: refer to institution protocols and pkg insert prior to prescribing for uses, premeds, and dosing incl. toxicity-related dose adjustments
axillary node positive breast CA, adjuvant tx
- [pre-existing bone marrow dysfunction]
- Dose: 75 mg/m^2/dose IV x1 on day 1 of 21-day cycle; Alt: 45 mg/m^2/dose IV x1 on days 1, 8 of 28-day cycle; Info: give x6 cycles; for heavily pretreated patients, pre-existing bone marrow depression, or if neoplastic bone marrow infiltration; part of multi-drug chemo regimen
- [all other patients]
- Dose: 100 mg/m^2/dose IV x1 on day 1 of 21-day cycle; Alt: 60 mg/m^2/dose IV x1 on days 1, 8 of 28-day cycle; Info: give x6 cycles; part of multi-drug chemo regimen
renal dosing
- [see below]
- Cr >5: consider decr. usual dose
- HD/PD: not defined
hepatic dosing
- [see below]
- bilirubin 1.2-3 or AST 2-4x ULN: decr. usual start dose by 50%; bilirubin 3.1-5 or AST >4x ULN: decr. usual start dose by 75%; bilirubin >5: avoid use
Peds Dosing .
Peds dosing is currently unavailable or not applicable for this drug.