Applies to the following strength(s): 2 mg/mL ; 50 mg ; 200 mg
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Usual Adult Dose for:
Additional dosage information:
Usual Adult Dose for Breast Cancer - Adjuvant
For use as a component of adjuvant therapy in patients with evidence of axillary node tumor involvement following resection of primary breast cancer:
Starting Dose: 100 to 120 mg/m2 by intravenous infusion every 3 to 4 weeks. The total dose may either be given on Day 1 of each cycle or divided equally and given on Days 1 and 8 of each cycle.
Renal Dose Adjustments
Although no specific dosage adjustments are available, lower doses should be considered in patients with severe renal impairment (serum creatinine >5 mg/dL).
Liver Dose Adjustments
If a patient has a bilirubin of 1.2 to 3 mg/dL or AST 2 to 4 times the upper limit of normal, then they should receive 1/2 of the normally recommended starting dose.
If a patient has a bilirubin >3 mg/dL or AST >4 times the upper limit of normal, then they should receive 1/4 of the normally recommended starting dose
Consideration should be given to administration of lower starting doses (75 to 90 mg/m2) for heavily pretreated patients, patients with preexisting bone marrow depression, or in the presence of neoplastic bone marrow infiltration.
Dosage adjustments after the first treatment cycle should be made based on both hematologic and nonhematologic toxicities Patients experiencing nadir platelet counts <50,000/mm3, absolute neutrophil counts <250/mm3, neutropenic fever, of grades 3/4 nonhematologic toxicity should have the day 1 dose in subsequent cycles reduced to 75% of the Day 1 dose given in the current cycle. Day 1 chemotherapy in subsequent courses of treatment should be delayed until platelet counts are >=100,000/mm3, absolute neutrophil counts are >=1500/mm3, and nonhematologic toxicities have recovered to <=grade 1.
For patients receiving a divided dose (day 1 and day 8), the day 8 dose should be 75% of day 1 if platelet counts are 75,000 to 100,000/mm3 and the absolute neutrophil count is 1000 to 1499/mm3. If day 8 platelet counts are <75,000/mm3 , absolute neutrophil counts are <1000/mm3, or grade 3/4 nonhematologic toxicity has occurred, the day 8 dose should be omitted.
Epirubicin is not recommended for use in patients with a baseline neutrophil count <1500 cells /mm3, severe myocardial insufficiency, recent myocardial infarction, severe arrhythmias, previous treatment with anthracyclines up to the maximum cumulative dose, or severe hepatic dysfunction.
Before initiating therapy with epirubicin, patients should be recovered from any acute toxicities (such as stomatitis, neutropenia, thrombocytopenia, and generalized infections) from prior cytotoxic treatments.
Assessment of blood counts, serum levels of total bilirubin, AST, creatinine, and cardiac function as measured by left ventricular ejection function (LVEF) are recommended before and during treatment with epirubicin.
Extra care is recommended in monitoring toxicity when administered to female patients >=70 years old.
Safety and effectiveness have not been established in pediatric patients (less than 18 years of age).
Data not available.
In clinical trials, the patients administered the 120 mg/m2 regimen also received prophylactic antibiotic therapy with trimethoprim-sulfamethoxazole or a fluoroquinolone.
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