#高警訊藥品

乳腺癌、胃癌、軟組織肉瘤 Breast cancer, Gastric cancer, Soft tissue sarcoma

Antineoplastic Agent, Anthracycline; Antineoplastic Agent, Topoisomerase II Inhibitor

1. Distribution: Vdss 21-27 L/kg
2. Protein binding: ~77% to albumin
3. Metabolism: Extensively via hepatic and extrahepatic (including RBCs) routes
4. Half-life elimination: Triphasic; Mean terminal 33 hours
5. Excretion: Feces (34% to 35%), urine (20% to 27%)

1. Severe hypersensitivity to epirubicin, other anthracyclines, anthracenediones, or any component of the formulation
2. Severe myocardial insufficiency, recent myocardial infarction, or severe arrhythmias
3. Previous treatment with anthracyclines up to the maximum cumulative dose
4. Severe persistent drug-induced myelosuppression
5. Severe hepatic impairment

Pregnant women should avoid handling epirubicin.

It is not known if epirubicin is present in human breast milk. Breastfeeding is not recommended during treatment and for >7 days after the last epirubicin dose.

Alopecia, Amenorrhea, Hot flash, Nausea and vomiting, Mucositis, Diarrhea, Neutropenia, Leukopenia, Anemia, Thrombocytopenia, Infection, Injection site reaction

Breast cancer:
1. CEF-120 regimen: 60 mg/m2 on days 1 and 8 every 28 days for 6 cycles in combination with cyclophosphamide and fluorouracil
2. FEC-100 regimen: 100 mg/m2 on day 1 every 21 days for 6 cycles in combination with cyclophosphamide and fluorouracil
Soft tissue sarcoma:
25 mg/m2 on days 1, 2, and 3 every 28 days for 4 cycles (in combination with ifosfamide and mesna) or 60 mg/m2 on days 1 and 2 every 21 days for 5 cycles (in combination with ifosfamide, mesna, and filgrastim)

The manufacturer's labeling recommends considering lower doses (dose not specified) in patients with severe renal impairment (serum creatinine >5 mg/dL).

Bilirubin 1.2-3 mg/dL or AST 2-4 times ULN: Administer 50% of recommended starting dose.
Bilirubin >3 mg/dL or AST >4 times ULN: Administer 25% of recommended starting dose.
Severe hepatic impairment (Child-Pugh class C or serum bilirubin >5 mg/dL): Use is contraindicated.