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Basic Drug Info
Drug Name:epirubicin hydrochloride
Manufacturer:OTN Generics Inc.
Other Info:Rx onlyManufactured by:Pfizer (Perth) Pty Limited, Bentley WA 6102 AustraliaManufactured for:OTN Generics Inc.South San Francisco, CA 94080LAB-0351-3.0April 2008



Clinical Trials:


Indications and Usage
Epirubicin Injection is indicated as a component of adjuvant therapy in patients with evidence of axillary node tumor involvement following resection of primary breast cancer.
Breast Carcinoma -- (brest KAN-ser) Cancer that forms in tissues of the breast, usually the ducts (tubes that carry milk to the nipple) and lobules (glands that make milk). It occurs in both men and women, although male breast cancer is rare.

Malignant neoplasm of breast -- A primary or metastatic malignant neoplasm involving the breast. The vast majority of cases are carcinomas arising from the breast parenchyma or the nipple. Malignant breast neoplasms occur more frequently in females than in males. -- 2003

Contraindications
Patients should not be treated with epirubicin Injection if they have any of the following conditions: baseline neutrophil count < 1500 cells/mm3; severe myocardial insufficiency, recent myocardial infarction, severe arrhythmias; previous treatment with anthracyclines up to the maximum cumulative dose; hypersensitivity to epirubicin, other anthracyclines, or anthracenediones; or severe hepatic dysfunction (see WARNINGS and DOSAGE AND ADMINISTRATION).
Hypersensitivity -- Altered reactivity to an antigen, which can result in pathologic reactions upon subsequent exposure to that particular antigen.

Liver Dysfunction --

Warnings

Epirubicin injection should be administered only under the supervision of qualified physicians experienced in the use of cytotoxic therapy.

Before beginning treatment with epirubicin, patients should recover from acute toxicities (such as stomatitis, neutropenia, thrombocytopenia, and generalized infections) of prior cytotoxic treatment.

Also, initial treatment with epirubicin should be preceded by a careful baseline assessment of blood counts; serum levels of total bilirubin, AST, and creatinine; and cardiac function as measured by left ventricular ejection function (LVEF).

Patients should be carefully monitored during treatment for possible clinical complications due to myelosuppression.

Supportive care may be necessary for the treatment of severe neutropenia and severe infectious complications.

Monitoring for potential cardiotoxicity is also important, especially with greater cumulative exposure to epirubicin.
Branded Drugs
The following US Branded drugs contain epirubicin hydrochloride


ELLENCE -- PFIZER INC


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