Brands, Medical Use, Clinical Data
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Brands / Synonyms
4'-Epiadriamycin; 4'-Epidoxorubicin; Ellence; Epi-Dx; Epiadriamycin; Epidoxorubicin; Epirubicin; Epirubicina [Inn-Spanish]; Epirubicina [Spanish]; Epirubicine [French]; Epirubicine [Inn-French]; Epirubicinum [Inn-Latin]; Epirubicinum [Latin]; IMI 28; Pharmorubicin Pfs; Pidorubicina [Inn-Spanish]; Pidorubicine [Inn-French]; Pidorubicinum [Inn-Latin]; Ridorubicin
For use as a component of adjuvant therapy in patients with evidence of axillary node tumor involvement following resection of primary breast cancer
Epirubicin is an antineoplastic in the anthracycline class. General properties of drugs in this class include: interaction with DNA in a variety of different ways including intercalation (squeezing between the base pairs), DNA strand breakage and inhibition with the enzyme topoisomerase II. Most of these compounds have been isolated from natural sources and antibiotics. However, they lack the specificity of the antimicrobial antibiotics and thus produce significant toxicity. The anthracyclines are among the most important antitumor drugs available. Doxorubicin is widely used for the treatment of several solid tumors while daunorubicin and idarubicin are used exclusively for the treatment of leukemia. Epirubicin may also inhibit polymerase activity, affect regulation of gene expression, and produce free radical damage to DNA. Epirubicin possesses an antitumor effect against a wide spectrum of tumors, either grafted or spontaneous. The anthracyclines are cell cycle-nonspecific.
Mechanism of Action
Epirubicin has antimitotic and cytotoxic activity. It inhibits nucleic acid (DNA and RNA) and protein synthesis through a number of proposed mechanisms of action: Epirubicin forms complexes with DNA by intercalation between base pairs, and it inhibits topoisomerase II activity by stabilizing the DNA-topoisomerase II complex, preventing the religation portion of the ligation-religation reaction that topoisomerase II catalyzes. It also interferes with DNA replication and transcription by inhibiting DNA helicase activity.
bone marrow aplasia, grade 4 mucositis, and gastrointestinal bleeding
Biotrnasformation / Drug Metabolism
Patients should not be treated with ELLENCE 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.
ELLENCE when used in combination with other cytotoxic drugs may show on-treatment additive toxicity,
especially hematologic and gastrointestinal effects.
Concomitant use of ELLENCE with other cardioactive compounds that could cause heart failure (e.g.,
calcium channel blockers), requires close monitoring of cardiac function throughout treatment.
There are few data regarding the coadministration of radiation therapy and epirubicin. In adjuvant
trials of epirubicin-containing CEF-120 or FEC-100 chemotherapies, breast irradiation was delayed until after
chemotherapy was completed. This practice resulted in no apparent increase in local breast cancer recurrence relative
to published accounts in the literature. A small number of patients received epirubicin-based chemotherapy
concomitantly with radiation therapy but had chemotherapy interrupted in order to avoid potential overlapping
toxicities. It is likely that use of epirubicin with radiotherapy may sensitize tissues to the cytotoxic actions of
irradiation. Administration of ELLENCE after previous radiation therapy may induce an inflammatory recall reaction at
the site of the irradiation.
Epirubicin is extensively metabolized by the liver. Changes in hepatic function induced by concomitant
therapies may affect epirubicin metabolism, pharmacokinetics, therapeutic efficacy, and/or toxicity.
Cimetidine increased the AUC of epirubicin by 50%. Cimetidine treatment should be stopped during
treatment with ELLENCE.
Drug-Laboratory Test Interactions
There are no known interactions between ELLENCE and laboratory tests.