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Ellence (Epirubicin Hydrochloride) - Summary



  1. Severe local tissue necrosis will occur if there is extravasation during administration (See PRECAUTIONS). Epirubicin must not be given by the intramuscular or subcutaneous route.
  2. Myocardial toxicity, manifested in its most severe form by potentially fatal congestive heart failure (CHF), may occur either during therapy with epirubicin or months to years after termination of therapy. The probability of developing clinically evident CHF is estimated as approximately 0.9% at a cumulative dose of 550 mg/m2, 1.6% at 700 mg/m2, and 3.3% at 900 mg/m2. In the adjuvant treatment of breast cancer, the maximum cumulative dose used in clinical trials was 720 mg/m2. The risk of developing CHF increases rapidly with increasing total cumulative doses of epirubicin in excess of 900 mg/m2; this cumulative dose should only be exceeded with extreme caution. Active or dormant cardiovascular disease, prior or concomitant radiotherapy to the mediastinal/pericardial area, previous therapy with other anthracyclines or anthracenediones, or concomitant use of other cardiotoxic drugs may increase the risk of cardiac toxicity. Cardiac toxicity with ELLENCE may occur at lower cumulative doses whether or not cardiac risk factors are present.
  3. Secondary acute myelogenous leukemia (AML) has been reported in patients with breast cancer treated with anthracyclines, including epirubicin. The occurrence of refractory secondary leukemia is more common when such drugs are given in combination with DNA-damaging antineoplastic agents, when patients have been heavily pretreated with cytotoxic drugs, or when doses of anthracyclines have been escalated. The cumulative risk of developing treatment-related AML or myelodysplastic syndrome (MDS), in 7110 patients with breast cancer who received adjuvant treatment with epirubicin-containing regimens, was estimated as 0.27% at 3 years, 0.46% at 5 years and 0.55% at 8 years.
  4. Dosage should be reduced in patients with impaired hepatic function (see DOSAGE AND ADMINISTRATION).
  5. Severe myelosuppression may occur.
  6. Epirubicin should be administered only under the supervision of a physician who is experienced in the use of cancer chemotherapeutic agents.


ELLENCE Injection (epirubicin hydrochloride injection) is an anthracycline cytotoxic agent, intended for intravenous administration.

ELLENCE Injection is indicated as a component of adjuvant therapy in patients with evidence of axillary node tumor involvement following resection of primary breast cancer.

See all Ellence indications & dosage >>


Media Articles Related to Ellence (Epirubicin)

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Mouse Studies May Explain Night Shift, Breast Cancer Link (CME/CE)
Source: MedPage Today OB/Gyn [2015.07.25]
(MedPage Today) -- Circadian rhythm disturbance resulted in earlier tumors in a breast cancer mouse model.

more news >>

Published Studies Related to Ellence (Epirubicin)

Randomized, phase III trial of sequential epirubicin and docetaxel versus epirubicin alone in postmenopausal patients with node-positive breast cancer. [2011.08.20]
PURPOSE: The Docetaxel Epirubicin Adjuvant (DEVA) trial evaluated the efficacy and toxicity of incorporating docetaxel after epirubicin to create a sequential anthracycline-taxane regimen in early breast cancer... CONCLUSION: These results suggest, within a relatively small trial, that substitution of docetaxel for epirubicin for the last three cycles of chemotherapy results in improved outcome in postmenopausal women with node-positive, early breast cancer compared with six cycles of epirubicin monotherapy.

Epirubicin and paclitaxel with G-CSF support in first line metastatic breast cancer: a randomized phase II study of dose-dense and dose-escalated chemotherapy. [2011.07]
An increased dose-intensity can be achieved by either higher dose of chemotherapy per cycle (dose-escalation) or by shortening the interval between cycles (dose-dense). This multicenter randomized phase II study assessed the efficacy and safety of two different approaches: epirubicin 110 mg/m(2) combined with paclitaxel 200 mg/m(2) every 21 days and epirubicin 75 mg/m(2) combined with paclitaxel 175 mg/m(2) every 10 days, both supported with G-CSF...

Predictive and prognostic impact of TP53 mutations and MDM2 promoter genotype in primary breast cancer patients treated with epirubicin or paclitaxel. [2011.04.27]
CONCLUSION: TP53 and CHEK2 mutations were associated with lack of response to epirubicin monotherapy. In contrast, TP53 mutations and MDM2 309G allele status conferred poor disease-specific survival among patients treated with primary paclitaxel but not epirubicin monotherapy.

A multicenter prospective phase II randomized trial of epirubicin/vinorelbine versus pegylated liposomal doxorubicin/vinorelbine as first-line treatment in advanced breast cancer. A GOIM study. [2011.04.12]
BACKGROUND: To evaluate activity and tolerability of two anthracycline-containing regimens as first-line treatment for anthracycline-naive relapsed breast cancer patients... CONCLUSIONS: Both anthracycline- containing regimens evaluated in the present study seem to be active and with a satisfactory tolerability in anthracycline-naive relapsed breast cancer patients.

Docetaxel and epirubicin compared with docetaxel and prednisone in advanced castrate-resistant prostate cancer: a randomised phase II study. [2011.02.15]
BACKGROUND: This randomised phase II study compared the activity and safety of the combination docetaxel (D)/epirubicin (EPI) with the conventional treatment D/prednisone (P) in advanced castrate-resistant prostate cancer (CRPC) patients... CONCLUSION: The treatment of advanced CRPC with weekly D combined with weekly EPI was feasible and tolerable, and led to superior PFS than the treatment with 3-weekly D and oral P.

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Clinical Trials Related to Ellence (Epirubicin)

Adjuvant Epirubicin/Cytoxan Followed By A Taxane VS. Epirubicin/Taxane As Treatment For Node-Positive Breast Cancer [Terminated]
The purpose of this study is to compare two combinations of drugs, epirubicin given with a taxane (ET) or epirubicin given with cyclophosphamide (cytoxan) and followed by a taxane to see if one of the combinations is better at preventing or delaying the time for breast cancer recurrence and death after 3 years. The study will also evaluate the side effects of both treatment combinations.

Study of Docetaxel in Breast Cancer Patients [Completed]
Primary objectives:

- To compare the disease free survival (DFS) in patients treated with the sequential

epidoxorubicin, cyclophosphamide, methotrexate, and fluorouracil (CMF) regimen to that in patients treated with the same treatment plus docetaxel given sequentially after epidoxorubicin

Secondary objectives:

- To compare the DFS in patients treated with the sequential epidoxorubicin, docetaxel and

CMF (only patients with > or = 4 lymph nodes) regimen to that in patients treated with sequential intensified epidoxorubicin/docetaxel/high dose (HD) cyclophosphamide regimen

- To evaluate the overall survival in each arm

- To evaluate the tolerability of a sequential intensified

epidoxorubicin/docetaxel/HD-cyclophosphamide (arm C)

- To compare the safety of a sequential epidoxorubicin/docetaxel/CMF (arm B) regimen

versus a standard sequential epidoxorubicin/CMF regimen (arm A)

A Phase I, Open-label, Study of Pazopanib in Combination With Epirubicin or Doxorubicin for Advanced Solid Tumors [Recruiting]
This is an open-label, four-arm, Phase I, dose escalation study to evaluate the safety and tolerability and to determine the optimal tolerated regimen (OTR) of pazopanib in combination with epirubicin or doxorubicin in patients with advanced solid tumors. Patients will be enrolled in cohorts of 3 to receive escalating doses of pazopanib and epirubicin or doxorubicin. Dose escalation schemas for each study arm are described in the protocol. For each arm, the OTR will be defined as the highest dose combination of the agents where no more than one out of six patients experiences a dose-limiting toxicity. Six to twelve additional patients in each arm will be studied with the OTR to evaluate toxicity and pharmacokinetics. This will allow an assessment of potential drug-drug interactions. Antitumor activity will be assessed using RECIST criteria.

Epirubicin and Docetaxel Combination (ET) or Epirubicin Followed by Docetaxel (E/T) for Node Negative (N0) High Risk Breast Cancer Patients [Recruiting]
The combination of taxanes, and especially docetaxel, with an anthracycline seems to be an important part of the chemotherapy regimens used in the adjuvant setting of patients with early-stage node-positive breast cancer patients. Whether sequential or concurrent administration of these drugs is preferable is not yet known, especially in patients with node-negative high risk tumors.

Dinaciclib and Epirubicin Hydrochloride in Treating Patients With Metastatic Triple-Negative Breast Cancer [Recruiting]
The purpose of this study is to find the highest tolerable dose of the experimental drug dinaciclib that can be given in combination with epirubicin (epirubicin hydrochloride) to patients with metastatic breast cancer

more trials >>

Reports of Suspected Ellence (Epirubicin) Side Effects

Disease Progression (2)Death (2)Oesophageal Carcinoma (2)Orthostatic Hypotension (1)Pulmonary Embolism (1)Loss of Consciousness (1)Cardio-Respiratory Arrest (1)Dizziness (1)Pleural Effusion (1)Myocardial Infarction (1)more >>

Page last updated: 2015-07-25

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