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Epirubicin (Epirubicin Hydrochloride) - Summary

 

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WARNING

  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 epirubicin 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.
 

EPIRUBICIN SUMMARY

Epirubicin hydrochloride injection

Epirubicin is an anthracycline cytotoxic agent, intended for intravenous administration.

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.

EPIRUBICIN NEWS HIGHLIGHTS

Media Articles Related to Epirubicin

Breakthrough's Comment On Research Suggesting Positive Or Negative Experiences Can Affect Breast Cancer Risk
Source: Health News from Medical News Today [2008.08.28]

2008 Breast Cancer Symposium Awards $14,000 To Oncology Fellows
Source: Cancer / Oncology News From Medical News Today [2008.08.28]

Stress may raise breast cancer risk in young women (Reuters)
Source: Y! Health Breast Cancer News [2008.08.28]

Breastfeeding Could Reduce Risk Of Aggressive Form Of Breast Cancer That Disproportionately Affects Black, Younger Women
Source: Breast Cancer News From Medical News Today [2008.08.27]

New Target For Fight Against Common Type Of Breast Cancer: Brk
Source: Breast Cancer News From Medical News Today [2008.08.27]

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Published Studies Related to Epirubicin

Phase II, randomized trial of preoperative epirubicin-paclitaxel +/- gefitinib with biomarker evaluation in operable breast cancer. [2008.07]

Postoperative dose-dense sequential chemotherapy with epirubicin, paclitaxel and CMF in patients with high-risk breast cancer: safety analysis of the Hellenic Cooperative Oncology Group randomized phase III trial HE 10/00. [2008.05]

Ionic Versus Nonionic Contrast Media Solvents Used with an Epirubicin-based Agent for Transarterial Chemoembolization of Hepatocellular Carcinoma. [2008.03]

Prevention of recurrence with epirubicin and lactobacillus casei after transurethral resection of bladder cancer. [2008.02]

Prevention of Recurrence With Epirubicin and Lactobacillus Casei After Transurethral Resection of Bladder Cancer. [2007.12.10]

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Clinical Trials Related to Epirubicin

Adjuvant Epirubicin/Cytoxan Followed By A Taxane VS. Epirubicin/Taxane As Treatment For Node-Positive Breast Cancer [Terminated]

Study of Docetaxel in Breast Cancer Patients [Completed]

Epirubicin and Cyclophosphamide Compared With Epirubicin and Paclitaxel in Treating Women With Metastatic Breast Cancer [Active, not recruiting]

Epirubicin and Docetaxel in the Treatment of Patients With Metastatic Breast Cancer [Terminated]

Cytoxan, Epirubicin and Capecitabine in Women With Breast Cancer [Active, not recruiting]

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Page last updated: 2008-08-28

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