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ELLENCE®(epirubicin HCl)

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ELLENCE® Quick Finder

HIGHLIGHTS OF PRESCRIBING INFORMATION

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WARNING: CARDIAC TOXICITY, SECONDARY MALIGNANCIES, EXTRAVASATION AND TISSUE NECROSIS, and SEVERE MYELOSUPPRESSION

  • Cardiac Toxicity: Myocardial damage, including acute left ventricular failure, can...
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1 INDICATIONS AND USAGE

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

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2 DOSAGE AND ADMINISTRATION

2.1 Important Administration Instructions

When possible, to reduce the risk of developing cardiotoxicity in patients receiving ELLENCE...

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3 DOSAGE FORMS AND STRENGTHS

Injection: 50 mg/25 mL (2 mg/mL), 200 mg/100 mL (2 mg/mL) clear red solution in a single-dose vial.

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5 WARNINGS AND PRECAUTIONS

5.1 Cardiac Toxicity

ELLENCE and other anthracycline drugs can result in either early (or acute) or late (delayed) cardiac toxicity.

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6 ADVERSE REACTIONS

The following clinically significant adverse reactions are described elsewhere in the labeling:

  • Cardiac Toxicity [see

    6.1 Clinical Trials Experience...

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7 DRUG INTERACTIONS

7.1 Cardiotoxic Agents

Closely monitor cardiac function when ELLENCE is used in combination with other cardiotoxic agents. Patients receiving...

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8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Risk Summary

Based on findings from...

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10 OVERDOSAGE

There is no known antidote for overdoses of ELLENCE. A 36-year-old man with non-Hodgkin's lymphoma received a daily 95 mg/m2 dose of ELLENCE for 5 consecutive days. Five days later, he...

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11 DESCRIPTION

ELLENCE (epirubicin hydrochloride injection) is an anthracycline topoisomerase inhibitor for intravenous administration. ELLENCE is supplied as a sterile, clear, red solution and is available in polypropylene...

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12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

Epirubicin is an anthracycline cytotoxic agent. Although it is known that anthracyclines can interfere with a number...

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13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

Conventional long-term animal studies to evaluate the carcinogenic potential of...

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14 CLINICAL STUDIES

14.1 Adjuvant Treatment of Breast Cancer

Two randomized, open-label, multicenter studies evaluated the use of ELLENCE 100 to 120 mg/m...

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15 REFERENCES

  1. "Hazardous Drugs". OSHA. http://www.osha.gov/SLTC/hazardousdrugs/index.html
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16 HOW SUPPLIED/STORAGE AND HANDLING

ELLENCE is available in polypropylene single-dose CYTOSAFE™ vials containing 2 mg epirubicin hydrochloride per mL as a sterile, preservative-free, ready-to-use, clear, red solution in the...

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17 PATIENT COUNSELING INFORMATION

Cardiac Toxicity

Inform patients that there is a risk of irreversible myocardial damage associated with...

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This product's labeling may have been updated. For the most recent prescribing information, please visit www.pfizer.com.

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