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ELLENCE®(epirubicin HCl)
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ELLENCE® Quick Finder
Highlights
Boxed Warning
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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Indications and Usage
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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Dosage and Administration
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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Dosage Forms and Strengths
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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Contraindications
4 CONTRAINDICATIONS
ELLENCE is contraindicated in patients with:
- Severe myocardial insufficiency [see Warnings and Precautions (5.1)]
- Recent...
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Warnings and Precautions
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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Adverse Reactions
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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Drug Interactions
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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Use in Specific Populations
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Risk Summary
Based on findings from...
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Overdosage
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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Description
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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Clinical Pharmacology
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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Nonclinical Toxicology
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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Clinical Studies
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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References
15 REFERENCES
- "Hazardous Drugs". OSHA. http://www.osha.gov/SLTC/hazardousdrugs/index.html
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How Supplied/Storage and Handling
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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Medication Guide
17 PATIENT COUNSELING INFORMATION
Cardiac Toxicity
Inform patients that there is a risk of irreversible myocardial damage associated with...
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