HIGHLIGHTS OF PRESCRIBING INFORMATIONThese highlights do not include all the... |
Did you find an answer to your question?
Yes
No
If you provide additional keywords, you may be able to browse through our database of Scientific Response Documents.
Our scientific content is evidence-based, scientifically balanced and non-promotional. It undergoes rigorous internal medical review and is updated regularly to reflect new information.
ELLENCE® (epirubicin HCl)
If you provide additional keywords, you may be able to browse through our database of Scientific Response Documents.
Our scientific content is evidence-based, scientifically balanced and non-promotional. It undergoes rigorous internal medical review and is updated regularly to reflect new information.
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...
Did you find an answer to your question?
Yes
No
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...
Did you find an answer to your question?
Yes
No
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...
Did you find an answer to your question?
Yes
No
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.
Did you find an answer to your question?
Yes
No
Contraindications
4 CONTRAINDICATIONS
ELLENCE is contraindicated in patients with:
- Severe myocardial insufficiency [see Warnings and Precautions (5.1)]
- Recent...
Did you find an answer to your question?
Yes
No
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.
...
Did you find an answer to your question?
Yes
No
Adverse Reactions
6 ADVERSE REACTIONS
The following clinically significant adverse reactions are described elsewhere in the labeling:
- Cardiac Toxicity [see Warnings and Precautions...
Did you find an answer to your question?
Yes
No
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...
Did you find an answer to your question?
Yes
No
Use in Specific Populations
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Risk Summary
Based on findings from...
Did you find an answer to your question?
Yes
No
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...
Did you find an answer to your question?
Yes
No
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...
Did you find an answer to your question?
Yes
No
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...
Did you find an answer to your question?
Yes
No
Nonclinical Toxicology
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
Conventional long-term animal studies to evaluate the carcinogenic potential of...
Did you find an answer to your question?
Yes
No
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...
Did you find an answer to your question?
Yes
No
References
15 REFERENCES
- "Hazardous Drugs". OSHA. http://www.osha.gov/SLTC/hazardousdrugs/index.html
Did you find an answer to your question?
Yes
No
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...
Did you find an answer to your question?
Yes
No
Medication Guide
17 PATIENT COUNSELING INFORMATION
Cardiac Toxicity
Inform patients that there is a risk of irreversible myocardial damage associated with...
Did you find an answer to your question?
Yes
No
Did you find an answer to your question?
Yes
No
Report Adverse Event
To report an adverse event related to a Pfizer product and you are not part of a clinical trial* for this product, click the link below to submit your information: Pfizer Safety Reporting Site
*If you are involved in a clinical trial for either product, adverse events should be reported to your coordinating study site.
If you cannot use the above website to report an adverse event related to a Pfizer product, please call Pfizer Medical Information at (800) 438-1985.
You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns either online at www.fda.gov/medwatchor by calling
(800)-332-1088.
(800)-332-1088.