ELLENCE® Contraindications (epirubicin HCl) | Pfizer Medical Information - US

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4 CONTRAINDICATIONS

ELLENCE is contraindicated in patients with:

Severe myocardial insufficiency [see Warnings and Precautions (5.1)]
Recent myocardial infarction or severe arrhythmias, or previous treatment with maximum cumulative dose of anthracyclines [see Warnings and Precautions (5.1)]
Severe persistent drug-induced myelosuppression [see Warnings and Precautions (5.4)]
Severe hepatic impairment (defined as Child-Pugh Class C or serum bilirubin level greater than 5 mg/dL) [see Warnings and Precautions (5.5)]
Severe hypersensitivity to ELLENCE, other anthracyclines, or anthracenediones [see Adverse Reactions (6.1)]

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.

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HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the...

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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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4 CONTRAINDICATIONS

ELLENCE is contraindicated in patients with:

Severe myocardial insufficiency [see Warnings and Precautions (5.1)]
Recent...

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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 Warnings and Precautions...

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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

"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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Report Adverse Event

Pfizer Safety

To report an adverse event related to Pfizer-BioNTech COVID-19 Vaccine (also known as COMIRNATY®, COVID-19 mRNA, Vaccine BNT162b2 or BNT162) or Pfizer COVID-19 Treatment (also known as PAXLOVID™ (nirmatrelvir tablets; ritonavir tablets)), 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 or would like to report an adverse event related to a different Pfizer product, please call Pfizer Safety at
(800) 438-1985.

FDA Medwatch

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.