Brand Name
Ellence
Generic Name
Epirubicin
View Brand Information FDA approval date: September 15, 1999
Classification: Anthracycline Topoisomerase Inhibitor
Form: Injection
What is Ellence (Epirubicin)?
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 Clinical Studies (1.
Approved To Treat
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Brand Information
Ellence (epirubicin hydrochloride)
WARNING: CARDIAC TOXICITY, SECONDARY MALIGNANCIES, EXTRAVASATION AND TISSUE NECROSIS, and SEVERE MYELOSUPPRESSION
- Cardiac Toxicity: Myocardial damage, including acute left ventricular failure, can occur with ELLENCE. The risk of cardiomyopathy is proportional to the cumulative exposure with incidence rates from 0.9% at a cumulative dose of 550 mg/m
- Secondary Malignancies: Secondary acute myelogenous leukemia (AML) and myelodysplastic syndrome (MDS) occur at a higher incidence in patients treated with anthracyclines, including ELLENCE
- Extravasation and Tissue Necrosis: Extravasation of ELLENCE can result in severe local tissue injury and necrosis requiring wide excision of the affected area and skin grafting. Immediately terminate the drug and apply ice to the affected area
- Severe myelosuppression resulting in serious infection, septic shock, requirement for transfusions, hospitalization, and death may occur
1INDICATIONS 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
2DOSAGE 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.
3CONTRAINDICATIONS
ELLENCE is contraindicated in patients with:
- Severe myocardial insufficiency
- Recent myocardial infarction or severe arrhythmias, or previous treatment with maximum cumulative dose of anthracyclines
- Severe persistent drug-induced myelosuppression
- Severe hepatic impairment (defined as Child-Pugh Class C or serum bilirubin level greater than 5 mg/dL)
- Severe hypersensitivity to ELLENCE, other anthracyclines, or anthracenediones
4ADVERSE REACTIONS
The following clinically significant adverse reactions are described elsewhere in the labeling:
- Cardiac Toxicity
- Secondary Malignancies
- Extravasation and Tissue Necrosis
- Severe Myelosuppression
- Tumor-Lysis Syndrome
- Thrombophlebitis and Thromboembolic Events
- Potentiation of Radiation Toxicity and Radiation Recall
4.1Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reactions rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The safety of ELLENCE was evaluated in two studies (Studies MA-5 and GFEA-05) evaluating combination regimens in patients with early breast cancer
4.2Postmarketing Experience
The following adverse reactions have been identified during post-approval use of ELLENCE. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Infections and infestations: sepsis, pneumonia
Immune system disorders: anaphylaxis
Metabolism and nutrition disorders: dehydration, hyperuricemia
Vascular disorders: shock, hemorrhage, embolism arterial, thrombophlebitis, phlebitis
Respiratory, thoracic and mediastinal disorders: pulmonary embolism
Gastrointestinal disorders: erosions, ulcerations, pain or burning sensation, bleeding, hyperpigmentation of the oral mucosa
Skin and subcutaneous tissue disorders: erythema, flushes, skin and nail hyperpigmentation, photosensitivity, hypersensitivity to irradiated skin (radiation-recall reaction), urticaria
Renal and urinary disorders: red coloration of urine for 1 to 2 days after administration
General disorders and administration site conditions: fever, chills
Injury, poisoning and procedural complications: chemical cystitis (following intravesical administration)
5OVERDOSAGE
There is no known antidote for overdoses of ELLENCE. A 36-year-old man with non-Hodgkin's lymphoma received a daily 95 mg/m
If an overdose occurs, provide supportive treatment (including antibiotic therapy, blood and platelet transfusions, colony-stimulating factors, and intensive care as needed) until the recovery of toxicities. Delayed CHF has been observed months after anthracycline administration. Observe patients carefully over time for signs of CHF and provided with appropriate supportive therapy.
6DESCRIPTION
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 vials containing 50 and 200 mg of epirubicin hydrochloride as a preservative-free, ready-to-use solution. Each milliliter of solution contains 2 mg of epirubicin hydrochloride. Inactive ingredients include 9 mg sodium chloride, USP, and water for injection, USP. The pH of the solution has been adjusted to 3.0 with hydrochloric acid and/or sodium hydroxide, NF.
Epirubicin hydrochloride is the 4-epimer of doxorubicin and is a semi-synthetic derivative of daunorubicin. The chemical name is (8S-
7REFERENCES
- "Hazardous Drugs".
8HOW SUPPLIED/STORAGE AND HANDLING
ELLENCE is available in polypropylene single-dose CYTOSAFE
Discard unused portion.
ELLENCE is available in ONCO-TAIN
ONCO-TAIN
Discard unused portion.
9PRINCIPAL DISPLAY PANEL - 50 mg/25 mL Vial Label
NDC 0009-5091-01
Single-dose Vial
50 mg/25 mL
For Intravenous Use Only
10PRINCIPAL DISPLAY PANEL - 50 mg/25 mL Vial Carton
NDC 0009-5091-01
Single-dose Vial
50 mg/25 mL
For Intravenous Use Only
Pfizer Injectables
11PRINCIPAL DISPLAY PANEL - 200 mg/100 mL Vial Label
NDC 0009-5093-01
Single-dose Vial
For Intravenous Use Only
Pfizer Injectables
12PRINCIPAL DISPLAY PANEL - 200 mg/100 mL Vial Carton
NDC 0009-5093-01
Single-dose Vial
200 mg/100 mL
For Intravenous Use Only
Pfizer Injectables
13PRINCIPAL DISPLAY PANEL - 50 mg/25 mL Vial Label ONCO-TAIN®
NDC 0009-5091-25
Ellence
50 mg/25 mL
For Intravenous Use Only
14PRINCIPAL DISPLAY PANEL - 50 mg/25 mL Vial Carton ONCO-TAIN®
NDC 0009-5091-25
One 25 mL Single-dose Vial.
Ellence
50 mg/25 mL
For Intravenous Use Only
Pfizer
Rx only
Warning: Hazardous Drug
15PRINCIPAL DISPLAY PANEL - 200 mg/100 mL Vial Label ONCO-TAIN®
NDC 0009-5093-10
Ellence
200 mg/100 mL
For Intravenous Use Only
16PRINCIPAL DISPLAY PANEL - 200 mg/100 mL Vial Carton ONCO-TAIN®
NDC 0009-5093-10
One 100 mL Single-dose Vial.
Ellence
200 mg/100 mL
For Intravenous Use Only
Pfizer
Rx only
Warning: Hazardous Drug
