ELLENCE- epirubicin hydrochloride injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

EPIRUBICIN HYDROCHLORIDE (UNII: 22966TX7J5) (EPIRUBICIN - UNII:3Z8479ZZ5X)

Available from:

Pharmacia & Upjohn Company LLC

INN (International Name):

EPIRUBICIN HYDROCHLORIDE

Composition:

EPIRUBICIN HYDROCHLORIDE 2 mg in 1 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 (14.1)] . ELLENCE is contraindicated in patients with: Risk Summary Based on findings from animal studies and its mechanism of action, ELLENCE can cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology (12.1)] ; avoid the use of ELLENCE during the 1st trimester. Available human data do not establish the presence or absence of major birth defects and miscarriage related to the use of epirubicin during the 2nd and 3rd trimesters. There are reports of fetal and/or neonatal cardiotoxicity following in utero exposure to epirubicin (see Error! Hyperlink reference not valid. ). In animal reproduction studies in pregnant rats, epirubicin was embryo-fetal lethal and caused structural abnormalities when administered during organogenesis at doses less than the maximum recommended human dose on a body surface

Product summary:

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 following strengths: 50 mg/25 mL Carton of one single-dose vial NDC 0009-5091-01 200 mg/100 mL Carton of one single-dose vial NDC 0009-5093-01 Discard unused portion. Store refrigerated between 2°C and 8°C (36°F and 46°F). Do not freeze. Protect from light. Storage of the solution for injection at refrigerated conditions can result in the formation of a gelled product. This gelled product will return to a slightly viscous to mobile solution after 2 to a maximum of 4 hours equilibration at controlled room temperature (15–25°C). Solution for injection should be used within 24 hours after removal from refrigeration. ELLENCE is a cytotoxic drug. Follow applicable special handling and disposal procedures1 [see References (15)].

Authorization status:

New Drug Application

Summary of Product characteristics

ELLENCE- EPIRUBICIN HYDROCHLORIDE INJECTION, SOLUTION
PHARMACIA & UPJOHN COMPANY LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ELLENCE SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ELLENCE.
ELLENCE (EPIRUBICIN HYDROCHLORIDE INJECTION)
INITIAL U.S. APPROVAL: 1999
WARNING: CARDIAC TOXICITY, SECONDARY MALIGNANCIES, EXTRAVASATION AND
TISSUE NECROSIS, AND SEVERE MYELOSUPPRESSION
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
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INDICATIONS AND USAGE
ELLENCE is an anthracycline topoisomerase inhibitor indicated as a
component of adjuvant therapy in
patients with evidence of axillary node tumor involvement following
resection of primary breast cancer (1).
DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
Injection: 50 mg/25 mL (2 mg/mL), 200 mg/100 mL (2 mg/mL) solution in
single-dose vials (3).
CONTRAINDICATIONS
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®
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 , 1.6%
AT 700 MG/M , AND 3.3% AT 900 MG/M . THE RISK OF CARDIOMYOPATHY IS
FURTHER
INCREASED WITH CONCOMITANT CARDIOTOXIC THERAPY. ASSESS LEFT
VENTRICULAR EJECTION
FRACTION (LVEF) BEFORE AND REGULARLY DURING AND AFTER TREATMENT WITH
ELLENCE
(5.1).
2
2
2
SECONDARY MALIGNANCIES: SECONDARY ACUTE MYELOGENOUS LEUKEMIA (AML) AND
MYELODYSPLASTIC SYNDROME (MDS) OCCUR AT A HIGHER INCIDENCE IN PATIENTS
TREATED
WITH ANTHRACYCLINES, INCLUDING ELLENCE (5.2).
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
(5.3).
SEVERE MYELOSUPPRESSION RESULTING IN SERIOUS INFECTION, SEPTIC SHOCK,
REQUIREMENT
FOR TRANSFUSIONS, HOSPITALIZATION, AND D