EPIRUBICIN HYDROCHLORIDE- epirubicin hydrochloride injection

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Impax Generics

INN (International Name):

EPIRUBICIN HYDROCHLORIDE

Composition:

EPIRUBICIN HYDROCHLORIDE 2 mg in 1 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Epirubicin Hydrochloride Injection 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)]. Patients should not be treated with epirubicin hydrochloride injection if they have any of the following conditions: Cardiomyopathy and/or heart failure, recent myocardial infarction or severe arrhythmias [see Warnings and Precautions (5.3)] Previous treatment with maximum cumulative dose of anthracyclines [see Warnings and Precautions (5)]. Hypersensitivity to epirubicin hydrochloride injection, other anthracyclines, or anthracenediones [see Adverse Reactions (6.2)]. Teratogenic Effects Pregnancy Category D. See ‘Warnings and Precautions’ section. Epirubicin hydrochloride injection can cause fetal harm when administered to a pregnant woman. Administration of 0.8 mg/kg/day intravenously of epirubicin to rats (about 0.04 times the maximum recommended single human dose on a body surface area bas

Product summary:

Epirubicin Hydrochloride Injection is available in colorless glass, single-dose vials, type I containing 2 mg epirubicin hydrochloride per mL as a sterile, preservative-free, ready-to-use solution in the following strengths: - 50 mg/25 mL single-dose vial, NDC 0115-1675-72                 1 vial per carton - 200 mg/100 mL single-dose vial, NDC 0115-1675-73             1 vial per carton Storage Conditions Store refrigerated between 2° and 8°C (36° and 46°F). Do not freeze. Protect from light. Retain in carton until time of use. For Single-Dose Only; Discard unused portion. Sterile, Nonpyrogenic, Preservative-free. The vial stopper is not made of natural rubber latex. 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 (15º to 25ºC). Solution for injection should be used within 24 hours after removal from refrigeration.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

EPIRUBICIN HYDROCHLORIDE- EPIRUBICIN HYDROCHLORIDE INJECTION
IMPAX GENERICS
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
EPIRUBICIN HYDROCHLORIDE
INJECTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
EPIRUBICIN HYDROCHLORIDE
INJECTION.
EPIRUBICIN HYDROCHLORIDE INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 1999
WARNING: SEVERE OR LIFE-THREATENING HEMATOLOGICAL AND OTHER ADVERSE
REACTIONS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
SEVERE LOCAL TISSUE NECROSIS ASSOCIATED WITH EXTRAVASATION DURING
ADMINISTRATION (5.9)
MYOCARDIAL TOXICITY, MANIFESTED IN ITS MOST SEVERE FORM BY POTENTIALLY
FATAL CONGESTIVE HEART FAILURE
(CHF) (5.3)
SECONDARY ACUTE MYELOGENOUS LEUKEMIA (AML) (5.4)
REDUCE DOSAGE IN PATIENTS WITH IMPAIRED HEPATIC FUNCTION (5.5)
SEVERE MYELOSUPPRESSION (5.2)
ADMINISTER ONLY UNDER THE SUPERVISION OF A PHYSICIAN WHO IS
EXPERIENCED IN THE USE OF CANCER
CHEMOTHERAPEUTIC AGENTS (5)
INDICATIONS AND USAGE
Epirubicin Hydrochloride Injection is an anthracycline topoisomerase
II inhibitor indicated as a component of adjuvant
therapy in patients with evidence of axillary node tumor involvement
following resection of primary breast cancer (1.1).
DOSAGE AND ADMINISTRATION
Administer intravenously in repeated 3- to 4-week cycles, either total
dose on Day 1 of each cycle or divided equally
and given on Days 1 and 8 of each cycle (2).
The recommended starting dose of epirubicin hydrochloride injection is
100 to 120 mg/m .Dosage reductions are
possible when given in certain combinations (2.1).
Dosage adjustments after the first treatment cycle should be made
based on hematologic and nonhematologic toxicities
(2.2).
Reduce dose in patients with hepatic impairment (2.2, 8.6, 12.3).
Consider lower doses in patients with severe renal impairment (2.2,
8.7, 12.3).
DOSAGE FORMS AND STRENGTHS
Single-dose vials containing 2 mg epirubicin hydrochloride per mL as a
sterile, preservative-free, ready-to-use solution (50
mg