EPIRUBICIN HYDROCHLORIDE - 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:

Fresenius Kabi USA, LLC

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)]. Pregnancy Category D. See ‘Warnings and Precautions’ section. Epirubicin hydrochloride 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 basis) during Days 5 to 1

Product summary:

Epirubicin Hydrochloride Injection is available in single-dose vials containing 2 mg epirubicin hydrochloride per mL as a sterile, preservative-free, ready-to-use solution in the following strengths: Store refrigerated between 2ºC and 8ºC (36ºF and 46ºF). 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 (15ºC to 25ºC).  Solution for injection should be used within 24 hours after removal from refrigeration. The container closure is not made with natural rubber latex.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

EPIRUBICIN HYDROCHLORIDE - EPIRUBICIN HYDROCHLORIDE INJECTION,
SOLUTION
FRESENIUS KABI USA, LLC
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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
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).
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, preser