EPIRUBICIN HYDROCHLORIDE injection solution

Страна: САЩ

Език: английски

Източник: NLM (National Library of Medicine)

Активна съставка:

epirubicin hydrochloride (UNII: 22966TX7J5) (epirubicin - UNII:3Z8479ZZ5X)

Предлага се от:

Greenstone, LLC

INN (Международно Name):

epirubicin hydrochloride

Композиция:

epirubicin hydrochloride 2 mg in 1 mL

Вид предписание :

PRESCRIPTION DRUG

Статус Оторизация:

New Drug Application Authorized Generic

Данни за продукта

EPIRUBICIN HYDROCHLORIDE- EPIRUBICIN HYDROCHLORIDE INJECTION, SOLUTION
GREENSTONE, LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
EPIRUBICIN HCL SAFELY AND EFFECTIVELY. SEE
FULL PRESCRIBING INFORMATION FOR EPIRUBICIN HCL.
EPIRUBICIN HCL (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)
RECENT MAJOR CHANGES
Boxed Warning
09/2011
Dosage and Administration, Preparation and Administration (2.3)
09/2011
Warnings and Precautions, Injection-Related Reactions, Hematologic,
Cardiac,
Secondary Leukemia, Coadministration with Cimetidine, Pregnancy, Male
Fertility
and Reproductive Outcomes, laboratory Testing, Inflammation following
Irradiation (5.1, 5.2, 5.3, 5.4, 5.11, 5.12, 5.13, 5.14, 5.15)
09/2011
Warnings and Precautions, Male Fertility and Reproductive Outcomes
(5.13)
11/2011
Drug Interactions, Cadioactive Compounds, cimetidine, other Cytotoxic
Drugs,
Radiation Therapy, Concomitant Therapies-Hepatic Function (7.1, 7.2,
7.3, 7.4, 7.5)
09/2011
INDICATIONS AND USAGE
Epirubicin HCl 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