Pays: États-Unis
Langue: anglais
Source: NLM (National Library of Medicine)
EPIRUBICIN HYDROCHLORIDE (UNII: 22966TX7J5) (EPIRUBICIN - UNII:3Z8479ZZ5X)
Hikma Pharmaceuticals USA Inc.
EPIRUBICIN HYDROCHLORIDE
EPIRUBICIN HYDROCHLORIDE 2 mg in 1 mL
INTRAVENOUS
PRESCRIPTION DRUG
Epirubicin Hydrochloride Injection, USP 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, other anthracyclines, or anthracenediones [see Adverse Reactions (6.2)]. Teratogenic Effects: 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 basi
Epirubicin Hydrochloride Injection, USP is available in glass single-use vials containing 2 mg epirubicin hydrochloride per mL as a sterile, preservative-free, ready-to-use solution in the following strengths: NDC 0143-9202-01 ; 50 mg/25 mL single use vial; individually boxed. NDC 0143-9203-01 ; 200 mg/100 mL single use vial; individually boxed. 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 (15 to 25ºC). Solution for injection should be used within 24 hours after removal from refrigeration. Manufactured by : THYMOORGAN PHARMAZIE GmbH, Schiffgraben 23, 38690 Goslar, Germany Distributed by : West-Ward Pharmaceuticals Eatontown, NJ 07724 USA Revised January 2016 127.207.013/00
Abbreviated New Drug Application
EPIRUBICIN HYDROCHLORIDE- EPIRUBICIN HYDROCHLORIDE INJECTION HIKMA PHARMACEUTICALS USA INC. ---------- 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, USP 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, USP 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 use vials containing 2 mg epirubicin hydrochloride per mL as a sterile, preservative-free, rea Lire le document complet