Pays: États-Unis
Langue: anglais
Source: NLM (National Library of Medicine)
DOXORUBICIN HYDROCHLORIDE (UNII: 82F2G7BL4E) (DOXORUBICIN - UNII:80168379AG)
Mylan Institutional LLC
DOXORUBICIN HYDROCHLORIDE
DOXORUBICIN HYDROCHLORIDE 10 mg in 5 mL
PRESCRIPTION DRUG
Abbreviated New Drug Application
DOXORUBICIN HYDROCHLORIDE- DOXORUBICIN HYDROCHLORIDE INJECTION MYLAN INSTITUTIONAL LLC ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE DOXORUBICIN HYDROCHLORIDE INJECTION, USP SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR DOXORUBICIN HYDROCHLORIDE INJECTION, USP. DOXORUBICIN HYDROCHLORIDE INJECTION, USP FOR INTRAVENOUS USE INITIAL U.S. APPROVAL: 1974 WARNING: CARDIOMYOPATHY, SECONDARY MALIGNANCIES, EXTRAVASATION AND TISSUE NECROSIS, AND SEVERE MYELOSUPPRESSION _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._ CARDIOMYOPATHY: MYOCARDIAL DAMAGE CAN OCCUR WITH DOXORUBICIN HYDROCHLORIDE WITH INCIDENCES FROM 1% TO 20% FOR CUMULATIVE DOSES FROM 300 MG/M TO 500 MG/M WHEN DOXORUBICIN HYDROCHLORIDE IS ADMINISTERED EVERY 3 WEEKS. 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 DOXORUBICIN HYDROCHLORIDE. (5.1). SECONDARY MALIGNANCIES: SECONDARY ACUTE MYELOGENOUS LEUKEMIA (AML) AND MYELODYSPLASTIC SYNDROME (MDS) OCCUR AT A HIGHER INCIDENCE IN PATIENTS TREATED WITH ANTHRACYCLINES, INCLUDING DOXORUBICIN HYDROCHLORIDE. (5.2). EXTRAVASATION AND TISSUE NECROSIS: EXTRAVASATION OF DOXORUBICIN HYDROCHLORIDE CAN RESULT IN SEVERE LOCAL TISSUE INJURY AND NECROSIS REQUIRING WIDE EXCISION 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 DEATH MAY OCCUR. (5.4). INDICATIONS AND USAGE Doxorubicin hydrochloride, USP is an anthracycline topoisomerase II inhibitor indicated: as a component of multiagent adjuvant chemotherapy for treatment of women with axillary lymph node involvement following resection of primary breast cancer (1.1). for the treatment of: acute lymphoblastic leukemia, acute myeloblastic leukemia, Hodgkin lymphoma, Non-Hodgkin lympho Lire le document complet