DOXORUBICIN HYDROCHLORIDE injection

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

DOXORUBICIN HYDROCHLORIDE (UNII: 82F2G7BL4E) (DOXORUBICIN - UNII:80168379AG)

Dostępny od:

Mylan Institutional LLC

INN (International Nazwa):

DOXORUBICIN HYDROCHLORIDE

Skład:

DOXORUBICIN HYDROCHLORIDE 10 mg in 5 mL

Typ recepty:

PRESCRIPTION DRUG

Status autoryzacji:

Abbreviated New Drug Application

Charakterystyka produktu

DOXORUBICIN HYDROCHLORIDE- DOXORUBICIN HYDROCHLORIDE INJECTION
MYLAN INSTITUTIONAL LLC
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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