DOXORUBICIN HYDROCHLORIDE injection

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

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

זמין מ:

Amneal-Agila, LLC

INN (שם בינלאומי):

DOXORUBICIN HYDROCHLORIDE

הרכב:

DOXORUBICIN HYDROCHLORIDE 10 mg in 5 mL

סוג מרשם:

PRESCRIPTION DRUG

מצב אישור:

Abbreviated New Drug Application

מאפייני מוצר

DOXORUBICIN HYDROCHLORIDE- DOXORUBICIN HYDROCHLORIDE INJECTION
AMNEAL-AGILA, LLC
----------
DOXORUBICIN HYDROCHLORIDE INJECTION, USP
FOR INTRAVENOUS USE ONLY
RX ONLY
WARNINGS
1. Severe local tissue necrosis will occur if there is extravasation
during administration (see
DOSAGE AND ADMINISTRATION). Doxorubicin must not be given by the
intramuscular or
subcutaneous route.
2. Myocardial toxicity manifested in its most severe form by
potentially fatal congestive heart
failure (CHF) may occur either during therapy or months to years after
termination of therapy.
The probability of developing impaired myocardial function based on a
combined index of signs,
symptoms and decline in left ventricular ejection fraction (LVEF) is
estimated to be 1% to 2% at a
total cumulative dose of 300 mg/m of doxorubicin, 3% to 5% at a dose
of 400 mg/m , 5% to 8%
at 450 mg/m and 6% to 20% at 500 mg/m . The risk of developing CHF
increases rapidly with
increasing total cumulative doses of doxorubicin in excess of 400 mg/m
. Risk factors (active or
dormant cardiovascular disease, prior or concomitant radiotherapy to
the mediastinal/pericardial
area, previous therapy with other anthracyclines or anthracenediones,
concomitant use of other
cardiotoxic drugs) may increase the risk of cardiac toxicity. Cardiac
toxicity with doxorubicin
may occur at lower cumulative doses whether or not cardiac risk
factors are present. Pediatric
patients are at increased risk for developing delayed cardiotoxicity.
3. Secondary acute myelogenous leukemia (AML) or myelodysplastic
syndrome (MDS) have
been reported in patients treated with anthracyclines, including
doxorubicin (see ADVERSE
REACTIONS). The occurrence of refractory secondary AML or MDS is more
common when
anthracyclines are given in combination with DNA-damaging
anti-neoplastic agents or
radiotherapy, when patients have been heavily pretreated with
cytotoxic drugs, or when doses of
anthracyclines have been escalated. The rate of developing secondary
AML or MDS has been
estimated in an analysis of 8563