DOXORUBICIN HYDROCHLORIDE injection powder lyophilized for solution

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

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

Saatavilla:

Pfizer Laboratories Div Pfizer Inc.

INN (Kansainvälinen yleisnimi):

DOXORUBICIN HYDROCHLORIDE

Koostumus:

DOXORUBICIN HYDROCHLORIDE 2 mg in 1 mL

Prescription tyyppi:

PRESCRIPTION DRUG

Valtuutuksen tilan:

Abbreviated New Drug Application

Valmisteyhteenveto

DOXORUBICIN HYDROCHLORIDE- DOXORUBICIN HYDROCHLORIDE INJECTION,
POWDER,
LYOPHILIZED, FOR SOLUTION
PFIZER LABORATORIES DIV PFIZER INC.
----------
DOXORUBICIN FOR INJECTION, USP
FOR INTRAVENOUS USE ONLY
RX ONLY
BOXED WARNING
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 o