DOXORUBICIN HYDROCHLORIDE- doxorubicin hydrochloride injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Fresenius Kabi USA, LLC

INN (International Name):

DOXORUBICIN HYDROCHLORIDE

Composition:

DOXORUBICIN HYDROCHLORIDE 2 mg in 1 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Doxorubicin Hydrochloride Injection, USP has been used successfully to produce regression in disseminated neoplastic conditions such as acute lymphoblastic leukemia, acute myeloblastic leukemia, Wilms'  tumor, neuroblastoma, soft tissue and bone sarcomas, breast carcinoma, ovarian carcinoma, transitional cell bladder carcinoma, thyroid carcinoma, gastric carcinoma, Hodgkin's disease, malignant lymphoma and bronchogenic carcinoma in which the small cell histologic type is the most responsive compared to other cell types. Doxorubicin is also indicated for use as a component of adjuvant therapy in women with evidence of axillary lymph node involvement following resection of primary breast cancer. Patients should not be treated with doxorubicin if they have any of the following conditions: baseline neutrophil count <1,500 cells/mm 3 ; severe hepatic impairment; recent myocardial infarction; severe myocardial insufficiency; severe arrhythmias; previous treatment with complete cumulative doses of doxoru

Product summary:

Doxorubicin Hydrochloride Injection, USP, 2 mg per mL, a sterile product which contains no preservatives, is available as follows: REFRIGERATE AT:   2 ° to 8 °C ( 36 ° to 46 °F). Protect from light (keep in outer carton). Preservative Free. Discard unused portion. The container closure is not made with natural rubber latex.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

DOXORUBICIN HYDROCHLORIDE - DOXORUBICIN HYDROCHLORIDE INJECTION,
SOLUTION
FRESENIUS KABI USA, LLC
----------
DOXORUBICIN HYDROCHLORIDE INJECTION USP
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) has 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 8,563 patients with early b