epirubicin hydrochloride- epirubicin hydrochloride injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

epirubicin hydrochloride (UNII: 22966TX7J5) (epirubicin - UNII:3Z8479ZZ5X)

Available from:

OTN Generics Inc.

INN (International Name):

epirubicin hydrochloride

Pharmaceutical form:

INJECTION, SOLUTION

Composition:

2 mg in 1 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Epirubicin Injection is indicated as a component of adjuvant therapy in patients with evidence of axillary node tumor involvement following resection of primary breast cancer. Patients should not be treated with epirubicin Injection if they have any of the following conditions: baseline neutrophil count < 1500 cells/mm3 ; severe myocardial insufficiency, recent myocardial infarction, severe arrhythmias; previous treatment with anthracyclines up to the maximum cumulative dose; hypersensitivity to epirubicin, other anthracyclines, or anthracenediones; or severe hepatic dysfunction (see WARNINGS and DOSAGE AND ADMINISTRATION).

Product summary:

Epirubicin injection is available in polypropylene single-use CYTOSAFE™ vials containing 2 mg epirubicin hydrochloride per mL as a sterile, preservative-free, ready-to-use solution in the following strengths: 50 mg/25 mL single-use vial              NDC 15210-404-28 200 mg/100 mL single-use vial          NDC 15210-404-29 Store refrigerated between 2°C and 8°C (36°F and 46°F). Do not freeze. Protect from light. Discard unused portion. Storage of the solution for injection at refrigerated conditions can result in the formation of a gelled product. This gelled product will return to a slightly viscous to mobile solution after 2 to a maximum of 4 hours equilibration at controlled room temperature (15–25°C).

Summary of Product characteristics

EPIRUBICIN HYDROCHLORIDE - EPIRUBICIN HYDROCHLORIDE INJECTION,
SOLUTION
OTN GENERICS INC.
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EPIRUBICIN HYDROCHLORIDE INJECTION
WARNING
1. Severe local tissue necrosis will occur if there is extravasation
during administration (See
PRECAUTIONS). Epirubicin 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 with epirubicin or
months to years after
termination of therapy. The probability of developing clinically
evident CHF is estimated as
approximately 0.9% at a cumulative dose of 550 mg/m , 1.6% at 700 mg/m
, and 3.3% at 900
mg/m . In the adjuvant treatment of breast cancer, the maximum
cumulative dose used in clinical
trials was 720 mg/m . The risk of developing CHF increases rapidly
with increasing total
cumulative doses of epirubicin in excess of 900 mg/m ; this cumulative
dose should only be
exceeded with extreme caution. Active or dormant cardiovascular
disease, prior or
concomitant radiotherapy to the mediastinal/pericardial area, previous
therapy with other
anthracyclines or anthracenediones, or concomitant use of other
cardiotoxic drugs may
increase the risk of cardiac toxicity. Cardiac toxicity with
epirubicin may occur at lower
cumulative doses whether or not cardiac risk factors are present.
3. Secondary acute myelogenous leukemia (AML) has been reported in
patients with breast
cancer treated with anthracyclines, including epirubicin. The
occurrence of refractory
secondary leukemia is more common when such drugs are given in
combination with DNA-
damaging antineoplastic agents, when patients have been heavily
pretreated with cytotoxic
drugs, or when doses of anthracyclines have been escalated. The
cumulative risk of
developing treatment-related AML or myelodysplastic syndrome (MDS), in
7110 patients with
breast cancer who received adjuvant treatment with
epirubicin-containing regimens, was
estimated as 0.27% at 3 years, 0.46% at 5 years and 0