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EPIRUBICIN Hydrochloride Injection Print E-mail
Epirubicin
 
LATEX-FREE • PRESERVATIVE-FREE • AP RATED
 
 Brand Name Equivalent: ELLENCE
  Electronic Catalog
 Therapeutic Category: Antineoplastic Agent

  • Consider these SAGENT benefits:
  • • Available in:
  •   - 50 mg per 25 mL single-dose vials
  •   - 200 mg per 100 mL single-dose vials
  • • LATEX-FREE
  • • Preservative-free
  • • Enhanced packaging and labeling designed to promote safety and help reduce medication errors,
      including:
  •   - Easy-to-read drug name and dosage strength
  •   - Bar coding
NDC #25021
 Description Strength Fill Volume Concentration
 Container Size Closure Unit of Sale
 Package Insert Storage Requirements Product Photos 360o View
203-25 Glass Vial 50 mg 25 mL
 2 mg per mL
 30 mL
 20 mm 1 Package Insert Package Insert
 Product Photos 360 Product View
203-51 Glass Vial 200 mg 100 mL
 2 mg per mL
 100 mL
 20 mm
 1 Package Insert Package Insert
 Product Photos 360 Product View
 
MSDS Sheet    Bar Codes    Wholesaler Item Numbers
WARNINGS:
  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/m2, 1.6% at 700 mg/m2, and 3.3% at 900 mg/m2. In the adjuvant treatment of breast cancer, the maximum cumulative dose used in clinical trials was 720 mg/m2. The risk of developing CHF increases rapidly with increasing total cumulative doses of epirubicin in excess of 900 mg/m2; 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 Hydrochloride Injection 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 0.55% at 8 years.
  4. Dosage should be reduced in patients with impaired hepatic function (see DOSAGE AND ADMINISTRATION).
  5. Severe myelosuppression may occur.
  6. Epirubicin should be administered only under the supervision of a physician who is experienced in the use of cancer chemotherapeutic agents.
   Please refer to full prescribing information.
 
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