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Please see full prescribing and safety information, including boxed warning, for  EPIRUBICIN vials.  

Available in:

  • 50 mg per 25 mL single-use vials
  • 200 mg per 100 mL single-use vials

Benefits:

  • AP Rated
  • Preservative-free
  • Not made with natural rubber latex

EPIRUBICIN Hydrochloride Injection*

Brand Name Equivalent: ELLENCE® (ELLENCE is a registered trademark of Pfizer Cork LLC.)
Therapeutic Category: Antineoplastic Agent

PreventIV MeasuresTM Features:

  • Easy-to-read drug name and dosage strength to aid in identifying the right product
  • Bar codes included on the vial and carton for ease of scanning
  • Unique label design to help products stand out on the shelf
  • Enhanced packaging and labeling designed to promote safety and help reduce the risk of medication errors
  • Yellow and black cytotoxic caution flag designed to alert healthcare workers who handle the product
NDC
#25021
Description Strength Fill
Volume
Concentration Container
Size
Closure Unit
of Sale
203-25 Glass Vial 50 mg 25 mL 2 mg per mL 30 mL 20 mm 1
203-51 Glass Vial 200 mg 100 mL 2 mg per mL 100 mL 20 mm 1

WARNING: RISK OF TISSUE NECROSIS, CARDIAC TOXICITY, SECONDARY ACUTE MYELOGENOUS LEUKEMIA, AND MYELOSUPPRESSION

  1. Severe local tissue necrosis will occur if there is extravasation during administration. Epirubicin hydrochloride injection must not be given by the intramuscular or subcutaneous route [see Warnings and Precautions (5.9)].
  2. Cardiac toxicity, including fatal congestive heart failure (CHF), may occur either during therapy with epirubicin hydrochloride injection 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 hydrochloride injection 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 [see Warnings and Precautions (5.3)].
  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 hydrochloride injection-containing regimens, was estimated as 0.27% at 3 years, 0.46% at 5 years, and 0.55% at 8 years [see Warnings and Precautions (5.4)].
  4. Severe myelosuppression may occur [see Warnings and Precautions (5.2)].