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U.S. Department of Health and Human Services

Safety

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Ellence (epirubicin hydrochloride) for Injection

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – February 2013

Summary View

 

CONTRAINDICATIONS

Patients should not be treated with Ellence Injection if they have any of the following conditions:
  • Cardiomyopathy and/or heart failure, recent myocardial infarction or severe arrhythmias
 

WARNINGS AND PRECAUTIONS

Pregnancy
  • Women of child-bearing potential should be advised to avoid becoming pregnant during treatment and should use effective contraceptive methods
 

ADVERSE REACTIONS

Overview of Acute and Delayed Toxicities
  • Other serious drug-related cardiovascular adverse events that occurred during clinical trials with Ellence, administered in different indications, include ventricular tachycardia, AV block, bundle branch block, bradycardia and thromboembolism.
 
Post-Marketing Experience
  • The following adverse reactions have been identified during post-approval use of ELLENCE. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
  • Infections and infestations: sepsis, pneumonia
  • Immune system disorders: anaphylaxis
  • Metabolism and nutrition disorders: dehydration, hyperuricemia
  • Vascular disorders: shock, haemorrhage, embolism arterial, thrombophlebitis, phlebitis
  • Respiratory, thoracic and mediastinal disorders: pulmonary embolism
  • Gastrointestinal disorders: erosions, ulcerations, pain or burning sensation, bleeding, hyperpigmentation of the oral mucosa
  • Skin and subcutaneous tissue disorders: erythema, flushes, skin and nail hyperpigmentation, photosensitivity, hypersensitivity to irradiated skin (radiation-recall reaction), urticaria
  • Renal and urinary disorders: red coloration of urine for 1 to 2 days after administration
  • General disorders and administration site conditions: fever, chills
  • Injury, poisoning and procedural complications: chemical cystitis (following intravesical administration)