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U.S. Department of Health and Human Services

Safety

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Novantrone (mitoxantrone HCl) Injection February 2009

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- February 2009

 

The detailed view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE sections. Deletions or editorial revisions made to these sections are not included in this summary. Read about the new physician labeling format.


Summary View

 

Sections Modified

Summary of Changes to Contraindications and Warnings

BOXED WARNING

  • Cardiotoxicity

WARNINGS

  • Cardiac Effects
    • Multiple Sclerosis

PATIENT PACKAGE INSERT

  • What is the most important information I should know about NOVANTRONE?
  • What are the possible side effects of NOVANTRONE?

BOXED WARNING

  • Cardiotoxicity: Congestive heart failure (CHF), potentially fatal, may occur either during therapy with NOVANTRONE or months to years after termination of therapy. Cardiotoxicity risk increases with cumulative NOVANTRONE dose and may occur whether or not cardiac risk factors are present.......

WARNINGS

  • Cardiac Effects
    • Multiple Sclerosis
      • Changes in cardiac function may occur in patients with multiple sclerosis treated with NOVANTRONE. In one controlled study.......MS patients should be assessed for cardiac signs and symptoms by history, physical examination, ECG, and quantitative LVEF evaluation using appropriate methodology....