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U.S. Department of Health and Human Services

Safety

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Myozyme (alglucosidase alfa) For Intravenous Infusion Only December 2008

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- December 2008

 

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

  • Risk of Anaphylaxis (revised)
  • Risk of Cardiorespiratory Failure (new)

WARNINGS

  • Anaphylaxis and Allergic Reactions (see BOXED WARNING)
  • Risk of Acute Cardiorespiratory Failure (see BOXED WARNING)

PRECAUTIONS

ADVERSE REACTIONS

BOXED WARNING

Risk of Anaphylaxis:

Life-threatening anaphylactic reactions have been observed in some patients during Myozyme infusions...

Risk of Cardiorespiratory Failure:

Patients with compromised cardiac or respiratory function may be at risk of serious acute exacerbation of their cardiac or respiratory compromise due to infusion reactions, and require additional monitoring.

WARNINGS

Anaphylaxis and Allergic Reactions:

Life-threatening and severe allergic reactions have been reported in some patients during and within three hours after Myozyme infusion. Reactions have included anaphylactic shock, cardiac arrest, respiratory distress, hypotension, bradycardia, hypoxia, bronchospasm, throat tightness, dyspnea, angioedema, and urticaria.