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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 of Changes to Contraindications and Warnings
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.
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.