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U.S. Department of Health and Human Services

Safety

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Aldurazyme (laronidase) Solution for Intravenous Infusion Only


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

  • Risk of Anaphylaxis

WARNINGS

  • Anaphylaxis and Allergic Reactions (see BOXED WARNING)

ADVERSE REACTIONS

  • Initial Paragraph
  • In clinical studies, the most common adverse reactions requiring intervention...
  • In postmarketing experience with Aldurazyme...
  • Immunogenicity

BOXED WARNING

WARNING: Risk of Anaphylaxis

Life-threatening anaphylactic reactions have been observed in some patients during Aldurazyme infusions. Therefore, appropriate medical support should be readily available when Aldurazyme is administered. Patients with compromised respiratory function or acute respiratory disease may be at risk of serious acute exacerbation of their respiratory compromise due to infusion reactions, and require additional monitoring.

WARNINGS: Anaphylaxis and Allergic Reactions (see BOXED WARNING)

See prescribing information for revised text.

 

Label approved 04/14/2008 is not available on this site

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