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Label Changes for:

Aldurazyme (laronidase) Solution for Intravenous Infusion Only

April 2008

Changes have been made to the BOXED WARNING, WARNINGS and ADVERSE REACTIONS sections of the safety label.

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


  • Risk of Anaphylaxis


  • Anaphylaxis and Allergic Reactions (see BOXED WARNING)


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


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