• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Safety

  • Print
  • Share
  • E-mail

Lumizyme (alglucosidase alfa)

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

  

 

August 2014*

Summary View

NOTE: extensive modifications were made to the PI

BOXED WARNINGS

  • extensive changes; please see PI for details

5 WARNINGS AND PRECAUTIONS

  • extensive changes in subsections; please see PI for details

6 ADVERSE REACTIONS

  • extensive changes to all subsections; please see PI for details

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy
  • category changed from B to C
8.3 Nursing Mothers
  • Alglucosidase alfa is present in human milk. In one case report, the enzymatic activity .... 
  • Exercise caution when administering alglucosidase alfa to a nursing mother. 

17 PATIENT COUNSELING INFORMATION

  • extensive changes; please see PI for details

* Posted with September 2014 MedWatch safety labeling changes

 

May 2014

Summary View

6 ADVERSE REACTIONS

6.3 Postmarketing Experience...section updated

 

July 2012

Summary View

ADVERSE REACTIONS

Postmarketing Experience
  • abdominal pain, nephrotic syndrome and proteinuria, as observed events to the package insert