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U.S. Department of Health and Human Services

Safety

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Somavert (pegvisomant for injection) August 2008


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

PRECAUTIONS

  • Lipohypertrophy
    • Lipohypertrophy has been reported in <5% of patients following pegvisomant administration.

ADVERSE REACTIONS

  • Postmarketing Experience
    • Lipohypertrophy has been reported in <5% of patients following pegvisomant administration.
    • Asymptomatic, transient elevations in transaminases up to 15 times ULN have been observed in <2% of patients in the post-marketing experience. These reports were not associated with an increase in bilirubin, and there were no clinical consequences for these patients...

PATIENT PACKAGE INSERT

  • INSTRUCTIONS FOR USE
    • Giving the Injection
      • Choose a different injection site each day so lumps do not develop...