Safety

Increlex (mecasermin [rDNA origin]) injection

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

March 2016

Summary View

ADVERSE REACTIONS

Immunogenicity
  • As with all therapeutic proteins, there is potential for immunogenicity. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies to INCRELEX with the incidence of antibodies to other products may be misleading.
  • Anti-IGF-1 antibodies were present at one or more of the periodic assessments in 14 of 23 children with Primary IGFD treated for 2 years. However, no clinical consequences of these antibodies were observed (e.g., attenuation of growth).

 

June 2012

Summary View 

ADVERSE REACTIONS

Post-Marketing Experience
  • Skin and Subcutaneous Tissue Disorders: alopecia, hair texture abnormal 

 

Page Last Updated: 04/15/2016
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