Label Changes for:

Increlex (mecasermin [rDNA origin]) injection

June 2014

Changes have been made to the ADVERSE REACTIONS sections of the safety label.

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

 

June 2014

ADVERSE REACTIONS

Post-Marketing Experience
  • General Disorders and Administrative Site Conditions: injection site reactions (e.g. erythema, pain, haematoma, haemorrhage, induration, rash, swelling).
  • Musculoskeletal and Connective Tissue Disorders: osteonecrosis/avascular necrosis (occasionally associated with slipped capital femoral epiphysis) 

 

February 2011

CONTRAINDICATIONS

Known Hypersensitivity
  • Increlex should not be used by patients who are allergic to mecasermin (rhIGF-1) or any of the inactive ingredients in Increlex or who have experienced a severe hypersensitivity to Increlex

WARNINGS AND PRECAUTIONS

Hypersensitivity and Allergic Reactions, including Anaphylaxis
  • Allergic reactions to Increlex have been reported post-marketing. They range from localized (injection site) reactions to systemic reactions, including anaphylaxis requiring hospitalization. Parents and patients should be informed that such reactions are possible and that if a systemic allergic reaction occurs treatment should be interrupted and prompt medical attention should be sought

ADVERSE REACTIONS

Post-Marketing Experience
  • Systemic hypersensitivity; anaphylaxis, generalized urticaria, angioedema, dyspnea

 

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