Label Changes for:
Increlex (mecasermin [rDNA origin]) injection
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)
- 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)
- 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
- Systemic hypersensitivity; anaphylaxis, generalized urticaria, angioedema, dyspnea