Label Changes for:

Somavert (pegvisomant for injection)

July 2012

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

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – July 2012

 

 

PRECAUTIONS

  • Patients should be instructed in the technique and importance of proper disposal of materials used for the administration of Somavert (e.g., needles and syringes, medical waste, vial). Patients should be cautioned against reuse of needles.

ADVERSE REACTIONS

Post-Marketing Experience
  • Systemic hypersensitivity reactions including anaphylactic/anaphylactoid reactions, laryngospasm, angioedema, generalized skin reactions (rash, erythema, pruritus, urticaria) have been reported in post-marketing use. Some patients required hospitalization. Symptoms did not re-occur in all patients after re-challenge
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