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U.S. Department of Health and Human Services

Safety

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Somavert (pegvisomant for injection)

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

 

December 2013

Summary View

ADVERSE REACTIONS

Postmarketing Experience
  • Registry of Patients with Acromegaly Treated with SOMAVERT ACROSTUDY is an international observational registry that captures long term safety data in patients with acromegaly treated with SOMAVERT, as used in clinical practice. Treatment dose and schedule were at the discretion of each treating physician. Although safety monitoring as per the recommended schedule was mandatory, not all assessments were performed at all time points for every patient. Because of this, comparison of rates of adverse events to those in the original clinical trial is not appropriate. In an interim report, there were 1288 patients enrolled (mean duration of treatment 3.7 years)…

 

July 2012

Summary View

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