Label Changes for:

Definity Vial for (Perflutren Lipid Microsphere) Injectable Suspension

October 2011

Changes have been made to the BOXED WARNING, WARNINGS, PRECAUTIONS and ADVERSE REACTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – October 2011

 

 

BOXED WARNING

  • Serious cardiopulmonary reactions, including fatalities, have occurred uncommonly during or following perflutren-containing microsphere administration [see WARNINGS AND PRECAUTIONS (5.1)]. Most serious reactions occur within 30 minutes of administration.....

 

WARNINGS AND PRECAUTIONS

Serious Cardiopulmonary Reactions, and:
 
Anaphylactoid Reactions:
  • minor changes in both sections.....

 

ADVERSE REACTIONS

Postmarketing Experience
  • Reported reactions included: ......

 

USE IN SPECIAL POPULATIONS

Geriatric Use
  • In clinical trials, the overall incidence of adverse reactions was similar for the <65 year age group and the ≥65 year age group. Of the total .....
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