DEFINITY

Why Use DEFINITY®? PROVEN SAFETY PROFILE


SAFETY ISSUES IN ULTRASOUND CONTRAST
Presented by:
Jonathan Goldman, MD, FASE, FACC
Chief Medical Officer, ICON Medical Imaging
Assistant Clinical Professor, UCSF
Audio Presentation

The safety of DEFINITY® is well documented in multiple clinical trials involving over 1,700 patients at more than 20 U.S. medical centers.1

The overall incidence of treatment-related adverse events was 8.4%. The most frequently reported treatment-related adverse experiences were in the Central and Peripheral nervous system (3.1%), Body as a Whole (2.4%) and Gastrointestinal system (1.8%). The most frequently reported treatment-related adverse experiences were:

Headache    2.3%
Back/renal pain 1.2%
Flushing 1.1%
Nausea 1.0%

In clinical trials, serious cardiopulmonary events occurred in 19 (1.1%) patients. None of these events, which included 8 deaths and 11 other serious adverse events, was attributed to DEFINITY®, but to progression of underlying disease.1

  1. DEFINITY® Prescribing Information.

INDICATIONS

Activated DEFINITY® (Perflutren Lipid Microsphere) Injectable Suspension is indicated for use in patients with suboptimal echocardiograms to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border.

CONTRAINDICATIONS

Do not administer DEFINITY® to patients with known or suspected right-to-left, bi-directional or transient right-to-left cardiac shunts, by intra-arterial injection, or to patients with known hypersensitivity to perflutren.

IMPORTANT SAFETY INFORMATION

WARNING:  Serious Cardiopulmonary Reactions

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.

  • Assess all patients for the presence of any condition that precludes DEFINITY® administration [See CONTRAINDICATIONS (4)].

  • Always have resuscitation equipment and trained personnel readily available.


In post marketing use, rare but serious cardiopulmonary or anaphylactoid reactions have been reported during or shortly following perflutren-containing microsphere administration [See ADVERSE REACTIONS (6)]. The risk for these reactions may be increased among patients with unstable cardiopulmonary conditions [See Postmarketing Experience (6.2)]. It is not always possible to reliably establish a causal relationship to drug exposure due to the presence of underlying cardiopulmonary disease.

Please see full Prescribing Information, including boxed WARNING regarding serious cardiopulmonary reactions.

 

HOME