DEFINITY

How to Use DEFINITY®: Dosing and Administration


Administration Options and Supplies Needed

Activated DEFINITY® can be administered in different ways to suit the needs of the clinical application.

It is important that aseptic procedures are adhered to throughout the preparation and administration process of activated DEFINITY®.

Dosing Option Benefits
IV Bolus1
  • Administer 10 µL/kg of activated DEFINITY® by slow IV injection over 30-60 seconds (to reduce attenuation artifacts)
  • Follow with a 10 mL preservative-free saline flush
  • Maximum allowable dose of activated DEFINITY® is 20 µL/kg
  • If necessary, a second 10 µL/kg dose followed by a second saline flush can be administered 30 minutes after first injection.
Continuous IV Infusion1
  • Add 1.3 mL activated DEFINITY® to 50 mL of preservative-free saline
  • Gently squeeze IV bag to evenly distribute microspheres
  • Initiate at 4.0 mL/minute; maximum 10.0 mL/minute
  • Adjust flow rate for optimal image enhancement
Diluted IV Bolus*
  • 1.3 mL of activated DEFINITY® diluted with 8.7 mL of preservative-free saline in a 10-cc syringe
  • Initial injection of up to 3 mL administered slowly (subsequent injection of 1 to 2 mL as needed)
  • Better suited for low MI non-linear imaging

*This method of dosing and administration is within the dosing range and administration type listed in the DEFINITY® Package Insert
 

 

  1. DEFINITY® US Package Insert.

 


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.

 

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