How to Use DEFINITY^®: Dosing and Administration

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Administration Options and Supplies Needed

Activated DEFINITY^® can be administered in different ways to suit the needs of the clinical application. Whether it is bolus or infusion, DEFINITY^® is easy to prepare and administer.

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^® package insert, April 2008, Lantheus Medical Imaging, Inc.

 

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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.

The safety and efficacy of DEFINITY® with exercise stress or pharmacologic stress testing have not been established.

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 during or following perflutren-containing microsphere administration. Assess all patients for the presence of any condition that precludes DEFINITY® administration (see CONTRAINDICATIONS). In patients with pulmonary hypertension or unstable cardiopulmonary conditions, monitor vital sign measurements, electrocardiography and cutaneous oxygen saturation during and for at least 30 minutes after DEFINITY® administration (see WARNINGS). 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). The risk for these reactions may be increased among patients with pulmonary hypertension or unstable cardiopulmonary conditions. 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 and Letter to Healthcare Providers.

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