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.

DEFINITY® IS INTENDED FOR ADMINISTRATION ONLY AFTER ACTIVATION IN THE VIALMIX® APPARATUS. Before injection, this product must be activated and prepared according to the instructions outlined below. The Vialmix® apparatus should be ordered from Lantheus Medical Imaging, Inc., 331 Treble Cove Road, North Billerica, MA 01862. For customer orders call 1-800-299-3431.

DEFINITY® may be injected by either an intravenous bolus or infusion.

Bolus: The recommended dose for activated DEFINITY® is 10 microliters (µL)/kg of the activated product by intravenous bolus injection within 30-60 seconds, followed by a 10 mL saline flush. If necessary, a second 10 microliters (µL)/kg dose followed by a second 10 mL saline flush may be administered 30 minutes after the first injection to prolong contrast enhancement.

Infusion: The recommended dose for activated DEFINITY® is via an IV infusion of 1.3 mL added to 50 mL of preservative-free saline. The rate of infusion should be initiated at 4.0 mL/minute, but titrated as necessary to achieve optimal image enhancement, not to exceed 10 mL/minute.

The maximum dose is either two bolus doses or one single intravenous infusion. The safety of bolus and infusion dosing in combination or in sequence, has not been studied.

Imaging: After baseline non-contrast echocardiography is completed, the mechanical index for the ultrasound device should be set at 0.8 or below (see WARNINGS). Then inject activated DEFINITY® (as described above) and begin ultrasound imaging immediately. The activated DEFINITY® echocardiogram images should be evaluated in combination with the non-contrast echocardiogram images.

DEFINITY® ACTIVATION, PREPARATION AND HANDLING INSTRUCTIONS:

1. Allow the vial to warm to room temperature before starting the activation procedure.
2. Activate DEFINITY® by shaking the vial for 45 seconds using a Vialmix®.
   
   Note: illustrations of this procedure are contained in the Vialmix® Users Guide.
   
   WARNING: DO NOT USE THIS DRUG UNLESS IT HAS COMPLETED A FULL 45 SECOND ACTIVATION CYCLE IN THE VIALMIX®. DEFINITY® WILL NOT BE PROPERLY ACTIVATED UNLESS THE FULL 45 SECOND ACTIVATION CYCLE IS COMPLETED. DO NOT REACTIVATE the vial if Vialmix® did not complete a full 45 second cycle. DO NOT REACTIVATE a successfully activated DEFINITY® vial (see step 3). DO NOT USE a Vialmix® that is not functioning properly. Refer to the "VIALMIX® User's Guide" for the "VIALMIX® CALIBRATION AND REPLACEMENT PROCEDURES" to ensure that a properly functioning Vialmix® is used.
   
   
3. Immediately after activation in the Vialmix®, activated DEFINITY® appears as a milky white suspension and may be used immediately after activation. If the product is not used within 5 minutes of Vialmix® activation, the microspheres should be resuspended by 10 seconds of hand agitation by inverting the vial before the product is withdrawn in a syringe. The activated DEFINITY® may be used for up to 12 hours from the time of Vialmix®, but only after the microspheres are resuspended by hand agitation. Store the activated DEFINITY® at room temperature in the original product vial.
4. Invert the vial and withdraw the activated milky white suspension using the Intellipin™ (Dispensing Pin) or 18 to 20 gauge syringe needle. Withdraw the material from the middle of the liquid in the inverted vial. DO NOT INJECT AIR INTO THE DEFINITY® VIAL.
5. Use the product immediately after its withdrawal from the vial; do not allow the product to stand in the syringe. FOR SINGLE USE ONLY: DEFINITY® does not contain bacterial preservative. Bacterial contamination with the risk of post-administration septicemia can occur following the puncture of the elastomeric septum. It is essential to follow directions for activation of DEFINITY® carefully and to adhere to strict aseptic procedures during preparation.

DEFINITY® is supplied as a single use 2 mL clear glass vial containing clear liquid. Each package (clear plastic clamshell) contains four (4) single-use vials.

Storage

Store between 2-8°C (36°-46°F) in a refrigerator.

CAUTION: Federal law prohibits dispensing without prescription.

Distributed By: Lantheus Medical Imaging, 331 Treble Cove Road, N. Billerica, Massachusetts 01862 USA. FDA Rev date: 5/12/2008

Bookmark this page: