Definity Dosage

Important Administration Instructions

• DEFINITY is intended for administration only after activation in the VIALMIX or VIALMIX RFID apparatus. Before injection, this product must be activated and prepared according to the instructions outlined below. The VIALMIX or VIALMIX RFID apparatus should be ordered from Lantheus Medical Imaging, 331 Treble Cove Road, North Billerica, MA, 01862. For customer orders call 1-800-299-3431.
• DEFINITY may be injected by either an intravenous (IV) bolus or infusion. Do not administer DEFINITY by intra-arterial injection [see Warnings and Precautions (5.3)].
• 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.

Dosage

Imaging Guidelines

After baseline non-contrast echocardiography is completed, set the mechanical index for the ultrasound device at 0.8 or below [see Warnings and Precautions (5.4)]. Then inject activated DEFINITY (as described above) and begin ultrasound imaging immediately. Evaluate the activated DEFINITY echocardiogram images in combination with the non-contrast echocardiogram images.

In a crossover trial of 64 patients randomized to both bolus and infusion, the duration of clinically useful contrast enhancement for fundamental imaging was approximately 3.4 minutes after a 10 microL/kg bolus and was approximately 7.1 minutes during the continuous infusion of 1.3 mL activated DEFINITY in 50 mL saline at a rate of 4 mL/min.

DEFINITY Activation, Preparation and Handling Instructions

Follow directions for activation of DEFINITY carefully and adhere to strict aseptic procedures during preparation.

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 device or VIALMIX RFID device.

   Note: illustrations of this procedure are contained in the VIALMIX or VIALMIX RFID User's Guide.

   Do not use this drug unless it has completed a full 45 second activation cycle in the VIALMIX or VIALMIX RFID. DEFINITY will not be properly activated unless the full 45 second activation cycle is completed. Error messages will display if the vial is not properly activated. Do not reactivate the vial if VIALMIX or VIALMIX RFID did not properly activate the vial. Never reactivate a successfully activated DEFINITY vial (see step 3). A VIALMIX or VIALMIX RFID that is not functioning properly must never be used. Only use a vial activated from a properly functioning VIALMIX or VIALMIX RFID. Refer to the VIALMIX or VIALMIX RFID User's Guide to ensure that a properly functioning VIALMIX or VIALMIX RFID is used.

3. Immediately after activation in the VIALMIX or VIALMIX RFID, 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 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 activation, 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), the PINSYNC (Vented Vial Adapter 13mm), 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.