Policies & Procedures for the Drug Definity

Definity, the trade name for perflutern lipid microsphere, is used intravenously for people with coronary artery disease during echo-cardiograph procedures. Definity is referred to as a micro bubble contrast agent. Because serious reactions, including fatalities, have resulted from the administration of Definity, strict policies and procedures govern its use.

Dosage and Administration

• A Vialmix is necessary for the preparation of Definity. The Definity vial should be at room temperature before administration. Activate by shaking the vial for a full 45 seconds in the Vialmix. . A lesser amount of time will not properly activate the drug. Definity may be administered by either infusion or an intravenous bolus. Do not use more than two boluses or one intravenous infusion. After being mixed, the activated Definity may be used up to 12 hours, but if not used within 5 minutes of mixing, 10 seconds of hand-mixing is necessary to resuspend the microspheres.

Monitoring Procedures

• According to the Food and Drug Administration (FDA), any patients infused with Definity should be monitored for at least 30 minutes. According to the FDA, the majority of serious reactions and deaths occur within that time frame. Resuscitation equipment, and properly trained personnel, must be available at all times during infusion.

Contraindications

• Definity should not be given by intra-arterial injection. Patients with bidirectional, transient or right to left cardiac shunts should not receive Definity. Any patient previously demonstrating sensitivity to perflutern should not have the drug. Such hypersensitivity could result in cardiac arrest, unconsciousness, respiratory distress, hypotension or atrial fibrillation. Serious cardiac reactions, including fatalities, have occurred in hypersensitive patients given perflutern. Other exclusions include women of childbearing age and heart transplant patients.