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Definity (Perflutren) - Summary

 
 



WARNING: Serious Cardiopulmonary Reactions

Serious cardiopulmonary reactions, including fatalities, have occurred during or within 30 minutes following DEFINITY ® administration.

  • Assess all patients for the presence of any condition that precludes DEFINITY ® administration (see CONTRAINDICATIONS).
  • Monitor patients during and for 30 minutes following DEFINITY ® administration, including vital sign measurements and electrocardiography in all patients and cutaneous oxygen saturation in patients at risk for hypoxemia. Always have resuscitation equipment and trained personnel readily available (see WARNINGS).
 

DEFINITY SUMMARY

Octafluoropropane (OFP) Protein Binding

The DEFINITY® vial contains components that upon activation yield perflutren lipid microspheres, a diagnostic drug that is intended to be used for contrast enhancement during the indicated echocardiographic procedures.

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.


See all Definity indications & dosage >>

NEWS HIGHLIGHTS

Published Studies Related to Definity (Perflutren)

A pilot randomized clinical safety study of sonothrombolysis augmentation with ultrasound-activated perflutren-lipid microspheres for acute ischemic stroke. [2008.05]
BACKGROUND AND PURPOSE: Ultrasound transiently expands perflutren-lipid microspheres (muS), transmitting energy momentum to surrounding fluids. We report a pilot safety/feasibility study of ultrasound-activated muS with systemic tissue plasminogen activator (tPA)... CONCLUSIONS: Perflutren microS reached and permeated beyond intracranial occlusions with no increase in sICH after systemic thrombolysis suggesting feasibility of further microS dose-escalation studies and development of drug delivery to tissues with compromised perfusion.

Sudden death after intravenous administration of a perflutren contrast agent: a case of pseudocomplication? [2009.06]
Perflutren cardiac ultrasound agents improve diagnostic accuracy in patients whose imaging is technically difficult. This report describes a case of sudden death approximately 5 minutes after the intravenous administration of 0.5 mL of perflutren contrast agent (Definity) during transthoracic echocardiography with suboptimal baseline images performed 10 days after coronary artery bypass graft surgery because of hypotension and tachycardia in a 73-year-old patient with severe left ventricular systolic dysfunction.

Acoustic and kinetic behaviour of definity in mice exposed to high frequency ultrasound. [2009.02]
Microbubble contrast agents have shown clinical potential for characterising blood flow using 1 to 10 MHz ultrasound; however, scaling their use for similar applications in the mouse with high frequency ultrasound (20 to 60 MHz) has not been addressed... These results suggest that quantitative contrast flow studies in the mouse using high frequency ultrasound are possible for doses between 10 and 60 microL kg(-1).

The safety of deFinity and Optison for ultrasound image enhancement: a retrospective analysis of 78,383 administered contrast doses. [2008.11]
BACKGROUND: The purpose of this retrospective analysis was to define the incidence of severe adverse events after exposure to ultrasound contrast agents... CONCLUSION: This multicenter, retrospective analysis includes the largest number of doses of ultrasound contrast agents ever published and a large number of patients evaluated in a wide variety of settings, including the critically ill. It shows that these agents have a good safety profile in both cardiac and abdominal ultrasound applications. The incidence of severe adverse reactions to ultrasound contrast agents is no greater, and may be lower, than that reported for contrast agents commonly used in other cardiac imaging tests.

Ultrasound-enhanced thrombolysis using Definity as a cavitation nucleation agent. [2008.09]
Ultrasound has been shown previously to act synergistically with a thrombolytic agent, such as recombinant tissue plasminogen activator (rt-PA) to accelerate thrombolysis. In this in vitro study, a commercial contrast agent, Definity, was used to promote and sustain the nucleation of cavitation during pulsed ultrasound exposure at 120 kHz...

more studies >>

Clinical Trials Related to Definity (Perflutren)

Evaluation of Intra-operative Ultrasound Contrast Enhancement in the Evaluation of Liver Tumors [Recruiting]
The primary purpose of this study is to demonstrate the safety and effectiveness of using an intra-operative ultrasound contrast agent(Definity®) for the identification of known liver tumors.

A Pilot Study of the Effects of Contrast Enhanced Endoscopic Ultrasound on Determining Vascular Involvement in Pancreatic Lesions [Not yet recruiting]
In the US, pancreas cancer is the fifth leading cause of cancer related deaths. It was estimated to have taken 36,800 lives in 2010. Unfortunately, curing pancreatic cancer requires surgical removal. Surgical removal of the pancreas is associated with high morbidity and mortality, as well as high rates of complications. One way to aid surgeons in removing pancreatic tumors is by providing them with a good idea of where the tumor is located and what surrounding structures are involved. This currently happens through many different modalities of imaging; usually computed tomography (CT) and endoscopic ultrasound. Even with these forms of imaging (and sometimes others), surgeons will occasionally open a patient and find that the tumor cannot be removed due to its involvement with surrounding structures.

One way to avoid potentially unnecessary procedures or to help a surgeon navigate this delicate procedure would be to provide more detailed information about the tumor. Several of the techniques currently used to image the body have rapidly advanced over recent years. Typical advancements come through better resolution of the images or contrast to enhance desired parts of the images. Ultrasound has not seen such a two pronged advance. Ultrasound has seen substantial advances in resolution to enhance picture quality, but contrast has not been used clinically to assess pancreatic masses whereas it is for cardiologists to use contrast to look at potential defects in the heart.

The contrast that is used with ultrasound is different from that of CT scans. CT scanners use a dye that can be potentially hazardous. This dye can lead to serious kidney damage in some patients. Ultrasound contrast, on the other hand, is made of small micro bubbles filled with a harmless gas. Because of the way ultrasound works, these micro bubbles reflect the sound waves differently than the surrounding tissue and thus provide contrast between normal tissue and abnormal tissue. The contrast used in this study, Definity, and is the same contrast used by Cardiologists.

The CE-EUS will be used for research purposes only and will not be used for any clinical decision making. The surgeon will be blinded to the results of the research CE-EUS. The investigators will compare the research pre-operative contrast enhanced endoscopic ultrasounds images with already completed standard-of-care CT scans, the actual pancreatic involvement seen in surgery and the pathology reports.

Effects of Nebivolol on Skeletal Muscle During Exercise in Hypertensive Patients [Recruiting]
The purpose of this study is to determine if Nebivolol improves microvascular perfusion in skeletal muscle during exercise in hypertensive patients and whether this improvement is accompanied by reduction in vascular oxidative stress or increased endothelial nitric oxide synthase (eNOS) expression in humans.

A Study of Commercial DEFINITY® to Monitor the Effects of the Heart's Pulmonary Artery Pressure [Recruiting]
The purpose of this clinical research is to learn if DEFINITY® 416 will cause any adverse effects during Right Heart Catheterization. This research was requested by the FDA.

Prospective Analysis and Comparison of Stress Echo to Real-Time Myocardial Contrast Stress Echo [Available]

more trials >>

Reports of Suspected Definity (Perflutren) Side Effects

Back Pain (6)Atrial Fibrillation (4)Anxiety (4)Pruritus (3)Unresponsive TO Stimuli (3)Ejection Fraction Decreased (3)Pain (2)Headache (2)Viith Nerve Paralysis (2)Fatigue (2)more >>


Page last updated: 2009-10-20

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