Flurpiridaz F 18

(Flyrcado®)

Flyrcado®

Drug updated on 3/28/2025

Dosage FormInjection (intravenous; 190 MBq/mL to 2,050 MBq/mL (5 mCi/mL to 55 mCi/mL) in a shielded multiple-dose vial with up to 30 mL fill volume)
Drug ClassRadioactive diagnostic agents
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated for positron emission tomography (PET) myocardial perfusion imaging (MPI) under rest or stress (pharmacologic or exercise) in adult patients with known or suspected coronary artery disease (CAD) to evaluate for myocardial ischemia and infarction

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Summary
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  • This summary is based on the review of two randomized controlled trial(s). [1-2]
  • Among evaluable patients (mean age 63.7 ± 9.5 years; 32.5% women; 52.3% with Body Mass Index (BMI) ≥ 30 kg/m²), flurpiridaz Positron Emission Tomography (PET) showed higher sensitivity (80.3%) than Single Photon Emission Computed Tomography (SPECT) (68.7%; P = 0.0003), with noninferior specificity (63.8% vs. 61.7%; P = 0.0004); the Area Under the Receiver Operating Characteristic (ROC) curve was greater for flurpiridaz PET (0.80 vs. 0.68; P < 0.001).
  • Among evaluable patients (mean age 62.3 ± 9.5 years; 31% women; 55% with BMI ≥ 30 kg/m²; 71% undergoing pharmacological stress), flurpiridaz PET had higher sensitivity (71.9% [95% Confidence Interval (CI): 67.0%–76.3%]) than SPECT (53.7% [95% CI: 48.5%–58.8%]; P < 0.001), but specificity (76.2% [95% CI: 71.8%–80.1%]) did not meet noninferiority to SPECT (86.6% [95% CI: 83.2%–89.8%]; P = Not Significant [NS]); flurpiridaz PET showed superior ROC performance in the overall population, women, obese patients, and those undergoing pharmacological stress (P < 0.001 for all).
  • Flurpiridaz PET was reported to be safe and well tolerated, with no significant safety concerns or adverse effects mentioned.

Product Monograph / Prescribing Information

Document TitleYearSource
Flyrcado (flurpiridaz F 18) Prescribing Information.2024GE Healthcare Inc., Marlborough, MA, USA

Randomized Controlled Trials

Document TitleSex DistributionYearSource
Flurpiridaz F-18 PET Myocardial Perfusion Imaging in Patients With Suspected Coronary Artery Disease
730Subjects
F: 0%
M: 100%
2023Journal of the American College of Cardiology
Phase-III Clinical Trial of Fluorine-18 Flurpiridaz Positron Emission Tomography for Evaluation of Coronary Artery Disease
755Subjects
F: 0%
M: 100%
2020Journal of the American College of Cardiology

Sex Distribution:

F:0%
M:100%
730Subjects

Year:

2023

Source:Journal of the American College of Cardiology


Sex Distribution:

F:0%
M:100%
755Subjects

Year:

2020

Source:Journal of the American College of Cardiology