FLYRCADO

The pharmacokinetics of flurpiridaz F 18 were evaluated in healthy subjects. Blood radioactivity peaked at 2.3 minutes with blood clearance followed by a rise and plateau at around 3% of the 296 MBq (8 mCi) flurpiridaz F 18 intravenous dose until 7 hours post administration. The fluorine-18 radioactivity in blood during the first 15-minutes post administration was associated with flurpiridaz while it was associated with flurpiridaz metabolites thereafter.

DistributionFlurpiridaz F 18 distribute...

14.1 Overview of Clinical Studies The safety and effectiveness of FLYRCADO were evaluated in two prospective, multicenter, open-label clinical studies in adults with either suspected coronary artery disease (CAD) (

Study 1NCT03354273) or known or suspected CAD (

Study 2NCT01347710). Subjects received two injections of FLYRCADO: one at rest and one during stress [see Dosage and Administration (2.2 , 2.3) ] . For the FLYRCADO stress injection, subjects received either a pharmacologic stress agent or engaged in exercise stress. PET myocardial perfusion imaging (MPI) was performed at both rest a...

The following serious adverse reactions are described elsewhere in the labeling: Risks Associated with Exercise or Pharmacologic Stress [see Warnings and Precautions (5.1) ] Most common adverse reactions occurring during FLYRCADO PET MPI under rest and stress (pharmacologic or exercise) (incidence ≥ 2%) are dyspnea, headache, angina pectoris, chest pain, fatigue, ST segment changes, flushing, nausea, abdominal pain, dizziness, and arrhythmia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contac...

None. None ( 4 )

Risk associated with exercise or pharmacologic stress: Serious adverse reactions such as myocardial infarction, arrhythmia, hypotension, broncho-constriction, stroke, and seizures may occur. Perform stress testing in the setting where cardiac resuscitation equipment and trained staff are readily available. When pharmacologic stress is selected, perform the procedure in accordance with the pharmacologic stress agent's prescribing information. ( 5.1 ) Radiation risks: Ensure safe handling to minim...