Flyrcado™ (flurpiridaz F 18) injection
GUIDELINES FOR PET MPI
ASNC and SNMMI recommend PET MPI for specific populations
ELEVATED QUALITY AND ACCURACY
Taking quality and clarity to the next level
SUPERIOR ACCURACY
Greater CAD diagnostic certainty
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Where to find Flyrcado
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References
- Flyrcado (flurpiridaz F 18) injection. Full Prescribing Information. Marlborough, MA: GE HealthCare.
- Maddahi J, Agostini D, Bateman™, et al. Flurpiridaz F-18 PET Myocardial perfusion imaging in patients with suspected coronary artery disease. J Am Coll Cardiol. 2023;82(16):1598-1610.
- Patel KK, Singh A, Bateman™. The potential of F-18 flurpiridaz PET/CT myocardial perfusion imaging for precision imaging. Curr Cardiol Rep. 2022;24(8):987-994.
- Driessen RS, Raijmakers PG, Stuijfzand WJ, Knaapen P. Myocardial perfusion imaging with PET. Int J Cardiovasc Imaging. 2017;33(7):1021-1031.
- Bourque JM. Cardiac PET perfusion imaging: AURORA lights the way to a new era. J Am Coll Cardiol. 2023;82(16):1611-1613.
- Maddahi J, Packard RRS. Cardiac PET perfusion tracers: current status and future directions. Semin Nucl Med. 2014;44(5):333-343.
- Iskandrian AE, Dilsizian V, Garcia EV, et al. Myocardial perfusion imaging: lessons learned and work to be done update. J Nucl Cardiol. 2018;25(1):39-52.
- Liga R, Neglia D. Emerging F-18-labelled PET myocardial perfusion tracers. Curr Cardiol Rep. 2020;22(10):116.
- Li DL, Kronenberg MW. Myocardial perfusion and viability imaging in coronary artery disease: clinical value in diagnosis, prognosis, and therapeutic guidance. Am J Med. 2021;134(8):968-975.
- Schindler TH, Bateman™, Berman DS, et al. Appropriate use criteria for PET myocardial perfusion imaging. J Nucl Med. 2020;61(8):1221-1265.
- Ladapo JA, Goldfeld KS, Douglas PS. Projected morbidity and mortality from missed diagnoses of coronary artery disease in the United States. Int J Cardiol. 2015;195:250-252.
- Bateman™, Dilsizian V, Beanlands RS, DePuey EG, Heller GV, Wolinsky DA. American Society of Nuclear Cardiology and Society of Nuclear Medicine and Molecular Imaging Joint Position Statement on the Clinical Indications for Myocardial Perfusion PET. J Nucl Med. 2016;57(10):1654-1656.
Important Safety Information
FLYRCADO™ (flurpiridaz F 18) injection, for intravenous use important safety information
Indications and Usage
FLYRCADO is a radioactive diagnostic drug 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.
Contraindications
None
Warnings and Precautions
- Risk associated with exercise or pharmacologic stress: Patients evaluated with exercise or pharmacologic stress may experience serious adverse reactions such as myocardial infarction, arrhythmia, hypotension, bronchoconstriction, stroke, and seizure. Perform stress testing in the setting where cardiac resuscitation equipment and trained staff are readily available. When pharmacologic stress is selected as an alternative to exercise, perform the procedure in accordance with the pharmacologic stress agent’s prescribing information.
- Radiation risks: FLYRCADO contributes to a patient’s overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk of cancer. Ensure safe handling to minimize radiation exposure to patients and health care providers. Advise patients to hydrate before and after administration and to void.
Adverse Reactions
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.
Use in Specific Populations
- Pregnancy
There are no data on use of flurpiridaz F 18 in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. If considering FLYRCADO administration to a pregnant woman, inform the patient about the potential for adverse pregnancy outcomes based on the radiation dose from flurpiridaz F 18 and the gestational timing of exposure.
FLYRCADO contains ethanol (a maximum daily dose of 337 mg anhydrous ethanol). If considering FLYRCADO administration to a pregnant woman, inform the patient about the potential for adverse pregnancy outcomes associated with ethanol exposure during pregnancy. - Lactation
Temporarily discontinue breastfeeding. A lactating woman should pump and discard breastmilk for at least 8 hours after FLYRCADO administration. - Pediatric Use
Safety and effectiveness of FLYRCADO in pediatric patients have not been established.
To report SUSPECTED ADVERSE REACTIONS, contact GE HealthCare at 800-654-0118 (option 2 then option 1) or by email at GPV.drugsafety@gehealthcare.com or FDA at 800-FDA-1088 or www.fda.gov/medwatch