Introducing Flyrcado: A Breakthrough Diagnostic Tool for Heart Health
What is the name of the drug and what does it do?
Flyrcado (pronounced FLYR-ca-doh), generic name flurpiridaz F 18, is a radioactive diagnostic drug approved on September 27, 2024, used for positron emission tomography (PET) myocardial perfusion imaging (MPI). It is designed to help doctors evaluate blood flow in the heart (myocardial perfusion) and detect areas of damage or reduced blood flow in adult patients with known or suspected coronary artery disease (CAD).
How does it work?
Flyrcado contains a radioactive tracer that targets the heart’s mitochondria, which are responsible for energy production in cells. When injected, it highlights areas of healthy heart tissue while revealing areas with reduced blood flow or damage, such as from a heart attack. Doctors use special imaging machines to create detailed pictures of the heart, helping them assess its health and detect any blockages or scarring.
What did the research discover?
Flyrcado was tested in two major clinical trials with over 2,300 adults who had either suspected or confirmed coronary artery disease. Patients underwent PET MPI scans using Flyrcado under rest and stress conditions (via exercise or medications). The studies found that Flyrcado had high sensitivity (ability to detect disease) and specificity (ability to rule out disease) for identifying significant blockages in coronary arteries. It performed better than traditional methods like SPECT MPI, offering clearer and more accurate imaging, even in patients with complex conditions.
What are some of the side effects?
Common side effects reported during clinical trials include:
- Shortness of breath (dyspnea)
- Headache
- Chest pain or discomfort
- Fatigue
- Nausea
- Dizziness
- Flushing
Less common but serious risks may include reactions related to stress testing, such as heart rhythm problems, low blood pressure, or seizures. Radiation exposure is also a concern, although the amount used is low and carefully managed.
What are the dosage recommendations and how is it prescribed?
Flyrcado is administered as an intravenous injection by a healthcare provider during a PET MPI procedure. Two doses are typically given:
- A lower dose (93–111 MBq) for rest imaging.
- A higher dose for stress imaging, depending on whether the patient undergoes pharmacologic (222–241 MBq) or exercise stress (333–352 MBq).
The scans are completed within one or two days, depending on the protocol chosen. Patients are advised to drink plenty of water before and after the procedure to reduce radiation exposure.
Source:
U.S. Food and Drug Administration. Full prescribing information: [Label for NDA 215168]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/215168s000lbl.pdf. Accessed 2024 Nov 21.
