Flurpiridaz

Flurpiridaz F 18 is an analog of the mitochondrial complex 1 (MC-1) inhibitor, pyridaben. Flurpiridaz F 18 is extracted by the myocardium proportional to the blood flow and binds to heart tissue that has biologically active mitochondria.

• FLYRCADO is 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. 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.

• None.contraindicated

Administer FLYRCADO via intravenous injection. ( 2.2 ) When rest and stress imaging are conducted on the same day, the recommended administered activities are ( 2.2 ): Rest imaging: 93 MBq to 111 MBq (2.5 mCi to 3 mCi) Pharmacologic stress imaging: 222 MBq to 241 MBq (6 mCi to 6.5 mCi) Exercise stress imaging: 333 MBq to 352 MBq (9 mCi to 9.5 mCi) When rest and stress imaging are conducted over two days, the recommended rest and stress administered activities, for both pharmacologic and exercise stress, are 93 MBq to 111 MBq (2.5 mCi to 3 mCi). ( 2.2 ) See full prescribing information for radiation safety, preparation, administration, imaging, and radiation dosimetry information. ( 2.1 , 2.2 , 2.3 , 2.4 ) 2.1 Radiation Safety – Drug Handling Handle FLYRCADO with appropriate safety measures to minimize radiation exposure [see Warnings and Precautions (5.2) ] . Use waterproof gloves and effective shielding, including lead-glass syringe shields, when handling and administering FLYRCADO. Radioactive drugs should be used by or under the control of healthcare providers who are qualified by specific training and experience in the safe use and handling of radionuclides, and whose experience and training have been approved by the appropriate governmental agency authorized to license the use of radionuclides. 2.2 Recommended Dosage, Preparation, and Administration Instructions Recommended Dosage The recommended activity for each type of examination is presented in Table 1.

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 minimize radiation exposure to patients and health care providers. ( 5.2 ) 5.1 Risks 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. 5.2 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 [see Dosage and Administration (2.1 , 2.4) ] . Advise patients to hydrate before and after administration and to void frequently after administration.

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, contact GE HealthCare at 1-800-654-0118 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. The safety of FLYRCADO was evaluated in 1,600 subjects in clinical studies, including 1,575 (98%) subjects with known or suspected coronary artery disease and 25 (2%) healthy subjects. All 1,600 subjects were dosed under rest conditions, with a mean dose of 102 MBq (2.8 mCi) FLYRCADO. A total of 1,568 (98%) subjects were also dosed under stress (exercise or pharmacologic) conditions, with a mean activity of 252 MBq (6.8 mCi) FLYRCADO by intravenous route.

Lactation: Temporarily discontinue breastfeeding. A lactating woman should pump and discard breastmilk for at least 8 hours after FLYRCADO administration. ( 8.2 ) 8.1 Pregnancy Risk Summary 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. All radiopharmaceuticals, including FLYRCADO, have the potential to cause fetal harm depending on the fetal stage of development and the magnitude of the radiation dose. 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). The lower limit of safety for ethanol use during pregnancy has not been established. Published studies have demonstrated that ethanol is associated with fetal harm including central nervous system abnormalities, behavioral disorders, and impaired intellectual development. If considering FLYRCADO administration to a pregnant woman, inform the patient about the potential for adverse pregnancy outcomes associated with ethanol exposure during pregnancy. The background risk of major birth defects and miscarriage for the indicated population is unknown.

Metabolism

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.

• Sep 27, 2024NDANDA215168Ge Hlthcare

The 5 most recently updated of 5 ClinicalTrials.gov registrations naming Flurpiridaz as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Ultralow Dose PET Imaging of 18F-flurpiridaz
  Enrolling by invitation · Phase 2 · Interventional · 200 enrolled · Akiva Mintz
  NCT07284576updated 2026-04-13
• A Study of Flurpiridaz (18F) Injection for PET Imaging for Assessment of MPI Quality Using HPLC and SPE Manufacturing Processes
  Completed · Phase 2 · Interventional · 38 enrolled · GE Healthcare
  NCT04594941updated 2023-08-01
• An International Study to Evaluate Diagnostic Efficacy of Flurpiridaz (18F) Injection PET MPI in the Detection of Coronary Artery Disease (CAD)
  Completed · Phase 3 · Interventional · 730 enrolled · GE Healthcare
  NCT03354273updated 2023-07-12
• A Phase 3 Multi-center Study to Assess PET Imaging of Flurpiridaz F 18 Injection in Patients With CAD.
  Completed · Phase 3 · Interventional · 795 enrolled · Lantheus Medical Imaging
  NCT01347710updated 2020-11-24
• Open Label Study to Access Flurpiridaz F18 in PET MPI Verses SPECT MPI
  Withdrawn · Phase 3 · Interventional · 0 enrolled · Lantheus Medical Imaging
  NCT01681524updated 2013-05-30

Frequently asked questions

How does Flurpiridaz work?

Flurpiridaz F 18 is an analog of the mitochondrial complex 1 (MC-1) inhibitor, pyridaben. Flurpiridaz F 18 is extracted by the myocardium proportional to the blood flow and binds to heart tissue that has biologically active mitochondria.

What is Flurpiridaz used for?

According to FDA labeling, Flurpiridaz carries indications including: FLYRCADO is 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. 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.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Flurpiridaz?

Flurpiridaz is classified as Imaging Contrast Activity, Positron Emitting Activity.

What are the contraindications for Flurpiridaz?

Flurpiridaz labeling lists contraindications including: None.. Always consult the full prescribing information and a clinician.