Overview
11 DESCRIPTION 11.1 Chemical Characteristics FLYRCADO (flurpiridaz F 18) injection is a radioactive diagnostic drug for intravenous use. The molecular formula of flurpiridaz F 18 is C 18 H 22 Cl 18 FN 2 O 3 , the molecular mass is 367.8, and the structural formula is: Chemically, flurpiridaz F 18 is 2- tert -butyl-4-chloro-5-[[4-(2-( 18 F)fluoranylethoxymethyl)phenyl]methoxy]pyridazin-3-one.
Mechanism of Action
12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action 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. Therefore, radioactivity in viable myocardium is higher than in infarcted tissue. 12.2 Pharmacodynamics The relationship between flurpiridaz F 18 plasma concentrations and successful imaging was not explored in clinical trials. 12.3 Pharmacokinetics The pharmacokinetics of flurpiridaz F 18 were evaluated in healthy subjects. Blood radioactivity peaked at 2.
Indications
- 1 INDICATIONS AND USAGE 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. ( 1 )
Common Doses
- 6.1 mL
- 1 mL
- 2 mL
Dosage
2 DOSAGE AND ADMINISTRATION 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.
Contraindications
- 4 CONTRAINDICATIONS None. None ( 4 )
Side Effects
- 6 ADVERSE REACTIONS 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.
Interactions
- No major interactions listed on the FDA label. Always consult a healthcare professional.