FDA Approves Cardiogen-82 (Rubidium Rb 82) for Myocardial Perfusion PET

Rubidium Chloride Rb 82 Injection is a radioactive diagnostic agent. Rubidium Rb 82 is a potassium analog that is taken up by viable myocardial cells. The uptake is proportional to regional myocardial blood flow. Under stress conditions, areas with reduced coronary flow reserve show relatively less uptake compared to normally perfused myocardium.

CardioGen-82, used to produce Rubidium Chloride Rb 82 Injection, is indicated for positron emission tomography (PET) of the myocardium under rest or pharmacologic stress conditions to evaluate regional myocardial perfusion in adult patients with suspected or existing coronary artery disease.

Dosing depends on the infusion system used. For the Model 510 Infusion System: 1,480 MBq (40 mCi) per dose, range 1,110-2,220 MBq (30-60 mCi), infused at 50 mL/min. For the Model 1700 Infusion System: 10-30 MBq/kg (0.27-0.81 mCi/kg) actual body weight, infused at 50 or 20 mL/min. Maximum dose: 2,220 MBq (60 mCi) or 100 mL per rest or stress component. Minimum interval between rest and stress doses: 10 minutes. Image acquisition: start 60-90 seconds after infusion, acquire for 5 minutes. If longer circulation time anticipated, wait 120 seconds.

Trial data not available in label.

Not reported in label.

Cardiogen-82 provides a radioactive diagnostic agent for PET myocardial perfusion imaging in adults with suspected or existing coronary artery disease. It is used to assess regional myocardial perfusion at rest and under pharmacologic stress. The agent is produced on-site using a generator system and requires appropriate radiation safety measures.