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FDA approved Cardiogen-82 (Rubidium Rb 82) for Myocardial Perfusion PETFDA approved new heart imaging drug to check blood flow in arteries.

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Key Takeaway
Consider Cardiogen-82 for PET myocardial perfusion imaging in adults with suspected or existing CAD.

The FDA has approved Cardiogen-82 (Rubidium Chloride Rb 82 Injection) for positron emission tomography (PET) of the myocardium to evaluate regional myocardial perfusion in adult patients with suspected or existing coronary artery disease. The agent is indicated for use under rest or pharmacologic stress conditions. Cardiogen-82 is a generator system that produces Rubidium Rb 82, a radioactive diagnostic agent, when eluted with saline. The approval provides clinicians with an additional option for noninvasive assessment of myocardial perfusion using PET imaging. The recommended dosing varies by infusion system: for the Model 510 system, 40 mCi (range 30-60 mCi) per dose; for the Model 1700 system, 0.27-0.81 mCi/kg actual body weight, not exceeding 60 mCi per dose. Image acquisition begins 60-90 seconds after infusion and lasts 5 minutes. The minimum interval between rest and stress doses is 10 minutes to allow for Rb 82 decay.

Clinical Details (Mechanism · Dosing · Trial Data · Warnings)
Mechanism of Action

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.

Indication & Patient Population

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 & Administration

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.

Key Clinical Trial Data

Trial data not available in label.

Warnings & Contraindications

Not reported in label.

Place in Therapy

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.

The FDA has approved a new drug called Cardiogen-82 (Rubidium Chloride Rb 82 Injection) for use with PET scans to evaluate blood flow in the heart muscle. This imaging test helps doctors assess patients who may have coronary artery disease, a condition where the arteries that supply blood to the heart become narrowed or blocked. The drug is given through an IV, either while you are resting or during a stress test that simulates exercise. The approval provides an additional tool for doctors to noninvasively check heart health without surgery or catheterization.

Cardiogen-82 is a generator system that produces a radioactive substance when mixed with saline. The dose depends on the specific infusion system used. For one system, the dose is 40 mCi (range 30-60 mCi). For another, it is based on body weight, not exceeding 60 mCi. Imaging starts about 60-90 seconds after the infusion and lasts about 5 minutes. There must be at least 10 minutes between rest and stress doses to allow the radioactive material to decay.

This approval means doctors have another option for diagnosing coronary artery disease. However, it does not replace other tests or treatments. If you have heart symptoms or risk factors, talk to your doctor about whether this imaging test is right for you. Your doctor can explain the benefits and risks based on your personal health history.

What this means for you:
Cardiogen-82 is a new option for PET scans to check heart blood flow. Talk to your doctor if you have heart concerns.

Study Details

Study typeFda approval
PublishedDec 1989
View Original Abstract ↓
1 INDICATIONS AND USAGE 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. CardioGen-82, used to produce Rubidium Chloride Rb 82 Injection, is a radioactive diagnostic agent 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.
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