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What is Cardiogen-82, and how does it work?
CardioGen-82 is a closed system used to produce rubidium Rb 82 chloride injection for intravenous administration.
Rubidium Rb 82 chloride injection is indicated for Positron Emission Tomography (PET) imaging of the myocardium under rest or pharmacologic stress conditions to evaluate regional myocardial perfusion in adult patients with suspected or existing coronary artery disease.
What are the side effects of Cardiogen-82?
UNINTENDED STRONTIUM-82 (Sr-82) AND STRONTIUM-85 (Sr-85) RADIATION EXPOSURE
Unintended radiation exposure occurs when the levels of Sr-82 or Sr-85 in the rubidium Rb 82 chloride injection exceed specified limits
Perform generator eluate tests:
1) Record each generator eluate volume, including waste and test volumes, and keep a record of the cumulative eluate volume.
2) Determine Rb-82, Sr-82, Sr-85 in the generator eluate:
- Once a day, prior to any drug administrations, and
- At additional daily tests after detection of an Alert
Limit. Alert Limits are:
- 14 L for the generator's cumulative eluate volume, or
- An eluate Sr-82 level of 0.002 μCi/ mCi Rb-82, or
- An eluate Sr-85 level of 0.02 Sr-85 μCi/ mCi Rb-82.
- Perform the additional daily tests at time points determined by the day's elution volume; tests are performed every 750 mL.
3) Stop use of a generator at an Expiration Limit of:
- 17 L for the generator's cumulative eluate volume, or
- 42 days post generator calibration date, or
- An eluate Sr-82 level of 0.01 μCi /mCi Rb-82, or
- An eluate Sr-85 level of 0.1 µCi /mCi Rb-82.
The following serious adverse reactions have been identified during postapproval use of CardioGen-82. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
- Unintended radiation exposure has occurred in some patients who received rubidium Rb 82 chloride injections at clinical sites where generator eluate testing appeared insufficient.
What is the dosage for Cardiogen-82?
Use CardioGen-82 only with an infusion system specifically designed for use with the generator and capable of accurate measurement and delivery of doses of rubidium Rb 82 chloride injection. Follow instructions in the Infusion System User's Guide for the set up and intravenous infusion of rubidium Rb 82 chloride injection dose(s).
Rubidium Rb 82 Chloride Injection Dosage
The recommended adult single dose of rubidium Rb 82 chloride injection is 1480 MBq (40 mCi) with a range of 1110-2220 MBq (30-60 mCi).
- Do not exceed a single dose of 2220 MBq (60 mCi).
- Use the lowest dose necessary to obtain adequate cardiac visualization consistent with the dosing goal of as low as reasonably achievable (ALARA).
- Individualize the dose by considering factors such as body size, and the imaging equipment and technique.
- Administer the single dose at 50 mL/minute through a catheter inserted into a large peripheral vein; do not to exceed a total infusion volume of 100 mL.
Administer two separate single doses to complete rest and stress myocardial perfusion imaging as follows:
For rest imaging:
- Administer a single (“rest”) rubidium Rb-82 chloride dose;
- Start imaging 60-90 seconds after completion of the infusion of the rest dose and acquire images for 5 minutes; if a longer circulation time is anticipated (e.g., in a patient with severe left ventricular dysfunction), start imaging 120 seconds after the rest dose.
For stress imaging:
- Begin the study 10 minutes after completion of the resting dose infusion, to allow for sufficient Rb-82 decay;
- Administer a pharmacologic stress agent in accordance with its prescribing information;
- After an interval of 3 minutes, infuse a single (“stress”) rubidium Rb-82 chloride dose;
- Start imaging 60-90 seconds after completion of the stress Rb-82 chloride dose infusion and acquire images for 5 minutes; if a longer circulation time is anticipated start imaging 120 sec after the stress dose.
What drugs interact with Cardiogen-82?
Is Cardiogen-82 safe to use while pregnant or breastfeeding?
- It is also not known whether rubidium Rb 82 chloride injection can cause fetal harm when administered to a pregnant woman; however, all radiopharmaceuticals have the potential to cause fetal harm depending on the fetal stage of development and the magnitude of the radiation dose.
- If considering rubidium Rb 82 chloride injection administration to a pregnant woman, inform the patient about the potential for adverse pregnancy outcomes based on the radiation dose from rubidium Rb-82 and the gestational timing of exposure.
- Administer rubidium Rb-82 to a pregnant woman only if clearly needed.
- It is not known whether rubidium Rb 82 chloride injection is excreted in human milk.
- Due to the short half-life of rubidium Rb-82 (75 seconds) it is unlikely that the drug would be excreted in human milk during lactation.
- However, because many drugs are excreted in human milk, caution should be exercised when rubidium Rb-82 chloride injection is administered to nursing women.
- Do not resume breastfeeding until one hour after the last infusion.
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CardioGen-82 is a closed system used to produce rubidium Rb 82 chloride injection for intravenous administration. Rubidium Rb 82 chloride injection is indicated for Positron Emission Tomography (PET) imaging 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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Heart disease (coronary artery disease) occurs when plaque builds up in the coronary arteries, the vessels that supply blood to the heart. Heart disease can lead to heart attack. Risk factors for heart disease include: Smoking High blood pressure High cholesterol Diabetes Family history Obesity Angina, shortness of breath, and sweating are just a few symptoms that may indicate a heart attack. Treatment of heart disease involves control of heart disease risk factors through lifestyle changes, medications, and/or stenting or bypass surgery. Heart disease can be prevented by controlling heart disease risk factors.
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The connection between stress and heart disease is not clear. Stress itself may be a risk factor, or high levels of stress may make risk factors for heart disease worse. The warning signs of stress can be physical, mental, emotional, or behavioral. Reducing stressors in an individuals life not only can lead to a more productive life, but may also decrease the risk for heart disease and causes of heart disease.
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Heart disease in women has somewhat different symptoms, risk factors, and treatment compared to heart disease in men. Many women and health professionals are not aware of the risk factors for heart disease in women and may delay diagnosis and treatment. Lifestyle factors such as diet, exercise, tobacco use, overweight/obesity, stress, alcohol consumption, and depression influence heart disease risk in women. High blood pressure, high cholesterol, and diabetes also increase women's risk of heart disease. Electrocardiogram (EKG or ECG), stress-ECG, endothelial testing, ankle-brachial index (ABI), echocardiogram, nuclear imaging, electron beam CT, and lab tests to assess blood lipids and biomarkers of inflammation are used to diagnose heart disease. Early diagnosis and treatment of heart disease in women saves lives. Heart disease can be prevented and reversed with lifestyle changes.
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Heart disease treatment in women should take into account female-specific guidelines that were developed by the American Heart Association. Risk factors and symptoms of heart disease in women differ from those in men. Treatment may include lifestyle modification (diet, exercise, weight management, smoking cessation, stress reduction), medications, percutaneous intervention procedure (PCI), and coronary artery bypass grafting (CABG). Heart disease is reversible with treatment.
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