Version May 2024
Patients are exposed to high radiation levels when the rubidium-82 generator is eluted with the incorrect eluent due to high strontium (Sr) 82 and Sr 85 breakthrough levels. Use only additive-free 0.9% sodium chloride to elute the generator, immediately stop the patient infusion, and permanently discontinue the use of the affected rubidium-82 generator if the incorrect solution is used to elute the generator; evaluate the patient's radiation-absorbed dose and monitor for the effects of radiation to critical organs such as bone marrow.
Excess radiation exposure occurs when the levels of Sr 82 and Sr 85 in the rubidium Rb-82 chloride injection exceed specified limits. Record each generator eluate volume, including waste and test volumes, and keep a record of the cumulative eluate volume. Strictly adhere to the generator eluate testing protocol to minimize the risk of excess radiation exposure, including daily testing and additional testing at alert limits. Stop using the generator if it reaches any of its expiration limits: 17 L for the generator's cumulative eluate volume, 42 days post generator calibration date, an eluate Sr 82 level of 0.01 mcCi per mCi Rb 82, or an eluate Sr 85 level of 0.1 mcCi per mCi Rb 82.
Note: Individualize the dose by considering factors such as body size and the imaging equipment and technique. Use the lowest dose necessary to obtain adequate cardiac visualization consistent with the dosing goal of as low as reasonably achievable.
Myocardial perfusion imaging: IV: Rest or stress imaging: 40 mCi (1,480 MBq) as a single dose; dosage range: 30 to 60 mCi (1,110 to 2,220 MBq); maximum single dose: 60 mCi (2,220 MBq).
There are no dosage adjustments provided in the manufacturer’s labeling; renal impairment is not expected to alter clearance.
There are no dosage adjustments provided in the manufacturer’s labeling; hepatic impairment is not expected to alter clearance.
Lengthen the delay between infusion and image acquisition; use with caution. Refer to adult dosing.
There are no adverse reactions listed in the manufacturer's labeling.
Use of a solution other than additive-free 0.9% sodium chloride to elute the generator.
Concerns related to adverse effects:
• Cardiovascular events: Arrhythmias, bronchoconstriction, cerebrovascular events, hypotension, and myocardial infarction (MI) have occurred due to pharmacologic agents used in conjunction with stress imaging. Appropriate measures for resuscitation should be available during use.
• Malignancy: Radiation-emitting products may increase the risk for cancer; use the smallest dose necessary and ensure safe handling to protect patients and healthcare workers.
Disease-related concerns:
• Heart failure: Use with caution in patients with heart failure; may be at increased risk of volume overload.
Special populations:
• Older adult: Use with caution in the elderly; may be at increased risk of volume overload. Delay between infusion and imaging should be lengthened.
Special handling:
• Radiopharmaceutical: Use appropriate precautions for handling, disposal, and minimizing exposure to patients and healthcare personnel. Use only under supervision of individuals with experience/training in the handling of radioactive materials approved by the applicable regulatory authority.
Other warnings/precautions:
• Appropriate use: Test may be done while patients are at rest or under pharmacologic stress conditions. Patients should be adequately hydrated prior to dosing; instruct patients to void frequently for at least 1 hour following administration to decrease radiation exposure to the bladder. Use only with an infusion system specifically designed for use with the generator and capable of accurate measurement and delivery of doses of rubidium-82 chloride injection.
• Excess radiation: [US Boxed Warning]: Excess radiation exposure occurs when the levels of strontium (Sr) 82 and Sr 85 in the rubidium Rb-82 chloride injection exceed specified limits. Record each generator eluate volume, including waste and test volumes, and keep a record of the cumulative eluate volume. Strictly adhere to the generator eluate testing protocol to minimize the risk of excess radiation exposure, including daily testing and additional testing at alert limits. Stop using the generator if it reaches any of its expiration limits: 17 L for the generator's cumulative eluate volume, 42 days post generator calibration date, an eluate Sr 82 level of 0.01 mcCi per mCi Rb 82, or an eluate Sr 85 level of 0.1 mcCi per mCi Rb 82.
• Radiation exposure: [US Boxed Warning]: Use only additive-free 0.9% sodium chloride to elute the generator; patients are exposed to high radiation levels when the rubidium-82 generator is eluted with the incorrect eluent due to high Sr 82 and Sr 85 breakthrough levels. Immediately stop the patient infusion and permanently discontinue the use of the affected rubidium-82 generator if the incorrect solution is used to elute the generator; evaluate the patient's radiation absorbed dose and monitor for the effects of radiation to critical organs such as bone marrow. Unintended exposure to strontium radiation does contribute to the patient's overall long-term cumulative radiation dose, which is associated with an increased risk of cancer.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Generator Column, for elution in producing Rubidium-82 chloride for injection:
CardioGen-82: Strontium Sr-82 90-150 mCi per generator system
No
IV: Use only with the CardioGen-82 Infusion System Model 510 or 1700. Administer as 2 separate single doses to complete rest and stress myocardial perfusion imaging. Administer at 50 mL/minute (Model 510 or 1700) or 20 mL/minute (Model 1700 only) through a catheter inserted into a large peripheral vein; maximum total infusion volume of 100 mL. Radiopharmaceutical; use appropriate precautions for handling and disposal. Ensure adequate hydration before and after administration. To minimize bladder exposure, patients should void as soon as PET scan completed and frequently thereafter for at least 1 hour. Also, refer to manufacturer's labeling for additional administration instructions.
Rest imaging: Administer as a single dose; start imaging 60 to 90 seconds after completion of infusion and acquire images for 5 minutes; if a longer circulation time is anticipated (eg, patients with severe left ventricular dysfunction), start imaging 120 seconds after the rest dose.
Stress imaging: Begin study 10 minutes after completion of rest dose infusion; administer pharmacologic stress agent, then after time interval specified in the pharmacological stress agent prescribing information, infuse single dose of rubidium-82 chloride; start imaging 60 to 90 seconds after completion of infusion and acquire images for 5 minutes; if a longer circulation time is anticipated (eg, patients with severe left ventricular dysfunction), start imaging 120 seconds after stress dose.
Myocardial perfusion imaging: 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.
Radiopharmaceutical: Use appropriate precaution for handling, disposal, and minimizing exposure to patients and healthcare personnel. Use under supervision of experienced personnel. Should be stored in original lead container or adequate radiation shield.
None known.
There are no known significant interactions.
Animal reproductive studies have not been conducted. All radiopharmaceuticals have the potential to cause fetal harm.
It is not known if rubidium-82 is present in breast milk.
According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and benefits of treatment to the mother. Rubidium-82 has a short half-life; potential exposure can be minimized by temporarily discontinuing breastfeeding for ≥1 hour after the last infusion.
Fluid overload (especially in elderly and heart failure patients) during and for several hours following infusion
Radioactive diagnostic agent which decays by positron and gamma emission to a photon that can be detected by imaging. It is the same as potassium ion in its behavior and is rapidly extracted by the myocardium proportional to blood flow.
Onset of Action: Myocardial activity: Within 1 minute; if areas of infarction or ischemia are present that may be visualized within 2-7 minutes
Metabolism: Decays rapidly to trace amounts of stable Kr 82 gas which is expired by the lungs
Half-life elimination: Physical half-life: 75 seconds
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