At a glance
What is it—and why does it matter?
Rubidium-82 behaves as a potassium analog; myocardial extraction of the tracer scales with perfusion, supporting PET perfusion imaging. Incorrect elution solution for CardioGen-82 can cause elevated strontium-82 and strontium-85 breakthrough in the eluate, increasing patient radiation exposure. Adult PET myocardial perfusion imaging with rubidium chloride Rb 82 generated by CardioGen-82 uses weight-based activity dosing (10–30 MBq/kg; 0.27–0.81 mCi/kg) delivered via IV infusion at specified flow rates (50 or 20 mL/min) into a large peripheral vein. CardioGen-82 (a rubidium Rb 82 generator) is indicated to generate rubidium chloride Rb 82 for PET myocardial imaging, including rest and pharmacologic stress protocols, to assess regional perfusion in adult coronary artery disease populations.
Sources for this introduction: [1] [2] [3] [4]
This published profile is a reference in progress. Findings retain their source context; missing topics are marked below.
What is it?
A molecule, not a product name.
This profile does not yet contain a published summary for this topic. This is a coverage gap, not evidence that no research exists.
How does it work?
Target, response, and disposition.
Mechanism
Rubidium-82 behaves as a potassium analog; myocardial extraction of the tracer scales with perfusion, supporting PET perfusion imaging.
- Source records
- 1
- Regulatory records
- 1
Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.
Exact passages, locators, and provenance
- supports · Source-backed record
“Rb 82 is analogous to potassium ion (K+) in its biochemical behavior and is extracted by the myocardium in proportion to the blood flow.”
These highlights do not include all the information needed to use CARDIOGEN-82 safely and effectively. See full prescribing information for CARDIOGEN-82.CARDIOGEN-82®(rubidium Rb 82 generator) to produce rubidium chloride Rb 82 injection, for intravenous useInitial U.S. Approval: 1989 · 12.1 Mechanism of Action
dailymed:ee95aa18-9f2f-40eb-9b4c-583bea6f36bf:a88c7de489b9:a88c7de489b9
Pharmacokinetics
The radionuclide rubidium-82 decays rapidly, with a physical half-life of 75 seconds.
- Source records
- 1
- Regulatory records
- 1
Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.
Exact passages, locators, and provenance
- supports · Source-backed record
“Rb 82 decays by positron emission and associated gamma emission with a physical half-life of 75 seconds.”
These highlights do not include all the information needed to use CARDIOGEN-82 safely and effectively. See full prescribing information for CARDIOGEN-82.CARDIOGEN-82®(rubidium Rb 82 generator) to produce rubidium chloride Rb 82 injection, for intravenous useInitial U.S. Approval: 1989 · 11.2 Nuclear Physical Characteristics
dailymed:ee95aa18-9f2f-40eb-9b4c-583bea6f36bf:a88c7de489b9:a88c7de489b9
What has been studied?
What the evidence says.
This profile does not yet contain a published summary for this topic. This is a coverage gap, not evidence that no research exists.
Risks and interactions
Risks, organized for scanning.
Safety findings
Incorrect elution solution for CardioGen-82 can cause elevated strontium-82 and strontium-85 breakthrough in the eluate, increasing patient radiation exposure.
- Source records
- 1
- Regulatory records
- 1
Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.
Exact passages, locators, and provenance
- supports · Source-backed record
“Patients are exposed to high radiation levels when the CardioGen-82 generator is eluted with the incorrect eluent due to high strontium (Sr) 82 and Sr 85 breakthrough levels.”
These highlights do not include all the information needed to use CARDIOGEN-82 safely and effectively. See full prescribing information for CARDIOGEN-82.CARDIOGEN-82®(rubidium Rb 82 generator) to produce rubidium chloride Rb 82 injection, for intravenous useInitial U.S. Approval: 1989 · WARNING: HIGH LEVEL RADIATION EXPOSURE WITH USE OF INCORRECT ELUENT and FAILURE TO FOLLOW THE ELUATE TESTING PROTOCOL
dailymed:ee95aa18-9f2f-40eb-9b4c-583bea6f36bf:a88c7de489b9:a88c7de489b9
Products and regulatory status
Same ingredient. Different records.
Regulatory status
CardioGen-82 (a rubidium Rb 82 generator) is indicated to generate rubidium chloride Rb 82 for PET myocardial imaging, including rest and pharmacologic stress protocols, to assess regional perfusion in adult coronary artery disease populations.
- Source records
- 1
- Regulatory records
- 1
Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.
Exact passages, locators, and provenance
- supports · Source-backed record
“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.”
These highlights do not include all the information needed to use CARDIOGEN-82 safely and effectively. See full prescribing information for CARDIOGEN-82.CARDIOGEN-82®(rubidium Rb 82 generator) to produce rubidium chloride Rb 82 injection, for intravenous useInitial U.S. Approval: 1989 · 1 INDICATIONS AND USAGE
dailymed:ee95aa18-9f2f-40eb-9b4c-583bea6f36bf:a88c7de489b9:a88c7de489b9
Administration context
The practical clinical context.
Administration
The generator is labeled to be used exclusively with the CardioGen-82 Infusion System Model 1700 for dose measurement and delivery of rubidium chloride Rb 82 injection.
- Source records
- 1
- Regulatory records
- 1
Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.
Exact passages, locators, and provenance
- supports · Source-backed record
“Use CardioGen-82 only with the CardioGen-82 Infusion System Model 1700, which is specifically designed for use with the generator and capable of accurate measurement and delivery of doses of Rubidium Chloride Rb 82 Injection.”
These highlights do not include all the information needed to use CARDIOGEN-82 safely and effectively. See full prescribing information for CARDIOGEN-82.CARDIOGEN-82®(rubidium Rb 82 generator) to produce rubidium chloride Rb 82 injection, for intravenous useInitial U.S. Approval: 1989 · 2.4 Infusion System
dailymed:ee95aa18-9f2f-40eb-9b4c-583bea6f36bf:a88c7de489b9:a88c7de489b9
Administration
For the rest phase of Rb 82 PET MPI, image acquisition begins 60–90 seconds after the first infusion and continues for 5 minutes.
- Source records
- 1
- Regulatory records
- 1
Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.
Exact passages, locators, and provenance
- supports · Source-backed record
“Start imaging 60 seconds to 90 seconds after completion of the first dose infusion and acquire images for 5 minutes.”
These highlights do not include all the information needed to use CARDIOGEN-82 safely and effectively. See full prescribing information for CARDIOGEN-82.CARDIOGEN-82®(rubidium Rb 82 generator) to produce rubidium chloride Rb 82 injection, for intravenous useInitial U.S. Approval: 1989 · 2.3 Image Acquisition Instructions
dailymed:ee95aa18-9f2f-40eb-9b4c-583bea6f36bf:a88c7de489b9:a88c7de489b9
Administration
Generator use must be discontinued when any labeled expiration threshold is met, including cumulative elution volume (17 L), time since calibration (60 days), or strontium breakthrough limits (Sr 82 0.01 microCi/mCi Rb 82; Sr 85 0.1 microCi/mCi Rb 82).
- Source records
- 1
- Regulatory records
- 1
Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.
Exact passages, locators, and provenance
- supports · Source-backed record
“Stop using the generator if it reaches any of its Expiration Limits:17 L for the generator’s cumulative eluate volume60 days post generator calibration dateAn eluate Sr 82 level of 0.01 microCi /mCi Rb 82An eluate Sr 85 level of 0.1 microCi /mCi Rb 82”
These highlights do not include all the information needed to use CARDIOGEN-82 safely and effectively. See full prescribing information for CARDIOGEN-82.CARDIOGEN-82®(rubidium Rb 82 generator) to produce rubidium chloride Rb 82 injection, for intravenous useInitial U.S. Approval: 1989 · WARNING: HIGH LEVEL RADIATION EXPOSURE WITH USE OF INCORRECT ELUENT and FAILURE TO FOLLOW THE ELUATE TESTING PROTOCOL
dailymed:ee95aa18-9f2f-40eb-9b4c-583bea6f36bf:a88c7de489b9:a88c7de489b9
Administration
Because of radionuclide decay considerations, the labeled protocol specifies a minimum 10-minute interval between rest and stress rubidium-82 doses.
- Source records
- 1
- Regulatory records
- 1
Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.
Exact passages, locators, and provenance
- supports · Source-backed record
“The minimum interval between the rest and stress doses is 10 minutes to allow sufficient Rb 82 decay.”
These highlights do not include all the information needed to use CARDIOGEN-82 safely and effectively. See full prescribing information for CARDIOGEN-82.CARDIOGEN-82®(rubidium Rb 82 generator) to produce rubidium chloride Rb 82 injection, for intravenous useInitial U.S. Approval: 1989 · 2.2 Dosing and Administration of Rubidium Chloride Rb 82 Injection
dailymed:ee95aa18-9f2f-40eb-9b4c-583bea6f36bf:a88c7de489b9:a88c7de489b9
Administration
Adult PET myocardial perfusion imaging with rubidium chloride Rb 82 generated by CardioGen-82 uses weight-based activity dosing (10–30 MBq/kg; 0.27–0.81 mCi/kg) delivered via IV infusion at specified flow rates (50 or 20 mL/min) into a large peripheral vein.
- Source records
- 1
- Regulatory records
- 1
Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.
Exact passages, locators, and provenance
- supports · Source-backed record
“The recommended dose of Rubidium Chloride Rb 82 Injection per rest or stress component of a PET MPI procedure in adults is 10 MBq/kg to 30 MBq/kg actual body weight (0.27 mCi/kg to 0.81 mCi/kg) administered by intravenous infusion at 50 mL/minute or 20 mL/minute through a catheter inserted into a large peripheral vein.”
These highlights do not include all the information needed to use CARDIOGEN-82 safely and effectively. See full prescribing information for CARDIOGEN-82.CARDIOGEN-82®(rubidium Rb 82 generator) to produce rubidium chloride Rb 82 injection, for intravenous useInitial U.S. Approval: 1989 · 2.2 Dosing and Administration of Rubidium Chloride Rb 82 Injection
dailymed:ee95aa18-9f2f-40eb-9b4c-583bea6f36bf:a88c7de489b9:a88c7de489b9
Administration
The labeled eluent for CardioGen-82 generator elution is additive-free 0.9% sodium chloride injection.
- Source records
- 1
- Regulatory records
- 1
Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.
Exact passages, locators, and provenance
- supports · Source-backed record
“Use only additive-free 0.9% Sodium Chloride Injection to elute the generator.”
These highlights do not include all the information needed to use CARDIOGEN-82 safely and effectively. See full prescribing information for CARDIOGEN-82.CARDIOGEN-82®(rubidium Rb 82 generator) to produce rubidium chloride Rb 82 injection, for intravenous useInitial U.S. Approval: 1989 · WARNING: HIGH LEVEL RADIATION EXPOSURE WITH USE OF INCORRECT ELUENT and FAILURE TO FOLLOW THE ELUATE TESTING PROTOCOL
dailymed:ee95aa18-9f2f-40eb-9b4c-583bea6f36bf:a88c7de489b9:a88c7de489b9
Dose records
For each component (rest or stress) of a rubidium chloride Rb 82 PET MPI procedure, the labeled maximum administered activity is 2,220 MBq (60 mCi) and the maximum administered volume is 100 mL.
- Source records
- 1
- Regulatory records
- 1
Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.
Exact passages, locators, and provenance
- supports · Source-backed record
“Do not exceed a maximum dose of 2,220 MBq (60 mCi) or a maximum volume of 100 mL per rest or stress component of a procedure.”
These highlights do not include all the information needed to use CARDIOGEN-82 safely and effectively. See full prescribing information for CARDIOGEN-82.CARDIOGEN-82®(rubidium Rb 82 generator) to produce rubidium chloride Rb 82 injection, for intravenous useInitial U.S. Approval: 1989 · 2.2 Dosing and Administration of Rubidium Chloride Rb 82 Injection
dailymed:ee95aa18-9f2f-40eb-9b4c-583bea6f36bf:a88c7de489b9:a88c7de489b9
Research status + gaps
What still needs better answers?
- No publishable claim yet for: contraindication, effect, identity, interaction
- 29 compiled claim(s) withheld by automated assurance: assurance_score_below_0.58 (10), assurance_score_below_0.72 (19), current_regulatory_source_required (7), high_risk_requires_regulatory_or_two_independent_sources (19), no_direct_support (29)
These are the limits of this profile, not an exhaustive list of scientific uncertainties.
References + discovery
Open the records yourself.
- These highlights do not include all the information needed to use CARDIOGEN-82 safely and effectively. See full prescribing information for CARDIOGEN-82.CARDIOGEN-82®(rubidium Rb 82 generator) to produce rubidium chloride Rb 82 injection, for intravenous useInitial U.S. Approval: 1989 ↗
dailymed · published 2026-05-14 · retrieved 2026-09-04T19:13:13Z
Publication history and provenance
Version 2 · Automated assessment · 2026-09-04T19:13:13Z
2514f83d63803311c6cd2fc8283689348dca272a6174f68103b6cfa9cd569fc4