CardioGen-82
Rubidium Chloride RB-82 · Injection, Solution · Intravenous
Uses
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. ( 1 )
Dosage and administration
Dosing: 10 MBq/kg to 30 MBq/kg actual body weight (0.27 mCi/kg to 0.81 mCi/kg) per rest or stress component of a procedure via intravenous infusion at 50 mL/minute or 20 mL/minute. ( 2.2 ) 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. ( 2.2 ) The minimum interval between the rest and stress doses is 10 minutes to allow sufficient Rb 82 decay. ( 2.2 ) Start image acquisition 60 seconds to 90 seconds after completion of the infusion; if a longer circulation time is anticipated, wait for 120 seconds. Image acquisition is 5 minutes long. ( 2.3 ) For radiation safety, infusion system, elution instruction, eluate testing, dose delivery, and expiration limits of CardioGen-82, and radiation dosimetry see full prescribing information. ( 2.1 , 2.5 , 2.6 , 2.7 , 2.8 , 2.9 ) 2.1 Radiation Safety - Drug Handling CardioGen-82, when eluted with additive-free 0.9% Sodium Chloride Injection, produces Rubidium Chloride Rb 82 Injection. Handle CardioGen-82, Rubidium Chloride Rb 82 Injection, and Infusion Systems with appropriate safety measures to minimize radiation exposure. Wear waterproof gloves and effective shielding throughout the entire preparation and handling [See Warnings and Precautions ( 5.4 )]. Limit the use of radiopharmaceuticals to healthcare providers who are qualified by specific training and experience in the safe use and handling of radionuclides and whose experience and training have been approved by the appropriate government agency authorized to license the use of radionuclides. 2.2 Dosing and Administration of Rubidium Chloride Rb 82 Injection Dosing 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. 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. Administration Instructions Observe aseptic techniques in all drug handling and administration. Use CardioGen-82 with the CardioGen-82 Model 1700 Infusion System to elute and administer Rubidium Chloride Rb 82 Injection. Use the lowest dose necessary, consistent with the goal of as low as reasonably achievable (ALARA), to obtain adequate cardiac visualization based on patient body weight and the imaging equipment and acquisition methodology used to perform the procedure. For example, 3D image acquisition may require doses at the lower end of the recommended range, compared to 2D imaging. Administer two single doses to complete rest and stress myocardial perfusion imaging (MPI) [see Dosage and Administration ( 2.3 )] . The minimum interval between the rest and stress doses is 10 minutes to allow sufficient Rb 82 decay. Instruct patients to void as soon as a study is completed and as often as possible thereafter for at least one hour [see Warnings and Precautions ( 5.4 )] . 2.3 Image Acquisition Instructions Rest Imaging Administer a single dose of Rubidium Chloride Rb 82 Injection. Start imaging 60 seconds to 90 seconds after completion of the first dose infusion and acquire images for 5 minutes. Stress Imaging Begin the study at least 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 the administration of the pharmacologic stress agent, administer the second dose of Rubidium Chloride Rb 82 Injection at the time interval according to the prescribing information of the pharmacologic stress agent. Start imaging 60 seconds to 90 seconds after completion of the second dose infusion and acquire images for 5 minutes. Rest and Stress Imaging If a longer circulation time is anticipated (e.g., in a patient with severe left ventricular dysfunction), start imaging 120 seconds after the dose. Acquisition may be started immediately post-injection if dynamic imaging is needed. 2.4 Infusion System 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. The accuracy of the CardioGen-82 Infusion System Model 1700 for measuring Rubidium Rb 82 Chloride Injection is as follows: For doses of 1,110 MBq to 2,220 MBq (30 mCi to 60 mCi), the system provides an accuracy of ± 10%. For doses of 370 MBq to 1,110 MBq (10 mCi to 30 mCi), the system provides an accuracy of ± 15%. Follow instructions in the CardioGen-82 Infusion System Model 1700 Operator’s Manual for the setup and administration of Rubidium Chloride Rb 82 Injection. 2.5 Directions for Eluting Rubidium Chloride Rb 82 Injection Use only additive-free 0.9% Sodium Chloride Injection to elute the generator [see Warnings and Precautions ( 5.1 )] . Prepare the 0.9% Sodium Chloride Injection for use with the Saline Tag. Prepare the intravenous port in accordance with the approved prescribing information of the 0.9% Sodium Chloride Injection. The intravenous administration port of the 0.9% Sodium Chloride Injection container must be penetrated only one time. Strap the saline tag provided with the CardioGen-82 Infusion System on the additive-free 0.9% Sodium Chloride Injection container and install on the CardioGen-82 Infusion System. Once the container port closure is penetrated, it should remain installed on the CardioGen-82 Infusion System for its entire period of use. A maximum of 12 hours from the initial port closure penetration is permitted, after which the bag must be replaced for the next patient. Allow at least 10 minutes between elutions for regeneration of Rb 82.
Dosage forms and strengths
Rubidium Rb 82 generator used to produce Rubidium Chloride Rb 82 Injection: strontium-82 (Sr 82), with an activity of 3,330 MBq to 5,550 MBq (90 mCi to 150 mCi) at calibration time, adsorbed on a hydrous stannic oxide column. Rubidium Rb 82 generator used to produce Rubidium Chloride Rb 82 Injection: 3,330 MBq to 5,550 MBq (90 mCi to 150 mCi) of strontium-82 (Sr 82) at calibration time, adsorbed on a hydrous stannic oxide column. ( 3 )
Contraindications
None. None. ( 4 )
Warnings and precautions
Risk Associated with Pharmacological Stress: Pharmacologic induction of cardiovascular stress may cause serious adverse reactions such as myocardial infarction, arrhythmia, hypotension, broncho-constriction, and cerebrovascular events. Perform testing only in setting where cardiac resuscitation equipment and trained staff are readily available. ( 5.3 ) 5.1 High Level Radiation Exposure with Use of Incorrect Eluent Additives present in solutions (particularly calcium ions) used by mistake to elute CardioGen-82 expose patients to high levels of radiation by causing the release of large amounts of Sr 82 and Sr 85 into the eluate regardless of the generator’s age or prior use . When solutions containing calcium ions are used, high levels of radioactivity are present in any subsequent eluate even with the use of additive-free 0.9% Sodium Chloride Injection. Use only additive-free 0.9% Sodium Chloride Injection to elute CardioGen-82. If an incorrect eluent is used, immediately stop the patient infusion, evaluate the patient’s radiation absorbed dose, and monitor for the effects of radiation to critical organs such as bone marrow . Permanently discontinue use of the affected CardioGen-82 generator [see Dosage and Administration ( 2.5 )] . 5.2 Excess Radiation Exposure with Failure to Follow the Eluate Testing Protocol Excess radiation exposure occurs when the Sr 82 and Sr 85 levels in the Rubidium Chloride Rb 82 Injection exceed the specified generator eluate limits. Strictly adhere to the eluate testing protocol to minimize radiation exposure to the patient. Stop using the CardioGen-82 generator when the expiration limits are reached [see Dosage and Administration ( 2.6 , 2.7 , 2.8 )]. 5.3 Risks Associated with Pharmacologic Stress Pharmacologic induction of cardiovascular stress may be associated with serious adverse reactions such as myocardial infarction, arrhythmia, hypotension, bronchoconstriction, and cerebrovascular events. Perform pharmacologic stress testing in accordance with the pharmacologic stress agent’s prescribing information and only in the setting where cardiac resuscitation equipment and trained staff are readily available. 5.4 Cumulative Radiation Exposure: Long-Term Risk of Cancer Rubidium chloride Rb 82 contributes to a patient’s overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk of cancer. Use the lowest dose of Rubidium Chloride Rb 82 Injection necessary for imaging and ensure safe handling to protect the patient and health care providers . Encourage patients to void as soon as a study is completed and as often as possible thereafter for a least one hour [see Dosage and Administration ( 2.1 , 2.2 )] .
Side effects
The following clinically significant adverse reactions are described elsewhere in the labeling: High Level Radiation Exposure with Use of Incorrect Eluent [see Warnings and Precautions ( 5.1 )] Excess Radiation Exposure with Failure to Follow Eluate Testing Protocol [see Warnings and Precautions ( 5.2 )] The following serious adverse reactions have been identified during post-approval 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. Radiation Exposure High level radiation exposure to the bone marrow from using an incorrect eluent. Excess radiation exposure due to insufficient eluate testing. To report SUSPECTED ADVERSE REACTIONS, contact Bracco Diagnostics Inc. at 1-800-257-8151 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
Use in specific populations
Lactation: Do not resume breastfeeding until at least one hour after administration of Rubidium Chloride Rb 82 Injection. ( 8.2 ) 8.1 Pregnancy Risk Summary There are no data available on the use of rubidium chloride Rb 82 in pregnant women. Animal reproductive studies have not been conducted with rubidium chloride Rb 82. However, all radiopharmaceuticals, including Rubidium Chloride Rb 82 Injection generated by CardioGen-82, have the potential to cause fetal harm depending on the fetal stage of development and the magnitude of the radiation dose. If considering Rubidium Chloride Rb 82 Injection administration to a pregnant woman, inform the patient about the potential for adverse pregnancy outcomes based on the radiation dose from rubidium-82 (Rb 82) and the gestational timing of exposure. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. 8.2 Lactation Risk Summary There is no information regarding the presence of rubidium chloride Rb 82 in human milk, the effects on the breastfed infant or the effects on milk production. Due to the short half-life of Rb 82 (75 seconds), exposure of a breastfed infant through breast milk can be minimized by temporary discontinuation of breastfeeding (see Clinical Considerations) . The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Rubidium Chloride Rb 82 Injection, any potential adverse effects on the breastfed child from Rb 82 or from the underlying maternal condition. Clinical Considerations Exposure to Rb 82 through breast milk can be minimized if breastfeeding is discontinued when Rubidium Chloride Rb 82 Injection is administered. Do not resume breastfeeding until at least one hour after administration of Rubidium Chloride Rb 82 Injection. 8.4 Pediatric Use The safety and effectiveness of CardioGen-82, used to produce Rubidium Chloride Rb 82 Injection, in pediatric patients have not been established. 8.5 Geriatric Use In elderly patients with a clinically important decrease in cardiac function, lengthen the delay between infusion and image acquisition [see Dosage and Administration ( 2.3 )]. Observe for the possibility of fluid overload.
Pregnancy
8.1 Pregnancy Risk Summary There are no data available on the use of rubidium chloride Rb 82 in pregnant women. Animal reproductive studies have not been conducted with rubidium chloride Rb 82. However, all radiopharmaceuticals, including Rubidium Chloride Rb 82 Injection generated by CardioGen-82, have the potential to cause fetal harm depending on the fetal stage of development and the magnitude of the radiation dose. If considering Rubidium Chloride Rb 82 Injection administration to a pregnant woman, inform the patient about the potential for adverse pregnancy outcomes based on the radiation dose from rubidium-82 (Rb 82) and the gestational timing of exposure. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
Pediatric use
8.4 Pediatric Use The safety and effectiveness of CardioGen-82, used to produce Rubidium Chloride Rb 82 Injection, in pediatric patients have not been established.
Geriatric use
8.5 Geriatric Use In elderly patients with a clinically important decrease in cardiac function, lengthen the delay between infusion and image acquisition [see Dosage and Administration ( 2.3 )]. Observe for the possibility of fluid overload.
Description
11.1 Generator Characteristics CardioGen-82 (rubidium Rb 82 generator) contains accelerator-produced Sr 82 adsorbed on stannic oxide in a lead-shielded column and provides a means to produce sterile nonpyrogenic Rubidium Chloride Rb 82 Injection, a radioactive diagnostic agent, for intravenous use. The chemical form of Rb 82 is 82 RbCl. The amount (mCi) of Rb 82 obtained in each elution will depend on the potency of the generator. When eluted at a rate of 50 mL/minute, each generator eluate at the end of elution should not contain more than 0.02 microCi of Sr 82 and not more than 0.2 microCi of Sr 85 per mCi of Rubidium Chloride Rb 82 Injection, and not more than 1 mcg of tin per mL of eluate. 11.2 Nuclear Physical Characteristics Rb 82 decays by positron emission and associated gamma emission with a physical half-life of 75 seconds. Table 3 shows the annihilation photons released following positron emission which are useful for detection and imaging studies. The decay modes of Rb 82 are: 95.5% by positron emission, resulting in the production of annihilation radiation, i.e., two 511 keV gamma rays; and 4.5% by electron capture, resulting in the emission of “prompt” gamma rays of predominantly 776.5 keV. Both decay modes lead directly to the formation of stable krypton 82 (Kr 82). Table 3. Principal Radiation Emission Data for Rb 82 Radiation Mean Percent Per Disintegration Mean Energy (keV) Annihilation photons (2) 191.01 511 (each) Gamma rays 13-15 776.5 The specific gamma ray constant for Rb 82 is 6.1 R/hour-mCi at 1 cm. The first half-value layer is 0.7 cm of lead (Pb). Table 4 shows a range of values for the relative attenuation of the radiation emitted by this radionuclide that results from interposition of various thicknesses of lead. For example, the use of a 7.0 cm thickness of Pb will attenuate the radiation emitted by a factor of about 1,000. Table 4. Radiation Attenuation by Lead Shielding Shield Thickness (Pb) cm Attenuation Factor 0.7 0.5 2.3 10 -1 4.7 10 -2 7.0 10 -3 9.3 10 -4 Sr 82 (half-life of 25 days) decays to Rb 82. To correct for physical decay of Sr 82, Table 5 shows the fractions that remain at selected intervals after the time of calibration. Table 5. Physical Decay Chart: Sr 82 half-life 25 days Days Fraction Remaining Days Fraction Remaining Days Fraction Remaining 0 Calibration time 1 21 0.559 41 0.321 1 0.973 22 0.543 42 0.312 2 0.946 23 0.529 43 0.304 3 0.920 24 0.514 44 0.295 4 0.895 25 0.500 45 0.287 5 0.871 26 0.486 46 0.279 6 0.847 27 0.473 47 0.272 7 0.824 28 0.460 48 0.264 8 0.801 29 0.448 49 0.257 9 0.779 30 0.435 50 0.250 10 0.758 31 0.423 51 0.243 11 0.737 32 0.412 52 0.237 12 0.717 33 0.401 53 0.230 13 0.697 34 0.390 54 0.224 14 0.678 35 0.379 55 0.218 15 0.660 36 0.369 56 0.212 16 0.642 37 0.359 57 0.206 17 0.624 38 0.349 58 0.200 18 0.607 39 0.339 59 0.195 19 0.591 40 0.330 60 0.189 20 0.574 To correct for physical decay of Rb 82, Table 6 shows the fraction of Rb 82 remaining in all 15 second intervals up to 300 seconds after time of calibration. Table 6. Physical Decay Chart: Rb 82 half-life 75 seconds Seconds Fraction Remaining Seconds Fraction Remaining 0 Elution time 1 165 0.218 15 0.871 180 0.19 30 0.758 195 0.165 45 0.66 210 0.144 60 0.574 225 0.125 75 0.5 240 0.109 90 0.435 255 0.095 105 0.379 270 0.083 120 0.33 285 0.072 135 0.287 300 0.063 150 0.25
Mechanism of action
12.1 Mechanism of Action Rb 82 is analogous to potassium ion (K + ) in its biochemical behavior and is extracted by the myocardium in proportion to the blood flow. Rb + participates in the sodium-potassium (Na + /K + ) ion exchange pumps that are present in cell membranes. The intracellular uptake of Rb 82 requires maintenance of ionic gradient across cell membranes. Rb 82 radioactivity is increased in viable myocardium reflecting intracellular retention, while the tracer is cleared from necrotic or infarcted tissue.
How supplied
How Supplied CardioGen-82 (rubidium Rb 82 generator), used to produce Rubidium Chloride Rb 82 Injection, is supplied in a lead shield surrounded by a labeled plastic container with an activity at calibration time of 3,330 MBq to 5,550 MBq (90 mCi to 150 mCi) of Sr 82 adsorbed on a hydrous stannic oxide column (NDC 0270-0091-01). The container label provides complete assay data for each generator. Storage and Handling Store the generator at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature]. Receipt, transfer, possession, storage, disposal or use of this product is subject to the radioactive material regulations and licensing requirements of the U.S. Nuclear Regulatory Commission (NRC), Agreement States or Licensing States as appropriate. Do not dispose of the generator in regular refuse systems. For questions about the disposal of the CardioGen-82 generator, contact Bracco Diagnostics Inc. at 1-800-447-6883, option 3.
Patient information
Post-Study Voiding Instruct patients to void after completion of each image acquisition session and as often as possible for one hour after completion of the PET scan [see Warnings and Precautions ( 5.4 )] . Pregnancy Advise a pregnant woman of the potential risk to a fetus [see Use in Specific Populations ( 8.1 )] . Lactation Advise lactating women that exposure to Rb 82 through breast milk can be minimized if breastfeeding is discontinued when Rubidium Chloride Rb 82 Injection is administered. Advise lactating women not to resume breastfeeding for at least one hour after administration of Rubidium Chloride Rb 82 Injection [see Use in Specific Populations ( 8.2 )] . Manufactured for Bracco Diagnostics Inc. Princeton, NJ 08540 Manufactured By GE Healthcare, Medi-Physics, Inc. Arlington Heights, IL 60004 CardioGen-82 ® Rubidium 82 Generators, Infusion Systems, and Accessories contain proprietary technology covered by one or more patents listed at www.braccoimaging.com/us-en/patents .
Label text from the FDA structured product label by Bracco Diagnostics Inc (revised May 14, 2026). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Rubidium Chloride Rb-82 in 1 product
CardioGen-82 NDC products (1)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 0270-0091 | Rubidium Chloride Rb-82 150 mCi/1 Injection, Solution | Bracco Diagnostics Inc | NDA |
CardioGen-82 recalls
- D-1684-2012 Oct 3, 2012 · Class II · Terminated
GMP deviation; Sr-82 levels exceeded alert limit specification
Frequently asked questions
What is CardioGen-82 used for?
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…
What are the side effects of CardioGen-82?
The following clinically significant adverse reactions are described elsewhere in the labeling: High Level Radiation Exposure with Use of Incorrect Eluent [see Warnings and Precautions ( 5.1 )] Excess Radiation Exposure with Failure to Follow Eluate Testing Protocol [see Warnings and Precautions ( 5.2 )] The following serious adverse reactions have been identified during post-approval use of… See the full label for the complete list.
Who makes CardioGen-82?
CardioGen-82 is listed by 1 labeler in the FDA NDC directory, including Bracco Diagnostics Inc.
Has CardioGen-82 been recalled?
The FDA enforcement database lists 1 recall for CardioGen-82, most recently D-1684-2012 (class ii): GMP deviation; Sr-82 levels exceeded alert limit specification