Rubidium Chloride Rb-82
Generic Name: rubidium chloride rb-82
Brand Names:
Cardiogen-82
11 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.
Overview
11 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.
Uses
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.
Dosage
2 DOSAGE AND ADMINISTRATION Dosing when using the Model 510 Infusion System: 1,480 MBq (40 mCi), with a range of 1,110 MBq to 2,220 MBq (30 mCi to 60 mCi) per rest or stress component of a procedure via intravenous infusion at 50 mL/min. ( 2.2 ) Dosing when using the Model 1700 Infusion System: 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.
Side Effects
6 ADVERSE REACTIONS 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.
Warnings
WARNING: HIGH LEVEL RADIATION EXPOSURE WITH USE OF INCORRECT ELUENT and FAILURE TO FOLLOW THE ELUATE TESTING PROTOCOL High Level Radiation Exposure with Use of Incorrect Eluent 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. Use only additive-free 0.9% Sodium Chloride Injection to elute the generator. 5 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. 4 CONTRAINDICATIONS None. None. ( 4 )
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.
Storage
16 HOW SUPPLIED/STORAGE AND HANDLING 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).
Frequently Asked Questions
What is Rubidium Chloride Rb-82 used for?▼
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.
What are the side effects of Rubidium Chloride Rb-82?▼
6 ADVERSE REACTIONS 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.
Can I take Rubidium Chloride Rb-82 during 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.
What are the important warnings for Rubidium Chloride Rb-82?▼
WARNING: HIGH LEVEL RADIATION EXPOSURE WITH USE OF INCORRECT ELUENT and FAILURE TO FOLLOW THE ELUATE TESTING PROTOCOL High Level Radiation Exposure with Use of Incorrect Eluent 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. Use only additive-free 0.9% Sodium Chloride Injection to elute the generator. 5 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. 4 CONTRAINDICATIONS None. None. ( 4 )
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.