Rubidium Chloride Rb-82 (2 brand names, 2 dosage forms, 2 routes)
Available dosage forms: INJECTABLE, SOLUTION.
Routes of administration: INJECTION, INTRAVENOUS.
Brand Names
- CARDIOGEN-82
- RUBY-FILL
Boxed Warning
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. If an incorrect solution is used to elute the CardioGen-82 generator: 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 the use of the affected generator [see Dosage and Administration (2.5) and Warnings and Precautions (5.1)]. Excess Radiation Exposure with Failure to Follow the Eluate Testing Protocol Excess radiation exposure occurs when the levels of Sr 82 or Sr 85 in the Rubidium Chloride Rb 82 Injection exceed specified limits. 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 60 days post generator calibration date An eluate Sr 82 level of 0.01 microCi /mCi Rb 82 An eluate Sr 85 level of 0.1 microCi /mCi Rb 82 [see Dosage and Administration (2.5, 2.6, 2.7, 2.8) and Warnings and Precautions (5.2)]
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.
Contraindications
None.
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.
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.