Cardiogen-82
Generic name:rubidium chloride rb-82
Dosage form: injection, solution
Drug class:Diagnostic radiopharmaceuticals
Medically reviewed by Drugs.com. Last updated on Oct 1, 2021.
On This Page
- Boxed Warning
- Indications and Usage
- Dosage and Administration
- Dosage Forms and Strengths
- Contraindications
- Warnings and Precautions
- Adverse Reactions/Side Effects
- Use In Specific Populations
- Description
- Clinical Pharmacology
- Nonclinical Toxicology
- Clinical Studies
- References
- How Supplied/Storage and Handling
- Patient Counseling Information
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 Sr 82 and Sr 85 breakthrough levels [see Warnings and Precautions (5.1)]
- Use only additive-free 0.9% Sodium Chloride Injection USP to elute the generator [see Dosage and Administration (2.5)]
- Immediately stop the patient infusion and permanently discontinue the use of the affected Cardiogen-82 generator if the incorrect solution is used to elute the generator [see Contraindications (4)]
- Evaluate the patient’s radiation absorbed dose and monitor for the effects of radiation to critical organs such as bone marrow [see Dosage and Administration (2.10)]
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 Rb 82 chloride injection exceed specified limits [see Warnings and Precautions (5.2)]
- Record each generator eluate volume, including waste and test volumes, and keep a record of the cumulative eluate volume [see Dosage and Administration (2.5)]
