RUBY-FILL® (Rubidium Rb82 Generator)

Note New Important Safety Information Effective April 2019

The RUBY-FILL® Rubidium82 Generator contains accelerator produced Strontium-82, which decays to Rubidium-82. When the generator is eluted with saline it produces a sterile, non-pyrogenic solution of Rb-82 Chloride used for Cardiac Positron Emission Tomography (PET), a non-invasive imaging procedure of the myocardium, to evaluate regional myocardial perfusion in adult patients with suspected or existing coronary artery disease.

Due to the short half-life (75 s) of Rb-82, the use of an elution system is required for delivery of the Rb-82 Chloride into a patient for the purposes of performing Myocardial Perfusion Imaging with PET.  The Rubidium Elution System has been exclusively designed for use with the RUBY-FILL® Rubidium 82 Generator and to deliver accurate doses of Rb-82 Chloride to patients.

Prescribing Information 

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Indication for Use:

RUBY-FILL is a closed system used to produce rubidium Rb 82 chloride injection for intravenous use. Rubidium Rb 82 chloride injection is a radioactive diagnostic agent indicated for Positron Emission Tomography (PET) imaging of the myocardium under rest or pharmacologic stress conditions to evaluate regional myocardial perfusion in adult patients with suspected or existing coronary artery disease

New Important Safety Information April 2019

Please note changes in Boxed Warning, Dosage and Administration, Directions for Eluting Rubidium Rb 82 Chloride Injection (2.5), Contraindications (4), Warnings and Precautions, High Level Radiation Exposure with Use of Incorrect Eluent (5.1).

WARNING: HIGH LEVEL RADIATION EXPOSURE WITH USE OF INCORRECT ELUENT AND FAILURE TO FOLLOW QUALITY CONTROL TESTING PROCEDURE

Please see full prescribing information for complete boxed warning

High Level Radiation Exposure with Use of Incorrect Eluent

Using incorrect eluent can cause high Sr 82 and Sr 85 breakthrough levels (5.1)

  • Use only additive-free 0.9%Sodium Chloride Injection USP to elute the generator (2.5)
  • Immediately stop the patient infusion and discontinue the use of the affected RUBY-FILL generator if the incorrect solution is used to elute the generator (4)
  • Evaluate the patient’s radiation absorbed dose and monitor for the effects of radiation to critical organs such as bone marrow (2.9).

Excess Radiation Exposure with Failure to Follow Quality Control Testing Procedure

Excess radiation exposure occurs when the levels of Sr 82 or Sr 85 in the rubidium Rb 82 chloride injection exceed specified limits (5.2)

  • Strictly adhere to the generator quality control testing procedure (2.6)
  • Stop use of a generator at any of its Expiration Limits (2.7)
Safety Data Sheets

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DISCLAIMER:

This information is not intended as medical advice. Responsibility for patient care resides with the healthcare professional on the basis of his or her professional license, experience and knowledge of the patient. For full Prescribing Information including indications, contraindications, warnings, precautions and adverse events, please see the appropriate product labeling.