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Importance of Myocardial Perfusion Positron Emission Tomography Recognized in New Joint Position Statement by the American Society of Nuclear Cardiology and the Society of Nuclear Medicine and Molecular Imaging

Monday, August 29, 2016 Research News J E 4
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CardioGen-82® (Rubidium Rb 82 Generator) is the only U.S. FDA-approved generator-based PET perfusion agent for the evaluation of patients with suspected or existing coronary artery disease.

IMPORTANT SAFETY INFORMATION:

WARNING: UNINTENDED STRONTIUM-82 (Sr-82) AND STRONTIUM-85 (Sr-85) RADIATION EXPOSURE

Unintended 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 (5.1)].

Perform generator eluate tests:

1)     Record each generator eluate volume, including waste and test volumes, and keep a record of the cumulative eluate volume [see Dosage and Administration (2.4)].

2)     Determine Rb-82, Sr-82, Sr-85 levels in the eluate:

  • Once daily, prior to any drug administrations, and
  • At additional daily tests after detection of an Alert Limit. Alert Limits are:
    • 14 L for the generator's cumulative eluate volume, or
    • An eluate Sr-82 level of 0.002 ?Ci/mCi Rb-82, or
    • An eluate Sr-85 level of 0.02 ?Ci/mCi Rb-82.
    • Perform the additional daily tests at time points determined by the day's elution volume; tests are performed every 750 mL [see Dosage and Administration (2.5)].

3)     Stop use of a generator at an Expiration Limit of:

  • 17 L for the generator's cumulative eluate volume, or
  • 42 days post generator calibration date, or
  • An eluate Sr-82 level of 0.01 ?Ci/mCi Rb-82, or
  • An eluate Sr-85 level of 0.1 ?Ci/mCi Rb-82 [see Dosage and Administration (2.6)].
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