High Level Radiation Exposure With Use of Incorrect Eluent and Failure To Follow Quality Control Testing Procedure

High Level Radiation Exposure with Use of Incorrect Eluent

• Patients are exposed to high radiation levels when the 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 discontinue the use of the affected RUBY-FILL (Rb 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 (2.9)].

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 [see Warnings and Precautions (5.2)].
• The system automatically generates a record and saves the data for each generator eluate volume, including flushing and test volumes. Total cumulative eluate volumes are also recorded and saved for the life of the generator [see Dosage and Administration (2.5)].
• Strictly adhere to the generator quality control testing procedure, to minimize the risk of excess radiation exposure, including daily testing and additional testing at Alert Limits [see Dosage and Administration (2.6)]
• Stop use of a generator at any of the following Expiration Limits. Expiry Limits are:
• 30 L for the generator's cumulative eluate volume, or
• Expiration date of the generator (60 days post-calibration)
• An eluate Sr 82 level of 0.01 mcCi /mCi (kBq/MBq) Rb 82, or
• An eluate Sr 85 level of 0.1 mcCi /mCi (kBq/MBq) Rb 82 [see Dosage and Administration (2.7)].