Label Changes for:

Cardiogen-82 (Rubidium Rb 82 Generator)

February 2012

Changes have been made to the BOXED WARNING, WARNINGS and PRECAUTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – February 2012

 

 

BOXED WARNING

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

Perform generator eluate tests:

  • Record each generator eluate volume, including waste and test volumes, and keep a record of the cumulative eluate volume…Determine Rb-82, Sr-82, Sr-85 in the generator eluate…Stop use of a generator at an Expiration Limit…

 

WARNINGS AND PRECAUTIONS

Unintended Sr-82 and Sr-85 Exposure
  • Unintended radiation exposure occurs when the Sr-82 and Sr-85 levels in rubidium Rb 82 chloride injections exceed the specified generator eluate limits. Unintended exposure to strontium radiation has occurred in some patients who received rubidium Rb 82 injections at clinical sites where generator eluate testing appeared insufficient…

 

Cumulative Radiation Exposure: Long-Term Risk of Cancer
  • Rubidium Rb 82 chloride injection, similar to other radiopharmaceuticals, contributes to a patient’s overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk of cancer. Use the lowest dose of rubidium Rb 82 chloride injection necessary for imaging and ensure safe handling to protect the patient and health care worker. Encourage patients to void as soon as a study is completed and as often as possible thereafter for at least one hour.

 

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