"The US Food and Drug Administration (FDA) has received multiple adverse event reports associated with the use of the Vascu-Guard Peripheral Vascular Patch (Baxter International Inc) during carotid endarterectomy (CEA).
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. The physical half lives of Sr-82 and Sr-85 are 25 days and 65 days, respectively, in contrast to Rb-82 which has a physical half-life of 75 seconds. Unintended exposure to strontium radiation contributes to a patient's overall cumulative radiation dose.
To minimize the risk of unintended radiation exposure, strict adherence to a daily eluate testing protocol is required. Stop using the rubidium generator when the expiration limits are reached [see DOSAGE AND ADMINISTRATION].
Risks Associated with Pharmacologic Stress
Pharmacologic induction of cardiovascular stress may be associated with serious adverse reactions such as myocardial infarction, arrhythmia, hypotension, bronchoconstriction, and cerebrovascular events. Perform pharmacologic stress testing in accordance with the pharmacologic stress agent's prescribing information and only in the setting where cardiac resuscitation equipment and trained staff are readily available.
Patients with congestive heart failure or the elderly may experience a transitory increase in circulatory volume load. Observe these patients during infusion and for several hours following rubidium chloride injection administration to detect delayed hemodynamic disturbances.
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 [see DOSAGE AND ADMINISTRATION]. Encourage patients to void as soon as a study is completed and as often as possible thereafter for at least one hour.
Carcinogenesis, Mutagenesis, Impairment of Fertility
No long-term studies have been performed to evaluate carcinogenic potential, mutagenicity potential, or to determine whether rubidium Rb 82 chloride injection may affect fertility in males or females.
Use In Specific Populations
Pregnancy Category C
Animal reproductive studies have not been conducted with rubidium Rb 82 chloride injection. It is also not known whether rubidium Rb 82 chloride injection can cause fetal harm when administered to a pregnant woman; however, all radiopharmaceuticals have the potential to cause fetal harm depending on the fetal stage of development and the magnitude of the radiation dose. If considering rubidium Rb 82 chloride injection administration to a pregnant woman, inform the patient about the potential for adverse pregnancy outcomes based on the radiation dose from rubidium Rb-82 and the gestational timing of exposure. Administer rubidium Rb-82 to a pregnant woman only if clearly needed.
It is not known whether rubidium Rb 82 chloride injection is excreted in human milk. Due to the short half-life of rubidium Rb-82 (75 seconds) it is unlikely that the drug would be excreted in human milk during lactation. However, because many drugs are excreted in human milk, caution should be exercised when rubidium Rb-82 chloride injection is administered to nursing women. Do not resume breastfeeding until one hour after the last infusion.
Rubidium Rb 82 chloride injection safety and effectiveness in pediatric patients have not been established.
In elderly patients with a clinically important decrease in cardiac function, lengthen the delay between infusion and image acquisition [see DOSAGE AND ADMINISTRATION]. Observe for the possibility of fluid overload [see WARNINGS AND PRECAUTIONS].
Reductions in renal function are not anticipated to alter clearance of rubidium Rb 82 chloride injection because Rb-82 decays to stable Kr-82 with a half-life of 75 seconds and Kr-82 is exhaled through the lungs.
Reductions in hepatic function are not anticipated to alter clearance of rubidium Rb 82 chloride injection.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 2/15/2012
Additional Cardiogen-82 Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Get the latest treatment options.