Product Monograph
Pharmacologic Stress in Myocardial Perfusion Imaging: Adenoscan

Post-marketing Experience

The following adverse events have been reported from marketing experience with Adenoscan. Because these events are reported voluntarily from a population of uncertain size and are associated with concomitant diseases and multiple drug therapies and surgical procedures, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Decisions to include these events in labeling are typically based on one or more of the following factors: (1) seriousness of the event, (2) frequency of the reporting, (3) strength of causal connection to the drug, or a combination of these factors.

Body as a Whole—Injection site reaction
Central Nervous System—Seizure activity, including tonic clonic (grand mal) seizures, and loss of consciousness
Digestive—Nausea and vomiting
Respiratory—Respiratory arrest

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IMPORTANT SAFETY INFORMATION

Intravenous Adenoscan^® (adenosine injection) is indicated as an adjunct to thallium-201 myocardial perfusion scintigraphy in patients unable to exercise adequately.

Adenoscan is contraindicated in patients with 2nd- or 3rd-degree AV block, sinus node disease, and known or suspected bronchoconstrictive or bronchospastic lung disease.

Approximately 2.6% and 0.8% of patients developed second- and third-degree AV block, respectively. All episodes of AV block have been asymptomatic, transient, and did not require intervention; less than 1% required termination of adenosine infusion.

Fatal cardiac arrest, sustained ventricular tachycardia (requiring resuscitation), and nonfatal myocardial infarction have been reported coincident with Adenoscan infusion. Patients with unstable angina may be at greater risk.

Side effects that were seen most often included flushing (44%), chest discomfort (40%), and dyspnea (28%). Side effects usually resolve quickly when infusion is terminated and generally do not interfere with test results.

Despite adenosine’s short half-life, 10.6% of the side effects started several hours after the infusion terminated, and 8.4% of the side effects that began during the infusion persisted for up to 24 hours after infusion. In many cases, it is not possible to know whether these late adverse events are the result of Adenoscan infusion.

Please see full prescribing information.