Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
6 ADVERSE REACTIONS The following adverse reactions are discussed in more detail in other sections of the labeling.
• Myocardial Ischemia [see Warnings and Precautions ( 5- 5.1)] • Sinoatrial and Atrioventricular Nodal Block [see Warnings and Precautions ( 5- 5.2)] • Atrial Fibrillation/Atrial Flutter [see Warnings and Precautions ( 5- 5.3)] • Hypersensitivity, Including Anaphylaxis [see Warnings and Precautions ( 5- 5.4)] • Hypotension [see Warnings and Precautions ( 5- 5.5)] • Hypertension [see Warnings and Precautions ( 5- 5.6)] • Bronchoconstriction [see Warnings and Precautions ( 5- 5.7)] • Seizure [see Warnings and Precautions ( 5- 5.8)] • Cerebrovascular Accident (Stroke) [see Warnings and Precautions ( 5- 5.9)] 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
During clinical development, 1,651 patients were exposed to LEXISCAN, with most receiving 0.4 mg as a rapid (≤ 10 seconds) intravenous injection.
Most of these patients received LEXISCAN in two clinical studies that enrolled patients who had no history of bronchospastic lung disease as well as no history of a cardiac conduction block of greater than first-degree AV block, except for patients with functioning artificial pacemakers.
In these studies (Studies 1 and 2), 2,015 patients underwent myocardial perfusion imaging after administration of LEXISCAN (N = 1,337) or ADENOSCAN (N = 678).
The population was 26–93 years of age (median 66 years), 70% male and primarily Caucasian (76% Caucasian, 7% African American, 9% Hispanic, 5% Asian).
Table 1 shows the most frequently reported adverse reactions.
Overall, any adverse reaction occurred at similar rates between the study groups (80% for the LEXISCAN group and 83% for the ADENOSCAN group).
Aminophylline was used to treat the reactions in 3% of patients in the LEXISCAN group and 2% of patients in the ADENOSCAN group.
Most adverse reactions began soon after dosing, and generally resolved within approximately 15 minutes, except for headache which resolved in most patients within 30 minutes.
5 WARNINGS AND PRECAUTIONS 5.1 Myocardial Ischemia Fatal and nonfatal myocardial infarction (MI), ventricular arrhythmias, and cardiac arrest have occurred following LEXISCAN injection.
Avoid use in patients with symptoms or signs of acute myocardial ischemia, for example unstable angina or cardiovascular instability;
these patients may be at greater risk of serious cardiovascular reactions to LEXISCAN.
Cardiac resuscitation equipment and trained staff should be available before administering LEXISCAN.
Adhere to the recommended duration of injection [see Dosage and Administration ( 2 )].
Like all medications, Lexiscan(r) (regadenoson) can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: