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 ( 5.1 ) ] Sinoatrial and Atrioventricular Nodal Block [see Warnings and Precautions ( 5.2 ) ] Atrial Fibrillation/Atrial Flutter [see Warnings and Precautions ( 5.3 ) ] Hypersensitivity, Including Anaphylaxis [see Warnings and Precautions ( 5.4 ) ] Hypotension [see Warnings and Precautions ( 5.5 ) ] Hypertension [see Warnings and Precautions ( 5.6 ) ] Bronchoconstriction [see Warnings and Precautions ( 5.7 ) ] Seizure [see Warnings and Precautions ( 5.8 ) ] Cerebrovascular Accident (Stroke) [see Warnings and Precautions ( 5.9 ) ] The most common (incidence ≥ 5%) adverse reactions to regadenoson injection are dyspnea, headache, flushing, chest discomfort, dizziness, angina pectoris, chest pain, and nausea ( 6 ).
To report SUSPECTED ADVERSE REACTIONS, contact Dr.
Reddy's Laboratories Inc., at 1-888-375-3784 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
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 regadenoson, with most receiving 0.4 mg as a rapid (≤ 10 seconds) intravenous injection.
Most of these patients received regadenoson 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 regadenoson (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.
5 WARNINGS AND PRECAUTIONS Myocardial Ischemia.
Fatal cardiac events have occurred.
Avoid use in patients with symptoms or signs of acute myocardial ischemia, for example unstable angina or cardiovascular instability, who may be at greater risk.
Cardiac resuscitation equipment and trained staff should be available before administration (5.1) .
Sinoatrial (SA) and Atrioventricular (AV) Nodal Block.
Like all medications, 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: