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Regadenoson is a brand name for Regadenoson. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: 1 INDICATIONS AND USAGE Regadenoson injection is a pharmacologic stress agent indicated for radionuclide myocardial perfusion imaging (MPI) in patients unable to undergo adequate exercise stress. Regadenoson injection is a pharmacologic stress agent indicated for radionuclide myocardial perfusion imaging (MPI) in…
Verbatim from this product's FDA label. Tap a section to expand.
4 mg regadenoson) administered as an intravenous injection within 10 seconds. 2) ] Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Do not administer regadenoson injection if it contains particulate matter or is discolored. · Administer the radionuclide myocardial perfusion imaging agent 10–20 seconds after the saline flush. The radionuclide may be injected directly into the same catheter as regadenoson injection.
4 mg regadenoson) administered as an intravenous injection within 10 seconds; followed immediately by saline flush and radiopharmaceutical (2) .
6 ADVERSE REACTIONS The following adverse reactions are discussed in more detail in other sections of the labeling. 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. gov/medwatch. 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.
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. Overall, any adverse reaction occurred at similar rates between the study groups (80% for the regadenoson group and 83% for the ADENOSCAN group). Aminophylline was used to treat the reactions in 3% of patients in the regadenoson 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. 2 )]. 1%) 0/618 (0%) Ventricular conduction abnormalities 64/1152 (6%) 31/581 (5%) *12-lead ECGs were recorded before and for up to 2 hours after dosing.
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.
1) . Sinoatrial (SA) and Atrioventricular (AV) Nodal Block. 2) . Atrial Fibrillation/Atrial Flutter. 3) . Hypersensitivity, including anaphylaxis, angioedema, cardiac or respiratory arrest, respiratory distress, decreased oxygen saturation, hypotension, throat tightness, urticaria, and rashes have occurred.
4). Hypotension. Adenosine receptor agonists, including regadenoson injection, induce vasodilation and hypotension. 5) . Hypertension. 6) . Bronchoconstriction. Adenosine receptor agonists, including regadenoson injection, may induce dyspnea, bronchoconstriction and respiratory compromise in patients with chronic obstructive pulmonary disease (COPD) or asthma.
7 ). Seizure. regadenoson injection may lower the seizure threshold. New onset or recurrence of convulsive seizures has occurred. Some seizures are prolonged and require urgent anticonvulsive management. 8). Cerebrovascular Accident (Stroke).
9). 1 Myocardial Ischemia Fatal and nonfatal myocardial infarction (MI), ventricular arrhythmias, and cardiac arrest have occurred following regadenoson. 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 regadenoson.
Cardiac resuscitation equipment and trained staff should be available before administering regadenoson. Adhere to the recommended duration of injection [see Dosage and Administration ( 2 )]. 2) ]. If serious reactions to regadenoson injection occur, consider the use of aminophylline, an adenosine antagonist, to shorten the duration of increased coronary blood flow induced by regadenoson [see Overdosage ( 10) ].
2) ]. Do not administer regadenoson injection to patients with: · Second- or third-degree AV block, or · sinus node dysfunction unless the patients have a functioning artificial pacemaker (4) .
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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†includes rhythm abnormalities (PACs, PVCs, atrial fibrillation/flutter, wandering atrial pacemaker, supraventricular or ventricular arrhythmia) or conduction abnormalities, including AV block. 001). Most respiratory adverse reactions resolved without therapy; a few patients received aminophylline or a short-acting bronchodilator.
No differences were observed between treatment arms in the reduction of >15% from baseline at two-hours in FEV 1 (Table 3). 4% *All patients continued the use of their respiratory medications as prescribed prior to administration of regadenoson.
†Patients may have reported more than one type of adverse reaction. Adverse reactions were collected up to 24 hours following drug administration. Pre-specified respiratory adverse reactions included dyspnea, wheezing, obstructive airway disorder, dyspnea exertional, and tachypnea.
‡Change from baseline at 2 hours. 73 m 2 ), no serious adverse events were reported through the 24-hour follow-up period. Inadequate Exercise Stress In an open-label, multi-center trial evaluating regadenoson administration following inadequate exercise stress, 1,147 patients were randomized into one of two groups.
Each group underwent two regadenoson stress myocardial perfusion imaging (MPI) procedures. Group 1 received regadenoson 3 minutes following inadequate exercise in the first regadenoson stress (MPI 1). Group 2 rested 1 hour after inadequate exercise to allow hemodynamics to return to baseline prior to receiving regadenoson (MPI 1).
Both groups returned for a second stress MPI 1-14 days later and received regadenoson without exercise (MPI 2). The most common adverse reactions are similar in type and incidence to those in Table 1 above for both Groups. The timing of the administration of regadenoson following inadequate exercise did not alter the common adverse reaction profile.
1 ) ]. The cardiac events were numerically higher in Group 1. 2%) 0 *A clinically significant cardiac event was defined as any of the following events found on the Holter ECG/12-lead ECG within one hour after regadenoson administration: ventricular arrhythmias (sustained ventricular tachycardia, ventricular fibrillation, Torsade de Pointes, ventricular flutter); ST-T depression (≥ 2 mm); ST-T elevation (≥ 1 mm); AV block (2:1 AV block, AV Mobitz I, AV Mobitz II, complete heart block); sinus arrest > 3 seconds in duration Or a Treatment Emergent Adverse Event (TEAE) per the MedDRA SMQ (narrow Scope) for myocardial infarction Or a TEAE preferred term (PT) of angina unstable within 24 hours of regadenoson administration.
2 Post-Marketing Experience The following adverse reactions have been reported from worldwide marketing experience with regadenoson. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
8 ) ] have been reported. Some events required intervention with fluids and/or aminophylline [see Overdosage ( 10 ) ]. QTc prolongation shortly after regadenoson administration has been reported. 9) ]. Gastrointestinal Abdominal pain, occasionally severe, has been reported a few minutes after regadenoson administration, in association with nausea, vomiting, or myalgias; administration of aminophylline, an adenosine antagonist, appeared to lessen the pain.
Diarrhea and fecal incontinence have also been reported following regadenoson administration. 4 ) ]. Musculoskeletal Musculoskeletal pain has occurred, typically 10-20 minutes after regadenoson administration; the pain was occasionally severe, localized in the arms and lower back and extended to the buttocks and lower legs bilaterally.
Administration of aminophylline appeared to lessen the pain. Respiratory Respiratory arrest, dyspnea and wheezing have been reported following regadenoson administration. 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.
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. Overall, any adverse reaction occurred at similar rates between the study groups (80% for the regadenoson group and 83% for the ADENOSCAN group). Aminophylline was used to treat the reactions in 3% of patients in the regadenoson 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. 2 )]. 1%) 0/618 (0%) Ventricular conduction abnormalities 64/1152 (6%) 31/581 (5%) *12-lead ECGs were recorded before and for up to 2 hours after dosing.
†includes rhythm abnormalities (PACs, PVCs, atrial fibrillation/flutter, wandering atrial pacemaker, supraventricular or ventricular arrhythmia) or conduction abnormalities, including AV block. 001). Most respiratory adverse reactions resolved without therapy; a few patients received aminophylline or a short-acting bronchodilator.
No differences were observed between treatment arms in the reduction of >15% from baseline at two-hours in FEV 1 (Table 3). 4% *All patients continued the use of their respiratory medications as prescribed prior to administration of regadenoson.
†Patients may have reported more than one type of adverse reaction. Adverse reactions were collected up to 24 hours following drug administration. Pre-specified respiratory adverse reactions included dyspnea, wheezing, obstructive airway disorder, dyspnea exertional, and tachypnea.
‡Change from baseline at 2 hours. 73 m 2 ), no serious adverse events were reported through the 24-hour follow-up period. Inadequate Exercise Stress In an open-label, multi-center trial evaluating regadenoson administration following inadequate exercise stress, 1,147 patients were randomized into one of two groups.
Each group underwent two regadenoson stress myocardial perfusion imaging (MPI) procedures. Group 1 received regadenoson 3 minutes following inadequate exercise in the first regadenoson stress (MPI 1). Group 2 rested 1 hour after inadequate exercise to allow hemodynamics to return to baseline prior to receiving regadenoson (MPI 1).
Both groups returned for a second stress MPI 1-14 days later and received regadenoson without exercise (MPI 2). The most common adverse reactions are similar in type and incidence to those in Table 1 above for both Groups. The timing of the administration of regadenoson following inadequate exercise did not alter the common adverse reaction profile.
1 ) ]. The cardiac events were numerically higher in Group 1. 2%) 0 *A clinically significant cardiac event was defined as any of the following events found on the Holter ECG/12-lead ECG within one hour after regadenoson administration: ventricular arrhythmias (sustained ventricular tachycardia, ventricular fibrillation, Torsade de Pointes, ventricular flutter); ST-T depression (≥ 2 mm); ST-T elevation (≥ 1 mm); AV block (2:1 AV block, AV Mobitz I, AV Mobitz II, complete heart block); sinus arrest > 3 seconds in duration Or a Treatment Emergent Adverse Event (TEAE) per the MedDRA SMQ (narrow Scope) for myocardial infarction Or a TEAE preferred term (PT) of angina unstable within 24 hours of regadenoson administration.
2 Post-Marketing Experience The following adverse reactions have been reported from worldwide marketing experience with regadenoson. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
8 ) ] have been reported. Some events required intervention with fluids and/or aminophylline [see Overdosage ( 10 ) ]. QTc prolongation shortly after regadenoson administration has been reported. 9) ]. Gastrointestinal Abdominal pain, occasionally severe, has been reported a few minutes after regadenoson administration, in association with nausea, vomiting, or myalgias; administration of aminophylline, an adenosine antagonist, appeared to lessen the pain.
Diarrhea and fecal incontinence have also been reported following regadenoson administration. 4 ) ]. Musculoskeletal Musculoskeletal pain has occurred, typically 10-20 minutes after regadenoson administration; the pain was occasionally severe, localized in the arms and lower back and extended to the buttocks and lower legs bilaterally.
Administration of aminophylline appeared to lessen the pain. Respiratory Respiratory arrest, dyspnea and wheezing have been reported following regadenoson administration.
2 Sinoatrial and Atrioventricular Nodal Block Adenosine receptor agonists, including regadenoson, can depress the SA and AV nodes and may cause first-, second- or third-degree AV block, or sinus bradycardia requiring intervention. In clinical trials first-degree AV block (PR prolongation > 220 msec) developed in 3% of patients within 2 hours of regadenoson administration; transient second-degree AV block with one dropped beat was observed in one patient receiving regadenoson.
2) ]. 2) ]. 4 Hypersensitivity, Including Anaphylaxis Anaphylaxis, angioedema, cardiac or respiratory arrest, respiratory distress, decreased oxygen saturation, hypotension, throat tightness, urticaria and rashes have occurred. 1) ]. Have personnel and resuscitative equipment immediately available.
5 Hypotension Adenosine receptor agonists, including regadenoson, induce arterial vasodilation and hypotension. In clinical trials, decreased systolic blood pressure (> 35 mm Hg) was observed in 7% of patients and decreased diastolic blood pressure (> 25 mm Hg) was observed in 4% of patients within 45 minutes of regadenoson administration.
The risk of serious hypotension may be higher in patients with autonomic dysfunction, hypovolemia, left main coronary artery stenosis, stenotic valvular heart disease, pericarditis or pericardial effusions, or stenotic carotid artery disease with cerebrovascular insufficiency.
2) ]. 6 Hypertension Administration of adenosine receptor agonists, including regadenoson, may result in clinically significant increases in blood pressure in some patients. Among patients who experienced an increase in blood pressure in clinical trials, the increase was observed within minutes of regadenoson administration.
2) ]. 2) ]. 7 Bronchoconstriction Adenosine receptor agonists, including regadenoson, may cause dyspnea, bronchoconstriction, and respiratory compromise. 2) , Overdosage ( 10) and Patient Counseling Information ( 17) ]. 8 Seizure Regadenoson may lower the seizure threshold; obtain a seizure history.
New-onset or recurrence of convulsive seizures has occurred following regadenoson. Some seizures are prolonged and require emergent anticonvulsive management. Aminophylline may increase the risk of seizures associated with regadenoson.
Methylxanthine use is not recommended in patients who experience a seizure in association with regadenoson administration. 9 Cerebrovascular Accident (Stroke) Hemorrhagic and ischemic cerebrovascular accidents have occurred. 6 ) ]. 1 Myocardial Ischemia Fatal and nonfatal myocardial infarction (MI), ventricular arrhythmias, and cardiac arrest have occurred following regadenoson.
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 regadenoson. Cardiac resuscitation equipment and trained staff should be available before administering regadenoson.
Adhere to the recommended duration of injection [see Dosage and Administration ( 2 )]. 2) ]. If serious reactions to regadenoson injection occur, consider the use of aminophylline, an adenosine antagonist, to shorten the duration of increased coronary blood flow induced by regadenoson [see Overdosage ( 10) ].
2 Sinoatrial and Atrioventricular Nodal Block Adenosine receptor agonists, including regadenoson, can depress the SA and AV nodes and may cause first-, second- or third-degree AV block, or sinus bradycardia requiring intervention. In clinical trials first-degree AV block (PR prolongation > 220 msec) developed in 3% of patients within 2 hours of regadenoson administration; transient second-degree AV block with one dropped beat was observed in one patient receiving regadenoson.
2) ]. 2) ]. 4 Hypersensitivity, Including Anaphylaxis Anaphylaxis, angioedema, cardiac or respiratory arrest, respiratory distress, decreased oxygen saturation, hypotension, throat tightness, urticaria and rashes have occurred. 1) ]. Have personnel and resuscitative equipment immediately available.
5 Hypotension Adenosine receptor agonists, including regadenoson, induce arterial vasodilation and hypotension. In clinical trials, decreased systolic blood pressure (> 35 mm Hg) was observed in 7% of patients and decreased diastolic blood pressure (> 25 mm Hg) was observed in 4% of patients within 45 minutes of regadenoson administration.
The risk of serious hypotension may be higher in patients with autonomic dysfunction, hypovolemia, left main coronary artery stenosis, stenotic valvular heart disease, pericarditis or pericardial effusions, or stenotic carotid artery disease with cerebrovascular insufficiency.
2) ]. 6 Hypertension Administration of adenosine receptor agonists, including regadenoson, may result in clinically significant increases in blood pressure in some patients. Among patients who experienced an increase in blood pressure in clinical trials, the increase was observed within minutes of regadenoson administration.
2) ]. 2) ]. 7 Bronchoconstriction Adenosine receptor agonists, including regadenoson, may cause dyspnea, bronchoconstriction, and respiratory compromise. 2) , Overdosage ( 10) and Patient Counseling Information ( 17) ]. 8 Seizure Regadenoson may lower the seizure threshold; obtain a seizure history.
New-onset or recurrence of convulsive seizures has occurred following regadenoson. Some seizures are prolonged and require emergent anticonvulsive management. Aminophylline may increase the risk of seizures associated with regadenoson.
Methylxanthine use is not recommended in patients who experience a seizure in association with regadenoson administration. 9 Cerebrovascular Accident (Stroke) Hemorrhagic and ischemic cerebrovascular accidents have occurred. 6 ) ].