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LEXISCAN 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 LEXISCAN ® (regadenoson) injection is a pharmacologic stress agent indicated for radionuclide myocardial perfusion imaging (MPI) in patients unable to undergo adequate exercise stress. LEXISCAN ® 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 LEXISCAN if it contains particulate matter or is discolored. • Administer LEXISCAN as an intravenous injection within 10 seconds into a peripheral vein using a 22 gauge or larger catheter or needle. • Administer a 5 mL saline flush immediately after the injection of LEXISCAN.
• 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 LEXISCAN. 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 LEXISCAN are dyspnea, headache, flushing, chest discomfort, dizziness, angina pectoris, chest pain, and nausea ( 6 ).
To report SUSPECTED ADVERSE REACTIONS, contact Astellas Pharma US, Inc. 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 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. 2 ) ]. Table 2 Rhythm or Conduction Abnormalities 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 LEXISCAN, induce vasodilation and hypotension. 5 ). • Hypertension. 6 ). • Bronchoconstriction. Adenosine receptor agonists, including LEXISCAN, may induce dyspnea, bronchoconstriction and respiratory compromise in patients with chronic obstructive pulmonary disease (COPD) or asthma.
7 ). • Seizure. LEXISCAN 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 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 ) ]. 2 ) ]. If serious reactions to LEXISCAN occur, consider the use of aminophylline, an adenosine antagonist, to shorten the duration of increased coronary blood flow induced by LEXISCAN [ see Overdosage ( 10 ) ].
2 ) ]. Do not administer LEXISCAN 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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in Studies 1 and 2 LEXISCAN N / N evaluable (%) ADENOSCAN N / N evaluable (%) Rhythm or conduction abnormalities 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 ).
Table 3 Respiratory Adverse Effects All patients continued the use of their respiratory medications as prescribed prior to administration of LEXISCAN. Asthma Cohort Chronic Obstructive Pulmonary Disease (COPD) Cohort LEXISCAN (N=356) Placebo (N=176) LEXISCAN (N=316) Placebo (N=151) Overall Pre-specified Respiratory Adverse Reaction 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. 7% FEV 1 reduction >15% 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 LEXISCAN administration following inadequate exercise stress, 1,147 patients were randomized into one of two groups.
Each group underwent two LEXISCAN stress myocardial perfusion imaging (MPI) procedures. Group 1 received LEXISCAN 3 minutes following inadequate exercise in the first LEXISCAN stress (MPI 1). Group 2 rested 1 hour after inadequate exercise to allow hemodynamics to return to baseline prior to receiving LEXISCAN (MPI 1).
Both groups returned for a second stress MPI 1-14 days later and received LEXISCAN 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 LEXISCAN following inadequate exercise did not alter the common adverse reaction profile.
1 ) ]. The cardiac events were numerically higher in Group 1. Table 4 Cardiac Events of Interest in Inadequate Exercise Stress Study Cardiac Event 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 LEXISCAN administration has been reported. 9 ) ]. Gastrointestinal Abdominal pain, occasionally severe, has been reported a few minutes after LEXISCAN 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 LEXISCAN administration. 4 ) ]. Musculoskeletal Musculoskeletal pain has occurred, typically 10-20 minutes after LEXISCAN 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 LEXISCAN administration.
2 Sinoatrial and Atrioventricular Nodal Block Adenosine receptor agonists, including LEXISCAN, 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 LEXISCAN administration; transient second-degree AV block with one dropped beat was observed in one patient receiving LEXISCAN.
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 LEXISCAN, 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 LEXISCAN 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 LEXISCAN, 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 LEXISCAN administration.
2 ) ]. 2 ) ]. 7 Bronchoconstriction Adenosine receptor agonists, including LEXISCAN, may cause dyspnea, bronchoconstriction, and respiratory compromise. 2 ) , Overdosage ( 10 ) and Patient Counseling Information ( 17 ) ]. 8 Seizure LEXISCAN may lower the seizure threshold; obtain a seizure history.
New-onset or recurrence of convulsive seizures has occurred following LEXISCAN injection. Some seizures are prolonged and require emergent anticonvulsive management. Aminophylline may increase the risk of seizures associated with LEXISCAN injection.
Methylxanthine use is not recommended in patients who experience a seizure in association with LEXISCAN administration. 9 Cerebrovascular Accident (Stroke) Hemorrhagic and ischemic cerebrovascular accidents have occurred. 6 ) ].