Official Home Page | Lexiscan (regadenoson) injection

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Web Name: Official Home Page | Lexiscan (regadenoson) injection

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You Are Now Leaving Lexiscan.com/HCP The website you are linking to is neither owned nor controlled by Astellas. Astellas is not responsible for the content or services onthissite. X The information contained on this site is intended for healthcare professionals in the United States only. Please verify that you are a US healthcare professional. aSymphony Health Solutions, NonRetailSource, January 2020, based on Astellas market definition of pharmacologic stress agents, as used in single-photon emission computed tomography myocardial perfusion imaging (SPECT MPI).IndicationLexiscan (regadenoson) injection is a pharmacologic stress agent indicated for radionuclide myocardial perfusion imaging (MPI) in patients unable to undergo adequate exercise stress.IMPORTANT SAFETY INFORMATIONContraindicationsDo not administer Lexiscan to patients with second- or third-degree AV block or sinus node dysfunction unless these patients have a functioning artificial pacemaker.Warnings and PrecautionsMyocardial IschemiaFatal and nonfatal myocardial infarction, 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. As noted in an animal study, longer injection times may increase the duration and magnitude of increase in coronary blood flow. 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.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 postmarketing experience, heart block (including third degree), and asystole within minutes of Lexiscan administration have occurred.Atrial Fibrillation/Atrial FlutterNew-onset or recurrent atrial fibrillation with rapid ventricular response and atrial flutter have been reported following Lexiscan injection.Hypersensitivity, Including Anaphylaxis Anaphylaxis, angioedema, cardiac or respiratory arrest, respiratory distress, decreased oxygen saturation, hypotension, throat tightness, urticaria and rashes have occurred. In clinical trials, hypersensitivity reactions were reported in fewer than 1 percent of patients.HypotensionAdenosine receptor agonists, including Lexiscan, induce arterial vasodilation and hypotension. 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. In postmarketing experience, transient ischemic attacks, seizures and syncope have been observed.HypertensionAdenosine receptor agonists, including Lexiscan, may result in clinically significant increases in blood pressure in some patients. In postmarketing experience, cases of potentially clinically significant hypertension have been reported, particularly in patients with underlying hypertension and when low-level exercise was included in the MPI.BronchoconstrictionAdenosine receptor agonists, including Lexiscan, may cause dyspnea, bronchoconstriction and respiratory compromise. Appropriate bronchodilator therapy and resuscitative measures should be available prior to and following Lexiscan administration.SeizureLexiscan 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.Cerebrovascular Accident (Stroke)Hemorrhagic and ischemic cerebrovascular accidents have occurred. Hemodynamic effects of Lexiscan including hypotension or hypertension may be associated with these adverse reactions.Adverse ReactionsIn clinical trials, the most common adverse reactions (≥5%) to Lexiscan were dyspnea, headache, flushing, chest discomfort, angina pectoris or ST-segment depression, dizziness, chest pain, nausea, abdominal discomfort, dysgeusia, and feeling hot. 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. Aminophylline was used as a reversal agent in 3% of patients.In postmarketing experience, the following additional adverse reactions have occurred: supraventricular tachyarrhythmias, acute coronary syndrome (ACS), tremor, QTc prolongation, abdominal pain in association with nausea, vomiting, or myalgias, diarrhea, fecal incontinence, wheezing and musculoskeletal pain. Lexiscan and SIMPLIFY THE STRESS are registered trademarks of Astellas US LLC. Lexiscan Support Solutionssm, a component of Astellas Pharma Support Solutionssm, is a service mark of Astellas Pharma US, Inc. Astellas and the flying star logo are registered trademarks of Astellas Pharma Inc. All other trademarks or registered trademarks are the property of their respective owners. Lexiscan was developed in collaboration with Gilead Palo Alto, Inc. (formerly CV Therapeutics, Inc.). 2020 Astellas Pharma US, Inc.All rights reserved.012 1387 PM6/19012 1478 PM12/19012-1491-PM3/20 With clinical experience and offering operational flexibility, Lexiscan (regadenoson) injection has been an important part of the nuclear cardiology community for over a decade and counting.1 Lexiscan is a pharmacologic stress agent indicated for radionuclide myocardial perfusion imaging (MPI) in patients unable to undergo adequate exercise stress. Access and reimbursement support is available for Lexiscan. SPECT MPI = single-photon emission computed tomography myocardial perfusion imaging. aSymphony Health Solutions, NonRetailSource, January 2020, based on Astellas market definition of pharmacologic stress agents, as used in SPECT MPI. Reference Lexiscan [package insert]. Northbrook, IL: Astellas Pharma US, Inc. With clinical experience and offering operational flexibility, Lexiscan (regadenoson) injection has been an important part of the nuclear cardiology community for over a decade and counting.1 Lexiscan is a pharmacologic stress agent indicated for radionuclide myocardial perfusion imaging (MPI) in patients unable to undergo adequate exercise stress. Access and reimbursement support is available for Lexiscan. Image is an artistic representation of coronary arteries. No depiction of action or function of Lexiscan is intended or implied. Mechanism of Action (MOA) See how Lexiscan induces coronary vasodilation at the molecular level. Learn more about the MOA Dosing and Administration Explore how Lexiscan dosing and administration can be integrated into existing operational workflows. Learn more about dosing Access and Reimbursement Learn about available support for access, reimbursement, coding, and billing. Explore Lexiscan Support SolutionsSMIndicationLexiscan (regadenoson) injection is a pharmacologic stress agent indicated for radionuclide myocardial perfusion imaging (MPI) in patients unable to undergo adequate exercise stress.IMPORTANT SAFETY INFORMATIONContraindicationsDo not administer Lexiscan to patients with second- or third-degree AV block or sinus node dysfunction unless these patients have a functioning artificial pacemaker.Warnings and PrecautionsMyocardial IschemiaFatal and nonfatal myocardial infarction, 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. As noted in an animal study, longer injection times may increase the duration and magnitude of increase in coronary blood flow. 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.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 postmarketing experience, heart block (including third degree), and asystole within minutes of Lexiscan administration have occurred.Atrial Fibrillation/Atrial FlutterNew-onset or recurrent atrial fibrillation with rapid ventricular response and atrial flutter have been reported following Lexiscan injection.Hypersensitivity, Including Anaphylaxis Anaphylaxis, angioedema, cardiac or respiratory arrest, respiratory distress, decreased oxygen saturation, hypotension, throat tightness, urticaria and rashes have occurred. In clinical trials, hypersensitivity reactions were reported in fewer than 1 percent of patients.HypotensionAdenosine receptor agonists, including Lexiscan, induce arterial vasodilation and hypotension. 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. In postmarketing experience, transient ischemic attacks, seizures and syncope have been observed.HypertensionAdenosine receptor agonists, including Lexiscan, may result in clinically significant increases in blood pressure in some patients. In postmarketing experience, cases of potentially clinically significant hypertension have been reported, particularly in patients with underlying hypertension and when low-level exercise was included in the MPI.BronchoconstrictionAdenosine receptor agonists, including Lexiscan, may cause dyspnea, bronchoconstriction and respiratory compromise. Appropriate bronchodilator therapy and resuscitative measures should be available prior to and following Lexiscan administration.SeizureLexiscan 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.Cerebrovascular Accident (Stroke)Hemorrhagic and ischemic cerebrovascular accidents have occurred. Hemodynamic effects of Lexiscan including hypotension or hypertension may be associated with these adverse reactions.Adverse ReactionsIn clinical trials, the most common adverse reactions (≥5%) to Lexiscan were dyspnea, headache, flushing, chest discomfort, angina pectoris or ST-segment depression, dizziness, chest pain, nausea, abdominal discomfort, dysgeusia, and feeling hot. 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. Aminophylline was used as a reversal agent in 3% of patients.In postmarketing experience, the following additional adverse reactions have occurred: supraventricular tachyarrhythmias, acute coronary syndrome (ACS), tremor, QTc prolongation, abdominal pain in association with nausea, vomiting, or myalgias, diarrhea, fecal incontinence, wheezing and musculoskeletal pain.ContraindicationsDo not administer Lexiscan to patients with second- or third-degree AV block or sinus node dysfunction unless these patients have a functioning artificial pacemaker.Warnings and PrecautionsMyocardial IschemiaFatal and nonfatal myocardial infarction, 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. As noted in an animal study, 
longer injection times may increase the duration and magnitude of increase in coronary blood flow. 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.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 postmarketing experience, heart block (including third degree), and asystole within minutes of Lexiscan administration have occurred.Atrial Fibrillation/Atrial FlutterNew-onset or recurrent atrial fibrillation with rapid ventricular response and atrial flutter have been reported following Lexiscan injection.Hypersensitivity, Including Anaphylaxis Anaphylaxis, angioedema, cardiac or respiratory arrest, respiratory distress, decreased oxygen saturation, hypotension, throat tightness, urticaria and rashes have occurred. In clinical trials, hypersensitivity reactions were reported in fewer than 1 percent of patients.HypotensionAdenosine receptor agonists, including Lexiscan, induce arterial vasodilation and hypotension. 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. In postmarketing experience, transient ischemic attacks, seizures and syncope have been observed.HypertensionAdenosine receptor agonists, including Lexiscan, may result in clinically significant increases in blood pressure in some patients. In postmarketing experience, cases 
of potentially clinically significant hypertension have been reported, particularly in patients with underlying hypertension and when low-level exercise was included 
in the MPI.BronchoconstrictionAdenosine receptor agonists, including Lexiscan, may cause dyspnea, bronchoconstriction and respiratory compromise. Appropriate bronchodilator therapy and resuscitative measures should be available prior to and following Lexiscan administration.SeizureLexiscan 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.Cerebrovascular Accident (Stroke)Hemorrhagic and ischemic cerebrovascular accidents have occurred. Hemodynamic effects of Lexiscan including hypotension or hypertension may be associated with these adverse reactions.Adverse ReactionsIn clinical trials, the most common adverse reactions (≥5%) to Lexiscan were dyspnea, headache, flushing, chest discomfort, angina pectoris or ST-segment depression, dizziness, chest pain, nausea, abdominal discomfort, dysgeusia, and feeling hot. 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. Aminophylline was used as a reversal agent in 3% of patients.In postmarketing experience, the following additional adverse reactions have occurred: supraventricular tachyarrhythmias, acute coronary syndrome (ACS), tremor, QTc prolongation, abdominal pain in association with nausea, vomiting, or myalgias, diarrhea, fecal incontinence, wheezing and musculoskeletal pain.IndicationLexiscan is a pharmacologic stress agent indicated for radionuclide myocardial perfusion imaging (MPI) in patients unable to undergo adequate exercise stress.

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