HIGHLIGHTS OF PRESCRIBING INFORMATION hypotension, …

1 HIGHLIGHTS OF PRESCRIBING INFORMATION hypotension, throat tightness, urticaria, and rashes have occurred. Have These HIGHLIGHTS do not include all the INFORMATION needed to use personnel and resuscitative equipment immediately available ( ). LEXISCAN safely and effectively. See full PRESCRIBING INFORMATION for Hypotension. Adenosine receptor agonists, including LEXISCAN, LEXISCAN . induce vasodilation and hypotension. The risk of serious hypotension . LEXISCAN (regadenoson) injection for intravenous use may be higher in patients with autonomic dysfunction, stenotic valvular Initial Approval: 2008 heart disease, pericarditis or pericardial effusions, stenotic carotid artery disease with cerebrovascular insufficiency, or hypovolemia ( ).

2 ----------------------------RECENT MAJOR CHANGES-------------------------- Hypertension. Adenosine receptor agonists, including LEXISCAN, may Dosage and Administration (2) 5/2018. induce clinically significant increases in blood pressure particularly in Warnings and Precautions, Myocardial Ischemia ( ) 5/2018 patients with a history of hypertension and when the MPI includes low level exercise ( ). ----------------------------INDICATIONS AND USAGE--------------------------- LEXISCAN is a pharmacologic stress agent indicated for radionuclide Bronchoconstriction.

3 Adenosine receptor agonists, including myocardial perfusion imaging (MPI) in patients unable to undergo adequate LEXISCAN, may induce dyspnea, bronchoconstriction and respiratory exercise stress (1). compromise in patients with chronic obstructive pulmonary disease (COPD) or asthma. Resuscitative measures should be available ( ). ----------------------DOSAGE AND ADMINISTRATION----------------------- Seizure. LEXISCAN may lower the seizure threshold. New onset or The recommended dose of LEXISCAN is 5 mL ( mg regadenoson) recurrence of convulsive seizures has occurred.

4 Some seizures are administered as an intravenous injection within 10 seconds; followed prolonged and require urgent anticonvulsive management. immediately by saline flush and radiopharmaceutical (2). Methylxanthine use is not recommended in patients who experience a seizure in association with LEXISCAN ( ). ---------------------DOSAGE FORMS AND STRENGTHS---------------------- Cerebrovascular Accident (Stroke). Hemorrhagic and ischemic Injection: Single-dose pre-filled syringe: mg/5 mL ( mg/mL) (3). cerebrovascular accidents have occurred ( ).

5 -------------------------------CONTRAIND ICATIONS------------------------------ ------------------------------ADVERSE REACTIONS------------------------------- Do not administer LEXISCAN to patients with: The most common (incidence 5%) adverse reactions to LEXISCAN are Second- or third-degree AV block, or dyspnea, headache, flushing, chest discomfort, dizziness, angina pectoris, sinus node dysfunction chest pain, and nausea (6). unless the patients have a functioning artificial pacemaker (4). To report SUSPECTED ADVERSE REACTIONS, contact Astellas Pharma US, Inc.

6 At 1-800-727-7003 or FDA at 1-800-FDA-1088 or -----------------------WARNINGS AND PRECAUTIONS------------------------ Myocardial Ischemia. Fatal cardiac events have occurred. Avoid use in patients with symptoms or signs of acute myocardial ischemia, for ------------------------------DRUG INTERACTIONS---------------------------- --- example unstable angina or cardiovascular instability, who may be at Methylxanthines, , caffeine, aminophylline and theophylline, greater risk. Cardiac resuscitation equipment and trained staff should be interfere with the activity of LEXISCAN ( , ).

7 Available before administration ( ). Aminophylline may be used to attenuate severe and/or persistent adverse Sinoatrial (SA) and Atrioventricular (AV) Nodal Block. Adenosine reactions to LEXISCAN ( , 10). receptor agonists, including LEXISCAN, can depress the SA and AV. Dipyridamole may increase the activity of LEXISCAN. When possible, nodes and may cause first-, second- or third-degree AV block, or sinus withhold dipyridamole for at least two days prior to LEXISCAN. bradycardia ( ). administration ( ). Atrial Fibrillation/Atrial Flutter.

8 New-onset or recurrent atrial fibrillation See 17 for PATIENT COUNSELING INFORMATION . with rapid ventricular response and atrial flutter have been reported ( ). Revised: 5/2018. Hypersensitivity, including anaphylaxis, angioedema, cardiac or respiratory arrest, respiratory distress, decreased oxygen saturation, FULL PRESCRIBING INFORMATION : CONTENTS*. 1 INDICATIONS AND USAGE Pregnancy 2 DOSAGE AND ADMINISTRATION Lactation 3 DOSAGE FORMS AND STRENGTHS Pediatric Use 4 CONTRAINDICATIONS Geriatric Use 5 WARNINGS AND PRECAUTIONS Renal Impairment Myocardial Ischemia 10 OVERDOSAGE.

9 Sinoatrial and Atrioventricular Nodal Block 11 DESCRIPTION. Atrial Fibrillation/Atrial Flutter 12 CLINICAL PHARMACOLOGY. Hypersensitivity, Including Anaphylaxis Mechanism of Action Hypotension Pharmacodynamics Hypertension Pharmacokinetics Bronchoconstriction 13 NONCLINICAL TOXICOLOGY. Seizure Carcinogenesis, Mutagenesis, Impairment of Fertility Cerebrovascular Accident (Stroke) Animal Toxicology and/or Pharmacology 6 ADVERSE REACTIONS 14 CLINICAL STUDIES. Clinical Trials Experience 16 HOW SUPPLIED/STORAGE AND HANDLING.

10 Post-Marketing Experience 17 PATIENT COUNSELING INFORMATION . 7 DRUG INTERACTIONS *Sections or subsections omitted from the full PRESCRIBING INFORMATION are not Effects of Other Drugs on LEXISCAN listed Effect of LEXISCAN on Other Drugs 8 USE IN SPECIFIC POPULATIONS. FULL PRESCRIBING INFORMATION . 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. 2 DOSAGE AND ADMINISTRATION.