Lexiscan
Generic Name: regadenoson
Date of Approval: April 10, 2008
Company: CV Therapeutics, Inc.
Treatment for: Pharmacologic Stress Agent
FDA Approves Lexiscan
The U.S. Food and Drug Administration (FDA) has approved Lexiscan (regadenoson) injection, an A2A adenosine receptor agonist, for use as a pharmacologic stress agent in radionuclide myocardial perfusion imaging (MPI).
Lexiscan is an A2A adenosine receptor agonist approved for use as a pharmacologic stress agent in radionuclide MPI studies in patients unable to undergo adequate exercise stress. Lexiscan was designed to produce coronary vasodilation and increase coronary blood flow by activation of the A2A adenosine receptor. Lexiscan is administered as a rapid bolus (approximately 10 seconds) with no dose adjustment required for body weight. Lexiscan should not be administered to patients with second- or third-degree AV block or sinus node dysfunction who do not have a functioning artificial pacemaker. Adenosine receptor agonists, including Lexiscan, induce arterial vasodilation and hypotension. The risk of serious hypotension may be higher in patients with cardiac or cerebrovascular insufficiency. Complete prescribing information is available at www.Lexiscan.com.
Lexiscan Clinical Trials
In two identically designed Phase III clinical trials, Lexiscan met primary endpoints for scan agreement rates by showing with 95 percent confidence that MPI studies conducted with Lexiscan were similar to MPI studies conducted with Adenoscan (adenosine injection).
Lexiscan was generally well-tolerated in both Phase III studies. The most common adverse events reported in patients who received Lexiscan were shortness of breath, headache, flushing, chest discomfort, dizziness and nausea.
Source: CV Therapeutics
Highlights of Lexiscan Prescribing Information
These highlights do not include all the information needed to use Lexiscan safely and effectively. See full prescribing information for Lexiscan.
Lexiscan Indications and Usage
Lexiscan is a pharmacologic stress agent indicated for radionuclide myocardial perfusion imaging (MPI) in patients unable to undergo adequate exercise stress.
Dosage and Administration
The recommended dose of Lexiscan is 5 mL (0.4 mg regadenoson) by rapid intravenous injection; followed immediately by saline flush and radiopharmaceutical.
Dosage Forms and Strengths
Single-use vial: Injection solution containing regadenoson 0.4 mg/5 mL (0.08 mg/mL)
Single-use pre-filled syringe: Injection solution containing regadenoson 0.4 mg/5 mL (0.08 mg/mL)
Contraindications
Do not administer Lexiscan to patients with:
- second or third degree AV block, or
- sinus node dysfunction
Warnings and Precautions
Fatal cardiac arrest, life threatening ventricular arrhythmias, or myocardial infarction may be induced by pharmacologic stress agents. Cardiac resuscitation equipment and trained staff should be available before administering Lexiscan.
Sinoatrial (SA) and atrioventricular (AV) 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.
Hypotension. Adenosine receptor agonists including Lexiscan induce vasodilation and hypotension. The risk of serious hypotension may be higher in patients with autonomic dysfunction, stenotic valvular heart disease, pericarditis or pericardial effusions, stenotic carotid artery disease with cerebrovascular insufficiency, or hypovolemia.
Adenosine receptor agonists may induce bronchoconstriction and respiratory compromise in patients with COPD or asthma. Resuscitative measures should be available.
Adverse Reactions
The most common (incidence ≥ 5%) adverse reactions to Lexiscan are dyspnea, headache, flushing, chest discomfort, dizziness, angina pectoris, chest pain, and nausea.
To report SUSPECTED ADVERSE REACTIONS, contact Astellas Pharma US, Inc. at 1-800-727-7003 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
Drug Interactions
Methylxanthines, e.g., caffeine and theophylline, may interfere with the activity of Lexiscan
Aminophylline may be used to attenuate severe and/or persistent adverse reactions to Lexiscan
Dipyridamole may increase the activity of Lexiscan. When possible, withhold dipyridamole for at least two days prior to Lexiscan administration
Patient Counseling Information
Patients should be instructed to avoid consumption of any products containing methylxanthines, including caffeinated coffee, tea or other caffeinated beverages, caffeine-containing drug products, and theophylline for at least 12 hours before a scheduled radionuclide MPI.
Prior to Lexiscan administration, patients should be informed of the most common reactions (such as shortness of breath, headache and flushing) that have been reported in association with Lexiscan during MPI.
Patients with COPD or asthma should be informed to discuss their respiratory history and administration of pre-and post-study bronchodilator therapy with their clinician before scheduling an MPI study with Lexiscan.
For more information, please visit www.lexiscan.com
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