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Lexiscan® (Regadenoson) Injection Study in Subjects With Asthma or Chronic Obstructive Pulmonary Disease (COPD) Presented as Late-Breaker at American Society of Nuclear Cardiology 2010
Date:9/25/2010

including Lexiscan, induce arterial vasodilation and hypotension. In postmarketing experience, syncope, transient ischemic attacks, and seizures have been observed. 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.

Adenosine receptor agonists, including Lexiscan, may result in clinically significant increases in blood pressure in some patients. When it occurred in clinical trials, increased blood pressure was observed within minutes of Lexiscan administration, and in most cases, resolved within 10 to 15 minutes. In some cases, blood pressure increases were observed 45 minutes following Lexiscan administration. 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.

Adenosine receptor agonists, including Lexiscan, may cause bronchoconstriction and respiratory compromise. For patients with known or suspected bronchoconstrictive disease, chronic obstructive pulmonary disease (COPD), or asthma, appropriate bronchodilator therapy and resuscitative measures should be available prior to Lexiscan administration.

Lexiscan overdosage may result in serious reactions. Aminophylline was used as a reversal agent in 3% of patients.

The most common adverse reactions (>5%) to Lexiscan are dyspnea, headache, flushing, chest discomfort, angina pectoris or ST-segment depression, dizziness, chest pain, nausea, abdominal discomfort, dysgeusia,
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SOURCE Astellas Pharma US, Inc.
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