DCSIMG
Lexiscan | Contraindications
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Important Safety Information  |  Prescribing Information

Contraindications1

Do not administer Lexiscan to patients with:

  • Second- or third-degree AV block, or
  • Sinus node dysfunction

unless these patients have a functioning artificial pacemaker.

Reference

  • Lexiscan (regadenoson) injection [package insert]. Northbrook, IL: Astellas Pharma US, Inc.

Click here for Lexiscan® (regadenoson) injection Full Prescribing Information
Click Here for Lexiscan® (regadenoson) Injection Full Prescribing Information(PDF - 189KB)

INDICATION

Lexiscan is a pharmacologic stress agent indicated for radionuclide myocardial perfusion imaging (MPI) in patients unable to undergo adequate exercise stress.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

Do 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 PRECAUTIONS

Myocardial Ischemia

Fatal 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. 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.

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.

Hypotension

Adenosine 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.

Hypertension

Adenosine 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.

Bronchoconstriction

Adenosine receptor agonists, including Lexiscan, may cause dyspnea, bronchoconstriction and respiratory compromise. Appropriate bronchodilator therapy and resuscitative measures should be available prior to Lexiscan administration.

ADVERSE REACTIONS

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, 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 adverse reactions have occurred: myocardial infarction, cardiac arrest, ventricular arrhythmias, supraventricular tachyarrhythmias including atrial fibrillation or flutter, heart block, asystole, marked hypertension, hypotension, seizure, syncope, QTc prolongation, tremor, abdominal pain in association with nausea, vomiting, or myalgias, diarrhea, fecal incontinence, wheezing and musculoskeletal pain.