Click here for Adenoscan® (adenosine) injection Full Prescribing Information
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INDICATION

Intravenous Adenoscan (adenosine) injection is indicated as an adjunct to thallium-201 myocardial perfusion scintigraphy in patients unable to exercise adequately.

IMPORTANT SAFETY INFORMATION

Adenoscan is contraindicated in patients with second- or third-degree AV block (unless these patients have a functioning artificial pacemaker), sinus node disease, known or suspected bronchoconstrictive or bronchospastic lung disease and known hypersensitivity to the product.

Fatal and nonfatal cardiac arrest, sustained ventricular tachycardia (requiring resuscitation), and myocardial infarction have occurred following Adenoscan infusion. 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 Adenoscan. Appropriate resuscitative measures should be available.

Adenoscan exerts a direct depressant effect on the SA and AV nodes and has the potential to cause first-, second- or third-degree AV block, or sinus bradycardia.

Adenosine receptor agonists, including Adenoscan, may cause bronchoconstriction and respiratory compromise. Resuscitative measures should be available prior to Adenoscan administration.

Adenoscan is a potent peripheral vasodilator and can cause significant hypotension. The risk of hypotension may be higher in patients with cardiac or cerebrovascular insufficiency.

Hemorrhagic and ischemic cerebrovascular accidents have occurred. Hemodynamic effects of Adenoscan injection including hypotension or hypertension may be associated with these adverse reactions.

New-onset or recurrence of convulsive seizures has occurred following Adenoscan injection. Some seizures are prolonged and require emergent anticonvulsive management. Aminophylline may increase the risk of seizures associated with Adenoscan injection. Methylxanthine use is not recommended in patients who experience seizures in association with Adenoscan administration.

Adenoscan should not be used in patients with known or suspected hypersensitivity to the product. Dyspnea, throat tightness, flushing, erythema, rash, and chest discomfort have occurred. Appropriate treatment and resuscitative measures should be available.

Atrial fibrillation has been reported in patients (with or without a history of atrial fibrillation) undergoing myocardial perfusion imaging with adenosine infusion. In these cases, atrial fibrillation began 1.5 to 3 minutes after initiation of Adenoscan, lasted for 15 seconds to 6 hours, and spontaneously converted to normal sinus rhythm.

Increases in systolic and diastolic pressure have been observed.

Most common adverse reactions (≥10%) to Adenoscan are flushing, chest discomfort, dyspnea, headache, discomfort of the throat, neck, or jaw, gastrointestinal discomfort, and lightheadedness/dizziness. Side effects with Adenoscan usually resolve quickly when the infusion is discontinued, although delayed or persistent effects have been observed.

In postmarketing experience, the following additional adverse reactions have occurred: cardiac failure, ventricular arrhythmia, nausea and vomiting, chest pain, injection site reaction, infusion site pain, loss of consciousness, bronchospasm, respiratory arrest and throat tightness.

Click here for Lexiscan® (regadenoson) injection Full Prescribing Information
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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.

Atrial Fibrillation/Atrial Flutter
New-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.

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.

Seizure
Lexiscan may lower the seizure threshold. 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 REACTIONS
In 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, tremor, QTc prolongation, abdominal pain in association with nausea, vomiting, or myalgias, diarrhea, fecal incontinence, wheezing and musculoskeletal pain.

a Based on procedure share data from Decision Resourcesb, April 2014.