These highlights do not include all the information needed to use ADENOSCAN safely and effectively. See full prescribing information for ADENOSCAN.
ADENOSCAN ® (adenosine) injection, for intravenous use
Initial U.S. Approval: 1995
RECENT MAJOR CHANGES
Warnings and Precautions: Cardiac Arrest, Ventricular Arrhythmias,
and Myocardial Infarction (5.1) 10/2013
Warnings and Precautions: Cerebrovascular Accidents (5.5) 8/2014
Warnings and Precautions: Seizures (5.6) 8/2014
Warnings and Precautions: Hypersensitivity (5.7) 8/2014
INDICATIONS AND USAGE
Adenoscan, a pharmacologic stress agent, is indicated as an adjunct to thallium-201 myocardial perfusion scintigraphy in patients unable to exercise adequately (1)
DOSAGE AND ADMINISTRATION
Recommended dose is 0.14 mg/kg/min infused over six minutes as a continuous peripheral intravenous infusion (total dose of 0.84 mg/kg) (2)
DOSAGE FORMS AND STRENGTHS
For Injection: 3 mg/mL in single-dose vials (3)
CONTRAINDICATIONS
-
•
-
Second- or third-degree AV block (except in patients with a functioning artificial pacemaker) ( 4)
-
•
-
Sinus node disease, such as sick sinus syndrome or symptomatic bradycardia (except in patients with a functioning artificial pacemaker) ( 4)
-
•
-
Known or suspected bronchoconstrictive or bronchospastic lung disease (e.g., asthma) ( 4)
-
•
-
Known hypersensitivity to Adenoscan ( 4)
WARNINGS AND PRECAUTIONS
-
•
-
Cardiac Arrest, Ventricular Arrhythmias, and Myocardial Infarction. Fatal cardiac events have occurred. Avoid use in patients with symptoms or signs of acute myocardial ischemia. Appropriate resuscitative measures should be available ( 5.1)
-
•
-
Sinoatrial (SA) and Atrioventricular (AV) Nodal Block. First-, second- or third-degree AV block, or sinus bradycardia can occur. Discontinue Adenoscan if patient develops persistent or symptomatic high-grade AV block ( 5.2)
-
•
-
Bronchoconstriction. Can induce dyspnea, bronchoconstriction, and respiratory compromise, especially in patients with obstructive pulmonary disease. Discontinue Adenoscan if patient develops severe respiratory difficulties ( 5.3)
-
•
-
Hypotension. Significant hypotension can occur. Discontinue Adenoscan if patient develops persistent or symptomatic hypotension ( 5.4)
-
•
-
Cerebrovascular Accidents. Hemorrhagic and ischemic cerebrovascular accidents have occurred ( 5.5)
-
•
-
Seizures. New onset or recurrence of convulsive seizures have occurred. Use of methylxanthines (e.g., caffeine, aminophylline and theophylline) is not recommended in patients who experience seizures in association with Adenoscan ( 5.6)
-
•
-
Hypersensitivity. Dyspnea, throat tightness, flushing, erythema, rash, and chest discomfort have occurred. Have personnel and resuscitative equipment immediately available ( 5.7)
-
•
-
Atrial Fibrillation. Reported in patients with or without a history of atrial fibrillation ( 5.8)
-
•
-
Hypertension. Clinically significant increases in systolic and diastolic pressure have been observed ( 5.9)
ADVERSE REACTIONS
Most common adverse reactions (incidence ≥ 10%) are: flushing; chest discomfort; shortness of breath; headache; throat, neck or jaw discomfort; gastrointestinal discomfort; and dizziness (6.1)
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 interfere with the activity of Adenoscan ( 7.1, 10)
-
•
-
Nucleoside transport inhibitors such as dipyridamole can increase the activity of Adenoscan ( 7.1)
See 17 for PATIENT COUNSELING INFORMATION.
Revised: 8/2014
