Label Changes for:

Lexiscan (regadenoson) Injection

September 2014

Changes have been made to the WARNINGS, PRECAUTIONS and ADVERSE REACTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)

 

September 2014

5 WARNINGS AND PRECAUTIONS

5.3 Atrial Fibrillation/Atrial Flutter
  • New-onset or recurrent atrial fibrillation with rapid ventricular response and atrial flutter have been reported following Lexiscan injection [see Adverse Reactions (6.2)].
5.8 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.
5.9 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 [see Warnings and Precautions (5.5) and (5.6)].

6 ADVERSE REACTIONS

The following adverse reactions are discussed in more detail in other sections of the labeling.

added:

  • Atrial Fibrillation/Atrial Flutter [see Warnings and Precautions (5.3)]
  • Seizure [see Warnings and Precautions (5.8)]
  • Cerebrovascular Accident (Stroke) [see Warnings and Precautions (5.9)
6.2 Postmarketing Experience

Cardiovascular:

  • Myocardial infarction, cardiac arrest, ventricular arrhythmias, supraventricular tachyarrhythmias including atrial fibrillation with rapid ventricular response (new-onset or recurrent), atrial flutter, heart block (including third-degree block), asystole, marked hypertension, symptomatic hypotension in association with transient ischemic attack, seizures and syncope.

Central Nervous System:

  • Tremor, seizure, transient ischemic attack, and cerebrovascular accident including intracranial hemorrhage [see Warnings and Precautions (5.8) and (5.9)]

7 DRUG INTERACTIONS

  • Methylxanthines (e.g., caffeine, aminophylline and theophylline) are non-specific adenosine receptor antagonists that interfere with the vasodilation activity of Lexiscan [see Clinical Pharmacology (12.2) and Patient Counseling Information (17)]. Patients should avoid consumption of any products containing methylxanthines as well as any drugs containing theophylline or aminophylline for at least 12 hours before Lexiscan administration.

17 PATIENT COUNSELING INFORMATION

  • Advise patients that they may be at increased risk of fatal and nonfatal heart attacks, abnormal heart rhythms, cardiac arrest, significant increase or decrease in blood pressure, hypersensitivity reactions, seizures, bronchoconstriction, or cerebrovascular accidents (stroke) with the use of Lexiscan [see Warnings and Precautions (5.1), (5.3), (5.4), (5.5), (5.6), (5.8) and (5.9)].
  • Patients should be instructed to avoid consumption of any products containing methylxanthines, including caffeinated coffee, tea or other caffeinated beverages, caffeine-containing drug products, aminophylline and theophylline for at least 12 hours before a scheduled radionuclide MPI. Question patients about a history of seizures.
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