Lexiscan (regadenoson) injection

This information is intended for U.S. consumers only Important Safety Information | Prescribing Information

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Read Lexiscan® (regadenoson) injection Full Prescribing Information (PDF - 193 KB)

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Use

Lexiscan (regadenoson) injection is a prescription drug given through an IV line that increases blood flow through the arteries of the heart during a cardiac nuclear stress test. Lexiscan is given to patients when they are unable to exercise adequately for a stress test.

Important Safety Information
  • Lexiscan should not be given to patients who have certain abnormal heart rhythms unless they have a pacemaker.
  • Lexiscan can cause serious or fatal cardiac arrest, abnormal heart rhythms or heart attack.
  • Allergic reactions can occur after Lexiscan injection.
  • Drugs such as Lexiscan may cause an increase or decrease in blood pressure, especially in patients with certain heart and blood vessel disorders.
  • Lexiscan can cause breathing difficulties. Before receiving Lexiscan, tell your doctor if you have respiratory diseases, such as COPD (chronic obstructive pulmonary disease) or asthma. Tell your doctor about all medications you use to manage these conditions.
  • Lexiscan can increase the risk of seizures. Before receiving Lexiscan, tell your doctor if you have a history of seizures.
  • Lexiscan can cause stroke, which may be a result of an increase or decrease in blood pressure.
  • The most common side effects that occurred in clinical trials of Lexiscan were shortness of breath, headache, flushing, chest discomfort or chest pain, dizziness, nausea, abdominal discomfort, a metallic taste in the mouth, and feeling hot. Most common side effects began soon after receiving Lexiscan and went away within 15 minutes except for headache, which resolved in most patients within 30 minutes.
  • Avoid consuming any caffeine-containing foods and beverages or medicines containing caffeine, aminophylline or theophylline in the 12 hours before your scheduled heart scan.
  • Ask your doctor if you should stop taking any medications you usually take before the day of the test.
  • For women who are nursing, pump and discard breast milk for 10 hours after receiving Lexiscan.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

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Lexiscan is a registered trademark of Astellas US LLC. All other trademarks or registered trademarks are the property of their respective owners.

Lexiscan was developed in collaboration with Gilead Palo Alto, Inc. (formerly CV Therapeutics, Inc.).

© 2018 Astellas Pharma US, Inc. All rights reserved. 012-1310-PM 6/18

Astellas Pharma US, Inc.