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

The recommended intravenous dose of Lexiscan is 5 mL (0.4 mg regadenoson)

• Administer Lexiscan as a rapid (approximately 10 seconds) injection into a peripheral vein using a 22 gauge or larger catheter or needle.
• Administer a 5 mL saline flush immediately after the injection of Lexiscan.
• Administer the radionuclide myocardial perfusion imaging agent 10-20 seconds after the saline flush. The radionuclide may be injected directly into the same catheter as Lexiscan.

NOTE: Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not administer Lexiscan if it contains particulate matter or is discolored.

Dosage Forms And Strengths

• Single-use vial: Injection solution containing regadenoson 0.4 mg/5 mL (0.08 mg/mL).
• Single-use pre-filled syringe: Injection solution containing regadenoson 0.4 mg/5 mL (0.08 mg/mL).

Lexiscan is supplied as a sterile, preservative-free solution containing 0.08 mg/mL regadenoson in the following packages:

• Single-use 5 mL vials (NDC 0469-6501-05).
• Single-use 5 mL pre-filled plastic Ansyr® syringes with luer-lock fitting (NDC 0469-6501-89).

Store at controlled room temperature, 25°C (77°F); excursions permitted to 15° to 30°C (59°-86°F).

Marketed by: Astellas Pharma US, Inc. Deerfield, IL 60015. Vials Manufactured by: Baxter Pharmaceutical Solutions LLC, Bloomington, IN 47403. Syringes Manufactured by: Hospira, Inc. Lake Forest, IL 60045 USA. FDA Rev date: 4/10/2008

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