Company:

Astellas

Stress agent (A_2A adenosine receptor agonist)

Regadenoson 0.4mg/5mL; soln for IV inj; preservative-free.

Radionuclide myocardial perfusion imaging (MPI) in patients unable to undergo adequate exercise stress.

Cardiac stress tests are conducted to visualize coronary blood flow in order to determine the extent of coronary artery disease. Many patients exercise on a treadmill in order to cause an increase in coronary blood flow, but some are unable to exercise enough to perform the test. For these patients, a drug that temporarily increases blood flow through the coronary arteries may be used to mimic the increase in coronary blood flow caused by exercise.

Regadenoson is an A_2A adenosine receptor agonist that causes coronary vasodilation and rapidly increases coronary blood flow for a short duration. There are several known adenosine receptor subtypes, including A₁, A_2B and A₃. Regadenoson has a much greater affinity for the A_2A subtype, which is the receptor primarily responsible for coronary vasodilation.

Regadenoson was compared to adenosine in two randomized, double-blind studies in 2015 patients who were indicated to undergo pharmacologic stress myocardial perfusion imaging. Each of 1871 patients who had images valid for the primary efficacy evaluation received an initial stress scan using adenosine. After the initial scan, patients were randomized to either regadenoson or adenosine and underwent a second test after a median of 7 days. In both studies, it was shown that the use of regadenoson was similar to adenosine for assessing the extent of reversible perfusion abnormalities.

≥18yrs: 5mL (0.4mg) by rapid IV injection over 10 seconds; follow immediately with saline flush (5mL) then radiopharmaceutical 10–20 seconds later. Use peripheral vein and 22G or larger needle or catheter.

<18yrs: not recommended.

2nd- or 3rd-degree AV block or sinus node dysfunction, unless paced.

Have resuscitative equipment and adequate trained personnel available. SA and AV block; may depress SA/AV nodes. Hypotension. Autonomic dysfunction. Left main coronary artery stenosis. Stenotic valvular heart disease. Pericarditis. Pericardial effusion. Stenotic carotid artery disease with cerebrovascular insufficiency. Hypovolemia. Asthma. COPD. Pregnancy (Cat.C). Nursing mothers: suspend nursing for 10 hours after treatment.

Antagonized by methylxanthines (eg, caffeine, theophylline; avoid for 12 hours prior); may use aminophylline to treat severe adverse effects. May be potentiated by dipyridamole (suspend use for ≥2 days prior).

Dyspnea, headache, flushing, chest pain/discomfort, dizziness, angina pectoris, nausea, hypotension, rhythm/conduction abnormalities, bronchoconstriction, respiratory compromise.

Single-use vial (5mL)—1
Single-use pre-filled syringe (5mL)—1

7/3/08