Rapiscan™ (Regadenoson)

The only hyperaemic stress agent indicated for Myocardial Perfusion Imaging in SPECT, CMR, CT and PET as well as fractional flow reserve.
Support

Adverse events reporting

Adverse events should be reported
Reporting forms and information can be found at: www.mhra.gov.uk/yellowcard
Adverse events should also be reported to GE Healthcare at:
gpv.drugsafety@gehealthcare.com
AT A GLANCE

Fast & efficient workflow

10 second injection in a single IV line with no need of an infusion pump

Simplified dosing

Single dose presentation with no dose adjustments for weight

Good tolerability

Well-tolerated and can be used with caution in COPD or asthma patients8-11
FEATURES

Stress Simplified by Design

Rapiscan is a pharmacological stress agent used in the diagnosis of coronary artery disease to simulate the effect of exercise. Rapiscan was developed specifically to address the needs of nuclear medicine and interventional cardiology by simplifying the pharmacological stress protocol, improving patient tolerability and providing an option for asthmatic and COPD patients.
SIMPLIFIED DOSING

Rapiscan is delivered through a single, fixed 10-second injection

Rapiscan is administered as a single, standard, fixed dose of 400 µg,  in 5 mL over a full 10 seconds - into a peripheral vein.

No dose adjustment is needed to account for body weight, age, gender, hepatic or renal function. Rapiscan is administered into a peripheral vein using a 22-gauge or larger catheter or needle; no infusion pump is required.
FAST & EFFICIENT WORKFLOW

Rapiscan is delivered using a fast and efficient protocol

Rapiscan offers pump-free, standard dose, IV injection administration and fast protocols. Stress agent and radiotracer are administered in 1 minute.

The injection of Rapiscan should be immediately followed by a 5 mL saline flush over 10 seconds. In MPI, radiotracer is administered 10-20 seconds after the saline flush. In the measurement of FFR, the lowest value of Pd/Pa achieved during steady-state hyperaemia is measured using a pressure wire.

It is suggested that you count out in your head the 10 seconds in one one-thousand intervals, followed by the 10-second flush, then, after 10 seconds, you administer the radiopharmaceutical.
IMPROVED TOLERABILITY OVER ADENOSINE

Rapiscan has demonstrated a good tolerability profile

Adverse reactions in most patients were mild, transient and required no medical intervention. Very common adverse events reported were dyspnoea, headache, flushing, chest pain, electrocardiogram ST changes, gastrointestinal discomfort, and dizziness.

In this study, regadenoson showed an excellent safety profile, with no serious immediate complications and a low incidence of non-serious complications.7
ADMINISTRATION IN ASTHMATIC AND COPD PATIENTS

Rapiscan can be used with caution in asthmatic and/or COPD patients.8-11

Stress testing is challenging in patients with COPD. Functional capacity is generally decreased in this patient population, limiting patients' ability to achieve physiologic stress through exercise.8 Pharmacologic stress testing is problematic, particularly due to the concern for adenosine-induced bronchoconstriction with conventional vasodilator stress agents.8

Available data from observational studies indicates that Rapiscan can be used with caution in patients with mild to moderate asthma and/or COPD.8-11
Regadenoson may cause bronchoconstriction and respiratory arrest (see section 4.8) , especially in patients with known or suspected bronchoconstrictive disease, chronic obstructive pulmonary disease (COPD) or asthma. Appropriate bronchodilator therapy and resuscitative measures should be available prior to regadenoson administration.
IMPROVED PATIENT EXPERIENCE

Patients have an improved experience with Rapiscan

In ADVANCE MPI 1 and ADVANCE MPI 2, the symptom groups of flushing (21% vs 32%), chest pain (28% vs 40%), and 'throat, neck or jaw pain' (7% vs 13%) were less frequent with Rapiscan; the incidence of headache (25% vs 16%) was more frequent with Rapiscan.
After receiving either adenosine or Rapiscan, patients were asked how they felt and how the test  compared  with the first adenosine test. 
Patients randomised to Rapiscan felt more comfortable compared with those randomised to adenosine and when patients were asked how the second test compared with the first adenosine test, those receiving Rapiscan said it felt better vs those receiving adenosine.4

Mode of action

Rapiscan is a selective A2A adenosine receptor agonist. Rapiscan was developed specifically for use in cardiac imaging for the diagnosis of CVD.

Effect on coronary blood flow

Rapiscan rapidly increases coronary blood flow and achieves peak maximal hyperaemia in 30 seconds and decreases to less than twice the baseline level within 10 minutes

Clinical efficacy in MPI

Rapiscan is indicated for myocardial perfusion imaging examinations with results comparable with adonesine.13

Clinical efficacy in FFR

Rapiscan demonstrates excellent reproducibility and comparable results for FFR to adenosine.

Summary of safety profile: Adverse reactions in most patients receiving regadenoson in clinical trials were mild, transient (usually resolving within 30 minutes after receiving regadenoson) and required no medical intervention. Adverse reactions occurred in approximately 80% of patients. The most common adverse reactions reported during clinical development in a total of 1,651 patients/subjects were: dyspnoea (29%), headache (27%), flushing (23%), chest pain (19%), electrocardiogram ST segment changes (18%), gastrointestinal discomfort (15%) and dizziness (11%).For full safety information, please refer to SPC before prescribing.

References

1. Zoghbi GJ, Iskandrian AE. Selective adenosine agonists and myocardial perfusion imaging. J Nucl Cardiol 2012; 19(1): 126–41.
2. Lieu HD et al. J Nucl Cardiol 2007; 14: 514-5
3.Cerqueira MO, et al. JACC  Cardiovesc imaging. 20081.307-316.
4.lskandrian AE, et al. JNucl Cardiol. 2007;14:645-658
5. Zoghbi and lskandrian A. Imaging Med 2010; 2 395-406.
6. Van Nunen LX et al. EuroIntervention 2015;11:905-913
7. Monmeneu Menadas JV et al. Int J Cardiovasc Imaging 2021 Jul 31. https://doi.org/10.1007/S10554-021-02363-4
8. Golzar al int JChron Obstruct Pulmon Dis. 2014; 9 129-137.
9. Prenner B et al. J Nucl Cardiol 2012; 19: 681–92.
10. Thomas GS et al.  J Nucl Cardiol 2008; 15(3): 319–28.
11. Leaker BR et al. J Nucl Cardiol 2008; 15(3): 329–36.
12. Achenbach S, et al Interv Cardiol 2017;12(2):97-109.
13. Mahmarian JJ, Cerqueira MD, Iskandrian AE et al. JACC Cardiovasc Imaging 2009; 2(8): 959-68

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