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Rapiscan™ (Regadenoson)

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

rapiscan-hero-desktop

Adverse events reporting

Adverse events should be reported.
Reporting forms and information can be found at https://yellowcard.mhra.gov.uk/ .
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.

simplified-dosing
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.

fast-efficient-workflow
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

improved-tolerability-over-adenosine-new
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.

asthmatic-and-copd-patients
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

improved-patient-experience

New Feature Cards

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.

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card1-info-expanded-desktop

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.

Rapiscan is a selective A2A adenosine receptor agonist. Rapiscan is a potent, low-affinity agonist eliciting rapid vasodilation for a sufficient duration for MPI or FFR measurement before quickly returning to baseline.

Its selectivity for the A2A receptor, responsible for vasodilation of the coronary arteries, which, in turn, increases coronary blood flow.1

1. Zoghbi GJ, Iskandrian AE. Selective adenosine agonists and myocardial perfusion imaging. J Nucl Cardiol 2012; 19(1): 126–41.

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

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card2-info-expanded-desktop

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.2

The low affinity of Rapiscan for the A2A adenosine receptor and the presence of a coronary artery A2A adenosine receptor reserve results in rapid induction following administration of Rapiscan and maintenance of maximal coronary blood flow enabling stress radionuclide MPI and FFR to be conducted.

2. Lieu HD et al. J Nucl Cardiol 2007; 14: 514-5

Clinical efficacy in MPI

Rapiscan is indicated for myocardial perfusion imaging examinations with results comparable with adonesine.13
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card3-half-width-card-desktop 01

Clinical efficacy in MPI

Rapiscan is indicated for myocardial perfusion imaging examinations with results comparable with adonesine.3,4

The ADVANCE MPI trials demonstrated that Rapiscan is similar to adenosine injection for assessing the presence and extent of reversible perfusion defects. Overall, and for each patient subgroup, Rapiscan is also similar to adenosine for detecting the presence or absence of any perfusion defect3, image quality3, detecting defect type4, and side-by-side comparison.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.

Clinical efficacy in FFR

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

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card4-half-width-card-desktop

Clinical efficacy in FFR

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

Rapiscan is a pharmacological stress agent for the measurement of FFR of a single coronary artery stenosis during invasive coronary angiography, when repeated FFR measurements are not anticipated. In a pooled analysis of FFR results as obtained using Rapiscan vs adenosine in five academic hospitals,Rapiscan was shown to have comparable FFR results to adenosine; no difference was shown between the means of FFR derived from IV Rapiscan and IV adenosine (p=0.93).6

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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JB02906UK September 2024