Today GE Healthcare and Rapidscan Pharma Solutions EU Ltd report the launch of Rapiscan® (regadenoson) in the United Kingdom, the first country in Europe to have access. Rapiscan is a new generation pharmacological stress agent for myocardial perfusion scintigraphy (MPS) in adult patients unable to undergo adequate exercise stress in the diagnosis of coronary artery disease (CAD)1 - the single most common cause of death and disability in Europe.2 MPS is a non-invasive scan of blood flow to the heart muscle. It has been appraised by the National Institute of Health and Clinical Excellence (NICE) and is found to be effective and cost-effective for the diagnosis and management of CAD³.

Richard Underwood, Professor of Cardiac Imaging at Imperial College London and the Royal Brompton Hospital, said, "We are happy that Rapiscan is now being made available in the UK and that we shall be the first in Europe to use it clinically. It provides a new option for patients who need MPS either to diagnose CAD or to assess its severity and to decide upon the best treatment. It is easier to use, appears to be better tolerated, and can be used in some patients with lung problems that may complicate the use of the older agents."

MPS provides images of blood flow to the heart muscle at rest and during exercise. Patients are commonly asked to exercise on a treadmill or bicycle and the images are created after injection of a small amount of a radioactive substance, called a radiopharmaceutical, during the exercise. Unfortunately, many MPS patients are unable to exercise adequately. For these, a pharmacological stress agent, such as Rapiscan, can be used to simulate the effects of exercise by increasing coronary blood flow.

Rapiscan is the first and only non-weight based, infusion pump-free pharmacological stress agent available in the UK.

Unlike older agents, Rapiscan requires no dose adjustment for varying body weight and is administered as a 10 second injection,1 which cuts the need for an infusion pump, extension line and infusion line set-up. Beyond the practical benefits, Rapiscan selectively stimulates the A2A adenosine receptors responsible for the increase in blood flow, but not other adenosine receptors believed to cause undesirable effects, such as difficulty in breathing or missing heart beats, that have been associated with the existing pharmacological stress agents.1,4

Steve Tomkins, the UK and Ireland Commercial Director for GE Healthcare's Medical Diagnostics division, comments, "This is a great opportunity for us to bring an important development to the nuclear medicine community, using our leadership in the field of nuclear cardiology and molecular imaging to support our customers in adopting this exciting product".

Every year more than 4 million Europeans die from diseases of the heart and blood vessels,1 accounting for almost half of total mortality in Europe.1 Timely and accurate diagnosis is vital in identifying patients who are appropriate for intensive medical intervention with more than 1.5 million Europeans undergoing myocardial perfusion imaging [MPI] tests annually.

Regadenoson was launched in the US in 2008 following clinical trials of over 2,000 patients with known or suspected CAD. 5,6 Today, regadenoson is currently the most widely used pharmacological stress agent in the US with several million patients having received it.

References: 1. Rapiscan Summary of Product Characteristics. Rapidscan Pharma Solutions EU Ltd. March 2011.
2. Scholte op Reimer WJM, Gitt AK, Boersma E, Simoons ML (eds.). Cardiovascular Diseases in Europe. Euro Heart Survey - 2006. Sophia Antipolis; European Society of Cardiology; 2006
3. nice/TA73
4. Buhr C, Gössl, M, Erbel R, Eggebrecth H "Regadenoson in the detection of coronary artery disease" Vasc Health Risk Manag. 2008;4(2):337-40.
5. Cerqueira MD, Nguyen P, Staehr P, et al, on behalf of the ADVANCE MPI Trial Investigators. Effects of age, gender, obesity and diabetes on the efficacy and safety of the selective A2A agonist Rapiscan versus adenosine: integrated ADVANCE MPI trial results. J Am Coll Cardiol 2008;1:307‐316.
6. Iskandrian AE, Bateman TM, Belardinelli L, et al. Adenosine versus Rapiscan comparative evaluation in myocardial perfusion imaging: results of the ADVANCE phase 3 multicenter international trial. J Nucl Cardiol 2007;14:645‐658.

RAPISCAN® (regadenoson solution for injection)

ABBREVIATED PRESCRIBING INFORMATION

PRESCRIBERS SHOULD READ THE SUMMARY OF PRODUCT CHARACTERISTICS (SPC)

Rapiscan vials contain regadenoson (400 microgram solution for injection). Indication: Pharmacological stress agent for radionuclide myocardial perfusion imaging in adult patients. Dosage and Administration: Each 5 ml vial contains 400 micrograms regadenoson, which is injected over 10 seconds into a peripheral vein followed by 5 mL saline (0.9% sodium chloride) solution flush. The radiopharmaceutical should be administered 10-20 seconds after saline injection. The same catheter may be used for Rapiscan and the radiopharmaceutical. Contra-indications: Hypersensitivity to active substance or excipients; patients with second or third degree AV block or sinus node dysfunction who do not have a functioning artificial pacemaker; unstable angina that has not been stabilised with medical therapy; severe hypotension; decompensated heart failure. Precautions: Rapiscan has the potential to cause serious and life-threatening reactions. Continuous ECG monitoring should be performed and vital signs monitored at frequent intervals until ECG parameters, heart rate and blood pressure have returned to pre-dose levels. Aminophylline may be administered by slow intravenous injection to attenuate severe and/or persistent adverse reactions to Rapiscan. Fatal cardiac arrest, life-threatening ventricular arrhythmias, and myocardial infarction may result from the ischaemia induced by pharmacologic stress agents like regadenoson. Adenosine receptor agonists including regadenoson can depress the sinoatrial (SA) and AV nodes and may cause first, second or third degree AV block, or sinus bradycardia. Adenosine receptor agonists including regadenoson induce arterial vasodilation and hypotension. The risk of serious hypotension may be higher in patients with autonomic dysfunction, hypovolemia, left main coronary artery stenosis, stenotic valvular heart disease, pericarditis or pericardial effusions, or stenotic carotid artery disease with cerebrovascular insufficiency. Adenosine receptor agonists may cause bronchoconstriction and respiratory compromise. For 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 Rapiscan administration. Regadenoson stimulates sympathetic output and may increase the risk of ventricular tachyarrhythmias in patients with a long QT syndrome. This medicinal product contains less than 1 mmol sodium (23 mg) per dose. However, the injection of sodium chloride 9 mg/ml (0.9%) solution given after Rapiscan contains 45 mg of sodium. To be taken into consideration by patients on a controlled sodium diet. Undesirable effects:Adverse reactions in most patients were mild, transient (usually resolving within 30 minutes) and required no medical intervention. Rapiscan may cause myocardial ischaemia, hypotension leading to syncope and transient ischaemic attacks, and SA/AV node block requiring intervention. Aminophylline may be used to attenuate severe or persistent adverse reactions. Very common adverse events reported were dyspnoea, headache, flushing, chest pain, electrocardiogram ST changes, gastrointestinal discomfort, and dizziness. Common adverse events reported were paraesthesia, hypoaesthesia, dysgeusia, angina pectoris, atrioventricular block, tachycardia, palpitations, other ECG abnormalities including electrocardiogram QT corrected interval prolonged, hypotension, throat tightness, throat irritation, cough, vomiting, nausea, oral discomfort, back, neck or jaw pain, pain in extremity, musculoskeletal discomfort, hyperhidrosis, malaise, and asthenia. See SPC for details of other undesirable effects. Presentation and basic NHS price: One carton contains a single vial of Rapiscan (400 micrograms regadenoson in 5mL solution for injection). Price is £39.50 per vial. ATC code:C01EB21. Legal Classification: POM. Product licence holder: Rapidscan Pharma Solutions EU Ltd, Regent's Place, 338 Euston Road, London, NW1 3BT, United Kingdom, is the Marketing Authorization Holder . Date of preparation: March 2011.

Adverse events should be reported. Reporting forms and information can be found at yellowcard. Adverse events should also be reported by phone 080 0652 1391, fax 080 0471 5035, or email safetyrapiscan-mpi. [Rapidscan Pharma Solutions EU Ltd]

Source:
Nicola Kent
Packer Forbes Communications