Loading…
Rapiscan is a brand name for Regadenoson. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: This medicinal product is for diagnostic use only. Rapiscan is a selective coronary vasodilator for use in adults as a pharmacological stress agent for: • myocardial perfusion imaging (MPI) in patients unable to undergo adequate exercise stress. • the measurement of fractional flow reserve (FFR) of a single coronary…
Verbatim from this product's EMA label. Tap a section to expand.
Treatment with Rapiscan is restricted to use in a medical facility where cardiac monitoring and resuscitation equipment are available. Posology The recommended dose is a single injection of 400 micrograms regadenoson (5 ml) into a peripheral vein, with no dose adjustment necessary for body weight.
g. 5). 5). 4). 1). Patients should remain sitting or lying down and be monitored at frequent intervals after the injection until the ECG parameters, heart rate and blood pressure have returned to pre-dose levels. 3 Repeated use For use in MPI: This product is to be administered only once within a 24 hour period.
Safety and tolerability of repeated use of this product within 24 hours has not been characterised.
For use in FFR:
This product is to be administered no more than twice, no less than10 minutes apart, during any 24-hour period. When administered twice 10 minutes apart in a 24-hour period, full safety data for the second injection of Rapiscan are not available.
Paediatric population The safety and efficacy of regadenoson in children below the age of 18 years have not yet been established. No data are available. 2). 2). 2). Method of administration For intravenous use. Myocardial perfusion imaging (MPI): • Rapiscan should be administered as a rapid, 10-second injection into a peripheral vein using a 22-gauge or larger catheter or needle.
9%) solution for injection should be administered immediately after the injection of Rapiscan. • The MPI acquisition protocol should be in line with clinical practice guidelines. 9%) solution for injection should be administered immediately after the injection of Rapiscan.
• FFR should be measured as the lowest value of Pd/Pa achieved during steady state hyperemia.
Summary of the 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%).
4). Signs of hypersensitivity (rash, urticaria, angioedema, anaphylaxis and/or throat tightness) may be immediate or delayed onset. 4). Tabulated list of adverse reactions Assessment of adverse reactions for regadenoson is based on safety data from clinical studies and post-marketing experience.
All adverse reactions are presented in the table below and are listed by system organ class and frequency. Frequencies are defined as very common (≥ 1/10), common (≥ 1/100 to < 1/10) uncommon (≥ 1/1,000 to < 1/100) and rare (≥ 1/10,000 to < 1/1,000).
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Immune system disorders:
Uncommon Hypersensitivity reactions including: Rash, urticaria, angioedema, anaphylaxis and/or throat tightness.
Psychiatric disorders:
Uncommon Anxiety, insomnia 7 Nervous system disorders: Very common Headache, dizziness Common Paraesthesia, hypoaesthesia, dysgeusia Uncommon Convulsions, syncope, transient ischaemic attack, unresponsiveness to stimuli, depressed level of consciousness, tremor, somnolence Rare Cerebrovascular accident Eye disorders: Uncommon Vision blurred, eye pain Ear and labyrinth disorders: Uncommon Tinnitus Cardiac disorders: Very common Electrocardiogram ST segment changes Common Angina pectoris, atrioventricular block, tachycardia, palpitations, other ECG abnormalities including electrocardiogram QT corrected interval prolonged Uncommon Cardiac arrest, myocardial infarction, complete AV block, bradycardia, atrial flutter, new-onset, worsening or recurrence of atrial fibrillation Vascular disorders: Very common Flushing Common Hypotension Uncommon Hypertension, pallor, peripheral coldness Respiratory, thoracic and mediastinal disorders: Very common Dyspnoea Common Throat tightness, throat irritation, cough Uncommon Tachypnoea, wheezing Not known Bronchospasm, Respiratory arrest Gastrointestinal disorders: Very common Gastrointestinal discomfort Common Vomiting, nausea, oral discomfort Uncommon Abdominal distension, diarrhoea, faecal incontinence Skin and subcutaneous tissue disorders: Common Hyperhidrosis Uncommon Erythema Musculoskeletal and connective tissue disorders: Common Back, neck or jaw pain, pain in extremity, musculoskeletal discomfort Uncommon Arthralgia General disorders and administration site conditions: Very common Chest pain Common Malaise, asthenia Uncommon Pain at injection site, general body pain Description of selected adverse reactions Fatal cardiac arrest, life-threatening ventricular arrhythmias and myocardial infarction may result from the ischaemia induced by pharmacologic stress agents.
8). Continuous ECG monitoring should be performed and vital signs should be monitored at frequent intervals until the ECG parameters, heart rate and blood pressure have returned to pre-dose levels. Regadenoson should be used with caution and should only be administered in a medical facility with cardiac monitoring and resuscitation equipment.
Aminophylline may be administered in doses ranging from 50 mg to 250 mg by slow intravenous injection (50 mg to 100 mg over 30-60 seconds) to attenuate severe and/or persistent adverse reactions to regadenoson but should not be used solely for the purpose of terminating a seizure induced by regadenoson.
Myocardial ischaemia Fatal cardiac arrest, life-threatening ventricular arrhythmias, and myocardial infarction may result from the ischaemia induced by pharmacologic stress agents like regadenoson. Regadenoson should be used with caution in patients with recent myocardial infarction.
Single Photon Emission Computed Tomography (SPECT) MPI clinical trials conducted with regadenoson excluded patients with recent (within 3 months) myocardial infarction. Clinical trials for the measurement of FFR excluded patients with an acute myocardial infarction, or within 5 days of an acute myocardial infarction.
Sinoatrial and atrioventricular nodal block 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. Hypotension 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.
8). The risk of significant increases in blood pressure may be higher in patients with uncontrolled hypertension. Consideration should be given to delaying regadenoson administration until blood pressure is well controlled Combination with exercise Use of regadenoson involving exercise has been associated with serious adverse reactions including hypotension, hypertension, syncope and cardiac arrest.
1. • Second or third degree atrioventricular (AV) block or sinus node dysfunction, unless these patients have a functioning artificial pacemaker. • Unstable angina that has not been stabilised with medical therapy. • Severe hypotension.
• Decompensated states of heart failure. 4
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Know a brand we are missing in European Union? Suggest a brand →
Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
4). Sinoatrial and atrioventricular nodal block Regadenoson, can depress the SA and AV nodes and may cause first, second or third degree AV block, or sinus bradycardia requiring intervention. In clinical trials first degree AV block (PR prolongation > 220 msec) developed in 3% of patients within 2 hours of regadenoson administration; transient second degree AV block with one dropped beat was observed in one patient receiving regadenoson.
In postmarketing experience, third degree heart block and asystole have been reported within minutes of regadenoson administration. Hypotension Adenosine receptor agonists, including regadenoson induce arterial vasodilation and hypotension.
In clinical trials, decreased systolic blood pressure (> 35 mm Hg) was observed in 7% of patients and 8 decreased diastolic blood pressure (> 25 mm Hg) was observed in 4% of patients within 45 minutes of regadenoson administration.
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.
In postmarketing experience, syncope and transient ischaemic attacks have been reported. 5% of patients. Most increases resolved within 10 to 15 minutes, but in some cases, increases were observed at 45 minutes following administration.
Long QT syndrome Regadenoson increases sympathetic tone, which causes an increase in heart rate and a shortening of the QT interval. In a patient with a long QT syndrome, sympathetic stimulation can result in less shortening of the QT interval than is normal and may even cause a paradoxical increase in the QT interval.
In these patients, the phenomenon of R-on-T syndrome can occur, wherein an extra beat interrupts […]
Patients who have had any symptoms or signs suggestive of acute myocardial ischaemia during exercise or recovery are likely to be at especially high risk of serious adverse reactions. 8). In post-marketing experience there have also been reports of cerebrovascular accident (CVA).
g. antipsychotics, antidepressants, theophyllines, tramadol, systemic steroids and quinolones). Aminophylline should be used with caution in patients with a history of seizures or who have other risk factors for seizures as it may prolong a seizure or cause multiple seizures because of its proconvulsant effect.
Therefore administration of aminophylline solely for the purpose of terminating 5 a seizure induced by regadenoson is not recommended. Atrial fibrillation or flutter Regadenoson should be used with caution in patients with a history of atrial fibrillation or flutter.
In post- marketing experience there have been cases of worsening or recurrence of atrial fibrillation after administration of regadenoson. 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. Long QT syndrome Regadenoson stimulates sympathetic output and may increase the risk of ventricular tachyarrhythmias in patients with a long QT syndrome.
Warnings related to excipients This medicinal product contains less than1 mmol sodium (23 mg) per dose. 9%) solution given after regadenoson contains 45 mg of sodium. To be taken into consideration by patients on a controlled sodium diet.