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Author: Rapidscan Pharma Solutions EU Ltd.


Long information

What is it?

Rapiscan is a solution for injection that contains the active substance regadenoson.

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Table of Contents
What is it used for?
How is it used?
How does it work?
How has it been studied?
What benefits has it shown during the studies?
What is the risk associated?
Why has it been approved?

What is it used for?

Rapiscan is for diagnostic use only. It is used in a type of heart scan called ?radionuclide myocardial perfusion imaging? to see the blood flow in the heart muscle.

Before this type of scan, the patient?s heart is usually put under stress by exercise such as walking or running on a treadmill to help dilate (widen) the blood vessels in the heart and increase the blood flow to the heart muscle. Rapiscan is used as a ?stress agent? that has a similar effect on the heart as exercise. It is used in adult patients (aged 18 years or over) who are unable to exercise enough for a stress test.

The medicine can only be obtained with a prescription.

How is it used?

Rapiscan must only be used in a hospital that has equipment for resuscitation and monitoring the patient.

It is given as a 10-second injection of 400 micrograms into a vein immediately followed by an injection of sodium chloride (salt) solution. The patient then undergoes the procedures for radionuclide myocardial perfusion imaging, starting with an injection of a radioactive substance 10 to 20 seconds after the sodium chloride injection. Because Rapiscan causes a rapid increase in heart rate and a fall in blood pressure, patients should remain sitting or lying down and be monitored frequently until the effects of the medicine have worn off.

Rapiscan should only be used once within any 24-hour period. Patients must not take any medicines or products that contain methylxanthines (such as caffeine or theophylline) for at least 12 hours before receiving Rapiscan. They should also stop receiving dipyridamole (a medicine used to prevent blood clots) for at least two days before receiving Rapiscan. For further information on the use of Rapiscan, see the summary of product characteristics (also part of the EPAR).

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How does it work?

The active substance in Rapiscan, regadenoson, is an A 2A adenosine receptor agonist. It works by attaching to A 2A adenosine receptors in the walls of the blood vessels in the heart, causing the blood vessels to widen and increasing blood flow into the heart muscle. This enables the blood flow in the heart to be seen more easily during myocardial perfusion imaging.

How has it been studied?

The effects of Rapiscan were first tested in experimental models before being studied in humans.

In two main studies, around 2,000 adult patients first had a myocardial perfusion imaging scan performed using adenosine (another medicine used as a stress agent) followed by a second scan with either adenosine or Rapiscan. The main measure of effectiveness was based on the similarity between the results of the scans with Rapiscan and adenosine.

What benefits has it shown during the studies?

The results of scans using Rapiscan and adenosine were comparable. The ?agreement rates? between the first and second scans were similar regardless of which of the two medicines were used for the second scan.

What is the risk associated?

The most common side effects with Rapiscan (seen in more than 1 patient in 10) are headache, dizziness, ST segment changes (an abnormal reading on the electrocardiogram or ECG), flushing (reddening of the skin), dyspnoea (difficulty breathing), gastrointestinal (stomach and gut) discomfort and chest pain. For the full list of all side effects reported with Rapiscan, see the package leaflet.

Rapiscan should not be used in people who may be hypersensitive (allergic) to regadenoson or any of the other ingredients. It must not be used in patients with slow heart rate unless they have a pacemaker, unstable angina (a type of chest pain that changes in severity) that has not been controlled with treatment, severe hypotension (low blood pressure) or decompensated heart failure (when the heart does not work as well as it should).

Why has it been approved?

The CHMP decided that Rapiscan?s benefits are greater than its risks and recommended that it be given marketing authorisation.

Rapiscan Page

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