Rapiscan

Package leaflet: Information for the user

Rapiscan 400 micrograms solution for injection

Regadenoson
Please read this leaflet carefully before you are given this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Rapiscan is and what it is used for
2. What you need to know before being given Rapiscan
3. How Rapiscan is administered
4. Possible side effects
5. How to store Rapiscan
6. Contents of the pack and other information

1. What Rapiscan is and what it is used for

Rapiscan contains the active substance regadenoson, which belongs to a group of medicines called coronary vasodilators. Regadenoson dilates the coronary arteries and increases heart rate. As a result, a greater amount of blood flows to the heart muscle.
This medicine is for diagnostic use only.
Rapiscan is used in adults for a type of heart scan called myocardial perfusion imaging.
During the scan, a diagnostic agent is used to obtain images showing how blood flows to the heart muscle. Normally, before the scan, the patient walks on a treadmill to stress the heart. During physical exercise, a small amount of diagnostic agent is injected into the body, usually into a vein in the hand. Subsequently, images of the heart are created. The doctor can then assess whether the heart muscle receives adequate blood flow during stress.
If sufficient physical exertion cannot be achieved to adequately stress the heart, Rapiscan will be administered to induce a comparable level of cardiac stress and increase blood flow.
Rapiscan is also used during catheterizations and imaging of the heart arteries (invasive coronary angiography) to dilate the coronary arteries in order to measure the pressure difference caused by a narrowing within one or more arteries. During cardiac catheterization, a long, thin tube called a catheter is inserted through the femoral or radial artery and advanced through the blood vessels to the heart. The physician performing the catheterization may also wish to measure the pressure difference (fractional flow reserve) due to a detected narrowing in one or more coronary arteries.

2. What you need to know before receiving Rapiscan

Do not take Rapiscan:

• if you have a slow heart rate (high-grade heart block or sick sinus syndrome) and do not have a pacemaker.
• if you have chest pain that occurs unexpectedly (unstable angina) and has not improved after treatment.
• if you have low blood pressure (hypotension).
• if you have heart failure.
• if you are allergic to regadenoson or to any of the other ingredients of Rapiscan listed in section 6 of this leaflet.

Talk to your doctor or nurse before receiving Rapiscan
Before Rapiscan is administered, your doctor must know:

• if you have recently had a serious heart problem (such as a heart attack or an abnormal heart rhythm).
• if you have a heart rhythm characterized by a very fast or irregular heartbeat (atrial fibrillation or atrial flutter).
• if you have uncontrolled high blood pressure, especially if accompanied by recent episodes of nosebleeds, headache, blurred or double vision.
• if you have had episodes of mini-strokes (known as transient ischemic attacks).
• if you have a heart rhythm disorder called long QT syndrome.
• if you have episodes of heart block (which can slow your heart rate) or a very slow heartbeat.
• if you have any heart or blood vessel condition, especially if it worsens when blood pressure drops. Such conditions include low blood volume (caused, for example, by severe diarrhea, dehydration, or diuretic use), inflammation around the heart (pericarditis), and certain forms of heart valve or arterial diseases (e.g., aortic or mitral stenosis).
• if you have a condition that causes seizures (fits), such as epilepsy, or have had such a condition.
• if you have asthma or a lung disease. If you have any of these conditions, inform your doctor before the injection is given.

Children and adolescents
Rapiscan must not be used in children and adolescents under 18 years of age.
Other medicines and Rapiscan
Inform your doctor if you are taking, have recently taken, or might take any other medicine.
Pay special attention to the following medicines:

• Theophylline, a medicine used to treat asthma and other lung diseases, must not be used for at least 12 hours before receiving Rapiscan, as it may block the effect of Rapiscan.
• Dipyridamole, a medicine used to prevent blood clots, must not be used for at least two days before receiving Rapiscan, as it may alter the effect of Rapiscan.

Rapiscan with food and drink
Do not consume food or drinks containing caffeine (e.g., tea, coffee, chocolate, cola, or cocoa) for at least 12 hours before receiving Rapiscan. Caffeine may interfere with the effect of Rapiscan.
Pregnancy and breastfeeding
Inform your doctor before receiving Rapiscan:

• if you are pregnant, suspect you may be pregnant, or are planning to become pregnant. There is insufficient information on the use of Rapiscan in pregnant women. Harmful effects have been observed in animal studies, but it is unknown whether there is a risk to humans. Your doctor will administer Rapiscan only if necessary.
• if you are breastfeeding. It is unknown whether Rapiscan passes into breast milk, and the medicine will be administered only if your doctor considers it necessary. Avoid breastfeeding for at least 10 hours after receiving Rapiscan.
  Ask your doctor for advice before taking any medicine.
  Driving and using machines
  Rapiscan may cause dizziness. It may also cause other symptoms (headache or shortness of breath) that could impair your ability to drive or operate machinery. These effects usually do not last longer than 30 minutes. Do not drive or operate machinery until your symptoms have improved.
  Rapiscan contains sodium
  This medicine contains less than 1 mmol (23 mg) of sodium per dose. After receiving Rapiscan, you will be given an injection of sodium chloride 9 mg/ml (0.9%) solution containing 45 mg of sodium. This should be taken into account if you have impaired kidney function or are on a low-sodium diet.

3. How Rapiscan is administered

Rapiscan is injected by a healthcare professional (a doctor, nurse, or healthcare technician)
in a medical facility where heart function and blood pressure can be monitored.
The medicine is injected directly into a vein as a single dose of 400 micrograms in a 5 ml solution. The injection will last approximately 10 seconds. The injected dose is not dependent on body weight.
You will also be injected with a solution of sodium chloride 9 mg/ml (0.9%) (5 ml) and a small amount of diagnostic agent.
When you receive Rapiscan, your heart rate will increase rapidly. Your heart rate and blood pressure will be monitored.
After the injection of Rapiscan, you must remain sitting or lying down until your heart rate and blood pressure return to your normal values. Your doctor, nurse, or healthcare technician will inform you when you may get up.
A heart scan will be performed after sufficient time has elapsed to allow the diagnostic agent to reach the heart muscle.
During catheterization of the heart arteries, the doctor may measure the pressure difference (also known as fractional flow reserve - FFR) caused by a narrowing in one or more of the heart arteries.
If considered necessary, a second dose of 400 micrograms may be injected at least 10 minutes after the first dose for this pressure difference measurement during the same catheterization procedure. Heart rate and blood pressure will be monitored throughout the entire procedure.
If you receive more Rapiscan than you should
Some people have experienced flushing, dizziness, and increased heart rate after receiving an excessive amount of Rapiscan. If your doctor considers that serious side effects occur or that the effect of Rapiscan lasts too long, they may administer an injection of a medicine called aminophylline, which reduces these effects.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Side effects are generally mild. They usually occur shortly after the injection of
Rapiscan and typically disappear within 30 minutes. They generally do not require treatment.
The more serious side effects include:

• sudden cardiac arrest or heart damage, heart block (a disturbance in the heart's electrical signals, where impulses do not pass from the upper to the lower chambers of the heart), rapid heartbeat
• low blood pressure, which may cause fainting or mini-stroke (including facial weakness or inability to speak). In rare cases, Rapiscan may cause a stroke (also known as cerebrovascular accident)
• an allergic reaction accompanied by skin rash, blisters, swelling under the skin near the eyes or throat, tightness in the throat, and difficulty breathing, which may occur immediately after injection of Rapiscan or after some time.

Inform your doctor immediately if you think you are experiencing serious side effects. Your doctor may
administer an injection of a medicine called aminophylline, which reduces these effects.
Very common
(may affect more than 1 in 10 people)

• headache, dizziness
• shortness of breath
• chest pain
• changes in heart activity test (electrocardiogram)
• skin redness
• stomach discomfort

Common
(may affect up to 1 in 10 people)

• heart pain (angina), irregular heartbeat, rapid heartbeat, sensation of missed heartbeat, fluttering or pounding sensation in the chest (palpitations)
• low blood pressure
• tightness in the throat, throat irritation, cough
• vomiting, nausea
• malaise or weakness
• excessive sweating
• pain in the back, arms, legs, neck, or jaw
• discomfort in bones and muscles
• tingling, reduced sensation, taste disturbances
• discomfort in the mouth

Uncommon
(may affect up to 1 in 100 people)

• sudden cardiac arrest or heart damage, heart block (a disturbance in the heart's electrical signals, where impulses do not pass from the upper to the lower chambers of the heart), slow heartbeat
• seizures, fainting, mini-stroke (including facial weakness or inability to speak), reduced reaction capacity (which may include a comatose state), tremor, drowsiness
• an allergic reaction accompanied by skin rash, blisters, swelling under the skin near the eyes or throat, tightness in the throat, difficulty breathing
• wheezing
• rapid breathing
• high blood pressure, pallor, cold extremities
• blurred vision, eye pain
• anxiety, difficulty sleeping
• ringing in the ear
• bloating, diarrhoea, involuntary loss of faeces
• erythema
• joint pain
• pain or discomfort around the injection site, body pain

Not known
(frequency cannot be estimated from the available data)

• difficulty breathing (bronchospasm)
• respiratory arrest

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or nurse.
You can also report side effects directly through the national reporting system listed in Annex V.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Rapiscan

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the vial after EXP and on the
carton after Exp. This medicine does not require any special storage conditions.
Do not use this medicine if you notice any changes in colour or the presence of particles.
Do not dispose of any medicine via wastewater or household waste. This will help protect
the environment. Healthcare professionals are responsible for the storage and disposal of this
medicine.

6. Package contents and other information

What Rapiscan contains
The active substance in Rapiscan is regadenoson. Each vial of Rapiscan injectable solution contains 400 micrograms of regadenoson in 5 ml of solution.
The other components are: edetate disodium, disodium phosphate, sodium dihydrogen phosphate, propylene glycol, water for injections.

Description of the appearance of Rapiscan and contents of the pack
Rapiscan injectable solution is a clear, colourless solution free from visible particles. Rapiscan is available in a carton containing a single-use vial with a rubber stopper and an aluminium seal. Rapiscan is available in 5 ml or 7 ml glass vials.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
GE Healthcare AS
Nycoveien 1
NO-0485 Oslo
Norway

Manufacturers:
Millmount Healthcare Limited,
Block 7, City North Business Campus,
Stamullen, Co Meath, K32 YD60
Ireland
Haupt Pharma Wolfratshausen GmbH
Pfaffenrieder Str. 5
D-82515 Wolfratshausen
Germany
GE Healthcare AS
Nycoveien 1
NO-0485 Oslo
Norway

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu.
This leaflet is available in all languages of the European Union/European Economic Area on the European Medicines Agency website.

The following information is intended exclusively for healthcare professionals:

Rapiscan must be administered as a 10-second rapid injection into a peripheral vein,
using a 22-gauge or larger catheter or needle.
Immediately after the injection of Rapiscan, 5 ml of sodium chloride 9 mg/ml (0.9%) solution for injection must be administered.
The diagnostic agent for myocardial perfusion imaging should be administered 10–20 seconds
after the sodium chloride 9 mg/ml (0.9%) solution for injection. The diagnostic agent may be
injected directly into the same catheter used for Rapiscan.
For FFR measurement, Rapiscan must be administered via a rapid 10-second injection into a peripheral vein, using a 22-gauge or larger catheter or needle.
10 ml of sodium chloride 9 mg/ml (0.9%) solution for injection must be administered immediately after the injection of Rapiscan. Standard catheterization and FFR measurement techniques must be followed. FFR must be measured as the lowest Pd/Pa value achieved during the steady-state of maximal hyperemia.
If deemed necessary, a second dose of 400 micrograms may be injected at least 10 minutes after the first dose for FFR measurement during the same catheterization procedure.
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Before administration, the medicinal product should be inspected visually for particulate matter and discoloration.
Any unused medicinal product and waste material must be disposed of in accordance with local regulations.
For further information, refer to the Summary of Product Characteristics.