Rapiscan 400mcg injectable solution

Introduction

Package Leaflet: Information for the User

Rapiscan 400 micrograms solution for injection

Regadenoson

Read all of 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 further questions, ask your doctor or pharmacist.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack:

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

1. What is Rapiscan and what is it used for

Rapiscan contains the active substance regadenoson. This belongs to a group of medicines called “coronary vasodilators”. It makes the heart’s arteries expand and the heart rate increase. This makes more blood flow to the heart muscles.

This medicine is for diagnostic use only.

Rapiscan is used in a type of heart scan in adults known as a “myocardial perfusion imaging study”.

The imaging study uses a radioactive substance called a “radiopharmaceutical”to create images. These images show if blood flow is going to the heart muscles. Usually, exercise on a treadmill is used to put stress on the heart before the imaging study. During exercise, a small amount of radiopharmaceutical is injected into the body, often into a vein in the hand. Then, images of the heart are taken, so the doctor can check if the heart muscles are getting enough blood flow when under stress.

If you cannot exercise enough to reach a sufficient heart rate, you will be given Rapiscan to provide a heart rate that can increase blood flow in a similar way.

Rapiscan is also used during heart catheterization and visualization of the heart’s arteries (invasive coronary angiography) to expand the heart’s arteries and measure the difference in pressure caused by a narrowing within one or more arteries. During heart catheterization, a long, thin tube called a catheter is inserted through the femoral or radial artery and passed through the blood vessels to the heart. The doctor performing the catheterization may also want to measure the difference in pressure (fractional flow reserve) due to a narrowing detected in one or more of the heart’s arteries.

2. What you need to know before you are given Rapiscan

Do not use Rapiscan

• if you have a slow heart rate (high-degree heart block or sick sinus syndrome) and you do not have a pacemaker.
• if you have chest pain that occurs unpredictably (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 any of the other ingredients of this medicine (listed in section 6).

Tell your doctor or nurse before using Rapiscan

Before you are given Rapiscan, your doctor needs to know:

• if you have had any recent serious heart problems(for example, a heart attack or abnormal heart rhythms).
• if you have a heart rate with very fast or irregular beats (atrial fibrillation or atrial flutter).
• if you have high blood pressure that is not controlled, especially if this has been accompanied by recent episodes of nosebleeds, headaches, or blurred or double vision.
• if you have had episodes of mini-strokes (called transient ischemic attacks).
• if you have a heart rhythm disorder called long QT syndrome.
• if you have episodes of heart block(which can slow the heart) or a very slow heart rate.
• if you have any heart or blood vessel condition, particularly one that worsenswhen your blood pressure drops. These conditions include low blood volume (caused, for example, by severe diarrhea or dehydration or use of water pills), inflammation around the heart (pericarditis), and some forms of heart valve or artery disease (for example, aortic or mitral stenosis).
• if you have a condition that causes seizures, such as epilepsy, or if you have ever had seizures.
• if you have asthmaor a lung disease.

If you have any of the above, tell your doctor before you are given the injection.

Children and adolescents

Rapiscan must not be used in children or adolescents under 18 years.

Using Rapiscan with other medicines

Tell your doctor if you are using or have recently used other medicines, including those obtained without a prescription.

Special care is needed with the following medicines:

• theophylline, a medicine used to treat asthma and other lung diseases, must not be used for at least 12 hours beforereceiving Rapiscan because it can block the effect of Rapiscan.
• dipyridamole, a medicine used to prevent blood clots, must not be used for at least two days beforereceiving Rapiscan because it can change the effect of Rapiscan.

Using Rapiscan with food and drink

Do not eat food or drink beverages containing caffeine (for example, tea, coffee, cocoa, cola, or chocolate) for at least 12 hours before receiving Rapiscan. This is because caffeine can interfere with the effect of Rapiscan.

Pregnancy and breastfeeding

Before you are given Rapiscan, tell your doctor:

• if you are pregnant, think you may be pregnant, or plan to become pregnant. There is not enough information on the use of Rapiscan in pregnant women. Harmful effects have been seen in animal studies, but it is not known if there is a risk to humans. Your doctor will only give you Rapiscan if it is clearly necessary.
• if you are breastfeeding. It is not known if Rapiscan can pass into breast milk, and it will only be given to you if your doctor thinks it is necessary. You should avoid breastfeeding for at least 10 hours after receiving Rapiscan.

Talk to your doctor before using any medicine.

Driving and using machines

Rapiscan may make you feel dizzy. It can cause other symptoms (headache or difficulty breathing) that could affect your ability to drive or use machines. These effects usually do not last more than 30 minutes. Do not drive or use machines until these effects have improved.

Rapiscan contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per dose. After you have been given Rapiscan, you will be given an injection of sodium chloride solution at a concentration of 9 mg/ml (0.9%), which contains 45 mg of sodium. This should be taken into account if you are on a low-sodium diet.

3. How Rapiscan is given

Rapiscan is injected by a healthcare professional(a doctor, nurse, or medical technician) in a medical center where your heart and blood pressure can be monitored. It is injected directly into a vein, as a single dose of 400 micrograms in a 5 ml solution; the injection will take about 10 seconds to complete. The injected dose does not depend on your weight.

You will also be givenan injection of sodium chloride solution at a concentration of 9 mg/ml (0.9%) (5 ml) and an injection of a small amount of a radioactive substance (radiopharmaceutical).

When you are given Rapiscan, your heart rate will increase rapidly. Your heart rate and blood pressure will be monitored.

After the injection of Rapiscan, you will need to remain seated or lying down until your heart rate and blood pressure return to normal. The doctor, nurse, or medical technician will tell you when you can get up.

A heart imaging study will be performed once enough time has passed for the radiopharmaceutical to reach the heart muscle.

During coronary artery catheterization, your doctor may measure the difference in pressure (also known as fractional flow reserve - FFR) due to a narrowing in one or more of the heart’s arteries.

If necessary, a second dose of 400 micrograms can be injected at least 10 minutes after the first dose to measure the difference in pressure during the same catheterization procedure. Your heart rate and blood pressure will be monitored throughout the procedure.

If you are given too much Rapiscan

Some people have experienced flushing, dizziness, and increased heart rate when given too much Rapiscan. If your doctor thinks you are experiencing serious side effects or if the effects of Rapiscan are lasting too long, you may be given an injection of a medicine called aminophylline, which reduces these effects.

4. Possible side effects

Like all medicines, Rapiscan can cause side effects, although not everybody gets them.

Side effects are usually mild. They usually start soon after you are given the injection of Rapiscan and usually disappear within 30 minutes. They do not usually need treatment.

The most serious side effects include:

• sudden cardiac arrest or heart damage, heart block (a disorder of the heart’s electrical signal in which the signal cannot pass from the upper to the lower chambers of the heart), fast heart rate
• low blood pressure, which can lead to fainting or mini-strokes (including weakness of the face or inability to speak). Rarely, Rapiscan can cause a stroke (also known as a cerebrovascular accident).
• after the injection of Rapiscan, an allergic reaction can occur, which can cause skin rash, hives, swelling under the skin near the eyes or throat, feeling of throat tightness, and difficulty breathing.

Tell your doctor immediately if you think you are experiencing serious side effects. Your doctor can then give you an injection of a medicine called aminophylline, which reduces these effects.

Very common side effects

(affects more than 1 person in 10)

• headache, dizziness
• difficulty breathing
• chest pain
• changes in heart tracing tests (electrocardiogram)
• flushing
• stomach upset

Common side effects

(affects between 1 and 10 people in 100)

• heart pain (angina), abnormal heart rhythms, fast heart rate, feeling that the heart is skipping a beat, fluttering or pounding heart (palpitations)
• low blood pressure
• throat tightness, throat irritation, cough
• vomiting, nausea
• feeling unwell or weak.
• excessive sweating
• back, arm, leg, neck, or jaw pain
• bone and muscle discomfort
• tingling, decreased sensitivity, taste changes
• mouth discomfort

Uncommon side effects

(affects between 1 and 10 people in 1,000)

• sudden cardiac arrest or heart damage, heart block (a disorder of the heart’s electrical signal in which the signal cannot pass from the upper to the lower chambers of the heart), slow heart rate
• seizures, fainting, mini-strokes (including weakness of the face or inability to speak), decreased responsiveness (which can include a comatose state), tremors, drowsiness
• an allergic reaction that can cause skin rash, hives, swelling under the skin near the eyes or throat, feeling of throat tightness, difficulty breathing

• wheezing
• rapid breathing
• high blood pressure, paleness, coldness of extremities
• blurred vision, eye pain
• anxiety, difficulty sleeping
• ringing in the ears
• swelling, diarrhea, involuntary loss of feces
• redness of the skin
• joint pain
• pain or discomfort around the injection site, body pain

Side effects of unknown frequency

(cannot be estimated from the available data)

• difficulty breathing (bronchospasm)
• respiratory arrest

Reporting of side effects

If you experience any side effects, talk to your doctor or nurse, even if they are not listed in this leaflet. You can also report side effects directly via 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. Storage of Rapiscan

Keep out of the sight and reach of children.

Do not use Rapiscan after the expiry date which is stated on the vial and on the outer packaging after EXP/CAD.

This medicine does not require any special storage conditions.

Rapiscan must not be used if the solution has changed color or contains solid particles.

Medicines should not be disposed of via wastewater or household waste. This will help protect the environment. Healthcare professionals are responsible for the disposal of this medicine.

6. Contents of the pack and other information

What Rapiscan contains

The active substance in Rapiscan is regadenoson. Each 5 ml vial of Rapiscan contains 400 micrograms of regadenoson.

The other ingredients are: disodium edetate, disodium phosphate dihydrate, sodium dihydrogen phosphate monohydrate, propylene glycol, water for injections.

Appearance and packaging

Rapiscan solution for injection is a clear, colorless solution without visible particles. Rapiscan is supplied in a pack containing a single 5 ml glass vial with a rubber stopper and an aluminum cap.

Marketing authorization holder and manufacturer

Marketing authorization holder:

GE Healthcare AS

Nycoveien 1

NO-0485 Oslo

Norway

Manufacturer:

AndersonBrecon (UK) Limited

Wye Valley Business Park

Hay-on-Wye, Hereford

HR3 5PG

United Kingdom

Millmount Healthcare Limited,

Block 7, City North Business Campus,

Stamullen, Co Meath, K32 YD60,

Ireland

Date of last approval of this leaflet MM/YYYY

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.

The leaflet for this medicine is available in all languages of the European Union/European Economic Area on the European Medicines Agency website.

This information is intended only for healthcare professionals:

Rapiscan should be administered as a rapid injection of 10 seconds into a peripheral vein using a catheter or needle of 22 gauge or larger.

Immediately after the injection of Rapiscan, 5 ml of sodium chloride injection solution at a concentration of 9 mg/ml (0.9%) should be administered.

The radiopharmaceutical for the myocardial perfusion imaging study should be administered 10-20 seconds after the sodium chloride injection solution at a concentration of 9 mg/ml (0.9%). The radiopharmaceutical can be injected directly into the same catheter used to administer Rapiscan.

For FFR measurement, Rapiscan should be administered as a rapid injection of 10 seconds into a peripheral vein using a catheter or needle of 22 gauge or larger. Immediately after the injection of Rapiscan, 10 ml of sodium chloride injection solution at a concentration of 9 mg/ml (0.9%) should be administered. Standard catheterization and FFR measurement techniques should be followed, and FFR should be measured as the lowest Pd/Pa value achieved during maximum hyperemia in a steady state.

If necessary, a second dose of 400 micrograms can be injected at least 10 minutes after the first dose to measure FFR during the same catheterization procedure.

In the absence of compatibility studies, this medicine should not be mixed with other medicines.

Before administration, this medicine should be visually inspected for particulate matter or color changes.

Disposal of unused medicine and all materials that have come into contact with it should be done in accordance with local regulations.

For further information, refer to the Summary of Product Characteristics or the complete package leaflet.