INTEGRILIN 2 mg/ml INJECTABLE SOLUTION

Introduction

Patient Information Leaflet: Information for the Patient

Integrilin 2mg/ml solution for injection

eptifibatide

Read all of this leaflet carefully before you start using 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, pharmacist, or nurse.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

1. What is Integrilin and what is it used for

Integrilin is a platelet aggregation inhibitor. This means it helps prevent the formation of blood clots.

It is used in adults with severe coronary insufficiency characterized by spontaneous and recent chest pain with electrocardiographic changes or biological changes. It is usually given together with aspirin and unfractionated heparin.

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

You should not be given Integrilin:

• if you are allergic to eptifibatide or any of the other ingredients of this medicine (listed in section 6)
• if you have recently had a gastric, intestinal, bladder, or other organ bleeding (e.g., if you have noticed unusual blood in your stools or urine) in the last 30 days
• if you have had a stroke within the last 30 days or any previous hemorrhagic stroke (also, make sure your doctor knows if you have ever had a stroke)
• if you have had a brain tumor or a condition affecting the blood vessels in the brain
• if you have had major surgery or serious injury within the last 6 weeks
• if you have a history of bleeding problems
• if you have a history of blood coagulation problems or low platelet count
• if you have severe high blood pressure
• if you have severe liver or kidney problems
• if you have been treated with another medicine of the same type as Integrilin.

If you have had any of the above situations, tell your doctor. If you have any questions, ask your doctor, pharmacist, or nurse.

Be careful with Integrilin:

• Integrilin is only recommended for use in adult patients hospitalized in coronary care units.
• Integrilin should not be used in children or adolescents under 18 years of age.
• Before and during treatment with Integrilin, blood samples will be taken as a safety measure to limit the possibility of unexpected bleeding.
• During the use of Integrilin, you will be carefully monitored for signs of unusual or unexpected bleeding.

Using Integrilin with other medicines

To avoid the possibility of interactions with other medicines, tell your doctor, pharmacist, or nurse if you are using, have recently used, or might use other medicines, including those bought without a prescription.

Especially:

• blood thinners (oral anticoagulants) or
• medicines that prevent blood clot formation, such as warfarin, dipyridamole, ticlopidine, aspirin (except those you may receive as part of your treatment with Integrilin).

Pregnancy and breastfeeding

The use of Integrilin is not normally recommended during pregnancy. Tell your doctor if you are pregnant, think you may be pregnant, or plan to become pregnant. Your doctor will assess whether the benefits of treatment with Integrilin for you outweigh the possible risks for your baby.

If you are breastfeeding, breastfeeding should be interrupted during the treatment period.

Integrilin contains sodium

• This medicine contains 13.8 mg of sodium (main component of cooking/table salt) in each 10 ml vial. This is equivalent to 0.69% of the maximum recommended daily intake of sodium for an adult.

3. How to use Integrilin

Integrilin is given into a vein by direct injection followed by an infusion (drip). The dose given is based on your weight. The recommended dose is 180 micrograms/kg given as a bolus (rapid intravenous injection), followed by an infusion of 2.0 micrograms/kg/minute for a maximum of 72 hours. If you have kidney disease, the infusion dose may be reduced to 1.0 microgram/kg/minute.

If you undergo percutaneous coronary intervention during treatment with Integrilin, the intravenous solution may be continued for a maximum of 96 hours.

You will also receive some doses of acetylsalicylic acid (aspirin) and heparin (if not contraindicated in your case).

If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.

4. Possible side effects

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

Very common side effects

These may affect more than 1 in 10 people

• minor or major bleeding (e.g., blood in the urine, stools, vomiting blood, or bleeding from surgery)
• anemia (decrease in the number of red blood cells or hemoglobin in the blood).

Common side effects

These may affect up to 1 in 10 people

• inflammation of a vein.

Uncommon side effects

These may affect up to 1 in 100 people

• decrease in the number of platelets (blood cells necessary for blood coagulation)
• decrease in blood flow to the brain.

Rare side effects

These may affect up to 1 in 10,000 people

• severe bleeding (e.g., bleeding inside the abdomen, brain, or lungs)
• fatal bleeding
• severe decrease in the number of platelets (blood cells necessary for blood coagulation)
• skin rash (such as hives or itching)
• severe allergic reaction.

If you notice any signs of bleeding, tell your doctor, pharmacist, or nurse immediately. Very rarely, bleeding has been severe and even fatal. Safety measures to prevent this include blood tests and close monitoring by healthcare professionals.

If you show symptoms of a severe allergic reaction or skin rash, tell your doctor, pharmacist, or nurse immediately.

Other effects that may occur in patients who need this type of treatment include those related to the condition being treated, such as rapid or irregular heartbeats, low blood pressure, shock, or cardiac arrest.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Integrilin

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date (EXP) stated on the outer packaging and on the vial. The expiry date is the last day of the month stated.

Store in a refrigerator (between 2°C and 8°C).

Keep the vial in the outer packaging to protect it from light. However, during administration of the Integrilin solution, protection from light is not necessary.

Before use, the contents of the vial should be examined.

Do not use Integrilin if you notice particles or a color change.

Once opened, the unused medicine should be discarded.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

Composition of Integrilin

• The active substance is eptifibatide. Each ml of solution for injection contains 2 mg of eptifibatide. A 10 ml vial of solution for injection contains 20 mg of eptifibatide.
• The other ingredients are citric acid monohydrate, sodium hydroxide, and water for injections.

Appearance and packaging

Integrilin solution for injection: 10 ml vial, pack containing 1 vial.

The clear, colorless solution is contained in a 10 ml glass vial, closed with a butyl rubber stopper and an aluminum cap with a folded edge.

Marketing authorization holder and manufacturer

Marketing authorization holder:

GlaxoSmithKline (Ireland) Limited, 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland

Manufacturer:

GlaxoSmithKline Manufacturing S.P.A., Strada Provinciale Asolana No. 90, San Polo di Torrile 43056, Parma, Italy

You can obtain more information on this medicine by contacting the local representative of the marketing authorization holder.

Date of last revision of this leaflet

Other sources of information

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