PATIENT INFORMATION LEAFLET

PLEASE READ BOTH SIDES OF THIS LEAFLET CAREFULLY IF YOU HAVE BEEN GIVEN OR WILL BE GIVEN ‘AGGRASTAT’ SOLUTION FOR INFUSION, EVEN IF YOU HAVE HAD THIS MEDICINE BEFORE. SOME OF THE INFORMATION IN YOUR LEAFLET MAY HAVE CHANGED.

Keep this leaflet. You may want to read it again.

AGGRASTAT® (50 micrograms/mL) Solution for Infusion

(tirofiban)

WHAT IS IN YOUR INJECTION?

HOW DOES YOUR MEDICINE WORK?

‘Aggrastat’ belongs to the group of medicines known as GP IIb/IIIa receptor antagonists, which are antiplatelet agents, for the blood. Your blood contains small particles called platelets which are involved in blood clotting. If blood clots develop in the blood vessels they can reduce the flow of blood to the heart and cause chest pain and heart attacks. ‘Aggrastat’ works by blocking a receptor on these platelets, which prevents them from sticking together and forming blood clots.

WHY DO YOU NEED TO BE GIVEN THIS MEDICINE?

Decreased blood flow to the heart can result in a certain kind of chest pain known as ‘unstable angina’ or ‘myocardial infarction’ (heart attack). If you have experienced severe chest pain within the last 12 hours your doctor will have conducted an electrocardiogram (ECG), a painless procedure in which electrical impulses in the heart are recorded, and taken a blood test to determine if you have unstable angina or have had a heart attack. Your doctor has prescribed ‘Aggrastat’ for you to help improve the blood flow in your heart and to help prevent you from having a heart attack or having another heart attack. You will also be given heparin and aspirin by your doctor.

In addition to using medicines, your doctor may decide to carry out a further test to study the blood supply to the heart. This test is called a coronary angiogram.

In some patients, the doctor may then recommend a procedure to improve the blood supply to the heart, with a balloon (angioplasty).

If your doctor decides to carry out any of these procedures he/she may continue to give you ‘Aggrastat’ to prevent further blood clots forming.

ARE THERE PATIENTS WHO SHOULD NOT TAKE THIS MEDICINE?

WHAT ELSE SHOULD YOU KNOW ABOUT ‘AGGRASTAT’?

You should tell your doctor about any medical problems you have or have had, and about any allergies.

Tell your doctor if you have or have had:

• resuscitation (cardiopulmonary resuscitation, [CPR]) within the last two weeks
• a diagnostic test in which tissue is removed for examination under the microscope (biopsy) in the last two weeks
• a procedure to break up kidney stones (lithotripsy) in the last two weeks
• a serious injury or major operation more than six weeks ago, but less than three months
• an ulcer in the stomach or duodenum (intestine) in the last three months
• uncontrolled high blood pressure
• acute inflammation of the membrane that surrounds the heart (pericarditis)
• active or known history of inflammation of blood vessels (vasculitis)
• a history or symptoms of possible damage to the lining of the aorta, the main blood vessel in the chest (aortic dissection)
• problems with the blood vessels in your retina (which is at the back of the eye)
• blood in your stools or in your urine
• treatment to break down blood clots within the last 48 hours (thrombolytic therapy)
• treatment with other medicines that affect blood clotting or platelets (e.g. coumarins, other GP IIb/IIIa receptor antagonists, dextran solutions)
• internal bleeding within the last year
• puncture of a non-compressible vessel (blood vessel) within 24 hours
• recently undergone an epidural procedure
• reduced pumping capacity of the heart such as heart failure or cardiogenic shock
• abnormal blood tests such as low platelet count, abnormal platelet function or anaemia
• other significant kidney or liver problems.

If you have had a major heart attack, ‘Aggrastat’ will not be used as a substitute for other clot dissolving drugs.

In addition, your healthcare professional will take some blood samples from you, for laboratory tests, before you start your treatment and at regular intervals throughout your treatment, to check the clotting of your blood and to check that your platelet count is normal and that your red blood cells are normal. Based on this information, your doctor may decide to adjust your dose of heparin.

If you have previously had treatment with a GPIIb/IIIa receptor antagonist, your healthcare professional should take a blood sample from you, within the first hour of being given ‘Aggrastat’, to check your platelet count.

Use of ‘Aggrastat’ in children is not recommended.

HOW SHOULD ‘AGGRASTAT’ BE GIVEN?

You will have been given or are about to be given ‘Aggrastat’ intravenously by a healthcare professional. Your doctor will decide on the appropriate dose, depending on your condition and your weight. ‘Aggrastat’ should ideally be given within 12 hours of the last angina attack.

Initially you will be given ‘Aggrastat’, via an intravenous drip through a vein in your arm, at an infusion rate of 0.4 microgram/kg/min for 30 minutes. After this initial infusion, ‘Aggrastat’ will be continued at a maintenance rate of 0.1 microgram/kg/min. Your treatment with ‘Aggrastat’ should last for at least 48 hours.

During your infusion, your healthcare professional may give you other drugs through the same line. For most drugs this is not a problem; however, you should not be given diazepam (a drug to help you relax) through the same tubing that is being used for ‘Aggrastat’.

If you have an angiogram your doctor can continue to give you ‘Aggrastat’. If you have an angioplasty or atherectomy your doctor can continue to give you ‘Aggrastat’ for at least 12 hours, but not more than 24 hours after these procedures.

The entire duration of treatment should not exceed 108 hours.

If you have kidney problems your doctor may reduce your dose by 50%.

While taking ‘Aggrastat’ your healthcare professional will also give you heparin and aspirin.

WHAT UNWANTED EFFECTS COULD YOUR MEDICINE HAVE?

Any medicine may have unintended or undesirable effects, so-called side effects. In studies the most frequent side effect reported was bleeding. If you notice blood in your stools or urine, large bruises or have been coughing or vomiting up blood you should tell your healthcare professional immediately.

Other side effects reported with ‘Aggrastat’ were fever, nausea and headache.

Abnormal laboratory test results have also been reported with ‘Aggrastat’. These have shown a reduced number of platelets and/or red cells in the blood and the presence of blood in the urine or faeces.

The following side effects have also been reported infrequently in post-marketing experience:

Bleeding: inside the skull, behind the peritoneum (membrane which lines the abdomen), in the pericardium (a fluid filled sac which covers the heart), in the lungs, or around the spinal cord.

Hypersensitivity: severe allergic reactions (e.g. tightness of the chest, nettle rash or hives), including anaphylactic reactions. These symptoms have occurred during initial treatment (also on the first day) and during re-administration of tirofiban. In some cases a severe decrease in platelet count has been reported.

General: sudden and/or severe decrease in platelet counts which may be associated with chills, low-grade fever or bleeding complications.

If you experience any of these symptoms or have any other unusual symptoms or feelings, you should let your doctor or healthcare professional know as soon as possible.

HOW SHOULD YOUR MEDICINE BE KEPT?

‘Aggrastat’ should be stored out of the reach of children. Your medicine should be stored inside the outer carton, and protected from freezing.

‘Aggrastat’ should not be used after the expiry date, which is clearly marked on the bag.

HOW CAN YOU OBTAIN MORE INFORMATION ABOUT ‘AGGRASTAT’?

This leaflet gives you some important patient information about ‘Aggrastat’ Solution for Infusion. If you have questions after you read it ask your doctor or pharmacist, who will give you further information.