Kengrexal 50 mg powder for concentrate for solution for injection / infusion.

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Kengrexal 50 mg powder for concentrate for solution for injection/infusion.

Cangrelor

1. WHAT KENGREXAL IS AND WHAT IT IS USED FOR

Kengrexal is an anti-platelet medicine that contains the active substance cangrelor.

Platelets are very small cells in the blood that can clump together and help the blood to clot. Sometimes clots can form within a damaged blood vessel such as in an artery in the heart and this can be very dangerous as the clot can cut off the blood supply (a thrombotic event), causing a heart attack (myocardial infarction).

Kengrexal diminishes the clumping of platelets and so reduces the chance of a blood clot forming.

You have been prescribed Kengrexal because you have blocked blood vessels in your heart (coronary artery disease) and you need a procedure (called a percutaneous coronary intervention – PCI) to remove the blockage. During this procedure you may have a stent inserted in your blood vessel to help to keep it open. Using Kengrexal reduces the risk that this procedure will cause a clot to form and block the blood vessels again.

Kengrexal is only for use in adults.

2. WHAT YOU NEED TO KNOW BEFORE YOU USE KENGREXAL

3. HOW TO USE KENGREXAL

Your treatment with Kengrexal will be supervised by a doctor experienced in caring for patients with heart disease. The doctor will decide how much Kengrexal you receive, and will prepare the medicine.

Kengrexal is for injection, followed by infusion (drip), into a vein. The dose given depends on your weight. The recommended dose is:

• 30 micrograms per kilogram body weight by injection, followed immediately by
• 4 micrograms per kilogram body weight per minute by infusion (drip), for at least 2 hours. The doctor will decide if you will need to be treated for longer periods.

If you have any further questions on the use of this medicine, ask your doctor.

4. POSSIBLE SIDE EFFECTS

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

If side effects occur, they may need medical attention.

Tell your doctor immediately if you notice any of the following:

• Bleeding from anywhere in the body. Bleeding is a common side effect of treatment with Kengrexal (may affect up to 1 in 10 people). Bleeding can be serious, and fatal outcomes have been reported.
• Allergic reaction (a rash, itching, throat tightening/swelling, swelling of the tongue or lips, difficulty breathing). Allergic reaction is a rare side effect of treatment with Kengrexal (may affect up to 1 in 1,000 people) but may be potentially serious.

Common side effects: may affect up to 1 in 10 people

• Minor bruising can occur anywhere in the body (including small red bruises on the skin or at the site of an injection under the skin causing swelling),
• dyspnoea (shortness of breath),
• bleeding leading to decreases in blood volume or red blood cell numbers,
• fluid discharge from injection or catheter sites.

Uncommon side effects: may affect up to 1 in 100 people

• Bleeding leading to fluid around the heart, blood in the chest cavity or bleeding from the nose, gastrointestinal tract, in the abdomen, or in the urine or from injection or catheter sites,
• increased levels of creatinine in the blood (identified by blood tests), indicating reduced kidney function,
• variations in blood pressure,
• rash, pruritus, urticaria,
• vessel puncture site haematoma.

Rare side effects: may affect up to 1 in 1,000 people

• Bleeding leading to low platelet count or anaemia,
• bleeding in the eye, brain (including stroke), pelvis and lung,
• bleeding from the site of wounds,
• balloon-like swelling in an artery or wall of the heart, which involves only a few layers of the vessel walls,
• severe allergic reactions,
• reduced clotting of the blood,
• bruising,
• swollen face.

Very rare side effects: may affect up to 1 in 10,000 people

• Bleeding under the skin or around the eye,
• infection of bleeding sites,
• heavy menstrual bleeding,
• bleeding from the penis, ear or pre-existing skin tumours.

5. HOW TO STORE KENGREXAL

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

Do not use this medicine after the expiry date which is stated on the label and carton after ‘EXP’. The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

Reconstituted solution: the powder should be reconstituted immediately prior to dilution and use. Do not refrigerate.

Diluted solution: From a microbiological point of view, unless the method of reconstitution/dilution precludes the risk of microbiological contamination, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.