What is a Patient Information Leaflet and why is it useful?

The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.

Black triangle. This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information.

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Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.

The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: EU/1/15/994/001.

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

▼This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.

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.
  • If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

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

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

Do not use Kengrexal:

  • If you are allergic to cangrelor or any of the other ingredients of this medicine (listed in section 6).
  • If you have a medical condition that is currently causing bleeding such as bleeding from the stomach or intestines or you have a condition which makes you more prone to uncontrolled bleeding (impaired haemostasis or irreversible coagulation disorders).
  • If you have recently undergone major surgery or suffered from any form of serious physical trauma such as a bone fracture or road traffic accident.
  • If you have uncontrolled very high blood pressure.
  • If you have ever had a stroke, or a ‘mini-stroke’ (also known as a transient ischaemic attack, TIA) caused by the temporary interruption of the blood supply to the brain.

Warnings and precautions

Talk to your doctor before using Kengrexal if:

  • You are, or you think you may be at increased risk of bleeding. For example, if you have a medical condition that affects blood clotting or because of another medical condition that may increase the risk of bleeding such as a recent serious injury, any recent surgery, history of a stroke or a transient ischaemic attack (TIA) or recent bleeding from your stomach or gut.
  • You suffer from impaired kidney function or require dialysis.
  • You have ever suffered from an allergic reaction to Kengrexal or any of its constituents.
  • You suffer from breathing difficulties such as asthma.
  • If you have been told by your doctor that you have an intolerance to some sugars.

Children and adolescents

Kengrexal is not recommended for children and adolescents under 18 years.

Other medicines and Kengrexal

You may receive acetylsalicylic acid (ASA) while you are treated with Kengrexal or another type of anti-platelet medicine (e.g., clopidogrel) before and after you are treated with Kengrexal.

Tell your doctor if you are taking other medicines that may increase the risk of side effects such as bleeding including blood thinners (anticoagulants e.g., warfarin).

Pregnancy and breast-feeding

Before using this medicine, tell your doctor if you are pregnant, if you think you may be pregnant or are planning to have a baby. Kengrexal is not recommended for use during pregnancy.

Driving and using machines

The effect of Kengrexal wears off quickly and it is unlikely to affect your ability to drive or to use machines.

Kengrexal contains sodium and sorbitol

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

This medicine contains less than 23 mg of sodium per vial, which means that it is essentially “sodium free”.

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:

  • a 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 use more Kengrexal than you should

This medicine will be given to you by a healthcare professional. Your doctor will decide how to treat you, including stopping the medicine and monitoring for signs of side effects.

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. Other uncommon side effects include reduced kidney function resulting in increased blood creatinine, variations in blood pressure, rash.

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, severe allergic reactions and 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.

Reporting of side effects

If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet.

You can also report side effects directly via the national reporting system listed. By reporting side effects you can help provide more information on the safety of this medicine.

United Kingdom

Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard

Ireland

HPRA Pharmacovigilance
Earlsfort Terrace
IRL - Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6762517
Website: www.hpra.ie
e-mail: [email protected]

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 medicinal product 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

What Kengrexal contains

The active ingredient is cangrelor. Each vial contains 50 mg cangrelor.

The other ingredients are mannitol, sorbitol and sodium hydroxide for pH adjustment.

What Kengrexal looks like and contents of the pack

Powder for concentrate for solution for injection / infusion in a glass vial.

Kengrexal is a white to off-white freeze-dried powder.

Kengrexal is available in packs of 10.

Marketing Authorisation Holder and Manufacturer

Chiesi Farmaceutici S.p.A.
Via Palermo, 26/A
43122 Parma
Italy

Manufacturer

Hälsa Pharma GmbH
Hafenweg 18 - 20
48155 Münster
Germany

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

United Kingdom
Chiesi Ltd
Tel: + 44 (0)161 488 5555

This leaflet was last revised in 11/2018.

Other sources of information

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