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: PLGB 08829/0187.
Kengrexal 50 mg powder for concentrate for solution for injection / infusion.
Kengrexal 50 mg powder for concentrate for solution for injection/infusion.
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
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.
Talk to your doctor before using Kengrexal if:
Kengrexal is not recommended for children and adolescents under 18 years.
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).
Tell your doctor if you are taking, have recently taken or might take any other medicines.
If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. Kengrexal is not recommended for use during pregnancy.
The effect of Kengrexal wears off quickly and it is unlikely to affect your ability to drive or to use machines.
Sorbitol is a source of fructose. If you have hereditary fructose intolerance (HFI), a rare genetic disorder, you must not receive this medicine. Patients with HFI cannot break down fructose, which may cause serious side effects.
You must tell your doctor before receiving this medicine if you have HFI.
This medicine contains less than 1 mmol sodium (23 mg) per vial, that is to say essentially ‘sodium-free’.
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:
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.
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:
Common side effects: may affect up to 1 in 10 people
Uncommon side effects: may affect up to 1 in 100 people
Rare side effects: may affect up to 1 in 1,000 people
Very rare side effects: may affect up to 1 in 10,000 people
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.
or search for MHRA Yellow Card in the Google Play or Apple App Store.
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.
The active substance is cangrelor. Each vial contains 50 mg cangrelor. After reconstitution 1 mL of concentrate contains 10 mg cangrelor and after dilution 1 mL of solution contains 200 micrograms cangrelor.
The other ingredients are mannitol, sorbitol and sodium hydroxide for pH adjustment.
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 vials.
Ireland & United Kingdom (Northern Ireland):
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
This leaflet was last revised in 01/2023.
Other sources of information
Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu