Patient Information Leaflet
Kengrexal 50 mg powder for concentrate for solution for injection and for infusion
cangrelor
Read this leaflet carefully before you start using this medicine, because it contains important information for you.
1.What Kengrexal is and what it is used for
2.What you need to know before you start using Kengrexal
3.How to use Kengrexal
4.Possible side effects
6.Contents of the pack and additional information
Kengrexal is an antiplatelet medication that contains the active ingredient cangrelor.
Platelets are very small blood cells that can clump together and help in blood clotting. Sometimes, clots can form inside a damaged blood vessel, such as an artery of the heart, and this can be very dangerous as the clot can interrupt blood flow (thrombotic event), producing a heart attack (myocardial infarction).
Kengrexal reduces platelet clumping and thus reduces the likelihood of a clot forming.
You have been prescribed Kengrexal because you have blocked blood vessels in your heart (coronary artery disease) and need an intervention (called percutaneous coronary intervention, PCI) to remove the blockage. During this procedure, you may have a stent implanted in the blood vessel to help keep it open. The use of Kengrexal reduces the risk of this procedure causing a clot that blocks the blood vessels again.
Kengrexal should only be used in adults.
No use Kengrexal
-if you are allergic to cangrelor or any of the other components of this medication (listed in section 6).
Warnings and precautions
Consult your doctor before starting to use Kengrexal if:
Children and adolescents
Kengrexal is not recommended for use in children and adolescents under 18 years old.
Other medications and Kengrexal
You may receive aspirin (AAS) while receiving treatment with Kengrexal or another type of antiplatelet medication (e.g., clopidogrel) before and after being treated with Kengrexal.
Inform your doctor if you are taking any medication that may increase the risk of adverse effects such as bleeding, including blood thinners (anticoagulants, e.g., warfarin).
Inform your doctor if you are taking, have taken recently, or may need to take any other medication.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medication. Kengrexal is not recommended during pregnancy.
Driving and operating machinery
The effect of Kengrexal disappears quickly and it is unlikely to affect your ability to drive or operate machinery.
Kengrexal contains sodium and sorbitol
Sorbitol is a source of fructose. If you suffer from hereditary fructose intolerance (HFI), a rare genetic disease, you should not receive this medication. Patients with HFI cannot break down fructose, which can cause severe adverse effects.
Consult your doctor before receiving this medication if you suffer from HFI.
This medication contains less than 1 mmol of sodium (23 mg) per vial; it is essentially "sodium-free".
Your treatment with Kengrexal will be monitored by an experienced doctor who specializes in treating patients with heart disease. The doctor will decide how much Kengrexal you will receive and prepare the medication.
Kengrexal is administered through an injection, followed by an infusion (drip), into a vein. The dose administered depends on your weight. The recommended dose is:
If you use more Kengrexal than you should
A healthcare professional will administer this medication to you. Your doctor will decide how to treat you, which may include suspending the medication and monitoring for signs of adverse effects.
In case of doubt, consult your doctor again.
Like all medicines, this medicine may cause side effects, although not everyone will experience them.
If you experience side effects, you may need medical attention.
Inform your doctorimmediatelyif you notice any of the following:
Frequent side effects: may affect up to 1 in 10people
Infrequent side effects: may affect up to 1 in 100people
Rare side effects: may affect up to 1 in 1,000people
Very rare side effects: may affect up to 1 in 10,000people
Reporting side effects
If you experience any type of side effect, consult your doctor, even if it is a possible side effect that does not appear in this leaflet.
You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Usehttps://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.
Keep this medication out of the sight and reach of children.
Do not use this medication after the expiration date that appears on the label and on the box after EXP. The expiration date is the last day of the month indicated.
No special storage conditions are required.
Reconstituted solution: the powder must be reconstituted immediately before dilution and use. Do not refrigerate.
Diluted solution:From a microbiological point of view, the medication must be used immediately,unless the reconstitution and dilution method excludes the risk of microbiological contamination. If not used immediately, the storage times and conditions in use before use are the responsibility of the user.
Kengrexal Composition
Product Appearance and Packaging Contents
Lyophilized powder for concentrate solution for injection and infusion in a glass vial.
Kengrexal is a white to off-white lyophilized powder.
Kengrexal is marketed in packs of 10 vials.
Marketing Authorization Holder
Chiesi Farmaceutici S.p.A.
Via Palermo, 26/A
43122 Parma
Italy
Responsible Person for Manufacturing
Diapharm GmbH & CO. KG
Am Mittelhafen 56
48155 Münster
Germany
For further information about this medicinal product, please contact the local representative of the marketing authorization holder:
Spain Ferrer Farma, S.A. Tel: +34 93 600 3700 |
Last Review Date of this Leaflet: January 2023
Other Sources of Information
The detailed information on this medicinal product is available on the website of the European Medicines Agency:http://www.ema.europa.eu.
---------------------------------------------------------------------------------------------------------------------------
This information is intended solely for healthcare professionals:
Kengrexal should be administered by a doctor with experience in acute coronary care or coronary intervention procedures and is intended for specialized use in a hospital and acute setting.
Dosage
The recommended dose of Kengrexal for patients undergoing ICP is a bolus intravenous injection of 30micrograms/kg followed immediately by an intravenous infusion of 4micrograms/kg/min. The bolus and infusion should be initiated before the procedure and should continue for at least two hours or for the duration of the procedure, whichever is longer. At the discretion of the doctor, the infusion may continue for a total of 4hours, see section 5.1.
Patients should be switched to oral P2Y12treatment for chronic treatment. To transition, a loading dose of oral P2Y12treatment (clopidogrel, ticagrelor, or prasugrel) should be administered immediately after discontinuing the cangrelor infusion. Alternatively, a loading dose of ticagrelor or prasugrel, but not clopidogrel, may be administered up to 30minutes before completing the infusion, see section 4.5.
Preparation Instructions
Kengrexal should be prepared using aseptic techniques.
The vial should be reconstituted immediately before dilution and use. Reconstitute each vial of 50mg by adding 5ml of sterile water for injection. Gently mix the vial until the contents are fully dissolved. Avoid vigorous mixing. Allow the foam to settle. Ensure that the contents of the vial are fully dissolved and that the reconstituted product is a clear, colorless to yellowish solution.
Do not use without dilution. Before administration, 5ml of reconstituted solution from each vial should be extracted and further dilutedwith 250ml of sodium chloride 9mg/ml (0.9%) solution or with 5% glucose solution for injection. Mix the bag well.
After reconstitution, the medicinal product should be visually inspected for the presence of particles.
Kengrexal is administered in a weight-based regimen consisting of an initial bolus injection followed by an intravenous infusion. The bolus and infusion should be administered from the infusion solution.
This dilution will produce a concentration of 200micrograms/ml and should be sufficient for at least twohours of administration, as needed. Patients weighing 100kg or more will require a minimum of two bags.
Have questions about this medication or your symptoms? Connect with a licensed doctor for guidance and personalized care.