Kengrexal 50 mg polvo para concentrado para solucion inyectable y para perfusion

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.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor.
• If you experience any side effects, consult your doctor, even if they are not listed in this leaflet. See section 4.

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

1. Storage of Kengrexal

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).

• if you have a disease that currently causes bleeding, such as bleeding in the stomach or intestines, or have a disease that increases the likelihood of uncontrolled bleeding (hemostasis disorder or irreversible coagulation disorders).
• if you have recently undergone major surgery or have suffered any type of severe physical trauma, such as a bone fracture or a traffic accident.
• if you have very high and uncontrolled blood pressure.
• if you have ever had a stroke or a mini-stroke (also known as a transient ischemic attack, TIA) caused by temporary interruption of blood flow to the brain.

Warnings and precautions

Consult your doctor before starting to use Kengrexal if:

• you have or may have a higher risk of bleeding. For example, if you have a disease that affects blood clotting or another disease that could increase the risk of bleeding, such as recent severe injury, recent surgical intervention, history of stroke or transient ischemic attack, or recent bleeding in the stomach or intestines;
• you have kidney failure or require dialysis;
• you have had any allergic reaction to Kengrexal or any of its components;
• you have respiratory problems, such as asthma;
• your doctor has informed you that you have intolerance to some sugars.

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:

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

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:

• Bleeding in any part of the body. Bleeding is a frequent side effect of Kengrexal treatment (it may affect up to 1 in 10people). Bleeding can be severeand fatal outcomes have been reported.
• Allergic reaction (skin rash, itching, narrowing/swelling of the throat, swelling of the tongue or lips, difficulty breathing). An allergic reaction is a rare side effect of Kengrexal treatment (it may affect up to 1 in 1,000people) but can be potentially severe.

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

• You may experience smaller bruises in any part of the body (including small red bruises on the skin or under the skin at the injection site that cause swelling),
• shortness of breath,
• bleeding that reduces blood volume or the number of red blood cells,
• discharge from the injection site or catheter.

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

• Bleeding that produces fluid around the heart, blood in the thoracic cavity or bleeding from the nose, digestive tract, abdomen or urine or from the injection site or catheter,

• increased levels of creatinine in the blood (identified in blood tests), indicating reduced kidney function,
• changes in blood pressure,
• skin rash, pruritus, urticaria,
• hematoma at the puncture site of the vessel.

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

• Bleeding that produces low platelet count or anemia,
• bleeding in the eyes, brain (including stroke), pelvis and lungs,
• bleeding from wounds,

• swelling similar to a balloon in an artery or heart wall, affecting only some layers of the vessel wall,

• severe allergic reactions,

• reduced blood coagulation,
• hematomas,

• facial swelling.

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

• Bleeding under the skin or around the eyes,
• infection at bleeding sites,
• heavy menstrual bleeding,
• bleeding from the penis, ear or pre-existing skin tumors.

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

• The active ingredient is cangrelor. Each vial contains 50mg of cangrelor.After reconstitution, 1ml of concentrate contains 10mg of cangrelor and after dilution, 1ml of solution contains 200micrograms of cangrelor.
• The other components are mannitol, sorbitol, and sodium hydroxide for pH adjustment.

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:

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.

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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.