Kengrexal - patient leaflet, side effects, dosage

B. PACKAGE LEAFLET

Package leaflet: Information for the patient

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

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 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.
• 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).

Tell your doctor if you are taking, have recently taken or might take any other medicines.

Pregnancy and breast-feeding

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.

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

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’.

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 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,
• 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

What Kengrexal contains

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.

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 vials.

Marketing Authorisation Holder

Chiesi Farmaceutici S.p.A.

Via Palermo, 26/A

43122 Parma

Italy

Manufacturer

Halsa Pharma GmbH

Hafenweg 18–20

48155 Münster

Germany

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

België/Belgiqu­e/Belgien	Lietuva
Ferrer Internacional, S.A..	Chiesi Pharmaceuticals GmbH
Tél/Tel: +32 15 28 74 15	Tel: +43 1 4073919
Efc^rapufl	Luxembourg/Lu­xemburg
Chiesi Bulgaria EOOD	Ferrer Internacional, S.A.
Tea.: + 359 29201205	Tel/Tel: +32 15 28 74 15

Česká republika Chiesi CZ s.r.o. Tel: +420 261221745	Magyarország Chiesi Hungary Kft. Tel.: +36–1–429 1060
Danmark Chiesi Pharma AB Tlf: +46 8 753 35 20	Malta Chiesi Farmaceutici S.p.A. Tel: + 39 0521 2791
Deutschland Ferrer Deutschland GmbH Tel: +49 (0) 2407 502311–0	Nederland Ferrer Internacional, S.A. Tél/Tel: +32 15 28 74 15
Eesti Chiesi Pharmaceuticals GmbH Tel: +43 1 4073919	Norge Chiesi Pharma AB Tlf: +46 8 753 35 20
EZZáSa Chiesi Hellas AEBE Tql: + 30 210 6179763	Österreich Chiesi Pharmaceuticals GmbH Tel: + 43 1 4073919
España Ferrer Farma, S.A. Tel: +34 93 600 3700	Polska Chiesi Poland Sp. z.o.o. Tel.: + 48 22 620 1421
France Bioprojet Pharma +33 (0)1 47 03 66 33	Portugal Ferrer Portugal, S.A Tel: +351 214449600
Hrvatska Chiesi Pharmaceuticals GmbH Tel: + 43 1 4073919	Romania Chiesi Romania S.R.L. Tel: + 40 212023642
Ireland Chiesi Farmaceutici S.p.A. Tel: + 39 0521 2791	Slovenija Chiesi Slovenija d.o.o. Tel: + 386–1–43 00 901
Ísland Chiesi Pharma AB Tlf: +46 8 753 35 20	Slovenská republika Chiesi Slovakia s.r.o. Tel: + 421 259300060
Italia Chiesi Italia S.p.A. Tel: + 39 0521 2791	Suomi/Finland Chiesi Pharma AB Tlf: +46 8 753 35 20
Kúnpog Chiesi Farmaceutici S.p.A. Tql: + 39 0521 2791	Sverige Chiesi Pharma AB Tlf: +46 8 753 35 20
Latvija Chiesi Pharmaceuticals GmbH Tel: + 43 1 4073919	United Kingdom (Northern Ireland) Chiesi Farmaceutici S.p.A. Tel: + 39 0521 2791

This leaflet was last revised in {MM/YYYY}.

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site:.

The following information is intended for healthcare professionals only:

Kengrexal should be administered by a physician experienced in either acute coronary care or in coronary intervention procedures and is intended for specialised use in an acute and hospital setting.

Posology

The recommended dose of Kengrexal for patients undergoing PCI is a 30 micrograms/kg intravenous bolus followed immediately by 4 micrograms/kg/min intravenous infusion. The bolus and infusion should be initiated prior to the procedure and continued for at least two hours or for the duration of the procedure, whichever is longer. At the discretion of the physician, the infusion may be continued for a total duration of four hours, see section 5.1.

Patients should be transitioned to oral P2Y12 therapy for chronic treatment. For transition, a loading dose of oral P2Y12 therapy (clopidogrel, ticagrelor or prasugrel) should be administered immediately following discontinuation of cangrelor infusion. Alternatively, a loading dose of ticagrelor or prasugrel, but not clopidogrel, may be administered up to 30 minutes before the end of the infusion, see section 4.5.

Instructions for preparation

Aseptic procedures should be used for the preparation of Kengrexal.

The vial should be reconsituted immediately prior to dilution and use. Reconstitute each 50 mg/vial by adding 5 mL of sterile water for injection. Swirl gently until all material is dissolved. Avoid vigorous mixing. Allow any foam to settle. Ensure that the contents of the vial are fully dissolved and the reconstituted material is a clear, colourless to pale yellow solution.

Do not use without dilution. Before administration, 5 mL reconstituted solution has to be withdrawn from each vial and must be diluted further with 250 mL sodium chloride 9 mg/mL (0.9%) solution for injection or glucose (5%) solution for injection. Mix the bag thoroughly.

The medicinal product should be inspected visually for particulate matter after reconstitution.

Kengrexal is administered as a weight-based regimen consisting of an initial intravenous bolus followed by an intravenous infusion. The bolus and infusion should be administered from the infusion solution.

This dilution will generate a concentration of 200 micrograms/mL and should be sufficient for at least two hours of dosing as required. Patients 100 kg and over will require a minimum of two bags.

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