Kengrexal

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. 1. Patients should be transitioned to oral P2Y12 therapy for chronic treatment.

5: • Clopidogrel: immediately following discontinuation of cangrelor infusion. • Prasugrel: immediately following discontinuation of cangrelor infusion. Alternatively, a loading dose of prasugrel may be administered up to 30 minutes before the end of the infusion.

• Ticagrelor: at any time during cangrelor infusion or immediately after discontinuation. 1). Elderly No dose adjustment is needed in elderly (≥75 years) patients. 2). 2). Paediatric population The safety and efficacy of cangrelor in children aged less than 18 years has not yet been established.

2 but no recommendation on a posology can be made. Method of administration Kengrexal is intended for intravenous use, only after reconstitution and dilution. Kengrexal should be administered via an intravenous line. The bolus volume should be administered rapidly (<1 minute), from the diluted bag via manual intravenous push or pump.

Ensure the bolus is completely administered before the start of PCI. Start the infusion immediately after administration of the bolus. 6.

8. Although most bleeding associated with the use of cangrelor occurs at the site of arterial puncture, haemorrhage can occur at any site. Any unexplained fall in blood pressure or haematocrit should lead to the serious consideration of a haemorrhagic event and the cessation of cangrelor administration.

Cangrelor should be used with caution in patients with disease states associated with an increased bleeding risk. Cangrelor should be used with caution in patients taking medicines that may increase the risk of bleeding. 4 Cangrelor has a half-life of three to six minutes.

Platelet function is restored within 60 minutes of stopping infusion. Intracranial haemorrhage Treatment with Kengrexal may increase the risk of intracranial haemorrhage. 02%), of which 4 bleeds with cangrelor and 1 bleed with clopidogrel were fatal.

8). Cardiac tamponade Treatment with Kengrexal may increase the risk of cardiac tamponade. 8). 8). 4%). 4%). Cangrelor should be used with caution in these patients. Hypersensitivity Hypersensitivity reactions may occur after treatment with Kengrexal.

007%). 8). Risk of dyspnoea Treatment with Kengrexal may increase the risk of dyspnoea. 4%). 8). 2 mg sorbitol in each vial. Patients with hereditary fructose intolerance (HFI) must not be given this medicine unless strictly necessary. Sodium This medicinal product contains less than 1 mmol sodium (23 mg) per vial, that is to say essentially ‘sodium-free’.

5 Interaction with other medicinal products and other forms of interaction Interaction studies have only been performed in adults. 5 Oral P2Y12 agents (clopidogrel, prasugrel, ticagrelor) When clopidogrel is administered during infusion of cangrelor, the expected inhibitory effect of clopidogrel on platelets is not achieved.

Administration of 600 mg clopidogrel immediately after the cessation of the cangrelor infusion results in the anticipated full pharmacodynamic effect. No clinically relevant interruption of P2Y12 inhibition was observed in phase III studies when 600 mg clopidogrel was administered immediately after discontinuation of the cangrelor infusion.

Risk of bleeding Treatment with Kengrexal may increase the risk of bleeding. 8. Although most bleeding associated with the use of cangrelor occurs at the site of arterial puncture, haemorrhage can occur at any site. Any unexplained fall in blood pressure or haematocrit should lead to the serious consideration of a haemorrhagic event and the cessation of cangrelor administration.

Cangrelor should be used with caution in patients with disease states associated with an increased bleeding risk. Cangrelor should be used with caution in patients taking medicines that may increase the risk of bleeding. 4 Cangrelor has a half-life of three to six minutes.

Platelet function is restored within 60 minutes of stopping infusion. Intracranial haemorrhage Treatment with Kengrexal may increase the risk of intracranial haemorrhage. 02%), of which 4 bleeds with cangrelor and 1 bleed with clopidogrel were fatal.

8). Cardiac tamponade Treatment with Kengrexal may increase the risk of cardiac tamponade. 8). 8). 4%). 4%). Cangrelor should be used with caution in these patients. Hypersensitivity Hypersensitivity reactions may occur after treatment with Kengrexal.

007%). 8). Risk of dyspnoea Treatment with Kengrexal may increase the risk of dyspnoea. 4%). 8). 2 mg sorbitol in each vial. Patients with hereditary fructose intolerance (HFI) must not be given this medicine unless strictly necessary. Sodium This medicinal product contains less than 1 mmol sodium (23 mg) per vial, that is to say essentially ‘sodium-free’.

• Active bleeding or increased risk of bleeding, because of impaired haemostasis and/or irreversible coagulation disorders or due to recent major surgery/trauma or uncontrolled severe hypertension. • Any history of stroke or transient ischaemic attack (TIA).

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