KENGREXAL Powder for concentrate solution

Active ingredients: Cangrelor

Therapeutic indications

Kengrexal, co-administered with acetylsalicylic acid (ASA), is indicated for the reduction of thrombotic cardiovascular events in adult patients with coronary artery disease undergoing percutaneous coronary intervention (PCI) who have not received an oral P2Y12 inhibitor prior to the PCI procedure and in whom oral therapy with P2Y12 inhibitors is not feasible or desirable.

Posology and method of administration

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.

Use with other anticoagulant agents

In patients undergoing PCI, standard procedural adjunctive therapy should be implemented (see section 5.1).

Elderly

No dose adjustment is needed in elderly (≥75 years) patients.

Renal impairment

No dose adjustment is needed in patients with mild, moderate or severe renal insufficiency (see sections 4.4 and 5.2).

Hepatic impairment

No dose adjustment is needed (see section 5.2).

Paediatric population

The safety and efficacy of cangrelor in children aged less than 18 years has not been established. No data are available.

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.

For instructions on reconstitution and dilution of the medicinal product before administration see section 6.6.

Overdose

In clinical studies, healthy volunteers received up to two times the proposed daily dose. In clinical trials, the maximum accidental overdose was 10 times (bolus) or 3.5 times the infusion dose normally administered and bleeding was the most frequently observed adverse event.

Bleeding is the most likely pharmacological effect of overdose. If bleeding occurs appropriate supportive measures should be taken, which may include stopping the medicinal product so platelet function can return.

There is no antidote to Kengrexal, however, the pharmacokinetic half-life of Kengrexal is three to six minutes. Platelet function is restored within 60 minutes of stopping the infusion.

Shelf life

Shelf life: 3 years.

The powder should be reconstituted immediately prior to dilution and use. Do not refrigerate. 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.

Special precautions for storage

This medicinal product does not require any special storage conditions. For storage conditions after reconstitution and dilution of the medicinal product see section 6.3.

Nature and contents of container

Powder in 10 mL glass vials (Type 1) closed with a Flurotec coated butyl rubber stopper and sealed with crimped aluminium seal.

Kengrexal is available in packs of 10 vials.

Special precautions for disposal and other handling

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.

Disposal

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.