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Home » Directories » FDA Approved Drugs » Kengreal (cangrelor)

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Kengreal (cangrelor)

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    General Information

    Kengreal (cangrelor) is a direct P2Y12 platelet receptor inhibitor that blocks ADP-induced platelet activation and aggregation. Cangrelor binds selectively and reversibly to the P2Y12 receptor to prevent further signaling and platelet activation. 

    Kengreal is specifically indicated as an adjunct to percutaneous coronary intervention for reducing the risk of periprocedural myocardial infarction, repeat coronary revascularization, and stent thrombosis in patients in who have not been treated with a P2Y12 platelet inhibitor and are not being given a glycoprotein IIb/IIIa inhibitor.

    Kengreal is supplied as asterile white to off-white lyophilized powder for reconstitution into an IV infusion. The recommended dosage is a 30 mcg/kg IV bolus followed immediately by a 4 mcg/kg/min IV infusion. Initiate the bolus infusion prior to PCI. The maintenance infusion should ordinarily be continued for at least 2 hours or for the duration of PCI, whichever is longer. 

    Clinical Results

    FDA Approval

    The FDA approval of Kengreal was based on CHAMPION PHOENIX, a randomized, double-blind study in which subjects with coronary artery disease (stable angina, UA/NSTEMI, STEMI) requiring PCI and receiving standard therapy including aspirin and heparin or bivalirudin were randomized to Kengreal (n=5472) or to clopidogrel (n=5470). Subjects who had already taken an oral P2Y12 platelet inhibitor or who had been administered glycoprotein IIb/IIIa inhibitors (GPI), or for whom GPI use was planned, were not eligible to enroll. Kengreal was administered as 30 mcg/kg bolus followed by 4 mcg/kg/min infusion for 2 to 4 hours. Clopidogrel 600 mg was administered immediately at the end of the Kengreal infusion in subjects randomized to Kengreal. Clopidogrel 300 mg or 600 mg was administered shortly before PCI or shortly afterward, in subjects randomized to clopidogrel. The primary outcome measure was the first occurrence of any one of the composite endpoint of all-cause mortality, myocardial infarction (MI), ischemia-driven revascularization (IDR), and stent thrombosis (ST) within 48 hours after randomization. Kengreal significantly reduced the occurrence of primary composite endpoint events compared to clopidogrel (relative risk reduction [RRR] 22%). Most of the effect was a reduction in post-procedural MIs detected solely by elevations in CK-MB (type 4a MI). Kengreal did not reduce the risk of death.

    Side Effects

    The most common adverse effect associated with the use of Kengreal is bleeding.

    Mechanism of Action

    Kengreal (cangrelor) is a direct P2Y12 platelet receptor inhibitor that blocks ADP-induced platelet activation and aggregation. Cangrelor binds selectively and reversibly to the P2Y12 receptor to prevent further signaling and platelet activation. 

    Additional Information

    For additional information regarding Kengreal or reducing periprocedural thrombotic events, please visit http://www.kengreal.com/

    Approval Date: 2015-06-01
    Date Created: 2015-06-26 09:44:33
    Company Name: The Medicines Company
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