These highlights do not include all the information needed to use KENGREAL safely and effectively. See full prescribing information for KENGREAL.
KENGREAL™ ( c angrelor) for injection, for intravenous use
Initial U.S. Approval: 201 5
INDICATIONS AND USAGE
KENGREAL is a P2Y12 platelet inhibitor indicated as an adjunct to percutaneous coronary intervention (PCI) for reducing the risk of periprocedural myocardial infarction (MI), repeat coronary revascularization, and stent thrombosis (ST) in patients in who have not been treated with a P2Y12 platelet inhibitor and are not being given a glycoprotein IIb/IIIa inhibitor. (1)
DOSAGE AND ADMINISTRATION
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KENGREAL is intended for administration via a dedicated IV line, only after reconstitution and dilution. (2.3)
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Administer 30 mcg/kg intravenous (IV) bolus prior to PCI followed immediately by a 4 mcg/kg/min IV infusion for at least 2 hours or duration of procedure, whichever is longer. (2.1)
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To maintain platelet inhibition after discontinuation of KENGREAL infusion, an oral P2Y12 platelet inhibitor should be administered. (2.2)
DOSAGE FORMS AND STRENGTHS
Single-use 10 mL vial containing 50 mg KENGREAL as a lyophilized powder for reconstitution (3.0)
CONTRAINDICATIONS
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Significant active bleeding (4.1)
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Hypersensitivity to KENGREAL or any component of the product (4.2)
WARNINGS AND PRECAUTIONS
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Bleeding: Like other drugs that inhibit platelet P2Y12 function, KENGREAL can increase the risk of bleeding (5.1)
ADVERSE REACTIONS
The most common adverse reaction is bleeding. (5.1, 6.1)
To report SUSPECTED ADVERSE REACTIONS, contact The Medicines Company at 1-888-977-6326 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS
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Clopidogrel: Do not administer during KENGREAL infusion. (7.1)
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Prasugrel: Do not administer during KENGREAL infusion. (7.1)
Revised: 6/2015
