cangrelor 50 MG Injection

INDICATIONS AND USAGE KENGREAL is indicated as an adjunct to percutaneous coronary intervention (PCI) to reduce the risk of periprocedural myocardial infarction (MI), repeat coronary revascularization, and stent thrombosis (ST) in patients who have not been treated with a P2Y 12 platelet inhibitor and are not being given a glycoprotein IIb/IIIa inhibitor [see Clinical Studies ( 14.1 )]. KENGREAL is a P2Y 12 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 P2Y 12 platelet inhibitor and are not being given a glycoprotein IIb/IIIa inhibitor. ( 1 )

DOSAGE AND ADMINISTRATION KENGREAL is intended for administration via a dedicated IV line, only after reconstitution and dilution. ( 2.3 ) 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 ) To maintain platelet inhibition after discontinuation of KENGREAL infusion, administer an oral P2Y 12 platelet inhibitor. ( 2.2 ) 2.1 Recommended Dosing The recommended dosage of KENGREAL 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. 2.2 Transitioning Patients to Oral P2Y 12 Therapy To maintain platelet inhibition after discontinuation of KENGREAL infusion, administer an oral P2Y 12 platelet inhibitor, as described below: Ticagrelor: 180 mg at any time during KENGREAL infusion or immediately after discontinuation [see Clinical Pharmacology ( 12.2 )] . Prasugrel: 60 mg immediately after discontinuation of KENGREAL [see Drug Interactions ( 7.1 ) and Clinical Pharmacology ( 12.2 )] . Clopidogrel: 600 mg immediately after discontinuation of KENGREAL [see Drug Interactions ( 7.1 ) and Clinical Pharmacology ( 12.2 )] . 2.3 Preparation and Administration KENGREAL is intended for IV administration, after reconstitution and dilution. Preparation Reconstitute the vial prior to dilution in a bag. For each 50 mg/vial, reconstitute 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, colorless to pale yellow solution. Parenteral drug products should be inspected visually for particulate matter after reconstitution. Before administration, each reconstituted vial must be diluted further with Normal Saline (Sodium Chloride Injection 0.9% USP) or 5% Dextrose Injection USP. Withdraw the contents from one reconstituted vial and add to one 250 mL saline bag. Mix the bag thoroughly. This dilution will result in a concentration of 200 mcg/mL and should be sufficient for at least 2 hours of dosing. Patients 100 kg and over will require a minimum of 2 bags. Reconstituted KENGREAL should be diluted immediately. Diluted KENGREAL is stable for up to 12 hours in 5% Dextrose Injection and 24 hours in Normal Saline at Room Temperature. Discard any unused portion of reconstituted solution remaining in the vial. Administration Administer KENGREAL via a dedicated IV line. Administer the bolus volume rapidly (<1 minute), from the diluted bag via manual IV push or pump. Ensure the bolus is completely administered before the start of PCI. Start the infusion immediately after administration of the bolus [see Dosage and Administration ( 2.1 )] . 2.1 Recommended Dosing The recommended dosage of KENGREAL 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. 2.2 Transitioning Patients to Oral P2Y 12 Therapy To maintain platelet inhibition after discontinuation of KENGREAL infusion, administer an oral P2Y 12 platelet inhibitor, as described below: Ticagrelor: 180 mg at any time during KENGREAL infusion or immediately after discontinuation [see Clinical Pharmacology ( 12.2 )] . Prasugrel: 60 mg immediately after discontinuation of KENGREAL [see Drug Interactions ( 7.1 ) and Clinical Pharmacology ( 12.2 )] . Clopidogrel: 600 mg immediately after discontinuation of KENGREAL [see Drug Interactions ( 7.1 ) and Clinical Pharmacology ( 12.2 )] . 2.3 Preparation and Administration KENGREAL is intended for IV administration, after reconstitution and dilution. Preparation Reconstitute the vial prior to dilution in a bag. For each 50 mg/vial, reconstitute 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, colorless to pale yellow solution. Parenteral drug products should be inspected visually for particulate matter after reconstitution. Before administration, each reconstituted vial must be diluted further with Normal Saline (Sodium Chloride Injection 0.9% USP) or 5% Dextrose Injection USP. Withdraw the contents from one reconstituted vial and add to one 250 mL saline bag. Mix the bag thoroughly. This dilution will result in a concentration of 200 mcg/mL and should be sufficient for at least 2 hours of dosing. Patients 100 kg and over will require a minimum of 2 bags. Reconstituted KENGREAL should be diluted immediately. Diluted KENGREAL is stable for up to 12 hours in 5% Dextrose Injection and 24 hours in Normal Saline at Room Temperature. Discard any unused portion of reconstituted solution remaining in the vial. Administration Administer KENGREAL via a dedicated IV line. Administer the bolus volume rapidly (<1 minute), from the diluted bag via manual IV push or pump. Ensure the bolus is completely administered before the start of PCI. Start the infusion immediately after administration of the bolus [see Dosage and Administration ( 2.1 )] .

WARNINGS AND PRECAUTIONS Bleeding: Like other drugs that inhibit platelet P2Y 12 function, KENGREAL can increase the risk of bleeding ( 5.1 ) 5.1 Bleeding Drugs that inhibit platelet P2Y 12 function, including KENGREAL, increase the risk of bleeding. In CHAMPION PHOENIX bleeding events of all severities were more common with KENGREAL than with clopidogrel [see Adverse Reactions ( 6.1 )] . Bleeding complications with KENGREAL were consistent across a variety of clinically important subgroups (see Figure 1). Once KENGREAL is discontinued, there is no antiplatelet effect after an hour [see Clinical Pharmacology ( 12.3 )] . 5.1 Bleeding Drugs that inhibit platelet P2Y 12 function, including KENGREAL, increase the risk of bleeding. In CHAMPION PHOENIX bleeding events of all severities were more common with KENGREAL than with clopidogrel [see Adverse Reactions ( 6.1 )] . Bleeding complications with KENGREAL were consistent across a variety of clinically important subgroups (see Figure 1). Once KENGREAL is discontinued, there is no antiplatelet effect after an hour [see Clinical Pharmacology ( 12.3 )] .

CONTRAINDICATIONS Significant active bleeding ( 4.1 ) Hypersensitivity to KENGREAL or any component of the product ( 4.2 ) 4.1 Significant Active Bleeding KENGREAL is contraindicated in patients with significant active bleeding [see Warnings and Precautions ( 5.1 ) and Adverse Reactions ( 6.1 )] . 4.2 Hypersensitivity KENGREAL is contraindicated in patients with known hypersensitivity (e.g., anaphylaxis) to KENGREAL or any component of the product [see Adverse Reactions ( 6.1 )] . 4.1 Significant Active Bleeding KENGREAL is contraindicated in patients with significant active bleeding [see Warnings and Precautions ( 5.1 ) and Adverse Reactions ( 6.1 )] . 4.2 Hypersensitivity KENGREAL is contraindicated in patients with known hypersensitivity (e.g., anaphylaxis) to KENGREAL or any component of the product [see Adverse Reactions ( 6.1 )] .

Mechanism of Action Cangrelor is a direct P2Y 12 platelet receptor inhibitor that blocks ADP-induced platelet activation and aggregation. Cangrelor binds selectively and reversibly to the P2Y 12 receptor to prevent further signaling and platelet activation.