Kengreal Dosage

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 P2Y12 Therapy

To maintain platelet inhibition after discontinuation of KENGREAL infusion, administer an oral P2Y12 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)].