Start and duration of therapy with Aggrastat

In patients who are managed with an early invasive strategy for NSTE-ACS but not planned to undergo angiography for at least 4 hours and up to 48 hours after diagnosis, Aggrastat 0.4 microgram/kg/min loading dose regimen should be initiated upon diagnosis. The recommended duration of the maintenance infusion should be at least 48 hours. Infusion of Aggrastat and unfractionated heparin may be continued during coronary angiography and should be maintained for at least 12 hours and not more than 24 hours after angioplasty/atherectomy. Once a patient is clinically stable and no coronary intervention procedure is planned by the treating physician, the infusion should be discontinued. The entire duration of treatment should not exceed 108 hours.

If the patient diagnosed with NSTE-ACS and managed with an invasive strategy undergoes angiography within 4 hours after the diagnosis, the Aggrastat 25 microgram/kg dose bolus regimen should be initiated at the start of PCI with the infusion continued for 12-24 hours and up to 48 hours.

In patients with acute myocardial infarction intended for primary PCI, the 25 microgram/kg dose bolus regimen should be initiated as soon as possible after diagnosis.

Concurrent therapy (unfractionated heparin, oral antiplatelet therapy, including ASA)

Treatment with unfractionated heparin is initiated with an i.v. bolus of 50-60 U/kg and then continued with a maintenance infusion of 1,000 U per hour. The heparin dosage is titrated to maintain an APTT of approximately twice the normal value.

Unless contra-indicated, all patients should receive oral antiplatelet agents, including but not limited to ASA, before the start of Aggrastat (see section 5.1). This medication should be continued at least for the duration of the infusion of Aggrastat.

Most studies investigating the administration of Aggrastat as an adjunct to PCI have used ASA in combination with clopidogrel as oral antiplatelet therapy. The efficacy of the combination of Aggrastat with either prasugrel or ticagrelor has not been established in randomised controlled trials.

If angioplasty (PCI) is required, heparin should be stopped after PCI, and the sheaths should be withdrawn once coagulation has returned to normal, e.g. when the activated clotting time (ACT) is less than 180 seconds (usually 2-6 hours after discontinuation of heparin).

Method of administration

AGGRASTAT SOLUTION

Instructions for use

Do not withdraw solution directly from the container with a syringe.

Directions for use of IntraVia^TM† containers

To open: Tear foil overpouch down side at slit and remove IntraVia™ container. Some opacity of the plastic due to moisture absorption during the sterilisation process may be observed. This is normal and does not affect the solution quality or safety. The opacity will diminish gradually. Check for minute leaks by squeezing inner bag firmly. If leaks are found, discard solution as sterility