INDICATIONS AND USAGE:
Acute Coronary Syndrome:
PRASIENT is indicated to reduce the rate of thrombotic cardiovascular (CV) events (including stent thrombosis) in patients with acute coronary syndrome (ACS) who are to be managed with percutaneous coronary intervention (PCI) as follows:
• Patients with unstable angina (UA) or non-ST-elevation myocardial infarction (NSTEMI).
• Patients with ST-elevation myocardial infarction (STEMI) when managed with primary or delayed PCI.
PRASIENT has been shown to reduce the rate of a combined endpoint of cardiovascular death, nonfatal myocardial infarction (MI), or nonfatal stroke compared to clopidogrel. The difference between treatments was driven predominantly by MI, with no difference on strokes and little difference on CV death.
It is generally recommended that antiplatelet therapy be administered promptly in the management of ACS because many cardiovascular events occur within hours of initial presentation. In the clinical trial that established the efficacy of PRASIENT, PRASIENT and the control drug were not administered to UA/NSTEMI patients until coronary anatomy was established. For the small fraction of patients that required urgent CABG after treatment with PRASIENT, the risk of significant bleeding was substantial. Because the large majority of patients are managed without CABG, however, treatment can be considered before determining coronary anatomy if need for CABG is considered unlikely. The advantages of earlier treatment with PRASIENT must then be balanced against the increased rate of bleeding in patients who do need to undergo urgent CABG.
PRASIENT is contraindicated in patients with active pathological bleeding history such as peptic ulcer or intracranial hemorrhage.
Prior Transient Ischemic Attack or Stroke.
PRASIENT is contraindicated in patients with a history of prior transient ischemic attack (TIA) or stroke.
Clinical Trials Experience
• Thrombotic thrombocytopenic purpura.
Hemorrhagic events: epistaxis, gastrointestinal hemorrhage, hemoptysis, subcutaneous hematoma, post-procedural hemorrhage, retroperitoneal hemorrhage, and retinal hemorrhage.
Other Adverse Events:
Other important non-hemorrhagic adverse events: severe thrombocytopenia, anemia, abnormal hepatic function, allergic reactions, and angioedema.
Non-Hemorrhagic treatment emergent adverse events reported at least 2.5%:
Hypertension, hypercholesterolemia/hyperlipidemia, headache, back pain, dyspnea, nausea, dizziness, cough, hypotension, fatigue, non-cardiac chest pain, atrial fibrillation, bradycardia, leukopenia, rash, pyrexia, peripheral edema, pain in extremity, diarrhea.
DOSAGE & ADMINISTRATION:
Initiate PRASIENT treatment as a single 60 mg oral loading dose and then continue at 10 mg orally once daily. Patients taking PRASIENT should also take aspirin (75 mg to 325 mg) daily. PRASIENT may be administered with or without food.
Dosing in Low Weight Patients:
Compared to patients weighing ≥60 kg, patients weighing <60 kg have an increased exposure to the active metabolite of prasugrel and an increased risk of bleeding on a 10 mg once daily maintenance dose. Consider lowering the maintenance dose to 5 mg in patients <60 kg. The effectiveness and safety of the 5 mg dose have not been prospectively studied.
Boxes of 7 or 30 film coated tablets.