Detailed Information

Effient®, co-administered with acetylsalicylic acid (ASA), is indicated for the prevention of atherothrombotic events in adult patients with acute coronary syndrome (i.e. unstable angina, non-ST segment elevation myocardial infarction [UA/NSTEMI] or ST segment elevation myocardial infarction [STEMI]) undergoing primary or delayed percutaneous coronary intervention (PCI).

Effient®, can cause significant, sometimes fatal, bleeding.1

Learn more about Effient  Learn more about Efficacy

Learn more about Effient
Learn more about Efficacy

GREATER PROTECTION

In TRITON-TIMI38, Effient® (prasugrel) plus aspirin(ASA) provided greater protection against thrombotic CV events vs Clopidogrel™(clopidogrel bisulfate) plus ASA in ACS-PCl patients.1

  • This benefit was primarily driven by a significant reduction in nonfatal MIs. Approximately 40% of MIs occurred periprocedurally1
  • In TRITON-TIMI 38, the loading dose of Clopidogrel was delayed relative to the placebo-controlled trials that supported its approval for ACS1

Selected Safety, Including Significant Bleeding Risk

Effient® can cause significant, sometimes fatal, bleeding. In TRITON-TIMI 38, overall rates of non-CABG TIMI major or minor bleeding were significantly higher with Effient® plus ASA(4.5%) compared with Clopidogrel plus ASA(3.4%). In patients who underwent CABG (n=437), the rates of CABG-related TIMI major or minor bleeding were 14.1% with Effient® plus ASA and 4.5% with Clopidogrel plus ASA.1

Learn more about Safety

APPROPRIATE PATIENT SELECTION

  • Without a prior history of transient ischemic attack(TIA) or stroke
    • Effient®(prasugrel) is contraindicated in patients with history of TIA or stroke1
  • Age<75 years
    • Effient® is generally not recommended in patients >= 75 years of age because of the increased risk of fatal and intracranial bleeding and uncertain benefit1
  • Body weight >=60kg(132lb)
    • Individuals with body weight <60kg had an increased risk of bleeding and an increased exposure to the active metabolite of Effient®1
    • Consider lowering the maintenance dose to 5mg in patients <60kg. The effectiveness and safety of the 5-mg dose have not been prospectively studied1

Effient® can cause significant, sometimes fatal, bleeding.1

Learn more about Safety


1Effient® (prasugrel) Prescribing Information. PA0201SPXSP
 

Last Update: 2 Nov 15

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