TIMI Bleeding Risk in TRITON-TIMI 38

*Intracranial hemorrhage or clinically overt bleeding associated with a fall in hemoglobin ≥5 g/dL. ^†Clinically overt bleeding associated with a fall in hemoglobin of ≥3 g/dL but <5 g/dL. ^‡ICH=intracranial hemorrhage. ^§Patients may be counted in more than one row.

• Patients at highest bleeding risk were those ≥75 years and those <60 kg (132 lb)¹
• Other hemorrhagic events occurred in TRITON-TIMI 38. Please see the Bleeding Reported as Adverse Events section of the Full Prescribing Information¹
• It may be possible to restore hemostasis with platelet transfusions; however, platelet transfusions within 6 hours of the loading dose or 4 hours of the maintenance dose may be less effective¹
• Effient is contraindicated in patients with active pathological bleeding, such as from a peptic ulcer or ICH, or a history of prior TIA or stroke, and in patients with hypersensitivity to prasugrel or any component of the product¹
  • Patients who experience a stroke or TIA while on Effient generally should have therapy discontinued

TRITON-TIMI 38 Bleeding Risk Through 15 Months by Patient Subgroup

*Intracranial hemorrhage or clinically overt bleeding associated with a fall in hemoglobin ≥5 g/dL. ^†Clinically overt bleeding associated with a fall in hemoglobin of ≥3 g/dL but <5 g/dL. ^‡Patients may be counted in more than one subgroup.

• Patients at highest bleeding risk for non-CABG TIMI major or minor bleeding were those ≥75 years of age or <60 kg (132 lb)¹
• The rates of life-threatening bleeding, including fatal bleeding, were 1.3% with Effient plus ASA and 0.8% with Plavix plus ASA (P=0.015)¹
• Effient is contraindicated in patients with active pathological bleeding such as from a peptic ulcer or intracranial hemorrhage, or a history of TIA or stroke, and in patients with hypersensitivity to prasugrel or any component of the product¹

TRITON-TIMI 38 Non-CABG Major or Minor Bleeding by All ACS and Weight and Age

A retrospective analysis of TRITON-TIMI 38 showed patients <60 kg (132 lb) or ≥75 years exhibited a higher incidence of bleeding.^1,2

*Intracranial hemorrhage or clinically overt bleeding associated with a fall in hemoglobin ≥5 g/dL. ^†Clinically overt bleeding associated with a fall in hemoglobin of ≥3 g/dL but <5 g/dL. ^‡Patients may be counted in more than one subgroup. ^§Numbers in parentheses are fatal bleeds.

Effient is contraindicated in patients with active pathological bleeding such as from a peptic ulcer or intracranial hemorrhage, and in patients with hypersensitivity to prasugrel or any component of the product¹

Age ≥75 years¹

• The risk of fatal bleeding was highest in patients ≥75 years of age
• In patients ≥75 years of age, Effient is generally not recommended, because of the increased risk of fatal and intracranial bleeding and uncertain benefit, except in high-risk situations (patients with diabetes or a history of prior MI) where its effect appears to be greater and its use may be considered

Body weight <60 kg¹

• Individuals with body weight <60 kg had an increased risk of bleeding and an increased exposure to the active metabolite of Effient. 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