IMPORTANT SAFETY INFORMATION

WARNING: BLEEDING RISK

Effient^® (prasugrel) can cause significant, sometimes fatal, bleeding.

Do not use Effient in patients with active pathological bleeding or a history of transient ischemic attack or stroke.

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 myocardial infarction [MI]) where its effect appears to be greater and its use may be considered.

Do not start Effient in patients likely to undergo urgent coronary artery bypass graft surgery (CABG). When possible, discontinue Effient at least 7 days prior to any surgery.

Additional risk factors for bleeding include:

body weight <60 kg
propensity to bleed
concomitant use of medications that increase the risk of bleeding (eg, warfarin, heparin, fibrinolytic therapy, chronic use of nonsteroidal anti-inflammatory drugs [NSAIDs])

Suspect bleeding in any patient who is hypotensive and has recently undergone coronary angiography, percutaneous coronary intervention (PCI), CABG, or other surgical procedures in the setting of Effient.

If possible, manage bleeding without discontinuing Effient. Discontinuing Effient, particularly in the first few weeks after acute coronary syndrome, increases the risk of subsequent cardiovascular events.

CONTRAINDICATIONS

Effient is contraindicated in patients with active pathological bleeding, such as from a peptic ulcer or intracranial hemorrhage (ICH), or a history of transient ischemic attack (TIA) or stroke, and in patients with hypersensitivity to prasugrel or any component of the product

WARNINGS AND PRECAUTIONS

Patients who experience a stroke or TIA while on Effient generally should have therapy discontinued. Effient should also be discontinued for active bleeding and elective surgery
Premature discontinuation of Effient increases risk of stent thrombosis, MI, and death
Thrombotic thrombocytopenic purpura (TTP), a rare but serious condition that can be fatal, has been reported with Effient, sometimes after a brief exposure (<2 weeks), and requires urgent treatment, including plasmapheresis
Hypersensitivity, including angioedema, has been reported in patients receiving Effient, including patients with a history of hypersensitivity reaction to other thienopyridines

ADVERSE REACTIONS

Bleeding, including life-threatening and fatal bleeding, is the most commonly reported adverse reaction

Please see Full Prescribing Information, including Boxed Warning regarding bleeding risk.

PGHCPISI03Oct2011.

ACS-PCI Patients
With Diabetes

Learn about using Effient to treat ACS-PCI patients with diabetes. Continue reading

Interactive Web Conferences

The Effient Interactive Web Conference Series is an online learning experience that includes experts in cardiology discussing the efficacy and safety of Effient. See the schedule

Clinical Data

Effient^® (prasugrel) 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 follows¹:

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

The loading dose of Effient is 60 mg and the maintenance dose is 10 mg once daily. Effient is available in 5-mg and 10-mg tablets.

The efficacy and safety of Effient was established through the TRITON-TIMI 38 clinical trial. TRITON-TIMI 38 was designed to test Effient plus ASA vs Plavix^® (clopidogrel bisulfate) plus ASA in the moderate- to high-risk ACS-PCI population (approximately 74% UA/NSTEMI, 26% STEMI) for up to 450 days.¹

TRITON-TIMI 38 Efficacy

Effient plus ASA has been shown to reduce the rate of a combined endpoint of cardiovascular death, nonfatal myocardial infarction (MI), or nonfatal stroke compared with Plavix^® (clopidogrel bisulfate) plus ASA. The difference between treatments was driven predominantly by MI, with no difference on strokes and little difference on CV death. Administration of the Plavix loading dose in TRITON-TIMI 38 was delayed relative to the placebo-controlled trials that supported its approval for ACS.¹

Visit these pages to read the Effient clinical data from the TRITON-TIMI 30 trial:

UA/NSTEMI clinical data STEMI clinical data ACS-PCI patients with diabetes clinical data

Clinical Guidelines

Effient is included in guidelines for UA/NSTEMI and STEMI patients undergoing PCI.^2-5 Read the guidelines.

References:

Effient^® (prasugrel) prescribing information. Daiichi Sankyo, Inc. and Eli Lilly and Company.
Wright RS, Anderson JL, Adams CD, et al. Circulation. 2011;123:2022-2060.
Wright RS, Anderson JL, Adams CD, et al. J Am Coll Cardiol. 2011;57:1920-1959.
Kushner FG, Hand M, Smith SC Jr, et al. J Am Coll Cardiol. 2009;54:2205-2241.
Kushner FG, Hand M, Smith SC Jr, et al. Circulation. 2009;120:2271-2306.

INDICATION

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

The loading dose of Effient is 60 mg and the maintenance dose is 10 mg once daily. Effient is available in 5-mg and 10-mg tablets.

IMPORTANT SAFETY INFORMATION

WARNING: BLEEDING RISK

Effient^® (prasugrel) can cause significant, sometimes fatal, bleeding.

Do not use Effient in patients with active pathological bleeding or a history of transient ischemic attack or stroke.

Do not start Effient in patients likely to undergo urgent coronary artery bypass graft surgery (CABG). When possible, discontinue Effient at least 7 days prior to any surgery.

Additional risk factors for bleeding include:

body weight <60 kg
propensity to bleed
concomitant use of medications that increase the risk of bleeding (eg, warfarin, heparin, fibrinolytic therapy, chronic use of nonsteroidal anti-inflammatory drugs [NSAIDs])

CONTRAINDICATIONS

Effient is contraindicated in patients with active pathological bleeding, such as from a peptic ulcer or intracranial hemorrhage (ICH), or a history of transient ischemic attack (TIA) or stroke, and in patients with hypersensitivity to prasugrel or any component of the product

WARNINGS AND PRECAUTIONS

Patients who experience a stroke or TIA while on Effient generally should have therapy discontinued. Effient should also be discontinued for active bleeding and elective surgery
Premature discontinuation of Effient increases risk of stent thrombosis, MI, and death
Thrombotic thrombocytopenic purpura (TTP), a rare but serious condition that can be fatal, has been reported with Effient, sometimes after a brief exposure (<2 weeks), and requires urgent treatment, including plasmapheresis
Hypersensitivity, including angioedema, has been reported in patients receiving Effient, including patients with a history of hypersensitivity reaction to other thienopyridines

ADVERSE REACTIONS

Bleeding, including life-threatening and fatal bleeding, is the most commonly reported adverse reaction

Please see Full Prescribing Information, including Boxed Warning regarding bleeding risk.

PGHCPISI03Oct2011.

Note: To view or print PDF files, you must have Adobe^® Acrobat Reader^®.

Download Adobe Acrobat Reader here.

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Prescribing Information | Medication Guide | Safety Information and Boxed Warning

^®Effient and the Effient logo are registered trademarks of Eli Lilly and Company.

Plavix^® is a registered trademark of sanofi-aventis Corp.

This site is intended for US Healthcare Professionals Only.

PGHCPISI03Oct2011.

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ACS-PCI PatientsWith Diabetes

Interactive Web Conferences

Clinical Data

TRITON-TIMI 38 Efficacy

Clinical Guidelines

References:

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For Healthcare Professionals

ACS-PCI Patients
With Diabetes

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