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 Prescribing Information, including Boxed Warning regarding bleeding risk, and Medication Guide.

PGHCPISI03Oct2011.

FIND OUT WHY EFFIENT MAY BE RIGHT FOR YOUR ACS-PCI PATIENTS

Clinical Guidelines

Effient is included in guidelines for UA/NSTEMI and STEMI patients undergoing PCI.^1-6

Read the Guidelines

Bleeding Risk

Review the bleeding rates observed in the TRITON-TIMI 38 trial.

See the Data

Clinical Data

Review the Effient clinical data from the TRITON-TIMI 38 trial.

Find Out More

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

See clinical data for Effient from the TRITON-TIMI 38 study related to these specific patient groups:

UA/NSTEMI Patients STEMI Patients ACS-PCI Patients With Diabetes Subgroup

References:

1. Jneid et al. Circulation. 2012;126:875-910.
2. Jneid et al. J Am Coll Cardiol. 2012;60:653-689.
3. Kushner et al. Circulation. 2009;120:2271-2306.
4. Kushner et al. J Am Coll Cardiol. 2009;54:2205-2241.
5. Levine et al. Circulation. 011;124:e574-e651.
6. Levine et al. J Am Coll Cardiol. 2011;58:e44-e122.

INDICATION

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 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

The loading dose (LD) of Effient is 60 mg and the maintenance dose (MD) 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 Prescribing Information, including Boxed Warning regarding bleeding risk, and Medication Guide.

PGHCPISI03Oct2011.

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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.

Other product and company names mentioned herein are the trademarks of their respective owners.

This site is intended for US Healthcare Professionals Only.

PGHCPISI03Oct2011.

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FIND OUT WHY EFFIENT MAY BE RIGHT FOR YOUR ACS-PCI PATIENTS

Clinical Guidelines

Bleeding Risk

Clinical Data

Interactive Web Conferences

Clinical Data

References:

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