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.

Clinical Guidelines

Effient is included in guidelines for UA/NSTEMI and STEMI patients undergoing PCI. Continue reading

ACS-PCI Patients
With Diabetes

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

Clinical Data

See clinical data from TRITON-TIMI 38 that shows how Effient compared with Plavix in ACS-PCI patients. Continue reading

Risk Factors for Future CV Events

Risk Factors for Future Thrombotic CV Events, Including Stent Thrombosis, in Patients With ACS-PCI

Patients

Diabetes^1-4
Previous myocardial infarction^1,5

Anatomy

Diffuse disease^2,4,5
Complex anatomy^2-6
Bifurcations^2,7,8
Vessel size^2-5
Long lesions^3-5

Procedure

Stent type^9,10
Longer stents^1,3,8
Undersized stents⁷
Multiple stents^3-5,11

Antiplatelet Response

Genetic variation^12-15
Concomitant medications^16,17
Premature discontinuation of oral antiplatelet therapy^1,3,8
Patient characteristics (eg, diabetes, obesity)^18-20

SELECTED SAFETY: CONTRAINDICATIONS

Effient is contraindicated in patients with active pathological bleeding, such as from a peptic ulcer or ICH, or a history of TIA or stroke, and in patients with hypersensitivity to prasugrel or any component of the product. Click here for Safety Information and Boxed Warning.

References:

Ergelen M, Uyarel H, Osmonov D, et al. Clin Appl Thromb Hemost. 2010;16:33-41.
Urban P, Gershlick AH, Guagliumi G, et al, on behalf of the e-Cypher Investigators. Circulation. 2006;113:1434-1441.
Baran KW, Lasala JM, Cox DA, et al, for the ARRIVE Investigators. Am J Cardiol. 2008;102:541-545.
Bezerra H, Perin E, Berger P, et al. J Invasive Cardiol. 2010;2:48-55.
Lasala JM, Cox DA, Dobies D, et al. Circ Cardiovasc Interv. 2009;2:285-293.
Costa JR Jr, Sousa A, Moreira AC, et al. JACC Cardiovasc Interv. 2010;3:12-18.
van Werkum JW, Heestermans AA, Zomer AC, et al. J Am Coll Cardiol. 2009;53:1399-1409.
Iakovou I, Schmidt T, Bonizzoni E, et al. JAMA. 2005;293:2126-2130.
Rinaldi MJ, Kirtane AJ, Piana RN, et al. Am Heart J. 2008;155:654-660.
Wenaweser P, Daemen J, Zwahlen M, et al. J Am Cardiol. 2008;52:1134-1140.
Madan P, Elayda MA, Lee VV, Wilson JM. Am Heart J. 2008;155:1068-1074.
Sibbing D, Stegherr J, Latz W, et al. Eur Heart J. 2009;30:916-922.
Giusti B, Gori AM, Marcucci R, et al. Am J Cardiol. 2009;103:806-811.
Simon T, Verstuyft C, Mary-Krause M, et al, for the French Registry of Acute ST-Elevation and Non–ST-Elevation Myocardial Infarction (FAST-MI) Investigators. N Engl J Med. 2009;360:363-375.
Collet JP, Hulot JS, Pena A, et al. Lancet. 2009;373:309-317.
Gaglia MA Jr, Torguson R, Hanna N, et al. Am J Cardiol. 2010;105:833-838.
Gupta E, Bansal D, Sotos J, Olden K. Dig Dis Sci. 2010;55:1964-1968.
Angiolillo DJ, Fernandez-Ortiz A, Bernando E, et al. Diabetes. 2005;54:2430-2435.
Angiolillo DJ, Bernardo E, Ramírez C, et al. J Am Coll Cardiol. 2006;48:298-304.
Angiolillo DJ, Fernández-Ortiz A, Bernardo E, et al. J Invasive Cardiol. 2004;16:169-174.

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 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.

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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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Clinical Guidelines

ACS-PCI PatientsWith Diabetes

Clinical Data

Risk Factors for Future CV Events

Risk Factors for Future Thrombotic CV Events, Including Stent Thrombosis, in Patients With ACS-PCI

Patients

Anatomy

Procedure

Antiplatelet Response

SELECTED SAFETY: CONTRAINDICATIONS

Related content:

References:

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For Healthcare Professionals

ACS-PCI Patients
With Diabetes

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