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

Genetic Variations

No Relevant Effect of Genetic Variation or Concomitant Medications Involving CYP450 Enzymes on the Active Metabolite of Effient

There are no relevant effects on the formation of the active metabolite of Effient^® (prasugrel) due to genetic variation in CYP2C19 or concomitant medications involving CYP450 enzymes.¹

There is also no relevant effect of genetic variation in CYP2B6, CYP2C9, or CYP3A5
Effient can be administered with drugs that are inducers or inhibitors or cytochrome P450 enzymes

Use caution when coadministering Effient with oral anticoagulants (eg, warfarin, fibrinolytic agents, heparin, NSAIDs used chronically) because of potential for increased risk of bleeding.¹

Any difference in the formation of the active metabolite of Effient compared with Plavix^® (clopidogrel bisulfate) has not been correlated to clinical outcomes.

SELECTED SAFETY: SIGNIFICANT BLEEDING RISK

Effient can cause significant, sometimes fatal, bleeding. 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 (diabetes or prior MI) where its effect appears to be greater and its use may be considered. Click here for Safety Information and Boxed Warning.

Reference:

Effient^® (prasugrel) Prescribing Information. Daiichi Sankyo, Inc. and Eli Lilly and Company.

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.

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

Download Adobe Acrobat Reader here.

Adobe^® Reader^® is a registered trademark of Adobe Systems Incorporated.

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.

You are now leaving the
EffientHCP.com Web site.

The link you clicked on will take you to a site maintained by a third party, which is solely responsible for its content. Daiichi Sankyo, Inc. and Lilly USA, LLC do not control, influence, or endorse this site, and the opinions, claims, or comments expressed on this site should not be attributed to Daiichi Sankyo, Inc. or Lilly USA, LLC. Daiichi Sankyo, Inc. and Lilly USA, LLC are not responsible for the privacy policy of any third-party Web sites. We encourage you to read the privacy policy of every Web site you visit.

Click "Continue" to proceed or "Return" to return to EffientHCP.com.

ContinueReturn

For Healthcare Professionals

The information contained at EffientHCP.com is technical in nature and was specifically created for US Healthcare Professionals. If you are not a US Healthcare Professional, please click the cancel button below.

Yes, I am a US Healthcare Professional and would like to continue.

Continue Cancel

Clinical Guidelines

ACS-PCI PatientsWith Diabetes

Clinical Data

Genetic Variations

No Relevant Effect of Genetic Variation or Concomitant Medications Involving CYP450 Enzymes on the Active Metabolite of Effient

Related content:

SELECTED SAFETY: SIGNIFICANT BLEEDING RISK

Reference:

You are now leaving theEffientHCP.com Web site.

For Healthcare Professionals

ACS-PCI Patients
With Diabetes

You are now leaving the
EffientHCP.com Web site.