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IMPORTANT SAFETY INFORMATION

What is the most important information I should know about Effient?

Effient^® (prasugrel) can cause bleeding. If you have unexplained or excessive bleeding while on Effient, contact your doctor right away as some bleeding can be serious, and sometimes fatal. Do not take Effient if you currently have abnormal bleeding, such as stomach or intestinal bleeding, bleeding in your head, or have a history of stroke, or “mini-stroke” (also known as transient ischemic attack or TIA).

Get medical help right away if you suddenly have slurring of speech, weakness or numbness in one part of your body, blurry vision, and/or severe headache. These may be symptoms of a stroke or TIA. If you have a stroke or TIA while taking Effient, your doctor will probably stop your Effient.

Before having any surgery, you should talk to your doctor about stopping Effient. If possible, Effient should be stopped at least 1 week (7 days) before any surgery, as instructed by the doctor who prescribed Effient for you.

You may also have a higher risk of bleeding if you take Effient and you: a) are age 75 or older, b) weigh less than 132 pounds, c) are taking anticoagulants (eg, warfarin) or regular daily use of NSAIDs, d) have had recent trauma, such as an accident or surgery, e) have severe liver problems, or f) have a stomach ulcer.

Do not stop taking Effient without talking to the doctor who prescribes it for you. People who are treated with angioplasty and have a stent, and stop taking Effient too soon, have a higher risk of a blood clot in the stent, having a heart attack, or dying.

What should I tell my doctor before taking Effient?

Tell your doctor about all of your medical conditions, allergies, and medicines you are taking.

What are the possible side effects of Effient?

Bleeding is the most common side effect of Effient.

TTP, a rare but life-threatening condition, has been reported with Effient, sometimes after a short time (less than 2 weeks). Get medical attention right away if you develop the following unexpected symptoms of TTP: fever, weakness, yellowing of the skin or eyes, or if skin becomes very pale or dotted with purple spots.

Serious allergic reactions can happen with Effient, or if you have had a serious allergic reaction to the medicines Plavix^® (clopidogrel) or ticlopidine. Get medical help right away if you get any of these symptoms of a severe allergic reaction: swelling or hives of your face, lips, in or around your mouth, or throat, trouble breathing or swallowing, chest pain or pressure, dizziness or fainting.

Other side effects may occur. For more information, talk to your doctor or pharmacist.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

For more information about Effient, please see the Full Prescribing Information, including Boxed Warning regarding bleeding risk, and Medication Guide.

PGDTCISI03Oct2011.

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Questions to Ask Your Doctor Whether you're heading to your first doctor visit since leaving the hospital or have been to a few appointments already, it helps to be prepared. Make the most of the time you spend with your doctor by customizing the Effient® (prasugrel) Doctor Discussion Guide below. Antiplatelet Medicine Questions What is my antiplatelet medicine for? How does my antiplatelet medicine work? What are the most common side effects of my antiplatelet medicine? How long will I need to take my antiplatelet medicine? How does my antiplatelet medicine interact with other medications? Stent Questions What is a stent? How does a stent work? What do I need to know about my stent? How long will my stent last? Am I still at risk, or did the stent fix the problem? What is stent thrombosis, and how can I help prevent it? What is the difference between a bare-metal stent and a drug-eluting stent, and which one do I have? General Questions What symptoms should I watch for, and what should I do if symptoms return? Can you explain the PCI procedure? What do you recommend about diet, exercise, and other lifestyle changes? How can I help reduce my risk for a future heart attack? Whether you're heading to your first doctor visit since leaving the hospital or have been to a few appointments already, it helps to be prepared. Make the most of the time you spend with your doctor by customizing the Effient® (prasugrel) Doctor Discussion Guide below. Antiplatelet Medicine Questions What is my antiplatelet medicine for? How does my antiplatelet medicine work? What are the most common side effects of my antiplatelet medicine? How long will I need to take my antiplatelet medicine? How does my antiplatelet medicine interact with other medications? Stent Questions What is a stent? How does a stent work? What do I need to know about my stent? How long will my stent last? Am I still at risk, or did the stent fix the problem? What is stent thrombosis, and how can I help prevent it? What is the difference between a bare-metal stent and a drug-eluting stent, and which one do I have? General Questions What symptoms should I watch for, and what should I do if symptoms return? Can you explain the PCI procedure? What do you recommend about diet, exercise, and other lifestyle changes? How can I help reduce my risk for a future heart attack?

Effient is indicated to help reduce the risk of a future heart-related event, such as a heart attack or stent clot, in patients who had an acute coronary syndrome (ACS) event that was treated with angioplasty. 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

What is the most important information I should know about Effient?

What should I tell my doctor before taking Effient?

Tell your doctor about all of your medical conditions, allergies, and medicines you are taking.

What are the possible side effects of Effient?

Bleeding is the most common side effect of Effient.

Other side effects may occur. For more information, talk to your doctor or pharmacist.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

For more information about Effient, please see the Full Prescribing Information, including Boxed Warning regarding bleeding risk, and Medication Guide.

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^®Effient and the Effient logo are registered trademarks of Eli Lilly and Company.
™Esstential Habits and the Esstential Habits logo are trademarks of Eli Lilly and Company.
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This site is intended for U.S. residents age 18 and over.
Copyright © 2011 Daiichi Sankyo, Inc. and Lilly USA, LLC. All Rights Reserved. PG71870 10/2011. PGDTCISI03Oct2011.

IMPORTANT SAFETY INFORMATION

What is the most important information I should know about Effient?

What should I tell my doctor before taking Effient?

What are the possible side effects of Effient?

Questions to Ask Your Doctor

Antiplatelet Medicine Questions

Stent Questions

General Questions

Antiplatelet Medicine Questions

Stent Questions

General Questions

IMPORTANT SAFETY INFORMATION

What is the most important information I should know about Effient?

What should I tell my doctor before taking Effient?

What are the possible side effects of Effient?