Indication

Effient taken with aspirin helps reduce the risk of a future heart-related event, such as a heart attack or blood clot in a stent, in patients who had an acute coronary syndrome (ACS) event that was treated with angioplasty. Effient is available in 5-mg and 10-mg tablets.

Your Stent Procedure

To help you understand the importance of your new stent, it may help to know more about the medical procedure you’ve undergone. Because you experienced a heart attack or heart-related chest pain while at rest (unstable angina), you underwent a procedure known as angioplasty.

During this procedure, your doctor may have placed a stent inside the blocked or partially blocked artery in your heart. If so, you’re not alone: in 70%–90% of cases, angioplasty involves the insertion of a stent.

What is a PCI?

Plaque Build Up

Your arteries carry oxygen and nutrients, as well as blood cells and platelets, to the organs throughout the body, including the heart itself. Sometimes plaque—a substance made up of cholesterol, fatty deposits, calcium and other materials in the body—can build up in your arteries.

Acute Coronary Syndrom

Over time, plaque built up on the heart artery walls. The plaque buildup ruptured (broke apart) and a blood clot formed over the rupture site. This resulted in a complete or partial blockage in one of your heart arteries. It restricted the flow of blood to your heart. Because your heart was not getting enough blood, it was deprived of oxygen and vital nutrients, which are needed for your heart to work properly. As a result, you suffered an acute coronary syndrome (ACS) event.

Percutaneous Coronary Intervention (PCI)

To open the blockage in your artery, your cardiologist performed a percutaneous coronary intervention (PCI), which may have included a stent procedure. That means a balloon with a stent wrapped around it was inflated to push the plaque back against your artery wall. When that happened, it locked in place to hold the artery open. This improved blood flow to your heart.

What is a stent?

A stent is a tiny structure made of wire mesh, similar to a spring found inside a ballpoint pen. Many patients who have had a heart attack or chest pain will have an angioplasty procedure, which usually includes a stent placement. When the balloon is inflated during an angioplasty, the stent expands, locks in place, and holds the artery open.

There are two types of stents—drug-eluting stents and bare-metal stents. Your doctor has decided which stent is right for you.

A drug-eluting stent has a medicated coating that is slowly released over time to prevent the artery from narrowing again. A stent that is not coated with a drug is called a bare-metal stent.

Your Stent in Action

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Your stent needed to be guided through your artery and placed in the precise area of your blockage. Your doctor placed the collapsed stent using a balloon-tipped tube called a catheter.

A stent is similar in size and shape to the spring found inside a ballpoint pen, but before a stent is positioned and expanded, it can be thinner than a dime.

Once your doctor positioned the stent in your blocked artery, the small balloon inside the stent was inflated. The stent expanded and locked into place.

This pushed the plaque blockage against your artery wall and opened a passage so blood could flow. The balloon was then deflated and the catheter was taken out.

The stent is made of thin metal mesh, and the “struts” or wires that make up the mesh can be .08 millimeters. After angioplasty, there’s a chance-platelets can stick together and form a blockage along these struts.

Effient and aspirin work together to stop platelets from sticking to each other and to the stent. This helps maintain your stent and helps to reduce the risk of another heart event in the future.

Your stent makes a passage in your artery that is only a few millimeters wide. That’s why it's so important for you to take your Effient, and keep the blood flowing freely to your heart.

It’s important to know that Effient 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 leads to death.

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

Indication

Effient taken with aspirin helps reduce the risk of a future heart-related event, such as a heart attack or blood clot in a stent, in patients who had an acute coronary syndrome (ACS) event that was treated with angioplasty. Effient is available in 5-mg and 10-mg tablets.

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), or if you are allergic to prasugrel or any of the ingredients in Effient.

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, f) have moderate to severe kidney problems, or g) have a stomach ulcer.

Call your doctor right away if you have any of these signs or symptoms of bleeding: unexpected bleeding or bleeding that lasts a long time, bleeding that is severe or you cannot control, pink or brown urine, red or black stool, bruises that happen without a known cause or get larger, cough up blood or blood clots or vomit blood or your vomit looks like coffee grounds.

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.

Effient is available by prescription only. For more information, talk to your healthcare provider 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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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), or if you are allergic to prasugrel or any of the ingredients in Effient.

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, f) have moderate to severe kidney problems, or g) have a stomach ulcer.

Call your doctor right away if you have any of these signs or symptoms of bleeding: unexpected bleeding or bleeding that lasts a long time, bleeding that is severe or you cannot control, pink or brown urine, red or black stool, bruises that happen without a known cause or get larger, cough up blood or blood clots or vomit blood or your vomit looks like coffee grounds.

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.

Effient is available by prescription only. For more information, talk to your healthcare provider 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.