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.

About Your Condition

Because you have recently experienced a heart attack or heart-related chest pain while at rest (unstable angina) and undergone angioplasty, it's important to know all you can so that you are better prepared to maintain your heart, your stent and your health. As always, if you have questions or concerns, you should speak with your doctor.

What is unstable angina?

Unstable angina is a type of heart-related chest pain that occurs when the heart doesn’t get enough oxygen. It is unexpected and usually happens while at rest. People who suffer from unstable angina often describe it feeling like a heaviness or tightness in the chest, aching or squeezing, or a fullness or burning of the chest. It may also include pain in the arm, shoulder or neck.

What is acute myocardial infarction?

This is a medical term for a heart attack, which occurs when the blood supply to part of the heart muscle itself—the myocardium—is severely reduced or stopped, depriving it of oxygen and other nutrients and resulting in the death of the heart muscle. Symptoms of acute myocardial infarction may feel similar to, or more severe than, unstable angina.

Recognize the symptoms of a heart attack.

Despite the steps you are taking to ensure your heart stays healthy, it is still important that you remain cautious and be aware of the symptoms of another heart attack. Symptoms that can occur with a heart attack include, but are not limited to:

  • Angina (chest pain or pressure), the most common symptom
  • Pain in the neck, shoulder, arm, back and jaw
  • Shortness of breath
  • Weakness or dizziness
  • Nausea
  • Sweating
  • Palpitations (irregular heartbeats, skipped beats or a "flip-flop" feeling in your chest)
  • A faster heartbeat

If you are experiencing symptoms of a heart attack, do not drive yourself to the hospital. Instead, call EMS (Emergency Medical Services)—or the equivalent 9-1-1 service in your area—immediately. Not only can these medical professionals get you to the hospital, but they are trained to provide care to heart patients. Do not wait to get help.

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.