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Generic Name: prasugrel (PRA soo grel)
Brand Names: Effient

What is Effient?

Effient (prasugrel) helps to prevent platelets in your blood from sticking together and forming a blood clot. An unwanted blood clot can occur with certain heart or blood vessel conditions.

Effient is used to prevent blood clots in people with acute coronary syndrome who are undergoing a procedure after a recent heart attack or stroke, and in people with certain disorders of the heart or blood vessels.

Effient may also be used for other purposes not listed in this medication guide.

Important information

You should not take Effient if you have any active bleeding such as a stomach ulcer or bleeding in the brain (such as from a head injury), a history of stroke, including TIA ("mini-stroke"), or you are scheduled to have surgery, especially heart bypass surgery (coronary artery bypass graft, or CABG).

Effient increases your risk of bleeding, which can be severe or life-threatening. Call your doctor or seek emergency medical attention if you have bleeding that will not stop, if you have black or bloody stools, or if you cough up blood or vomit that looks like coffee grounds.

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You may need to stop using the medicine at least 7 days before any surgery or dental treatment. Do not stop taking Effient unless your doctor tells you to. Stopping too soon could cause life-threatening medical problems.

While you are taking Effient, do not take NSAIDs (non-steroidal anti-inflammatory drugs) without your doctor's advice. NSAIDs include ibuprofen (Motrin, Advil), naproxen (Aleve, Naprosyn), diclofenac (Voltaren), diflunisal (Dolobid), etodolac (Lodine), flurbiprofen (Ansaid), indomethacin (Indocin), ketoprofen (Orudis), ketorolac (Toradol), mefenamic acid (Ponstel), meloxicam (Mobic), nabumetone (Relafen), piroxicam (Feldene), and others.

Before taking this medicine

You should not use Effient if you are allergic to prasugrel, or if you have:

  • any active bleeding such as a stomach ulcer or bleeding in the brain (such as from a head injury);

  • a history of stroke, including TIA ("mini-stroke"); or

  • if you are scheduled to have surgery, especially heart bypass surgery (coronary artery bypass graft, or CABG).

To make sure Effient is safe for you, tell your doctor if you have:

  • a stomach ulcer;

  • stomach or intestinal bleeding;

  • a history of surgery, injury, or medical emergency;

  • liver or kidney disease;

  • if you weigh less than 132 pounds;

  • if you also use other medicines to treat or prevent blood clots; or

  • if you have ever had a severe allergic reaction to clopidogrel (Plavix) or ticlopidine (Ticlid).

Effient is not expected to be harmful to an unborn baby. However, aspirin is usually given with Effient, and aspirin can cause bleeding when it is taken during the last 3 months of pregnancy. Aspirin can also cause side effects in a newborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

It is not known whether prasugrel passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

How should I take Effient?

Take Effient exactly as it was prescribed for you. Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Effient is usually given together with aspirin. Follow your doctor's instructions about how much aspirin to take and for how long.

Effient can be taken with or without food.

Because prasugrel keeps your blood from coagulating (clotting) to prevent unwanted blood clots, Effient can also make it easier for you to bleed, even from a minor injury such as a fall or a bump on the head. Contact your doctor or seek emergency medical attention if you fall or hit your head, or have any bleeding that will not stop.

If you need surgery or dental work, tell the surgeon or dentist ahead of time that you are using Effient. You may need to stop using the medicine for at least 7 days before surgery to prevent excessive bleeding.

Do not stop taking Effient unless your doctor tells you to. If you stop taking this medicine too soon you could have life-threatening medical problems such as a blood clot or a heart attack.

Store at room temperature away from moisture and heat. Keep the tablets in their original container, along with the packet or canister of moisture-absorbing preservative. Keep the bottle tightly closed when not in use.

Effient dosing information

Usual Adult Dose for Acute Coronary Syndrome:

Initiate treatment as a single 60 mg oral loading dose and then continue at 10 mg orally once daily. Patients should also take aspirin (75 mg to 325 mg) daily.

Usual Geriatric Dose for Acute Coronary Syndrome:

Effient is generally not recommended in patients 75 years of age or older, except in high-risk situations (diabetes mellitus or prior MI) where its effect appears to be greater and its use may be considered.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking Effient?

Avoid activities that may increase your risk of bleeding or injury. Use extra care to prevent bleeding while shaving or brushing your teeth.

Ask your doctor before taking a nonsteroidal anti-inflammatory drug (NSAID) for pain, arthritis, fever, or swelling. This includes aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), and others. Using an NSAID with Effient may cause you to bruise or bleed easily.

Effient side effects

Get emergency medical help if you have signs of an allergic reaction to Effient: hives; dizziness, chest pain, difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • a light-headed feeling, like you might pass out;

  • any bleeding that will not stop;

  • pink or brown urine;

  • signs of a serious blood-clotting problem - pale skin, purple spots under your skin or on your mouth, fever, fast heart rate, weakness, stomach pain, trouble breathing, jaundice (yellowing of the skin or eyes);

  • signs of stomach bleeding - bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds; or

  • signs of a stroke - sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance.

The risk of bleeding is higher in older adults.

Common Effient side effects may include:

  • nosebleeds; or

  • easy bruising or bleeding.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

What other drugs will affect Effient?

Taking Effient with certain other drugs can increase your risk of bleeding. Tell your doctor about all your current medicines and any you start or stop using, especially:

  • any other medicines to treat or prevent blood clots, including heparin or warfarin (Coumadin, Jantoven); or

  • NSAIDs (nonsteroidal anti-inflammatory drugs) - aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib, diclofenac, indomethacin, meloxicam, and others.

This list is not complete. Other drugs may interact with prasugrel, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Where can I get more information?

  • Your pharmacist can provide more information about Effient.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Effient only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2015 Cerner Multum, Inc. Version: 2.01. Revision Date: 2015-08-26, 3:35:44 PM.