What is prasugrel?

Prasugrel 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.

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

Important Information

You should not take prasugrel if you have active bleeding such as a stomach ulcer or bleeding in the brain, if you have ever had a stroke or "mini-stroke", or if you are scheduled to have surgery, especially heart bypass surgery.

Prasugrel 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.

You may need to stop using the medicine for a short time before any surgery or dental treatment. Do not stop taking prasugrel unless your doctor tells you to.

Before taking this medicine

You should not use prasugrel if you are allergic to it, 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).

Tell your doctor if you have ever had:

• a stomach ulcer;

• bleeding problems;

• surgery, an injury, or a medical emergency;

• liver or kidney disease;

• a severe allergic reaction to clopidogrel (Plavix) or ticlopidine (Ticlid); o

• if you weigh less than 132 pounds; or

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

Aspirin is usually given with prasugrel, and aspirin can cause bleeding when 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.

You should not breast-feed while using prasugrel.

How should I take prasugrel?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Prasugrel can be taken with or without food.

If you also take aspirin, follow your doctor's instructions about how much aspirin to take and for how long.

Because prasugrel keeps your blood from clotting, this medicine can also make it easier for you to bleed, even from a minor injury such as a fall or a bump on the head. Seek emergency medical attention if you 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 prasugrel. You may need to stop using the medicine for a short time.

Do not stop taking prasugrel 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.

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

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 prasugrel?

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 prasugrel may cause you to bruise or bleed easily.

Prasugrel side effects

Get emergency medical help if you have signs of an allergic reaction: 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 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.

Prasugrel dosing information

Usual Adult Dose for Acute Coronary Syndrome:

Initial dose: 60 mg orally once
Maintenance dose: 10 mg orally once a day

Comments:
-No clear benefit was observed when the loading dose of this drug was administered prior to diagnostic coronary angiography compared to at the time of percutaneous coronary intervention (PCI); however, risk of bleeding was increased with early administration in patients undergoing PCI or early coronary artery bypass graft surgery (CABG).
-Aspirin 75 to 325 mg daily should be taken with this drug.

Use: To reduce the rate of thrombotic cardiovascular events (including stent thrombosis) in patients with acute coronary syndrome (ACS) who are to be managed with PCI for unstable angina (UA), non-ST segment elevation myocardial infarction (NSTEMI), or ST segment elevation myocardial infarction (STEMI).

Usual Geriatric Dose for Acute Coronary Syndrome:

65 to less than 75 years:
-Initial dose: 60 mg orally once
-Maintenance dose: 10 mg orally once a day

75 years or older: Use is generally not recommended in such patients, except in high-risk situations (e.g., diabetes or prior myocardial infarction) when benefit outweighs risk.

Comments:
-No clear benefit was observed when the loading dose of this drug was administered prior to diagnostic coronary angiography compared to at the time of percutaneous coronary intervention (PCI); however, risk of bleeding was increased with early administration in patients undergoing PCI or early coronary artery bypass graft surgery (CABG).
-Aspirin 75 to 325 mg daily should be taken with this drug.

Use: To reduce the rate of thrombotic cardiovascular events (including stent thrombosis) in patients with acute coronary syndrome (ACS) who are to be managed with PCI for unstable angina (UA), non-ST segment elevation myocardial infarction (NSTEMI), or ST segment elevation myocardial infarction (STEMI).

What other drugs will affect prasugrel?

Taking prasugrel with certain other drugs can increase your risk of bleeding. Tell your doctor about all your other medicines, especially:

• opioid medication;

• 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 affect prasugrel, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Further information

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.