Effient 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 in people who've had a balloon angioplasty to open blocked arteries after having a heart attack or severe chest pain.

Effient may help lower your risk of having another heart attack or stroke.

You should not take Effient 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.

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.

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

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:

• 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 ever had:

• a stomach ulcer, colon polyps, or diverticulosis;

• bleeding problems;

• surgery, an injury, or a medical emergency;

• liver or kidney disease;

• if you are allergic to clopidogrel or ticlopidine;

• if you weigh less than 132 pounds (60 kilograms); or

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

Tell your doctor if you are pregnant or breastfeeding.

Take Effient exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. If you also take aspirin, follow your doctor's instructions about how much to take and for how long.

Effient can be taken with or without food.

Swallow the tablet whole and do not crush, chew, or break it.

Because Effient keeps your blood from clotting, this medicine can also make it easier for you to bleed, even from a minor injury. Seek emergency medical attention if you have any bleeding that will not stop.

Tell your doctor if you have a planned surgery or dental work.

Do not stop using Effient without your doctor's advice, even if you feel fine. Stopping this medicine too soon may increase your risk of a blood clot, heart attack, or death.

Store Effient 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.

Usual Adult Dose of Effient 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 of Effient 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).

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

• 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 ever had:

• a stomach ulcer, colon polyps, or diverticulosis;

• bleeding problems;

• surgery, an injury, or a medical emergency;

• liver or kidney disease;

• if you are allergic to clopidogrel or ticlopidine;

• if you weigh less than 132 pounds (60 kilograms); or

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

Tell your doctor if you are pregnant or breastfeeding.

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.

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

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

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

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.

Prasugrel increases your risk of bleeding, which can be severe or life-threatening.

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.

Tell your doctor about all your other medicines, especially:

• opioid medication; or

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

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 drug interactions are listed here.