Prasugrel (PRA-soo-grel)

Prevents strokes and heart attacks in patients who need to have a heart procedure called percutaneous coronary intervention (PCI).

Brand Name(s):

There may be other brand names for this medicine.

When This Medicine Should Not Be Used:

How to Use This Medicine:

Tablet

• Your doctor will tell you how much of this medicine to use and how often. Your dose may need to be changed several times in order to find out what works best for you. Do not use more medicine or use it more often than your doctor tells you to.
• You may take this medicine with or without food.
• Your doctor may tell you to take aspirin with this medicine.
• This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions. Ask your pharmacist for the Medication Guide if you do not have one. Your doctor might ask you to sign some forms to show that you understand this information.

If a dose is missed:

• If you miss a dose or forget to use your medicine, use it as soon as you can. If it is almost time for your next dose, wait until then to use the medicine and skip the missed dose. Do not use extra medicine to make up for a missed dose.

How to Store and Dispose of This Medicine:

• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.
• Ask your pharmacist, doctor, or health caregiver about the best way to dispose of any leftover medicine after you have finished your treatment. You will also need to throw away old medicine after the expiration date has passed.
• Keep all medicine away from children and never share your medicine with anyone.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Make sure your doctor knows if you are also using aspirin or any other type of pain or arthritis medicine called NSAIDs (such as ibuprofen, Aleve®, Celebrex®, Vioxx®), blood thinners (such as heparin, warfarin, or Coumadin®), or other medicines to prevent or treat blood clots (such as alteplase, reteplase, Activase®, or Retavase®).

Warnings While Using This Medicine:

• Make sure your doctor knows if you are pregnant or breastfeeding, or if you have kidney disease, liver disease, diabetes, or a history of heart attacks or bleeding problems. Tell your doctor if you are allergic to clopidogrel (Plavix®) or ticlopidine (Ticlid®).
• This medicine may increase your risk of bleeding. The risk increases if you are 75 years of age and older, if you have had a recent trauma or surgery (such as CABG), stomach or bowel bleeding that keeps coming back, stomach ulcer, severe liver problems, if you weigh less than 60 kilograms (kg) or 132 pounds (lbs), or if you are taking other medicines (such as blood thinners or NSAIDs). Tell your doctor if you have any of these conditions before using this medicine.
• Check with your doctor right away if you have the following symptoms: change in mental status, dark or bloody urine, difficulty with speaking, fever, pale color of the skin, pinpoint red spots on the skin, seizures, weakness, or yellow eyes or skin. These maybe symptoms of a serious condition called thrombotic thrombocytopenic purpura (TTP).
• This medicine may cause serious allergic reactions, including angioedema. Angioedema can be life-threatening and requires immediate medical attention. Stop using this medicine and tell your doctor right away if you have chest pain; a rash; itching; swelling of the face, lips, tongue, or throat; or trouble with swallowing or breathing while you are using the medicine.
• Make sure any doctor or dentist who treats you knows that you are using this medicine. You may need to stop using this medicine several days before having surgery or medical tests.
• Do not stop taking this medicine without checking with your doctor first. To do so may increase your risk for clots.
• Your doctor will need to check your blood or urine at regular visits while you are using this medicine. Be sure to keep all appointments.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blood in your urine or stools.
• Chest pain, shortness of breath, or troubled breathing.
• Fast, slow, pounding, or uneven heartbeat.
• Fever, chills, cough, sore throat, and body aches.
• Lightheadedness, dizziness, or fainting.
• Nosebleeds.
• Pinpoint red spots on the skin.
• Rapid weight gain.
• Seizures.
• Shortness of breath, tiredness, uneven heartbeat, and yellowing of your skin or the whites of your eyes.
• Swelling in your hands, ankles, or feet.
• Unusual bleeding or bruising.
• Unusual tiredness or weakness.
• Vomiting of blood like coffee grounds.

If you notice these less serious side effects, talk with your doctor:

• Back pain.
• Headache.
• Nausea, vomiting, diarrhea, or stomach pain.
• Pain in the arms or legs.
• Rash.

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088