Prasugrel

Generic Name: Prasugrel (PRA-soo-grel)Brand Name: Effient

Prasugrel can cause severe and sometimes fatal bleeding. It should not be used in patients who have an active bleeding problem or a history of stroke or transient ischemic attack (TIA; "mini-stroke"). Prasugrel is usually not recommended in patients over 74 years old, except in high-risk situations (eg, diabetes, history of heart attack); the risk of severe side effects may be increased.

Do not use Prasugrel if you will be having bypass heart surgery (coronary artery bypass graft [CABG]). Tell your doctor that you take Prasugrel if you have recently had or will be having any type of surgery. If possible, Prasugrel should be stopped for at least 7 days before surgery.

Tell your doctor if you have risk factors for bleeding, including a body weight of less than 132 lbs (60 kg) or a history of easy or persistent bleeding. Tell your doctor if you take a medicine that may increase your risk of bleeding, such as warfarin, heparin, nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, ibuprofen), or fibrinolytic agents (eg, alteplase).

Tell your doctor if dizziness occurs while you take Prasugrel . Do not suddenly stop Prasugrel without checking with your doctor. This may increase the risk of severe heart problems or death.

Prasugrel is used for:

Reducing the risk of having another serious heart or blood vessel problem (eg, heart attack, stroke, blood clots in your stent, death). It is intended for use in patients who have had a heart attack, angina, or a procedure called angioplasty.

Prasugrel is a platelet aggregation inhibitor. It works by slowing or stopping platelets from clumping together to form clots.

Do NOT use Prasugrel if:

  • you are allergic to any ingredient in Prasugrel
  • you have an active bleeding problem (eg, ulcer, bleeding in the brain) or a history of stroke or TIA ("mini-stroke")
  • you will be having bypass heart surgery (CABG)

Contact your doctor or health care provider right away if any of these apply to you.

Before using Prasugrel :

Some medical conditions may interact with Prasugrel . Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have active bleeding, diabetes, or liver problems
  • if you have a history of heart attack, stomach or intestinal problems (eg, ulcers, polyps, diverticulosis), easy or persistent bleeding, or recent injury or surgery
  • if you will be having surgery (including dental surgery)
  • if you weigh less than 132 lbs (60 kg)

Some MEDICINES MAY INTERACT with Prasugrel . Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Anticoagulants (eg, heparin, warfarin), fibrinolytic agents (eg, alteplase), or NSAIDs (eg, ibuprofen) because the risk of bleeding may be increased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Prasugrel may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Prasugrel :

Use Prasugrel as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Prasugrel comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Prasugrel refilled.
  • Take Prasugrel by mouth with or without food.
  • Swallow Prasugrel whole. Do not break, crush, or chew before swallowing.
  • You will also need to take aspirin while you take Prasugrel . Check with your doctor about what dose of aspirin you should take.
  • If you miss a dose of Prasugrel , take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Prasugrel .

Important safety information:

  • Dizziness may occur while you are taking Prasugrel . This effect may be worse if you take it with alcohol or certain medicines. Use Prasugrel with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Do not suddenly stop Prasugrel without checking with your doctor. This may increase the risk of severe heart problems or death.
  • Prasugrel may reduce the number of clot-forming cells (platelets) in your blood. Avoid activities that may cause bruising or injury. Tell your doctor if you have unusual bruising or bleeding. Tell your doctor if you have dark, tarry, or bloody stools.
  • Prasugrel may cause a serious and sometimes fatal condition called thrombotic thrombocytopenic purpura (TTP). Contact your doctor right away if you develop purple patches on the skin, fever, weakness, unusually pale skin, yellowing of the skin or eyes, or change in the amount of urine produced. Discuss any questions with your doctor.
  • Tell your doctor or dentist that you take Prasugrel before you receive any medical or dental care, emergency care, or surgery. If possible, Prasugrel should be stopped for at least 7 days before surgery.
  • Lab tests, including blood pressure, may be performed while you use Prasugrel . These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Use Prasugrel with caution in the ELDERLY; they may be more sensitive to its effects, especially the risk of serious and sometimes fatal bleeding (including bleeding in the brain). Prasugrel is usually not recommended in patients older than 74 years old except in high-risk situations (eg, diabetes, history of heart attack).
  • Prasugrel should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Prasugrel while you are pregnant. It is not known if Prasugrel is found in breast milk. If you are or will be breast-feeding while you use Prasugrel , check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Prasugrel :

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Back pain; cough; diarrhea; mild bruising or bleeding; nausea; nosebleeds; tiredness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black, tarry stools; change in the amount of urine; chest pain; confusion; coughing up blood; dark or bloody urine; dizziness; fast or irregular heartbeat; fever, chills, or persistent sore throat; one-sided weakness; pale skin; purple spots on the skin; seizure; severe or persistent headache; severe or persistent nosebleeds; shortness of breath; speech problems; stomach pain; unusual bruising; unusual or severe bleeding (eg, excessive bleeding from cuts , increased menstrual bleeding, unexplained vaginal bleeding, unusual bleeding from the gums when brushing); unusual tiredness or weakness; vision changes; vomit that contains blood or looks like coffee grounds; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately.

Proper storage of Prasugrel :

Store Prasugrel at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store in the original container with the lid tightly closed. Do not remove the desiccant (gray cylinder) from the bottle. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Prasugrel out of the reach of children and away from pets.

General information:

  • If you have any questions about Prasugrel , please talk with your doctor, pharmacist, or other health care provider.
  • Prasugrel is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Prasugrel . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

  • Prasugrel Professional Patient Advice (Wolters Kluwer)
  • prasugrel Advanced Consumer (Micromedex) - Includes Dosage Information
  • Effient Prescribing Information (FDA)
  • Effient Consumer Overview