Generic Name: prasugrel (PRA-soo-grel)
Brand Name: Effient
Effient 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"). The risk of severe side effects may be increased in patients older than 74 years old. Effient is usually not recommended in these patients, except in certain situations (eg, diabetes, history of heart attack).
Do not use Effient if you will be having bypass heart surgery (coronary artery bypass graft [CABG]). Tell your doctor that you take Effient if you have recently had or will be having any type of surgery. If possible, Effient 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 or fainting occurs while you take Effient. Do not suddenly stop Effient without checking with your doctor. This may increase the risk of severe heart problems or death.
Effient 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.
Effient is a platelet aggregation inhibitor. It works by slowing or stopping platelets from clumping together to form clots.
Do NOT use Effient if:
- you are allergic to any ingredient in Effient
- 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 Effient:
Some medical conditions may interact with Effient. 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 had a severe allergic reaction (eg, severe rash, hives, difficulty breathing, dizziness) to any other thienopyridine (eg, clopidogrel)
- if you have diabetes, liver problems, or kidney problems
- if you have a history of heart attack, stomach or bowel problems (eg, bleeding, 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 Effient. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Anticoagulants (eg, heparin, warfarin), apixaban, dabigatran, desirudin, fibrinolytic agents (eg, alteplase), NSAIDs (eg, ibuprofen), rivaroxaban, or other medicines to prevent or treat blood clots 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 Effient 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 Effient:
Use Effient as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Effient comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Effient refilled.
- Take Effient by mouth with or without food.
- Do not break Effient before you swallow it.
- You will also need to take aspirin while you take Effient, as directed by your doctor.
- If you miss a dose of Effient, 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 unless your doctor tells you to.
Ask your health care provider any questions you may have about how to use Effient.
Important safety information:
- Dizziness may occur while you are taking Effient. This effect may be worse if you take it with alcohol or certain medicines. Use Effient with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
- Do not suddenly stop Effient without checking with your doctor. This may increase the risk of severe heart problems or death.
- Effient 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.
- Effient 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 or mouth, fever, unusual bruising or bleeding, unusual tiredness or weakness, unusually pale skin, yellowing of the skin or eyes, or change in the amount of urine produced. Discuss any questions with your doctor.
- Call your doctor right away if you fall or injure yourself, especially if you hit your head. You may need to be checked by your doctor.
- Tell your doctor or dentist that you take Effient before you receive any medical or dental care, emergency care, or surgery. If possible, Effient should be stopped for at least 7 days before surgery as directed by your doctor.
- Lab tests, including blood pressure, may be performed while you use Effient. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- Use Effient 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). Effient is usually not recommended in patients older than 74 years old except in certain situations (eg, diabetes, history of heart attack).
- Effient 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 Effient while you are pregnant. It is not known if this medicine is found in breast milk. If you are or will be breast-feeding while you use Effient, check with your doctor. Discuss any possible risks to your baby.
Possible side effects of Effient:
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:
Seek medical attention right away if any of these SEVERE side effects occur:
Back pain; cough; diarrhea; headache; mild bruising or bleeding; nausea; nosebleeds; tiredness.
Severe allergic reactions (rash; hives; itching; difficulty breathing or swallowing; tightness in the chest; swelling of the mouth, face, lips, throat, or tongue; unusual hoarseness); black, tarry stools; change in the amount of urine produced; chest pain; confusion; coughing up blood; dark or bloody urine; dizziness; fainting; fast, slow, or irregular heartbeat; fever, chills, or persistent sore throat; one-sided weakness; pale skin; purple spots on the skin or mouth; seizure; severe or persistent headache; severe or persistent nausea, vomiting, or diarrhea; severe or persistent nosebleeds; shortness of breath; speech problems; stomach pain; swelling of the hands, ankles, or feet; 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 (eg, blurred vision); 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. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.Proper storage of Effient:
Store Effient at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). 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 Effient out of the reach of children and away from pets.
- If you have any questions about Effient, please talk with your doctor, pharmacist, or other health care provider.
- Effient 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.
- Check with your pharmacist about how to dispose of unused medicine.
This information should not be used to decide whether or not to take Effient or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Effient. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Effient. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using Effient.
Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.