Prasugrel

Prasugrel is a prescription medication used to lower the chance of heart attack, stroke, or death in people who have had a heart attack or severe chest pain and have been treated with angioplasty (surgery for a blocked artery).

Prasugrel belongs to a group of drugs called antiplatelet agents. It works by preventing platelets from forming clots which can cause heart attack or stroke.

This medication comes in tablet form and is usually taken once a day, with or without food. Prasugrel should be taken with aspirin.

Common side effects include back pain, cough, diarrhea, and headache.

Prasugrel is used to lower the risk of serious problems with the heart or blood vessels in adults who:

• have had a heart attack or severe chest pain that happens when your heart does not get enough oxygen, and
• have been treated with a procedure called “angioplasty” (also called balloon angioplasty)

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Prasugrel may be found in some form under the following brand names:

• Effient

Prasugrel can cause serious side effects, including:

• See "Drug Precautions".
• A blood clotting problem called Thrombotic Thrombocytopenic Purpura (TTP). TTP can happen with prasugrel, sometimes after a short time (less than 2 weeks). TTP is a blood clotting problem where blood clots form in blood vessels and can happen all over the body. TTP needs to be treated in a hospital right away, because you may die. Get medical help right away if you have any of these symptoms and they cannot be explained by another medical condition:
  • purplish spots called purpura on the skin or mucous membranes (such as on the mouth) due to bleeding under the skin
  • paleness or jaundice (a yellowish color of the skin or eyes)
  • feeling tired or weak
  • fever
  • fast heart rate or feeling short of breath
  • headache, speech changes, confusion, coma, stroke, or seizure
  • low amount of urine or urine that is pink-tinged or has blood in it
  • stomach area (abdominal) pain, nausea, vomiting, or diarrhea
  • visual changes
• Serious allergic reactions. Serious allergic reactions can happen with prasugrel, or if you have had a serious allergic reaction to the medicine clopidogrel (Plavix) or ticlopidine (Ticlid). Get medical help right away if you get any of these symptoms of a severe allergic reaction while taking prasugrel.
  • swelling or hives of your face, lips, in or around your mouth, or throat
  • trouble breathing or swallowing
  • chest pain or pressure
  • dizziness or fainting

Tell your doctor if you have any side effect that bothers you or that does not go away.

These are not all of the possible side effects of prasugrel. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088.

Tell all of your doctors and dentists that you are taking prasugrel. They should talk to the doctor who prescribed prasugrel for you, before you have any surgery or invasive procedure.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Certain medicines may increase your risk of bleeding. 

Know the medicines you take. Keep a list of them and show it to your doctor and pharmacist when you get a new medicine.

• Prasugrel is used to lower your chance of having a heart attack or other serious problems with your heart or blood vessels.
  • However, prasugrel can cause bleeding, which can be serious and sometimes may lead to death. You should not start to take prasugrel if it is likely that you will have heart bypass surgery (coronary artery bypass graft surgery or CABG) right away. You have a higher risk of bleeding if you take prasugrel and then have heart bypass surgery.
• Do not take prasugrel if you:
  • currently have abnormal bleeding, such as stomach or intestinal bleeding, or bleeding in your head
  • have had a stroke or “mini-stroke” (also known as transient ischemic attack or TIA)
  • are allergic to prasugrel or any of the ingredients in prasugrel.
• Get medical help right away if you think you may be having a stroke or TIA. Symptoms that you may be having a stroke or TIA include:
  • sudden slurring of speech,
  • sudden weakness or numbness in one part of your body,
  • sudden blurry vision, or sudden severe headache.
• If you have a stroke or TIA while taking prasugrel, your doctor will probably stop your prasugrel. Follow your doctor's instructions about stopping prasugrel. Do not stop taking prasugrel unless your doctor tells you to.
• Before having any surgery you should talk to your doctor about stopping prasugrel. If possible, prasugrel should be stopped at least 1 week (7 days) before any surgery, as instructed by the doctor who prescribed prasugrel for you.

Your risk of bleeding while taking prasugrel may be higher if you also:

• have had trauma, such as an accident or surgery
• have stomach or intestine bleeding that is recent or keeps coming back, or you have a stomach ulcer
• have severe liver problems
• weigh less than 132 pounds
• take other medicines that increase your risk of bleeding, including:
  • warfarin sodium (Coumadin, Jantoven)
  • a medicine that contains heparin
  • other medicines to prevent or treat blood clots
  • regular daily use of non-steroidal anti-inflammatory drugs (NSAIDs)

Tell your doctor if you take any of these medicines. Ask your doctor if you are not sure if your medicine is one listed above.

Prasugrel increases your risk of bleeding because it lessens the ability of your blood to clot. While you take prasugrel:

• you will bruise and bleed more easily
• you are more likely to have nose bleeds
• it will take longer for any bleeding to stop

Call your doctor right away if you have any of these signs or symptoms of bleeding:

• unexpected bleeding or bleeding that lasts a long time
• bleeding that is severe or you cannot control
• pink or brown urine
• red or black stool (looks like tar)
• bruises that happen without a known cause or get larger
• cough up blood or blood clots
• vomit blood or your vomit looks like “coffee grounds”

Do not stop taking prasugrel without talking to the doctor who prescribes it for you. People who are treated with angioplasty and have a stent, and stop taking prasugrel too soon, have a higher risk of a blood clot in the stent, having a heart attack, or dying. If you must stop prasugrel because of bleeding, your risk of a heart attack may be higher.

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of prasugrel there are no specific foods that you must exclude from your diet when receiving prasugrel.

Prasugrel may not be right for you. Tell your doctor about all of your medical conditions, including if you:

• have any bleeding problems
• have had a stroke or “mini-stroke” (also known as transient ischemic attack or TIA)
• are allergic to any medicines, including clopidogrel (Plavix) or ticlopidine (Ticlid)
• have a history of stomach ulcers, colon polyps, diverticulosis
• have liver problems
• have had any recent severe injury or surgery
• plan to have surgery or a dental procedure. 
• pregnant, or are planning to get pregnant. It is not known if prasugrel will harm your baby.
• if you are breastfeeding. It is not known if prasugrel passes into your breastmilk. You and your doctor should decide if you will take prasugrel or breastfeed. You should not do both without talking with your doctor.

Tell all of your doctors and dentists that you are taking prasugrel. They should talk to the doctor who prescribed prasugrel for you, before you have any surgery or invasive procedure.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Prasugrel falls into category B. There are no well-done studies that have been done in humans with prasugrel. But in animal studies, pregnant animals were given this medication, and the babies did not show any medical issues related to this medication.

Tell your doctor if you are breastfeeding. It is not known if prasugrel passes into your breastmilk. You and your doctor should decide if you will take prasugrel or breastfeed. You should not do both without talking with your doctor.

• Take prasugrel exactly as prescribed by your doctor.
• Take prasugrel one time each day.
• You can take prasugrel with or without food.
• Take prasugrel with aspirin as instructed by your doctor.
• Your doctor will decide how long you should take prasugrel. Do not stop taking prasugrel without first talking to the doctor who prescribed it for you. 
• If you miss a dose, take prasugrel as soon as you remember. If it is almost time for your next dose, skip the missed dose. Just take the next dose at your regular time. Do not take two doses at the same time unless your doctor tells you to.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

Prasugrel treatment is typically initiated with a single 60 mg oral loading dose.

The recommended dose of prasugrel is 10 mg once daily.

For patients <60 kg the dose may be reduced to 5 mg once daily.

If you take too much prasugrel, call your local emergency room or poison control center right away.

• Keep prasugrel at room temperature between 59°F to 86°F (15°C to 30°C).
• Keep prasugrel in the container it comes in.
• Keep the container closed tightly with the gray cylinder inside.
• Protect prasugrel from moisture.

Keep prasugrel and all medicines out of the reach of children.

WARNING: BLEEDING RISK

Prasugrel can cause significant, sometimes fatal, bleeding.

Do not use prasugrel in patients with active pathological bleeding or a history of transient ischemic attack or stroke.

In patients ≥75 years of age, prasugrel is generally not recommended, because of the increased risk of fatal and intracranial bleeding and uncertain benefit, except in high-risk situations (patients with diabetes or a history of prior MI) where its effect appears to be greater and its use may be considered.

Do not start prasugrel in patients likely to undergo urgent coronary artery bypass graft surgery (CABG). When possible, discontinue prasugrel at least 7 days prior to any surgery.

Additional risk factors for bleeding include:

• body weight <60 kg
• propensity to bleed
• concomitant use of medications that increase the risk of bleeding (e.g., warfarin, heparin, fibrinolytic therapy, chronic use of non-steroidal anti-inflammatory drugs [NSAIDs])

Suspect bleeding in any patient who is hypotensive and has recently undergone coronary angiography, percutaneous coronary intervention (PCI), CABG, or other surgical procedures in the setting of Prasugrel.

If possible, manage bleeding without discontinuing Prasugrel. Discontinuing Prasugrel, particularly in the first few weeks after acute coronary syndrome, increases the risk of subsequent cardiovascular events.