Prasugrel, Oral

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KEY POINTS

• This medicine is taken by mouth to prevent blood clots. Take it exactly as directed. Do not stop taking this medicine unless the healthcare provider who prescribed this medicine tells you to.
• While taking this medicine, you may bleed more easily or it may take longer for you to stop bleeding. Be careful while shaving, cutting fingernails or toenails, or when using sharp objects.
• Keep all appointments for tests to see how this medicine affects you.
• Along with its needed effects, your medicine may cause some unwanted side effects. Adults over the age of 75 or people who weigh less than 132 pounds are at greater risk for side effects. Tell your healthcare provider if you have any side effects that continue or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: antiplatelet

Generic and brand names: prasugrel, oral; Effient

What is this medicine used for?

This medicine is taken by mouth to prevent blood clots, especially in people who have had heart attacks, severe chest pain, or who have had angioplasty.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine
• A stroke or transient ischemic attack (TIA)
• Bleeding problems or blood disorders
• Liver or kidney disease
• Ulcers, diverticulosis, or polyps in the colon

Tell your healthcare provider if you have recently had a serious injury or any kind of surgery, or if you are scheduled to have a surgery or dental work. Also tell your provider if you are taking medicine that may increase your risk of bleeding.

Females of childbearing age: Tell your healthcare provider if you are pregnant or become pregnant while taking this medicine. Do not breast-feed while taking this medicine without your healthcare provider's approval.

How do I take it?

Read the Medication Guide that comes in the medicine package when you start taking this medicine and each time you get a refill.

Check the label on the medicine for directions about your specific dose. Take this medicine exactly as directed by your healthcare provider. This is a strong medicine that can cause serious side effects or bleeding if you take too much. Do not stop taking this medicine unless your healthcare provider approves. Take it regularly each day.

Check with your healthcare provider before using this medicine in children under age 18.

You may take this medicine with or without food. Taking it with meals may lessen the chance the drug will upset your stomach. Take this medicine with a glass of water.

You should also take aspirin while taking this medicine. Talk with your provider about this.

What if I miss a dose?

If you miss a dose, take it as soon as you remember unless it is almost time for the next scheduled dose. In that case, skip the missed dose and take the next one as directed. Do not take double doses. If you are not sure of what to do if you miss a dose, or if you miss more than one dose, contact your healthcare provider.

What if I overdose?

If you or anyone else has intentionally taken too much of this medicine, call 911 or go to the emergency room right away. If you pass out, have seizures, weakness or confusion, or have trouble breathing, call 911. If you think that you or anyone else may have taken too much of this medicine, call the poison control center. Do this even if there are no signs of discomfort or poisoning. The poison control center number is 800-222-1222.

Symptoms of an acute overdose may include: vomiting, extreme tiredness, shortness of breath, enlarged pupils, trouble walking, blood in vomit or bowel movements.

What should I watch out for?

This medicine may cause severe or life-threatening bleeding. While taking this medicine, you may bleed more easily or it may take longer for you to stop bleeding. Avoid activities where you could be bruised, cut, or injured. Report any unusual bruising or bleeding to your healthcare provider right away.

You will need to have blood tests regularly to see how this medicine affects you. It is very important to keep these appointments.

Adults over the age of 75 or people who weigh less than 132 pounds are at greater risk for side effects. Talk with your provider about this.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking this medicine. You may need to stop this medicine several days before you have a dental procedure or general surgery. Before stopping this medicine, contact the healthcare provider who prescribed this medicine to you. Do not stop taking this medicine unless the healthcare provider who prescribed this medicine tells you to. Your healthcare provider should then tell you when to start taking this medicine again, after the surgery or dental work.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; tightness in your chest; swelling of your lips, tongue, and throat); sudden weakness, numbness, or tingling, especially on one side of your body; sudden or severe headache; sudden trouble with vision, speech, balance, or walking.

Serious (Report these to your healthcare provider right away.): Unusual bruising or bleeding; unusual tiredness, weakness, or paleness; red or purple spots on skin; bloody diarrhea; black, tarry bowel movements; blood in vomit or urine; light-colored bowel movements; dark urine; trouble urinating; yellowing of your skin or eyes; fast or irregular heartbeat; trouble breathing; severe dizziness or fainting; chest pain; severe stomach pain, diarrhea, nausea, or vomiting; unexplained fever; confusion; seizures.

Other: Headache, mild dizziness, mild nausea, mild diarrhea, back pain, cough.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• Antibiotics such as clarithromycin (Biaxin) and telithromycin (Ketek)
• Antidepressants such as citalopram (Celexa), escitalopram (Lexapro), fluoxetine (Prozac), fluvoxamine (Luvox), nefazodone, and sertraline (Zoloft)
• Antifungal medicines such as itraconazole (Sporanox), ketoconazole (Nizoral), posaconazole (Noxafil), and voriconazole (Vfend)
• Antiviral medicines such as ombitasvir/paritaprevir/ritonavir/dasabuvir (Viekira) and ombitasvir/paritaprevir/ritonavir (Technivie)
• Aspirin and other salicylates
• Cancer medicines such as ceritinib (Zykadia) and idelalisib (Zydelig)
• HIV medicines such as atazanavir (Reyataz), darunavir (Prezista), efavirenz (Sustiva), elvitegravir/cobicistat/emtricitabine/tenofovir (Stribild), fosamprenavir (Lexiva), indinavir (Crixivan), lopinavir/ritonavir (Kaletra), nelfinavir (Viracept), ritonavir (Norvir), and saquinavir (Invirase)
• Medicines to treat or prevent blood clots such as anagrelide (Agrylin), apixaban (Eliquis), argatroban, bivalirudin (Angiomax), cilostazol (Pletal), clopidogrel (Plavix), dabigatran (Pradaxa), dalteparin (Fragmin), dipyridamole (Persantine), enoxaparin (Lovenox), fondaparinux (Arixtra), heparin, rivaroxaban (Xarelto), ticagrelor (Brilinta), and warfarin (Coumadin)
• Medicines to treat pulmonary hypertension such as epoprostenol (Flolan, Veletri), iloprost (Ventavis), and treprostinil (Remodulin, Tyvaso)
• Morphine (Kadian, MS Contin)
• Natural remedies such as alfalfa, angelica, anise, arnica, bilberry, bladderwrack, bromelain, capsicum, cat's claw, chamomile, dong quai, evening primrose, fenugreek, feverfew, fish oil, garlic, ginger, ginkgo biloba, ginseng, glucosamine, grape seed, green tea, horse chestnut, licorice, papain, passionflower, red clover, SAMe, sweet clover, turmeric, and willow
• Pain medicines such as celecoxib (Celebrex), diclofenac (Cambia, Voltaren, Zipsor), diflunisal, etodolac, fenoprofen (Nalfon), ibuprofen (Advil, Motrin), indomethacin (Indocin), ketoprofen, ketorolac, nabumetone (Relafen), naproxen (Aleve, Anaprox, Naprelan), oxaprozin (Daypro), piroxicam (Feldene), sulindac (Clinoril), and tolmetin
• Paroxetine (Brisdelle, Paxil, Pexeva)
• Vitamin E or multivitamins that contain vitamin E

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine at room temperature. Keep the container tightly closed. Protect it from heat, high humidity, and bright light.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicine in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.