Vorapaxar, Oral

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KEY POINTS

• This medicine is taken by mouth to reduce the risk heart attack, stroke, or other heart or blood vessel problems in people who have had a heart attacks or peripheral artery disease. Take it exactly as directed. Do not stop taking this medicine unless the healthcare provider who prescribed this medicine tells you to.
• Keep all appointments for tests to see how this medicine affects you.
• This medicine increases your risk of bleeding. Be careful while shaving, cutting fingernails or toenails, or when using sharp objects.
• This medicine may cause unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, 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: vorapaxar, oral; Zontivity

What is this medicine used for?

This medicine is taken by mouth to reduce the risk of heart attack, stroke, or other heart or blood vessel problems in people who have had a heart attack or have peripheral artery disease. It may be used along with aspirin or clopidogrel.

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), or any bleeding in your brain
• Bleeding problems or blood disorders
• Liver or kidney problems
• Stomach ulcers

Tell your 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.

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. Do not stop taking this medicine unless your healthcare provider approves. Take it regularly each day.

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. Take any other medicine prescribed by your healthcare provider, such as aspirin or clopidogrel, exactly as directed.

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

You may take this medicine with or without food. Take this medicine with a glass of water.

What if I miss a dose?

If you miss a dose, 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, nausea, diarrhea, blood in your bowel movements or urine, vomiting blood, unusual bruising or bleeding.

What should I watch out for?

While taking this medicine, and for about 4 weeks after you stop taking it, you may bleed more easily and 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.

Do not take aspirin or products that contain aspirin without your healthcare provider's approval while you are taking this medicine. Many nonprescription medicines may contain aspirin. Also, do not drink alcohol or take any other medicines unless your healthcare provider approves.

You may need to have blood tests regularly to see how this medicine affects you. Keep all appointments for tests and checkups.

Adults over the age of 65 may be at greater risk for side effects, especially bleeding. Talk with your healthcare 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 taking this medicine several days before 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; blisters or red or purple spots on skin; bloody diarrhea; black, tarry bowel movements; blood in vomit or urine; unusual or severe shortness of breath; confusion; depression; chest pain; fast, slow, or irregular heartbeat; severe dizziness or fainting.

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 azithromycin (Zithromax, Zmax), clarithromycin (Biaxin), erythromycin (E.E.S., Ery-Tab, Erythrocin), rifabutin (Mycobutin), rifampin (Rifadin), rifapentine (Priftin), and telithromycin (Ketek)
• Antidepressants such as citalopram (Celexa), desvenlafaxine (Pristiq), duloxetine (Cymbalta), escitalopram (Lexapro), fluoxetine (Prozac), fluvoxamine (Luvox), nefazodone, sertraline (Zoloft), and venlafaxine (Effexor)
• Antifungal medicines such as itraconazole (Sporanox), ketoconazole (Nizoral), posaconazole (Noxafil), and voriconazole (Vfend)
• Antiseizure medicines such as carbamazepine (Carbatrol, Epitol, Equetro, Tegretol), oxcarbazepine (Trileptal), phenobarbital, phenytoin (Dilantin, Phenytek), and primidone (Mysoline)
• Aspirin and medicines that contain aspirin
• Bosentan (Tracleer)
• Cancer medicines such as enzalutamide (Xtandi), idelalisib (Zydelig), and mitotane (Lysodren)
• Conivaptan (Vaprisol)
• Dexamethasone
• HIV medicines such as atazanavir (Reyataz), cobicistat (Tybost), darunavir (Prezista), delavirdine (Rescriptor), efavirenz (Sustiva), elvitegravir/cobicistat/emtricitabine/tenofovir (Stribild), etravirine (Intelence), fosamprenavir (Lexiva), indinavir (Crixivan), lopinavir/ritonavir (Kaletra), nelfinavir (Viracept), nevirapine (Viramune), ritonavir (Norvir), and saquinavir (Invirase)
• Medicines to treat or prevent blood clots such as apixaban (Eliquis), cilostazol (Pletal), clopidogrel (Plavix), dabigatran (Pradaxa), dalteparin (Fragmin), dipyridamole (Persantine), edoxaban (Savaysa), enoxaparin (Lovenox), fondaparinux (Arixtra), heparin, prasugrel (Effient), rivaroxaban (Xarelto), ticagrelor (Brilinta), and warfarin (Coumadin)
• Natural remedies such as alfalfa, anise, bilberry, bladderwrack, bromelain, cat's claw, chamomile, dong quai, evening primrose, fenugreek, feverfew, garlic, ginger, ginkgo biloba, ginseng, glucosamine, green tea, horse chestnut, licorice, red clover, SAMe, St. John's wort, turmeric, and willow
• Nonsteroidal anti-inflammatory medicines (NSAIDs) such as celecoxib (Celebrex), diclofenac (Cambia, Voltaren, Zipsor), diflunisal, ibuprofen (Advil, Motrin), indomethacin (Indocin), ketoprofen, ketorolac, nabumetone (Relafen), naproxen (Aleve, Anaprox, Naprelan), oxaprozin (Daypro), and piroxicam (Feldene)
• Omega-3-Acid Ethyl Esters (Epanova)
• Paroxetine (Brisdelle, Paxil, Pexeva)
• Vitamin E or multivitamins that contain vitamin E

Do not drink alcohol while taking this medicine without your healthcare provider's approval.

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 in the original container at room temperature. Keep the container tightly closed so that the medicine stays dry. Be very careful to protect the medicine from moisture. 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.