Zontivity 2.08 mg tablet

Generic name:
Vorapaxar - oral

Pronunciation
(VOR-a-PAX-ar)

Brand name(s)
Zontivity

Vorapaxar increases the risk of bleeding, which may include bleeding in the brain and other serious (possibly fatal) bleeding problems.

Do not use vorapaxar if you have had a stroke, mini-stroke (transient ischemic attack - TIA), or bleeding in the brain in the past; or if you have any current bleeding problems. Discuss the benefits and risks of this medication with your doctor.

Vorapaxar is used to help prevent heart attacks and strokes in people who have had a heart attack or have poor blood flow (peripheral arterial disease).

It works by blocking certain blood cells called platelets from sticking together and forming harmful blood clots. Harmful blood clots can cause heart attacks, strokes, and other serious problems. This "anti-platelet" effect helps keep blood flowing smoothly in your body.

Read the Medication Guide provided by your pharmacist before you start taking vorapaxar and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth with or without food as directed by your doctor, usually once daily. Take it regularly to get the most benefit from it. To help you remember, take it at the same time each day.

Your doctor may direct you to take other anti-platelet drugs (such as aspirin, clopidogrel) with this medication. Follow your doctor's directions carefully.

Do not increase your dose or take this medication more often than prescribed. Your condition will not improve any faster, and your risk of side effects will increase.

Keep taking vorapaxar even if you feel well. Do not stop taking it without consulting your doctor.

Easy bruising/bleeding, such as nosebleeds, may occur. If this effect lasts or gets worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Get medical help right away if you have any very serious side effects, including any of these signs of bleeding:

• bleeding that doesn't stop or bleeding too much
• stomach/abdominal pain
• lasting nausea/vomiting
• coughing or vomiting up blood
• vomit that looks like coffee grounds
• bloody/black/tarry stools
• bloody/pink/dark urine
• sudden severe headache
• confusion
• dizziness
• fainting
• seizures
• unusual weakness
• weakness on one side of the body
• trouble speaking
• unusual drowsiness
• loss of consciousness

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before taking vorapaxar, tell your doctor or pharmacist if you are allergic to it or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• stroke (including mini-strokes, TIAs)
• current and past bleeding problems (such as bleeding in the brain, stomach ulcers, hemophilia)
• recent surgery
• serious injury
• liver disease

While you are taking this medication, it may take longer than usual for bleeding to stop if you have a cut or injury. To lower the chance of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.

Since vorapaxar stays in your body for a long time, you will still be at risk for bleeding for about 4 weeks after this medication is stopped.

Limit alcoholic beverages. Daily use of alcohol, especially when combined with this medicine, may increase your risk for stomach bleeding.

Before having surgery, tell your doctor or dentist that you are taking this medication and about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this medication passes into breast milk. Consult your doctor before breastfeeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug include:

• tipranavir
• antidepressants (such as amitriptyline, clomipramine, SSRIs including paroxetine/citalopram, SNRIs including duloxetine/desvenlafaxine/venlafaxine)
• other drugs that can cause bleeding/bruising (including anticoagulants such as dabigatran, warfarin)

Other medications can affect the removal of vorapaxar from your body, which may affect how vorapaxar works. Examples include azole antifungals (such as itraconazole, ketoconazole), cobicistat, HIV protease inhibitors (such as nelfinavir), macrolide antibiotics (such as clarithromycin), rifamycins (such as rifampin), ritonavir, St. John's wort, drugs used to treat seizures (such as carbamazepine, phenytoin), among others.

Check all prescription and nonprescription medicine labels carefully since many contain pain relievers/fever reducers (aspirin, NSAIDs such as ibuprofen or naproxen). These drugs also have anti-platelet effects and may increase your risk of side effects if taken together. However, if your doctor has told you to take low-dose aspirin to prevent heart attack or stroke (usually 81-162 milligrams a day), you should keep taking the aspirin unless your doctor tells you not to. Ask your doctor or pharmacist for more details.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669.

Do not share this medication with others.

Lab and/or medical tests (such as complete blood count) should be done while you are taking this medication. Keep all medical and lab appointments. Consult your doctor for more details.

If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

Store in the original bottle or blister packs at room temperature away from moisture. Do not store in the bathroom. Keep the drying agent (desiccant) in the bottle. Tightly close the bottle when not in use. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.