Zontivity helps to prevent platelets in your blood from sticking together and forming a blood clot. An unwanted blood clot can occur with certain heart or blood vessel conditions.

Zontivity is used to lower the risk of stroke or serious heart problems in people who have had a heart attack or a blood vessel disorder affecting circulation in the arms and legs.

Zontivity is sometimes used together with aspirin or clopidogrel (Plavix).

You should not use Zontivity if you have active bleeding, stomach or intestinal bleeding, a head injury, or if you have a history of stroke (including "mini-stroke"), bleeding in your brain, or increased pressure inside the skull.

Zontivity increases your risk of bleeding, which can be severe or life-threatening. Call your doctor or seek emergency medical attention if you have bloody or tarry stools, red or brown urine, any bleeding that will not stop, or if you cough up blood or vomit that looks like coffee grounds.

Zontivity is usually taken once per day. Follow all directions on your prescription label and read all medication guides or instruction sheets.

You may take Zontivity with or without food.

You may also need to take aspirin or clopidogrel (Plavix). Follow your doctor's instructions very carefully.

If you need surgery or any dental work, tell the surgeon or dentist ahead of time that you are using Zontivity. You may need to stop using the medicine for a short time to prevent bleeding.

You should not stop using this medicine suddenly. Stopping suddenly may make your condition worse.

Zontivity can have long lasting effects in your body. You may still bleed more easily for as long as 4 weeks after you stop using this medicine.

Store at room temperature away from moisture and heat. Keep the tablets in their original container, along with the packet or canister of moisture-absorbing preservative.

Usual Adult Dose for Thromboembolic Disorder:

2.08 mg orally once a day, with or without food

Comments: Use with aspirin and/or clopidogrel

Uses: For reduction of thrombotic cardiovascular events in patients with a history of myocardial infarction (MI) or with peripheral arterial disease (PAD)

Usual Adult Dose for Peripheral Arterial Disease:

2.08 mg orally once a day, with or without food

Comments: Use with aspirin and/or clopidogrel

Uses: For reduction of thrombotic cardiovascular events in patients with a history of myocardial infarction (MI) or with peripheral arterial disease (PAD)

You should not use Zontivity if you are allergic to vorapaxar, or if you have:

• active bleeding;

• stomach or intestinal bleeding;

• a head injury or bleeding in your head;

• a history of stroke;

• a history of transient ischemic attack (TIA) or "mini-stroke"; or

• a history of bleeding in your brain or increased pressure inside the skull.

Vorapaxar increases your risk of bleeding, which can be severe or life-threatening, especially if:

• you have a bleeding or blood clotting disorder such as hemophilia;

• you are an older adult;

• you are underweight;

• you have liver or kidney disease;

• you take a blood thinner (warfarin, Coumadin, Jantoven);

• you take certain antidepressants (Celexa, Paxil, Prozac, Zoloft, Cymbalta, Effexor, and others); or

• you take an NSAID (nonsteroidal anti-inflammatory drug) such as aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib, diclofenac, indomethacin, meloxicam, and others.

To make sure Zontivity is safe for you, tell your doctor if you have recently had any heart procedures, such as:

• heart bypass surgery (coronary artery bypass graft, or CABG);

• angioplasty (a catheter is inserted to place a "stent" in a blood vessel to open up a blocked or narrowed artery); or

• coronary angiography (a special dye is injected into a blood vessel that allows your coronary arteries to be easily seen on an x-ray).

Vorapaxar may harm an unborn baby. Use effective birth control to prevent pregnancy, and tell your doctor if you become pregnant.

You should not breastfeed while using Zontivity.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Get emergency medical help if you have signs of an allergic reaction to Zontivity is: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• a light-headed feeling, like you might pass out;

• easy bruising or bleeding (nosebleeds, bleeding gums);

• red or brown urine, bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;

• any bleeding that will not stop;

• low red blood cells (anemia) - pale skin, unusual tiredness, feeling light-headed or short of breath, cold hands and feet; or

• signs of a stroke - sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance.

Common Zontivity is side effects may include:

• bleeding;

• anemia;

• depression; or

• rash.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Other drugs may interact with vorapaxar, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.