Zontivity® is a protease-activated receptor-1 (PAR-1) antagonist indicated for the reduction of thrombotic cardiovascular events in patients with a history of myocardial infarction (MI) or with peripheral artery disease (PAD).  Zontivity has been shown to reduce the rate of a combined endpoint of cardiovascular death, MI, stroke, and urgent coronary revascularization.

Important Safety Information

ZONTIVITY (vorapaxar) is an anti-platelet prescription medicine used to treat people who have had a heart attack or reduced blood flow in their legs or other vessels in their body (peripheral arterial disease).

ZONTIVITY is used with aspirin, with clopidogrel (Plavix®), or with aspirin and clopidogrel to lower your chance of having another serious problem with your heart or blood vessels, such as heart attack, stroke, or death but ZONTIVITY (and similar drugs) can cause bleeding that can be serious and lead to death.

While you take ZONTIVITY and for about 4 weeks after your treatment with ZONTIVITY is stopped:

  • you may bruise and bleed more easily (nose bleeds may be common)
  • it will take longer than usual for any bleeding to stop.

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

  • bleeding that is severe or that you cannot control
  • pink, red, or brown urine
  • vomiting blood or your vomit looks like “coffee grounds”
  • red or black stools (looks like tar)
  • coughing up blood or blood clots.

Do not take ZONTIVITY if you:

  • have had a stroke or “mini stroke” (also known as transient ischemic attack or TIA)
  • have had bleeding in your brain
  • currently have unusual bleeding, such as bleeding in your head, stomach or intestines (an ulcer).

If you have a stroke, TIA, or bleeding in your brain while taking ZONTIVITY your doctor should stop your treatment with ZONTIVITY. Follow your doctor’s instructions about stopping ZONTIVITY.

Take ZONTIVITY exactly as prescribed by your doctor. Do not stop taking ZONTIVITY without first talking to the doctor who prescribed it for you.

Before you take ZONTIVITY, tell your doctor if you:

  • have had bleeding problems or history of stomach ulcers
  • have had a stroke or “mini-stroke” (also known as transient ischemic attack or TIA)
  • have had bleeding (hemorrhage) in your brain
  • have had any recent serious injury or surgery
  • plan to have surgery or a dental procedure
  • have kidney problems or severe liver problems
  • are pregnant or plan to become pregnant. It is not known if ZONTIVITY will harm your unborn baby.
  • are breastfeeding or plan to breastfeed. It is not known if ZONTIVITY passes into your breast milk. You and your doctor should decide if you will take ZONTIVITY or breastfeed. You should not do both.

Tell all of your doctors and dentists that you are taking ZONTIVITY with aspirin, with clopidogrel (Plavix®), or with aspirin and clopidogrel. They should talk to the doctor who prescribed ZONTIVITY for you before you have any surgery or dental procedure.

The possible side effects of ZONTIVITY include:

  • Anemia (low level of red blood cells)
  • Depression
  • Rash

These are not all the possible side effects of ZONTIVITY.

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, dietary or herbal supplements. Taking ZONTIVITY with certain other medicines may increase your risk of bleeding and may affect how ZONTIVITY works.

The risk information provided here is not comprehensive. To learn more, talk about ZONTIVITY with your pharmacist or other health care providers. The product information can be found at www.zontivity.com or 1-866-207-6592.

Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088

For more information, please visit zontivityhcp.comThis product information is intended only for residents of the United States.