Generic Name: vorapaxar
Date of Approval: May 8, 2014
Company: Merck Sharp & Dohme Corp.

Treatment for: Prevention of Cardiovascular Events in High Risk Patients

FDA Approves Zontivity

The U.S. Food and Drug Administration has approved Zontivity (vorapaxar), the first in a new class of drugs called protease-activated receptor-1 (PAR-1) antagonists. It is an anti-platelet agent designed to inhibit the formation of blood clots. It is used for the secondary prevention of thrombotic cardiovascular events in high risk patients, reducing the risk of heart attack, stroke, cardiovascular death, and need for procedures to restore the blood flow to the heart in patients with a history of heart attack or peripheral arterial disease.

Zontivity increases the risk of bleeding which may be life threatening, and the product label includes a Boxed Warning to alert health care professionals about this risk. It must not be used in people who have previously had a stroke, transient ischemic attack (TIA), or intracranial hemorrhage.

Zontivity is taken once daily, with or without food. It should be should be prescribed with daily aspirin and/or clopidogrel. Tablets are yellow, oval-shaped, and film-coated with “351” on one side and the Merck logo on the other side.

The most common side effects include bleeding and bruising. Bleeding may be life-threatening and should reported immediately.

Zontivity is made by Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc..

Zontivity Medication Guide

Read this Medication Guide before you start taking this medicine and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your medical condition or your treatment.

Slideshow: 10 Common Symptoms That Should Never Be Ignored

Important information

Zontivity (and similar drugs) can cause bleeding that can be serious and lead to death. Call your doctor right away if you have any of these signs or symptoms of bleeding:

  • 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.

During treatment and for about four weeks after your treatment 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.

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 experience any of the above during your treatment, your doctor will advise you to stop taking Zontivity. Follow your doctor's instructions carefully.

What is Zontivity?

Zontivity is a prescription anti-platelet agent medicine used inhibit the formation of blood clots in people who have

  • had a heart attack or
  • reduced blood flow in their legs (peripheral arterial disease).

It is used with aspirin and/or clopidogrel to lower your chance of having another serious problem with your heart or blood vessels, such as heart attack, stroke, or death.

It is not known if this medicine is safe and effective in children.

What should I tell my doctor before taking Zontivity?

Before you take this medicine, 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 any recent serious injury or surgery
  • plan to have surgery or a dental procedure
  • have severe liver problems
  • are pregnant or plan to become pregnant. It is not known if this medicine will harm your unborn baby.
  • are breastfeeding or plan to breastfeed. It is not known if this medicine passes into your breast milk. You and your doctor will need to 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. They should talk to the doctor who prescribed it for you before you have any surgery or dental procedure.

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 also affect how well it works.

Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.

How should I take Zontivity?

Take exactly as prescribed by your doctor.

  • Take dose one time each day, with or without food.
  • Take with aspirin and/or clopidogrel as prescribed by your doctor.
  • Do not stop taking this medicine without first talking to the doctor who prescribed it for you.
  • If you overdose, call your doctor, or go to the nearest emergency room right away.

Zontivity side effects

  • Serious bleeding. See Important information above.
  • Anemia (low level of red blood cells)
  • Depression
  • Rash

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

See also: Side effects (in more detail)

Storage information

  • Store at room temperature between 68°F to 77°F (20°C to 25°C).
  • Keep the tablets in the bottle they come in.
  • Keep the bottle tightly closed.
  • The bottle contains a desiccant packet to help keep your medicine dry (protect it from moisture). Keep the desiccant packet in the bottle. Do not throw away the desiccant packet.
  • Store blister packs in the original package it comes in.
  • Keep this medicine and all other medicines out of the reach of children.

You can ask your doctor or pharmacist for information that is written for health professionals.

For more information, go to www.zontivity.com or call 1-800-622-4477.

What are the ingredients?

Active ingredient: vorapaxar sulfate

Inactive ingredients: Tablet: lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, povidone, and magnesium stearate
Film coating: lactose monohydrate, hypromellose, titanium dioxide, triacetin (glycerol triacetate), and iron oxide yellow