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Vorapaxar

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Warning

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.

Precautions

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.

Side Effects

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.