Vorapaxar

IMPORTANT WARNING:

Vorapaxar may cause severe bleeding that can be life-threatening and even cause death. Tell your doctor if you have or have ever had a stroke or mini-stroke; bleeding in the brain; any type of blood or bleeding disorder; or a stomach ulcer. Your doctor will probably tell you not to take vorapaxar. Also tell your doctor if you currently have any unusual type of bleeding such as bleeding in the head, stomach, or intestines; if you have had a recent surgery or injury;or have kidney or liver disease. Tell your doctor and pharmacist if you are taking anagrelide (Agrylin); nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen (Advil, Motrin, others), indomethacin (Indocin, Tivorbex), ketoprofen, and naproxen (Aleve, Anaprox, others) taken on a regular basis; dabigatran (Pradaxa); dalteparin (Fragmin); enoxaparin (Lovenox); fondaparinux (Arixtra); heparin; rivaroxaban (Xarelto); selective serotonin reuptake inhibitors (SSRIs) such as citalopram (Celexa), fluoxetine (Prozac, Sarafem), fluvoxamine (Luvox), paroxetine (Brisdelle, Paxil), and sertraline (Zoloft); and serotonin and norepinephrine reuptake inhibitors (SNRIs) such as duloxetine (Cymbalta), desvenlafaxine (Khedezla, Pristiq), milnacipran (Fetzima, Savella), and venlafaxine (Effexor); and warfarin (Coumadin, Jantoven). If you experience any of the following symptoms during your treatment and for at least 4 weeks after you stop taking the medication, call your doctor immediately: bleeding that is unexpected, severe, or that you cannot control; pink, red, or brown urine; vomiting blood or material that looks like coffee grounds; red or tarry black stools; coughing up blood or blood clots; nosebleeds; headache; dizziness; or weakness.

Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with vorapaxar and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) or the manufacturer's website to obtain the Medication Guide.

Talk to your doctor about the risks of taking vorapaxar.

WHY is this medicine prescribed?

Vorapaxar is used together with other medications, such as aspirin and clopidogrel (Plavix), to reduce the risk of serious or life-threatening heart or blood vessel problems such as heart attack and stroke in people who have already had a heart attack or have problems with the blood flow in their legs. Vorapaxar is in a class of medications called protease-activated receptor-1 (PAR-1) antagonists. It works by preventing platelets (a type of blood cell) from collecting and forming clots that may cause a heart attack or stroke.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

Vorapaxar comes as a tablet to take by mouth. It is usually taken with or without food once a day. Take vorapaxar at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take vorapaxar exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Vorapaxar will only decrease your risk of having a heart attack or stroke as long as you continue to take the medication. Do not stop taking vorapaxar without talking to your doctor.

What SPECIAL PRECAUTIONS should I follow?

Before taking vorapaxar,

• tell your doctor and pharmacist if you are allergic to vorapaxar, any other medications, or any of the ingredients in vorapaxar tablets. Ask your pharmacist or check the Medication Guide for a list of the ingredients.

• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, and nutritional supplements you are taking or plan to take. Be sure to mention the medications listed in the IMPORTANT WARNING section and any of the following: certain antifungals such as itraconazole (Sporanox, Onmel), ketoconazole (Nizoral), and posaconazole (Noxafil); boceprevir (Victrelis); carbamazepine (Carbatrol, Tegretol); clarithromycin (Biaxin, in PrevPac); conivaptan (Vaprisol); certain medications for human immunodeficiency virus (HIV) such as indinavir (Crixivan), nelfinavir (Viracept), ritonavir (Norvir, in Kaletra), and saquinavir (Invirase); nefazodone; phenytoin (Dilantin, Phenytek); rifampin (Rifadin, Rimactane); telaprevir (Incivek); and telithromycin (Ketek); Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

• tell your doctor what herbal products you are taking, especially St. Johns wort.

• tell your doctor if you have or have ever had any medical condition especially those listed in the IMPORTANT WARNING section.

• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking vorapaxar, call your doctor.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do IF I FORGET to take a dose?

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

What SIDE EFFECTS can this medicine cause?

Vorapaxar may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• tiredness
• weakness
• pale skin
• cool hands and feet

Some side effects can be serious. If you experience any of the symptoms listed in the IMPORTANT WARNING section, call your doctor immediately or get emergency medical treatment.

Vorapaxar may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about STORAGE and DISPOSAL of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Do not remove the desiccant (drying agent) from the bottle, if one has been provided.

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

What OTHER INFORMATION should I know?

Keep all appointments with your doctor.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.