Edoxaban

IMPORTANT WARNING:

If you have atrial fibrillation (a condition in which the heart beats irregularly, increasing the chance of clots forming in the body, and possibly causing strokes) and are taking edoxaban to help prevent strokes or serious blood clots, you are at a higher risk of having a stroke after you stop taking this medication. Do not stop taking edoxaban without talking to your doctor. Continue to take edoxaban even if you feel well. Be sure to refill your prescription before you run out of medication so that you will not miss any doses of edoxaban. If you need to stop taking edoxaban, your doctor may prescribe another anticoagulant (''blood thinner'') to help prevent a blood clot from forming and causing you to have a stroke.

If you have epidural or spinal anesthesia or a spinal puncture while taking a 'blood thinner' such as edoxaban, you are at risk of having a blood clot form in or around your spine that could cause you to become paralyzed. Tell your doctor if you have an epidural catheter that is left in your body or have or have ever had repeated epidural or spinal punctures, spinal deformity, or spinal surgery. Tell your doctor and pharmacist if you are taking anagrelide (Agrylin); aspirin and other nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen (Advil, Motrin, others), indomethacin (Indocin, Tivorbex), ketoprofen, and naproxen (Aleve, Anaprox, others); cilostazol (Pletal); clopidogrel (Plavix); dipyridamole (Persantine); eptifibatide (Integrilin); heparin; prasugrel (Effient); ticagrelor (Brilinta); ticlopidine; tirofiban (Aggrastat), and warfarin (Coumadin, Jantoven). If you experience any of the following symptoms, call your doctor immediately: back pain, muscle weakness, numbness or tingling (especially in your legs), loss of control of your bowels or bladder, or inability to move your legs.

Keep all appointments with your doctor and the laboratory. Your doctor will order a test to check how well your kidneys are working before and periodically during your treatment with edoxaban.

Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with edoxaban 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/downloads/Drugs/DrugSafety/) or the manufacturer's website to obtain the Medication Guide.

Talk to your doctor about the risk of taking edoxaban.

WHY is this medicine prescribed?

Edoxaban is used help prevent strokes or blood clots in people who have atrial fibrillation (a condition in which the heart beats irregularly, increasing the chance of clots forming in the body and possibly causing strokes) that is not caused by heart valve disease. Edoxaban is also used to prevent deep vein thrombosis (DVT; a blood clot, usually in the leg) and pulmonary embolism (PE; a blood clot in the lung) in people who have been treated with an injectable blood thinner medicine for 5 to 10 days. Edoxaban is in a class of medications called factor Xa inhibitors. It works by blocking the action of a certain natural substance that helps blood clots to form.

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?

Edoxaban comes as a tablet to take by mouth. It is usually taken with or without food once a day. Take edoxaban at around the same times 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 edoxaban exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

If you are unable to swallow the tablets, crush and mix them with 2 to 3 ounces (60 to 90 mL) of water or applesauce. Take the mixture immediately.

If you have a gastric tube, the tablets can be crushed and mixed in water and given through the tube. Ask your doctor or pharmacist how you should take the medication. Follow those directions carefully.

What SPECIAL PRECAUTIONS should I follow?

Before taking edoxaban,

• tell your doctor and pharmacist if you are allergic to edoxaban, any other medications, or any of the ingredients in edoxaban 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, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention the medications listed in the IMPORTANT WARNING section and any of the following: amiodarone (Cordarone, Pacerone), atorvastatin (Lipitor, in Caduet, in Liptruzet), cyclosporine (Gengraf, Neoral), digoxin (Lanoxin), dronedarone (Multaq), erythromycin (E.E.S., E-Mycin, Erythrocin), esomeprazole (Nexium, in Vimovo), ketoconazole (Nizoral), quinidine, rifampin (Rifadin, in Rifamate, in Rifater, Rimactane), selective serotonin-reuptake inhibitors such as citalopram (Celexa), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem, Selfemra), fluvoxamine (Luvox), paroxetine (Brisdelle, Paxil, Pexeva), and sertraline (Zoloft); serotonin–norepinephrine reuptake inhibitors (SNRI) such as desvenlafaxine (Khedezla, Pristiq), duloxetine (Cymbalta), levomilnacipran (Fetzima), milnacipran (Savella), and venlafaxine (Effexor); and verapamil (Calan, Covera, Isoptin, Verelan, in Tarka). Your doctor may need to change the doses of your medications or monitor you carefully for side effects. Many other medications may also interact with edoxaban, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list.

• tell your doctor if you have heavy bleeding anywhere in your body that cannot be stopped. Your doctor will probably tell you not to take edoxaban.

• tell your doctor if you weigh 132 pounds (60 kilograms) or less and if you have or have ever had any type of bleeding problem, a mechanical heart valve, antiphospholipid syndrome (an autoimmune disorder that causes blood clots), cancer of the stomach or intestine, or heart, kidney or liver disease.

• tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while taking edoxaban, 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 on the same day. However, if it is the next day, 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?

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

• rash
• unusual tiredness or weakness
• dizziness
• pale skin

Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING section, stop taking edoxaban and call your doctor immediately:

• bleeding gums
• nosebleeds
• heavy vaginal bleeding
• red, pink, or brown urine
• red or black, tarry stools
• coughing up or vomiting blood or material that looks like coffee grounds

Edoxaban 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).

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.

Symptoms of overdose may include the following:

• unusual bleeding or bruising
• bloody, black, or tarry stools
• blood in urine
• coughing up or vomiting blood or material that looks like coffee grounds

What OTHER INFORMATION should I know?

Before having any laboratory test, tell your doctor and the laboratory personnel that you are taking edoxaban.

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.