Edoxaban, Oral

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KEY POINTS

• This medicine is taken by mouth to treat or prevent blood clots and reduce the risk of stroke. Take it exactly as directed. Do NOT stop taking this medicine without your healthcare provider's approval. You are at risk of having a stroke when you stop taking this medicine and must be monitored closely.
• This medicine may cause you to bleed more easily and bleeding may take longer to stop. You have a higher risk of developing a blood clot if you receive spinal anesthesia or have a spinal puncture while taking this medicine.
• Keep all appointments for tests to see how this medicine affects you.
• This medicine may cause unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: factor Xa inhibitor; anticoagulant (medicine that reduces the chance of blood clots forming)

Generic and brand names: edoxaban, oral; Savaysa

What is this medicine used for?

This medicine is taken by mouth to

• Reduce the risk of blood clots and stroke in people who have atrial fibrillation
• Treat blood clots in the veins of your legs (deep vein thrombosis) or lungs (pulmonary embolism)

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine
• A stroke or transient ischemic attack (TIA)
• Bleeding problems or blood disorders
• Heart valve problems
• Kidney or liver problems
• Surgery on your spine or a catheter in your spine
• Ulcers

Females of childbearing age: Tell your healthcare provider if you are pregnant or plan to become pregnant. It is not known whether this medicine will harm an unborn baby. If you take this medicine during pregnancy tell your doctor right away if you have any bleeding or symptoms of blood loss. Do not breast-feed without your healthcare provider's approval.

How do I use it?

Read the Medication Guide that comes in the medicine package when you start taking this medicine and each time you get a refill.

Check the label on the medicine for directions about your specific dose. Take this medicine exactly as your healthcare provider prescribes. Do not take more or less than prescribed. Do not stop taking this medicine without your healthcare provider's approval. You are at risk of having a stroke when you stop taking this medicine and must be monitored closely.

Check with your healthcare provider before using this medicine in children under age 18.

Take this medicine with food to lessen the chance the drug will upset your stomach.

What if I miss a dose?

If you miss a dose, take it as soon as you remember on the same day. Take your next dose at your usual time the next day. Do not take double doses. If you are not sure of what to do if you miss a dose, or if you miss more than one dose, contact your healthcare provider.

What if I overdose?

If you or anyone else has intentionally taken too much of this medicine, call 911 or go to the emergency room right away. If you pass out, have seizures, weakness or confusion, or have trouble breathing, call 911. If you think that you or anyone else may have taken too much of this medicine, call the poison control center. Do this even if there are no signs of discomfort or poisoning. The poison control center number is 800-222-1222.

Symptoms of an acute overdose may include: blood in the urine or bowel movements, vomiting blood, bleeding that won't stop.

What should I watch out for?

This medicine may cause you to bleed more easily and bleeding may take longer to stop. Avoid sports and activities that may cause injuries. Talk with your healthcare provider about which sports or activities you should avoid. If you fall or are injured, contact your healthcare provider right away. You may have serious internal bleeding without being aware of it. Do not drink alcohol or take aspirin while receiving this medicine unless your healthcare provider approves. It may increase the risk of bleeding.

Your risk of developing a blood clot in or around your spine is higher if you take this medicine and receive spinal anesthesia or have a spinal puncture. This kind of blood clot may cause paralysis. Tell your healthcare provider right away if you have tingling, numbness, or muscle weakness, especially in your legs and feet.

You will need to have regular checkups and lab tests while you are taking this medicine. Keep all appointments.

This medicine may make you feel faint or dizzy. Do not drive or operate machinery until you are fully alert.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking this medicine.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives, itching, rash, tightness or pain in your chest, swelling of your lips, tongue or throat, trouble breathing); sudden weakness, numbness, or tingling, especially on one side of your body; sudden or severe headache; sudden trouble with vision, speech, balance, or walking.

Serious (Report these to your healthcare provider right away.): Unusual bruising or bleeding; dark urine or bowel movements; bloody urine; increased menstrual flow or vaginal bleeding; vomiting blood or material that looks like coffee grounds; black or tarry bowel movements; painful urination; unusual tiredness or weakness; swelling, numbness, or tingling in fingers, legs, or toes, or any unexplained swelling; pain in your legs; sore throat; fever; yellowing of your skin or eyes; severe headache, dizziness, or weakness; fainting; rash; itching; stomach pain; severe joint or muscle pain; chest pain; shortness of breath; back pain; loss of bladder or bowel control; pain, swelling, or new wound leakage around surgical incision site.

Other: Mild nausea, mild itching, muscle spasms.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• Antibiotics such as azithromycin (Zithromax, Zmax), clarithromycin (Biaxin), erythromycin (E.E.S., Ery-Tab, Erythrocin), rifabutin (Mycobutin), and rifampin (Rifadin)
• Antifungal medicines such as itraconazole (Sporanox) and ketoconazole (Nizoral)
• Antiseizure medicines such as carbamazepine (Carbatrol, Epitol, Equetro, Tegretol), phenobarbital, phenytoin (Dilantin, Phenytek), and primidone (Mysoline)
• Antiviral medicines such as ledipasvir/sofosbuvir (Harvoni), ombitasvir/paritaprevir/ritonavir/dasabuvir (Viekira), ombitasvir/paritaprevir/ritonavir (Technivie), and simeprevir (Olysio)
• Aspirin and other salicylates
• Cancer medicines such as abiraterone (Zytiga), crizotinib (Xalkori), doxorubicin (Doxil), ibrutinib (Imbruvica), lapatinib (Tykerb), nilotinib (Tasigna), sunitinib (Sutent), vandetanib (Caprelsa), vemurafenib (Zelboraf), and vinblastine
• Dexamethasone
• Heart medicines such as amiodarone (Cordarone, Pacerone), diltiazem (Cardizem, Cartia, Tiazac), dronedarone (Multaq), felodipine, nicardipine (Cardene), quinidine, ranolazine (Ranexa), and verapamil (Calan, Covera, Verelan)
• HIV medicines such as atazanavir (Reyataz), darunavir (Prezista), delavirdine (Rescriptor), efavirenz (Sustiva), elvitegravir/cobicistat/emtricitabine/tenofovir (Stribild), etravirine (Intelence), fosamprenavir (Lexiva), indinavir (Crixivan), lopinavir/ritonavir (Kaletra), nelfinavir (Viracept), nevirapine (Viramune), ritonavir (Norvir), saquinavir (Invirase), and tipranavir (Aptivus)
• Immunosuppressants such as cyclosporine (Gengraf, Neoral, Sandimmune) and tacrolimus (Astagraf, Prograf, Protopic)
• Natural remedies such as alfalfa, anise, arnica, bilberry, black cohosh, bromelain, cat's claw, celery, chamomile, dong quai, evening primrose oil, fenugreek, feverfew, garlic, ginger, ginkgo biloba, ginseng, goldenseal, grapeseed, green tea, horse chestnut, licorice, red clover, St. John's wort, sweet clover, turmeric, and willow
• Nefazodone
• Nonsteroidal anti-inflammatory medicines (NSAIDs) such as diclofenac (Cambia, Voltaren, Zipsor), ibuprofen (Advil, Motrin), indomethacin (Indocin), ketoprofen, ketorolac, nabumetone (Relafen), naproxen (Aleve, Anaprox, Naprelan), oxaprozin (Daypro), piroxicam (Feldene), and sulindac (Clinoril)
• Other medicines to treat or prevent blood clots such as apixaban (Eliquis), cilostazol (Pletal), clopidogrel (Plavix), dabigatran (Pradaxa), dalteparin (Fragmin), dipyridamole (Persantine), enoxaparin (Lovenox), fondaparinux (Arixtra), heparin, prasugrel (Effient), rivaroxaban (Xarelto), ticagrelor (Brilinta), vorapaxar (Zontivity), and warfarin (Coumadin)

Do not drink any alcohol while taking this medicine without your healthcare provider's approval.

Ask your healthcare provider or pharmacist if you need to avoid products that contain grapefruit, Seville oranges, or tangelos while you are taking this medicine. These fruits and juices can affect the way this medicine works and may increase your risk of serious side effects.

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine at room temperature. If you have the bottle, keep the container tightly closed. If you have the blister pack, do not remove a tablet until you are ready to take it. Protect the medicine from heat, high humidity, and bright light.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Keep all medicines out of the reach of children.

Do not share medicines with other people.