Edoxaban

Edoxaban stops certain clotting substances in the blood from working.

Edoxaban is used to reduce the risk of stroke from a blood clot in people with a heart rhythm disorder known as atrial fibrillation. edoxaban is used when the atrial fibrillation is not due to a heart valve issue.

Edoxaban is also used to treat a type of blood clot called deep vein thrombosis (DVT), which can lead to blood clots in the lungs (pulmonary embolism). A DVT can sometimes happen after a person has been treated with an injectable blood thinner for 5 to 10 days.

Edoxaban may also be used for reasons not listed in this medication guide.

Your kidney function may need to be checked before you start edoxaban.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

You may take edoxaban with or without food.

If you cannot swallow a tablet whole, crush the tablet and mix it with 2 or 3 ounces of water or applesauce. Swallow the mixture right away without chewing. Do not save it for later use.

Edoxaban can make it easier for you to bleed, even from a minor injury. Seek medical attention if you have bleeding that will not stop.

If you need surgery, dental work, or a medical procedure, tell the doctor or dentist ahead of time that you are using this medication. If you need anesthesia, you may need to stop using edoxaban for a short time.

Do not change your dose or stop taking this medication without first talking to your doctor. Stopping suddenly can increase your risk of blood clot or stroke.

Store at room temperature away from moisture and heat.

Edoxaban can make it easier for you to bleed. Contact your doctor immediately if you notice any signs of bleeding, such as: bleeding gums, nosebleeds, heavy menstrual periods or unusual vaginal bleeding, blood in your urine, bloody or black stools, coughing up blood, or vomit that looks like coffee grounds.

Many other medications can raise your risk of bleeding when taken with edoxaban. Inform your doctor about all the medicines you have used recently.

Edoxaban can lead to a very serious blood clot around your spinal cord if you have a spinal tap or receive spinal anesthesia (epidural). Let any doctor who treats you know that you are taking edoxaban.

Do not stop taking edoxaban without first consulting your doctor. Stopping suddenly can increase your risk of a blood clot or stroke.

You should not use edoxaban if you are allergic to it, or if you have active or uncontrolled bleeding.

Edoxaban can cause a very serious blood clot around your spinal cord if you undergo a spinal tap or receive spinal anesthesia (epidural). This type of blood clot could lead to long-term paralysis and may be more likely to happen if:

• you have a genetic spinal defect;
• you have a spinal catheter in place;
• you have a history of spinal surgery or repeated spinal taps;
• you have recently had a spinal tap or epidural anesthesia;
• you are taking an NSAID--Advil, Aleve, Motrin, and others; or
• you are using other medicines to treat or prevent blood clots.

Edoxaban may cause you to bleed more easily, especially if you have:

• a bleeding disorder that is inherited or caused by disease;
• hemorrhagic stroke;
• uncontrolled high blood pressure;
• stomach or intestinal bleeding or ulcer; or
• if you take certain medicines such as aspirin, enoxaparin, heparin, warfarin (Coumadin, Jantoven), clopidogrel (Plavix), or certain antidepressants.

Tell your doctor if you have ever had:

• an artificial heart valve;
• bleeding problems; or
• liver or kidney disease.

Taking edoxaban during pregnancy may cause bleeding in the mother or the unborn baby. Tell your doctor if you are pregnant or if you become pregnant.

You should not breast-feed while using edoxaban.

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Also seek emergency medical attention if you have symptoms of a spinal blood clot: back pain, numbness or muscle weakness in your lower body, or loss of bladder or bowel control.

Edoxaban can make you bleed more easily. Call your doctor right away if you see signs of bleeding such as:

• easy bruising or bleeding (nosebleeds, bleeding gums, heavy menstrual bleeding);
• pain, swelling, or drainage from a wound or where a needle was injected into your skin;
• bleeding from wounds or needle injections, any bleeding that will not stop;
• headaches, dizziness, weakness, feeling like you might faint;
• urine that looks red, pink, or brown; or
• bloody or tarry stools, coughing up blood, or vomit that looks like coffee grounds.

Common side effects of edoxaban may include:

• bleeding; or
• low red blood cells (anemia)--pale skin, unusual tiredness, feeling light-headed or short of breath, cold hands and feet.

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

Usual Adult Dose for Atrial Fibrillation:

60 mg orally once a dayUse: Prevention of stroke and systemic embolism in nonvalvular atrial fibrillation.

Usual Adult Dose for Deep Vein Thrombosis:

60 mg orally once a day following 5 to 10 days of initial therapy with a parenteral anticoagulantUse: Treatment of deep vein thrombosis and pulmonary embolism following 5 to 10 days of initial parenteral anticoagulant therapy.

Usual Adult Dose for Pulmonary Embolism:

60 mg orally once a day following 5 to 10 days of initial therapy with a parenteral anticoagulantUse: Treatment of deep vein thrombosis and pulmonary embolism following 5 to 10 days of initial parenteral anticoagulant therapy.

Take the medicine as soon as you can, but if it is almost time for your next dose, skip the missed dose. Do not take two doses at one time.

Get your prescription refilled before you run out of medicine completely.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

• Overdose may cause excessive bleeding.

• Avoid activities that may increase your risk of bleeding or injury. Use extra care to prevent bleeding while shaving or brushing your teeth.

Tell your doctor about all your other medicines, especially:

• any other medications to treat or prevent blood clots;
• a blood thinner--heparin warfarin (Coumadin, Jantoven);
• NSAIDs (nonsteroidal anti-inflammatory drugs)--aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib, diclofenac, indomethacin, meloxicam, and others; or
• an antidepressant--citalopram, duloxetine, fluoxetine, sertraline, paroxetine, venlafaxine, Cymbalta, Prozac, Pristiq, Paxil, Zoloft, and others.

This list is not complete and many other drugs may affect edoxaban. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.