Savaysa blocks the activity of certain clotting substances in the blood.

Savaysa is used to lower the risk of stroke caused by a blood clot in people with a heart rhythm disorder called atrial fibrillation. This medicine is used when the atrial fibrillation is not caused by a heart valve problem.

Savaysa 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). Savaysa should be used after 5 to 10 days of using an injectable blood thinner.

Savaysa can cause you to bleed more easily. Call your doctor at once if you have signs of bleeding such as: bleeding gums, nosebleeds, heavy menstrual periods or abnormal vaginal bleeding, blood in your urine, bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds.

Many other drugs can increase your risk of bleeding when used with Savaysa. Tell your doctor about all medicines you have recently used.

Savaysa can cause a very serious blood clot around your spinal cord if you undergo a spinal tap or receive spinal anesthesia (epidural). Tell any doctor who treats you that you are taking this medicine.

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

Take Savaysa exactly as it was prescribed for you. 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.

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

You may take Savaysa 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.

Savaysa 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 Savaysa 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.

Usual Adult Dose for Atrial Fibrillation:

60 mg orally once a day

Use: 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 anticoagulant; your dose may be lower if you have a low weight.

Uses: Treatment of deep venous thrombosis and pulmonary embolism following 5-10 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 anticoagulant; your dose may be lower if you have a low weight.

Uses: Treatment of deep venous thrombosis and pulmonary embolism following 5-10 days of initial parenteral anticoagulant therapy

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

Savaysa 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 cause long-term paralysis, and may be more likely to occur 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.

Savaysa 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.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next 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.

Get emergency medical help if you have signs of an allergic reaction to Savaysa: hives; difficult 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.

Savaysa can cause you to bleed more easily. Call your doctor at once if you have 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 in your skin;

• bleeding from wounds or needle injections, any bleeding that will not stop;

• headaches, dizziness, weakness, feeling like you might pass out;

• urine that looks red, pink, or brown; or

• bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds.

Common Savaysa side effects 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 occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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);

• 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 interact with edoxaban. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.