Alert

edoxaban

Pronunciation: e DOX a ban

Brand: Savaysa

What is the most important information I should know about edoxaban?

Edoxaban 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 edoxaban. Tell your doctor about all medicines you have recently used.

Edoxaban 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 edoxaban.

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

What is edoxaban?

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

Edoxaban 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.

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 occur after a person has been treated with an injectable blood thinner for 5 to 10 days.

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

What should I discuss with my healthcare provider before taking edoxaban?

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 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.

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.

How should I take edoxaban?

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

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.

What happens if I miss a dose?

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.

What happens if I overdose?

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

Overdose may cause excessive bleeding.

What should I avoid while taking edoxaban?

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

What are the possible side effects of edoxaban?

Get emergency medical help if you have signs of an allergic reaction: 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.

Edoxaban 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 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.

What other drugs will affect edoxaban?

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.

Where can I get more information?

Your pharmacist can provide more information about edoxaban.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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