edoxaban

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Pronunciation: e DOX a ban

Brand: Savaysa

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

You should not use edoxaban if you have an artificial heart valve, or if you have active or uncontrolled bleeding. You may not be able to use edoxaban if you have normal kidney function (your doctor will check your kidneys before you start taking edoxaban).

Edoxaban can cause a very serious blood clot around your spinal cord if you undergo a spinal tap or receive spinal anesthesia (epidural), especially if you have a genetic spinal defect, if you have a spinal catheter in place, if you have a history of spinal surgery or repeated spinal taps, or if you are also using other drugs that can affect blood clotting. This type of blood clot can lead to long-term or permanent paralysis.

Get emergency medical help if you have symptoms of a spinal cord blood clot such as back pain, numbness or muscle weakness in your lower body, or loss of bladder or bowel control.

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 is an anticoagulant (blood thinner) that prevents the formation of blood clots.

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:

  • an artificial heart valve; or
  • active or uncontrolled bleeding.

You may not be able to use edoxaban if you have normal kidney function (your doctor will check your kidneys before you start taking edoxaban).

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 take a blood thinner--heparin, warfarin, Coumadin, Jantoven;
  • you take aspirin or medicines that contain aspirin (including cough or cold medicine);
  • you take an NSAID--aspirin, Advil, Aleve, Motrin, Celebrex, 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, heparin, warfarin (Coumadin, Jantoven), or clopidogrel (Plavix).

To make sure you can safely take edoxaban, tell your doctor if you have kidney or liver disease.

It is not known whether this medicine will harm an unborn baby. However, this medicine could cause bleeding complications during childbirth. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether edoxaban passes into breast milk or if it could harm a nursing baby. You should not breast-feed while you are using edoxaban.

How should I take edoxaban?

Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not take this medicine in larger or smaller amounts or for longer than recommended.

You may take edoxaban with or without food.

Edoxaban increases your risk of bleeding, which can be severe or life-threatening. Call your doctor or seek emergency medical attention if you have bleeding that will not stop, if you have black or bloody stools, or if you cough up blood or vomit that looks like coffee grounds.

Tell any doctor who treats you that you are using edoxaban. If you need surgery or dental work, tell the surgeon or dentist ahead of time that you are taking edoxaban. If you need anesthesia for a medical procedure or surgery, you may need to stop using edoxaban for a short time.

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

Use edoxaban regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

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.

Call your doctor at once if you have:

  • easy bruising or bleeding (nosebleeds, bleeding gums, heavy menstrual bleeding);
  • pain, bruising, or bleeding where a needle was injected in your skin;
  • any bleeding that will not stop;
  • headache, dizziness, weakness, feeling like you might pass out;
  • urine that looks red, pink, or brown;
  • bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds; or
  • low red blood cells (anemia) --pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating.

Common side effects may include:

  • bleeding;
  • low red blood cells;
  • rash; or
  • abnormal liver function tests.

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?

Other drugs may interact with edoxaban, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

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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