Edoxaban (e-DOX-a-ban)

Prevents and treats blood clots, and lowers risk of stroke. This medicine is a blood thinner.

Brand Name(s):

Savaysa

When This Medicine Should Not Be Used:

How to Use This Medicine:

Tablet

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
• If you are unable to swallow the tablet whole, you may crush and mix it with 2 to 3 ounces of water and give it by mouth or through a gastric tube. You may also mix the crushed tablets with soft foods (including applesauce).
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how edoxaban works. Tell your doctor if you are using any of the following:
  • Rifampin
  • Another blood thinner (including heparin, warfarin)
  • NSAID pain or arthritis medicine (including aspirin, naproxen)
  • Medicine to treat depression (including SNRIs, SSRIs)

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant, or if you have kidney disease, liver disease, bleeding problems, spine problems, antiphospholipid syndrome, heart valve disease, an artificial heart valve, or a history of back surgery.
• Do not breastfeed during treatment with this medicine.
• This medicine may cause the following problems:
  • Increased risk for bleeding
  • Increased risk for blood clots in your spine or back after a spinal procedure
• Do not suddenly stop using this medicine without asking your doctor first. You risk of stroke is higher if you stop using this medicine suddenly.
• Tell any doctor or dentist who treats you that you are using this medicine.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Back pain, numbness, tingling, or muscle weakness in your legs or feet, loss of bladder or bowel control
• Bleeding from your gums or nose, heavy menstrual bleeding
• Chest pain, coughing up blood, trouble breathing
• Numbness or weakness in your arm or leg, or on one side of your body, pain in your lower leg
• Pink or red urine, red or black stools
• Sudden or severe headache, problems with vision, speech, or walking
• Unusual bleeding, bruising, or weakness
• Vomiting blood or material that looks like coffee grounds

If you notice these less serious side effects, talk with your doctor:

• Rash

If you notice other side effects that you think are caused by this medicine, tell your doctor

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