Pronunciation:

e-DOX-a-ban

Brand Names:

• Savaysa

Dosage Forms:

• Tablet

Warnings:

Reduced Efficacy in Nonvalvular Atrial Fibrillation Patients with a Creatinine Clearance (CrCl) Greater than 95 mL/minute; Premature Discontinuation of Edoxaban Increases the Risk of Ischemic Events; Spinal/Epidural HematomaReduced Efficacy in Nonvalvular Atrial Fibrillation Patients with CrCl greater than 95 mL/min: Edoxaban should not be used in patients with CrCl greater than 95 mL/min. In the ENGAGE AF-TIMI 48 study, nonvalvular atrial fibrillation patients with CrCl greater than 95 mL/min had an increased rate of ischemic stroke with edoxaban 60 mg once daily compared to patients treated with warfarin. In these patients another anticoagulant should be used.Premature Discontinuation of Edoxaban Increases the Risk of Ischemic Events: Premature discontinuation of any oral anticoagulant in the absence of adequate alternative anticoagulation increases the risk of ischemic events. If edoxaban is discontinued for a reason other than pathological bleeding or completion of a course of therapy, consider coverage with another anticoagulant as described in the transition guidance.Spinal/Epidural Hematoma: Epidural or spinal hematomas may occur in patients treated with edoxaban who are receiving neuraxial anesthesia or undergoing spinal puncture. These hematomas may result in long-term or permanent paralysis. Consider these risks when scheduling patients for spinal procedures .

Classifications:

Therapeutic—

Anticoagulant

Pharmacologic—

Factor Xa Inhibitor

Uses of This Medicine:

Edoxaban is used to prevent stroke and blood clots in patients with a certain heart rhythm problem (eg, nonvalvular atrial fibrillation).

Edoxaban is also used to treat deep venous thrombosis, a condition in which harmful blood clots form in the blood vessels of the legs. These blood clots can travel to the lungs and can become lodged in the blood vessels of the lungs, causing a condition called pulmonary embolism. This medicine is used in patients who have been treated with an injectable blood thinner for 5 to 10 days.

Edoxaban is a factor Xa inhibitor, an anticoagulant. It works by decreasing the clotting ability of the blood and helps prevent harmful clots from forming in the blood vessels.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of edoxaban in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of edoxaban in the elderly.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Defibrotide

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Abciximab
• Aceclofenac
• Acemetacin
• Acenocoumarol
• Adagrasib
• Alteplase, Recombinant
• Amiodarone
• Amoxicillin
• Amtolmetin Guacil
• Anagrelide
• Anistreplase
• Apixaban
• Ardeparin
• Argatroban
• Aspirin
• Atazanavir
• Azithromycin
• Bemiparin
• Berotralstat
• Betrixaban
• Bivalirudin
• Bromfenac
• Bufexamac
• Cangrelor
• Caplacizumab-yhdp
• Capmatinib
• Carbamazepine
• Celecoxib
• Certoparin
• Choline Salicylate
• Cilostazol
• Citalopram
• Clarithromycin
• Clonixin
• Clopidogrel
• Cobicistat
• Cyclosporine
• Dabigatran Etexilate
• Dalteparin
• Danaparoid
• Darunavir
• Desirudin
• Desvenlafaxine
• Dexibuprofen
• Dexketoprofen
• Diclofenac
• Diflunisal
• Dipyridamole
• Dipyrone
• Dronedarone
• Droxicam
• Duloxetine
• Enoxaparin
• Epoprostenol
• Eptifibatide
• Erythromycin
• Escitalopram
• Etodolac
• Etofenamate
• Etoricoxib
• Felbinac
• Fenoprofen
• Fepradinol
• Feprazone
• Floctafenine
• Flufenamic Acid
• Fluoxetine
• Flurbiprofen
• Fluvoxamine
• Fondaparinux
• Fosphenytoin
• Heparin
• Ibrutinib
• Ibuprofen
• Iloprost
• Indomethacin
• Inotersen
• Itraconazole
• Ketoconazole
• Ketoprofen
• Ketorolac
• Lenacapavir
• Lepirudin
• Levetiracetam
• Levomilnacipran
• Levothyroxine
• Lornoxicam
• Loxoprofen
• Lumiracoxib
• Meclofenamate
• Mefenamic Acid
• Meloxicam
• Melphalan
• Methotrexate
• Milnacipran
• Morniflumate
• Nabumetone
• Nadroparin
• Naproxen
• Nefazodone
• Nepafenac
• Niflumic Acid
• Nimesulide
• Nimesulide Beta Cyclodextrin
• Omadacycline
• Orlistat
• Oxaliplatin
• Oxaprozin
• Oxyphenbutazone
• Parecoxib
• Parnaparin
• Paroxetine
• Phenindione
• Phenobarbital
• Phenprocoumon
• Phenylbutazone
• Phenytoin
• Piketoprofen
• Piracetam
• Piroxicam
• Pranoprofen
• Prasugrel
• Primidone
• Proglumetacin
• Propyphenazone
• Proquazone
• Protein C
• Quinidine
• Reteplase, Recombinant
• Reviparin
• Rifampin
• Rivaroxaban
• Rofecoxib
• Salicylic Acid
• Salsalate
• Sarecycline
• Selexipag
• Sertraline
• Sibutramine
• Sodium Salicylate
• St John's Wort
• Streptokinase
• Sulfinpyrazone
• Sulindac
• Tenecteplase
• Tenoxicam
• Testosterone
• Tiaprofenic Acid
• Ticagrelor
• Ticlopidine
• Tinzaparin
• Tirofiban
• Tolfenamic Acid
• Tolmetin
• Trazodone
• Treprostinil
• Turmeric
• Urokinase
• Valdecoxib
• Valproic Acid
• Venlafaxine
• Verapamil
• Vilazodone
• Vorapaxar
• Vortioxetine
• Warfarin

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Antiphospholipid syndrome or
• Artificial heart valve or
• Heart valve disease (mitral stenosis) or
• Kidney disease, severe or
• Liver disease, moderate or severe—Use is not recommended in patients with these conditions.

• Bleeding, active—Should not be used in patients with this condition.

• Bleeding problems, history of or
• Catheter insertion in the spine or
• Surgery (eg, spine), recent or history of—Use with caution. The risk of bleeding may be increased.

• Kidney disease, moderate—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use of This Medicine:

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. When your supply of this medicine is running low, contact your doctor or pharmacist ahead of time. Do not allow yourself to run out of this medicine.

This medicine comes with a Medication Guide. It is very important that you read and understand this information. Be sure to ask your doctor if you have any questions.

You may take this medicine with or without food.

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 (eg, applesauce).

If you are using another medicine to thin the blood (eg, heparin, warfarin, Coumadin®, Jantoven®), your doctor will give you very specific instructions about how to switch to edoxaban. Carefully follow the instructions and ask your doctor if you have any questions.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):
  • For prevention of strokes and blood clots in patients with nonvalvular atrial fibrillation:
    • Adults—60 milligrams (mg) once a day. Your doctor may adjust your dose as needed or tolerated.
    • Children—Use and dose must be determined by your doctor.
  • For treatment of deep venous thrombosis and pulmonary embolism:
    • Adults—60 milligrams (mg) once a day. Your doctor may adjust your dose as needed or tolerated.
    • Children—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly and to decide if you should continue to take it. Blood and urine tests may be needed to check for unwanted effects.

Make sure any doctor who treats you knows that you are using this medicine. You may need to stop using this medicine for several days before having surgery, including dental procedures.

Do not suddenly stop using this medicine without asking your doctor first. You might have a higher risk of stroke after you stop using this medicine.

Check with your doctor right away if you have any unusual bleeding or bruising, black, tarry stools, blood in the urine or stools, headache, dizziness, or weakness, pain, swelling, or discomfort in a joint, pinpoint red spots on your skin, unusual nosebleeds, or unusual vaginal bleeding that is heavier than normal. These may be signs of bleeding problems.

This medicine may increase the risk of forming blood clots in the spine or epidural area, which may lead to long-term or permanent paralysis. This is more likely to occur if you have an epidural catheter placed in your back, are taking NSAID or blood clotting medicine, a history of repeated epidural punctures or problems with your spine, or have had surgery on your spine. Tell your doctor right away if you have back pain, loss of bladder or bowel control, tingling, numbness, or muscle weakness, especially in your legs and feet.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Bloody nose

heavy non-menstrual vaginal bleeding

pale skin

trouble breathing

unusual bleeding or bruising

unusual tiredness or weakness

Less common

Bloody or black, tarry stools

vomiting of blood or material that looks like coffee grounds

Rare

Confusion

cough

difficulty with speaking

double vision

fever

headache, sudden, severe

inability to move the arms, legs, or facial muscles

inability to speak

nausea

slow speech

vomiting

Incidence not known

Back pain

bleeding gums

bloody or cloudy urine

burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

chest tightness

difficult or painful urination

fast heartbeat

hives, itching, rash, redness of the skin

hoarseness

irritation

joint pain, stiffness or swelling

large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, sex organs

leg weakness

loss of bladder or bowel control

paralysis

pinpoint red spots on the skin

stomach pain

sudden decrease in amount of urine

swelling of the eyelids, face, lips, hands, or feet

trouble swallowing

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Incidence not known

Dizziness

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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