Edoxaban (Oral)

Overview

Patients who are diagnosed with certain heart health issues, such as nonvalvular atrial fibrillation (NVAF), for example, are at a higher risk of developing blood clots and stroke, which could be fatal. To decrease these risks, doctors prescribe Edoxaban, an RX-only medicine that is taken orally.

Edoxaban is additionally prescribed for patients who have recently received injectable blood thinners. In this case, it is usually administered within 5 - 10 days of receiving the injectable blood thinner.

In the United States, Edoxaban is available under the drug name Savaysa. When taken, the drug acts fast by activating its anticoagulant effects within one to two hours. It continues to work around the clock to decrease the chances of a person developing a stroke or blood clot.

The mechanisms of action for Edoxaban are straightforward. The treatment targets blood clots that form in the leg region a condition known as deep vein thrombosis and prevents them from traveling elsewhere in the body. In other words, Edoxaban diffuses blood clots in the legs.

If deep vein thrombosis is left untreated, blood clots often reroute to vessels in the lungs, a condition known as pulmonary embolism.

Conventionally, Warfarin has been pushed as one of the most preferred anticoagulants in the marketplace. When Edoxaban was approved by the FDA in 2015, however, it quickly solved some of the drawbacks of Warfarin, which are namely:

  • Delayed onset or activation
  • High risk of GI bleeding or hemorrhagic stroke
  • More drug interactions
  • Small therapeutic window
  • The need for close monitoring and testing

Edoxaban quickly outranked Warfarin as a faster-acting blood clot prevention agent with fewer downsides. However, this medicine isn't for everyone. In some cases, it may be replaced with Warfarin or other anticoagulants.

Conditions Treated?

Type Of Medicine?

  • Anticoagulant
  • Factor Xa Inhibitor
  • Novel Oral Anti-Coagulants (NOACs)

Side Effects

Edoxaban may cause many side effects, ranging from mild to severe.

Some of the most common side effects of Edoxaban include:

  • Bleeds
  • Changes in stool color
  • Difficulty breathing
  • Drowsiness
  • Easy bruising
  • Heavier menstruation
  • Lethargy
  • Nosebleeds

Some rare side effects have also been noted and these include:

  • Coughing
  • Extreme headaches
  • Feeling confused
  • Feeling nauseous
  • Immobility, particularly in the face, arms and legs
  • Paralysis
  • Pins and needles sensation
  • Skin rashes
  • Speech impediments
  • Spikes in temperature
  • Urinary or bowel incontinence
  • Vision changes
  • Weakness in the muscles

Dosage

Edoxaban is supplied in tablet form in the following strengths:

  • 15 mg orange and round imprinted with DSC L15
  • 30 mg pink and round imprinted with DSC L30
  • 60 mg yellow and round imprinted with DSC L60

The dosage amounts are different for each patient and based on several variables, including:

  • The patient's age, weight and medical history
  • The strength of the medicine
  • How long the treatment lasts

The table below provides a general overview of dosage amounts. However, it is not a substitute for the prescription provided by your pharmacist or medical provider. As a result, do not stop or alter the dosage before first consulting with your healthcare provider.

To prevent blood clots and strokes in patients with nonvalvular atrial fibrillation, the dose amounts are:

  • Children: varies by patient
  • Adults: 60 mg once daily

To treat deep vein thrombosis/pulmonary embolism, the dose amounts are:

  • Children: varies by patient
  • Adults: 60 mg once daily

Edoxaban can be taken with or without foods.

When taking this medicine, it is critical that patients follow prescribed dosage amounts for best results. This means that you should always take the medicine on time and within the timeframe prescribed.

In most cases, refills are standard. To ensure you have a consistent supply on hand at all times, be sure to complete refills at least a week in advance.

As abrupt discontinuation of anticoagulants increases the risk of a stroke, the following transitional guides are suggested when switching from another anticoagulant to Savaysa or Edoxaban:

  • Warfarin to Savaysa: Stop Warfarin and start Savaysa when the international normalized ratio is less than 2.5
  • Vitamin K antagonists to Savaysa: Stop Warfarin and start Savaysa when the international normalized ratio is less than 2.5
  • Low molecular weight Heparin (LMWH) to Savaysa: Stop use and commence Savaysa at the next normal scheduled dose
  • Unfractionated Heparin to Savaysa: Stop the infusion and commence Savaysa four hours later

Similarly, if you are switching from Savaysa to another anticoagulant, specific guidelines are provided to reduce the risks of stroke.

If you miss a dose of Edoxaban, take it as soon as you remember, but do not double the prescription within a 24 hour period. Ask your doctor or pharmacist if you are unsure of what to do in the event of a missed dose.

If you accidentally swallow more than the prescribed dose, contact 911 right away. One thing to keep in mind is that the anticoagulating effects of Edoxaban are irreversible, even when traditional medicines, such as protamine sulfate, tranexamic acid, and Vitamin K, are employed.

Interactions

Contraindications have been found when Edoxaban is used concurrently with certain drugs, including but not limited to:

  • Enoxaparin
  • Citalopram
  • Levomilnacipran
  • Dipyrone
  • Tinzaparin
  • Fenoprofen
  • Amtolmetin Guacil
  • Anistreplase
  • Lepirudin
  • Dalteparin
  • Nabumetone
  • Anagrelide
  • Rivaroxaban
  • Felbinac
  • Proquazone
  • Aspirin
  • Fluvoxamine
  • Cilostazol
  • Proglumetacin
  • Desvenlafaxine
  • Danaparoid
  • Nimesulide
  • Duloxetine
  • Warfarin
  • Acenocoumarol
  • Choline Salicylate
  • Orlistat
  • Iloprost
  • Valdecoxib
  • Naproxen
  • Fondaparinux
  • Cangrelor
  • Tolmetin
  • Desirudin
  • Prasugrel
  • Mefenamic Acid
  • Selexipag
  • Etofenamate
  • Droxicam
  • Vortioxetine
  • Flurbiprofen
  • Floctafenine
  • Bemiparin
  • Diclofenac
  • Dabigatran Etexilate
  • Nimesulide Beta Cyclodextrin
  • Apixaban
  • Lornoxicam
  • Ibuprofen
  • Oxaprozin
  • Flufenamic Acid
  • Lumiracoxib
  • Tolfenamic Acid
  • Paroxetine
  • Escitalopram
  • Indomethacin
  • Dexketoprofen
  • Sertraline
  • Tenoxicam
  • Certoparin
  • Pranoprofen
  • Sibutramine
  • Ticlopidine
  • Tenecteplase
  • Bufexamac
  • Epoprostenol
  • Piroxicam
  • Loxoprofen
  • Sulindac
  • Celecoxib
  • Venlafaxine
  • Alteplase, Recombinant
  • Sulfinpyrazone
  • Acemetacin
  • Vilazodone
  • Heparin
  • Ketoprofen
  • Ketorolac
  • Phenindione
  • Fepradinol
  • Clopidogrel
  • Nadroparin
  • Treprostinil
  • Niflumic Acid
  • Parecoxib
  • Piketoprofen
  • Bromfenac
  • Nefazodone
  • Oxyphenbutazone
  • Dexibuprofen
  • Protein C
  • Urokinase
  • Milnacipran
  • Vorapaxar
  • Reteplase, Recombinant
  • Dipyridamole
  • Tiaprofenic Acid
  • Phenylbutazone
  • Reviparin
  • Meloxicam
  • Ardeparin
  • Salsalate
  • Streptokinase
  • Etoricoxib
  • Parnaparin
  • Meclofenamate
  • Fluoxetine
  • Rofecoxib
  • Eptifibatide
  • Defibrotide
  • Sodium Salicylate
  • Morniflumate
  • Salicylic Acid
  • Aceclofenac
  • Argatroban
  • Tirofiban
  • Feprazone
  • Clonixin
  • Abciximab
  • Phenprocoumon
  • Bivalirudin
  • Etodolac
  • Diflunisal
  • Nepafenac
  • Piracetam
  • Rifampin
  • Propyphenazone

If patients need one or more of these medicines, healthcare workers generally adjust the dosage amounts of each drug to reduce the risk of negative side effects.

Based on the listings above, Edoxaban should not be used with the following classes of drugs:

  • Anticoagulants
  • Antiplatelets
  • P-GP inducers
  • P-GP inhibitors
  • Thrombolytics

Caution is generally exercised by healthcare workers when patients have pre-existing illnesses. Edoxaban is not recommended for patients who have or have had:

  • A heart valve disease
  • A synthetic valve
  • A spinal catheter
  • Bleeding disorders
  • Liver or kidney disease
  • Recent surgery

Warnings

An insert label is included with all Edoxaban prescriptions, which includes general precautions.

There are some limitations associated with prescribing Edoxaban in patients with NVAF. This medicine is not recommended for individuals who have NVAF with a creatine clearance of more than 95 ml/min due to the increased risk of ischemia.

Doctors sometimes order new anticoagulant medicines for patients when the previous brand name isn't working or isn't tolerated by the patient. Some examples of popular anticoagulants include:

  • Coumadin
  • Heparin
  • Jantoven
  • Warfarin

Nevertheless, switching anticoagulant medicines involves add-on requirements. Your doctor will give you specific instructions on how to substitute the drugs, and, in due course, reduce the chance of adverse side effects. Patients are advised to follow these guidelines in full and know when to call for emergency medical help, if necessary.

Patients who are taking Edoxaban to reduce blood clots or strokes should plan for follow-up appointments. Assessments are completed during these well-checks to determine if the medicine is working as it should. In most cases, blood and urine tests are performed to get a more accurate measure of Edoxaban's efficiency.

If you have an upcoming surgery or dental procedure prearranged, be sure to tell your healthcare provider that you are taking Edoxaban. Taking this drug within 24 hours of an upcoming procedure increases the risk of bleeding. During medical emergencies where surgical procedures cannot wait, the medical provider will weigh the benefits and risks before proceeding. In most cases, Edoxaban can be resumed after surgery, when a doctor confirms that it is safe to do so.

In most cases, patients are gradually weaned from Edoxaban. Abruptly discontinuing this medicine increases the risk of stroke. As a result, patients should always consult their primary care provider before stopping this medication. If premature discontinuation is necessary, this transition is generally made with another type of anticoagulant, except in cases of rare complications or pathological bleeding.

One of the possible side effects of Edoxaban is bleeding. A few warning signs to pay attention to include:

  • Bleeding from the nose
  • Blood in the stools
  • Bloody urine
  • Easily bruised skin
  • Feeling faint or dizzy
  • A nonstop headache
  • Red spots on the skin
  • Stools that look black or tarry
  • Swollen or painful joints
  • Unexplained lethargy

If any of these symptoms occur, consult your primary care physician right away.

In rare cases, Edoxaban could cause blood clots in the spinal region, which could possibly progress to permanent or irreversible paralysis. This risk is increased in patients who have or take:

  • An epidural catheter
  • Antiplatelet agents
  • Antithrombotic agent
  • Aspirins
  • Blood clotting medicines
  • Fibrinolytic therapy
  • NSAIDs
  • Past incidences of spinal issues
  • Spinal surgery

Some of the warning signs of blood clot developments in the spine include:

  • Bowel incontinence
  • Numbness
  • Pain in the back area
  • Sudden weakness in the muscles
  • Tingling
  • Urinary incontinence

If any of these symptoms occur while using Edoxaban, call 911 immediately.

There are many negative drug interactions listed for Edoxaban. As a result, patients are advised to discuss with their doctor any drugs they are taking before commencing treatment with Edoxaban. This disclosure should include the use of all prescription and non-prescription medicines, such as over the counter herbs, supplements and vitamins.

Data is lacking on how Edoxaban affects pregnant women and developing fetuses. Nevertheless, medical experts know that pregnancy increases the risks of thromboembolism, especially in high-risk patients. The drug should, therefore, be used with caution in this group. If administered, neonates should be consistently monitored for bleeding.

Similarly, during labor and delivery, Edoxaban should be used as a last course of treatment, due to the risk of spinal hematomas. For the safety of patients during labor and delivery, medical specialists typically prescribe an anticoagulant featuring a shorter shelf life.

In lab tests conducted on rats, Edoxaban was shown to be present in lactating mothers' milk, which could lead to hemorrhaging in infants. As a result, Edoxaban use is not recommended for nursing mothers.

Storage

Edoxaban should be stored at a room temperature of 20-25°C (68-77°F). This drug should be kept out of the reach of children.

Any unused portions should be discarded of appropriately. Your pharmacist may recommend returning to the pharmacy via the take-back program to help prevent misuse.

Summary

Edoxaban is intended to decrease the chances of developing a stroke or blood clots due to nonvalvular atrial fibrillation (NVAF) 'a type of abnormal heartbeat. Individuals who are diagnosed with this condition are at a greater risk of developing blood clots in the heart, lungs and brain.

Just one pill of Edoxaban per day, however, reduces the risk of ischemia and blood clots in patients with nonvalvular atrial fibrillation. This medicine is also given to patients who have recently received an injectable blood thinner.

Edoxaban is ultimately a new class of anticoagulant that is preferred as the first line of treatment for blood clots resulting from NVAF. This is mainly due to its fast-acting nature and the benefits of decreased side effects when compared to traditional anticoagulants such as Warfarin or Heparin, for example.

Edoxaban contains no food restrictions, which means that it can be taken with or without food, without exacerbating adverse reactions.

Some of the most common warning associated with Edoxaban is the risk of bleeding or bruising. If these symptoms develop, seek medical help right away. Patients are advised to read the insert label in full and educate themselves on the possible side effects of using Edoxaban to decipher when it's necessary to call 911 for help.

In rare cases, Edoxaban could lead to paralysis. Some of the warning signs of a spinal blood clot include tingling or numb sensations, sudden weakness in the muscles, back pain and incontinence. Should these symptoms occur, seek medical help right away.

This medicine may be prescribed for life. It is important to take the medicine exactly as prescribed and never discontinue use unless you consult with a medical provider. Doing so could increase the risk of getting a stroke.

Also, inform your doctor if you have any upcoming surgery or dental procedure, as Edoxaban increases the risk of bleeding. Moreover, if you are pregnant, nursing, or plan to be, notify your medical provider before using Edoxaban.