Edoxaban

Class and Category

Pharmacologic Class: Factor Xa inhibitor
Therapeutic ClassAnticoagulant

Indications and Dosages

To reduce the risk of stroke and systemic embolism in nonvalvular atrial fibrillation
TABLETS
Adults: 
60 mg once daily.
DOSAGE ADJUSTMENT For patients with impaired renal failure (creatinine clearance between 15 and 50 ml/min), the dosage is reduced to 30 mg once daily.

To treat deep vein thrombosis and pulmonary embolism
TABLETS
Adults: 
60 mg once daily following 5 to 10 days of initial therapy with a parenteral anticoagulant.
DOSAGE ADJUSTMENT For patients with impaired renal failure (creatinine clearance between 15 and 50 ml/min), patients who weigh less than or equal to 60 kg (132 lb), or patients who are taking selected concomitant P-gp inhibitors (quinidine, verapamil, or short-term concomitant administration of azithromycin, clarithromycin, erythromycin, oral itraconazole or oral ketoconazole), dosage reduced to 30 mg once daily.

Mechanism of Action
Inhibits free FXa and prothrombinase activity and inhibits thrombin-induced platelet aggregation. By inhibiting FXa in the coagulation cascade, thrombin generation and formation are reduced.

Contraindications
Active pathological bleeding, hypersensitivity to edoxaban or its components.

Interactions
DRUGS
Anticoagulants, Antiplatelets, Aspirin or Aspirin-containing products, NSAIDs (long-term use), selective serotonin reuptake inhibitors, serotonin-norepinephrine reuptake inhibitors, thrombolytics: Increased risk of bleeding
Rifampin: Decreased effectiveness of edoxaban
Quinidine, Verapamil, or short-term concomitant administration of azithromycin, clarithromycin, erythromycin, oral itraconazole or oral ketoconazole: Increased blood level with increased risk of bleeding in patients being treated for deep venous thrombosis or pulmonary embolism

Adverse Reactions
CNS: Intracranial bleeding
EENT: Epistaxis, intraocular bleeding
GI: Elevated liver enzymes, GI bleeding
GU: Hematuria, vaginal bleeding
HEME: Anemia, bleeding, thrombocytopenia
RESP: Interstitial lung disease
SKIN: Rash, urticaria
Other: Angioedema, hypersensitivity reactions

Childbearing Considerations
PREGNANCY
  • Drugs may cause fetal harm because the use of drugs may increase the risk of bleeding in the fetus and neonate.
  • Use with caution only if the benefit to the mother outweighs the potential risk to a fetus.
    LACTATION
    • It is not known if the drug is present in breast milk.
    • Breastfeeding is not recommended during drug therapy.

    Nursing Considerations
    • Know that edoxaban should not be administered to a patient who has a creatinine clearance greater than 95 ml/min because of an increased risk of ischemic stroke.
    • Keep in mind that edoxaban is not recommended for use in patients with a mechanical heart valve or who have moderate to severe mitral stenosis because the effects of edoxaban in these patients are unknown.
    • Know that for a patient unable to swallow tablets, a tablet should be crushed and mixed with 2 to 3 ounces of water and immediately administered by mouth or through a gastric tube. The crushed tablet can also be mixed with applesauce and immediately given by mouth.
    • Be aware that edoxaban should be withheld for at least 24 hours before invasive or surgical procedures are performed to reduce the risk of bleeding. If it is not possible to delay the procedure, monitor the patient closely for bleeding. If edoxaban was withheld, know that it may be restarted after the invasive or surgical procedure as soon as the patient has achieved adequate hemostasis. Be prepared to administer a parenteral anticoagulant if oral medication cannot be initially taken and then when oral medication can be taken, the patient may be switched to edoxaban.
    • Know that when a patient is being transitioned to edoxaban from warfarin or other vitamins K antagonists, warfarin should be discontinued and edoxaban started when the INR is 2.5 or less; transitioned from oral anticoagulants other than warfarin or other vitamin K antagonists, the current oral anticoagulant should be discontinued and edoxaban started at the time of the next scheduled dose of the other oral anticoagulant; transitioned from low-molecular-weight heparin, the low-molecular-weight heparin should be discontinued and edoxaban started at the time of the next scheduled administration of the low-molecular-weight heparin, or transitioned from unfractionated heparin, the unfractionated heparin infusion should be discontinued and edoxaban started 4 hours later.
    • Be aware that when a patient is being transitioned from edoxaban (60 mg dose) to warfarin, the dose of edoxaban should be reduced to 30 mg, and warfarin began concomitantly. When a patient is being transitioned from edoxaban (30 mg dose) to warfarin, the dose of edoxaban should be reduced to 15mg and warfarin began concomitantly. When a stable INR of 2 or greater is achieved in either situation, edoxaban should be discontinued. Know that a second method of transitioning a patient from edoxaban to warfarin may be used. In this method, edoxaban should be discontinued and a parenteral anticoagulant and warfarin administered, as ordered, at the same time as the next scheduled edoxaban dose. Once a stable INR of 2 or greater is achieved, the parenteral anticoagulant should be discontinued and warfarin therapy continued. Be aware that when a patient is being transitioned from edoxaban to a non-vitamin K-dependent oral anticoagulant, edoxaban should be discontinued and the other oral anticoagulant started at the time of the next dose of edoxaban. Know that when a patient is being transitioned from edoxaban to a parenteral anticoagulant, edoxaban should be discontinued and the parenteral anticoagulant should be started at the time of the next dose of edoxaban.
    WARNING: Monitor patients receiving edoxaban and epidural or spinal anesthesia or spinal puncture because spinal hematomas can occur, causing long-term or permanent paralysis. Watch for evidence of neurologic impairment, such as changes in motor or sensory function. If present, notify the prescriber immediately; the patient needs urgent care to minimize the effect of hematoma. Use of indwelling epidural catheters; concurrent use of other drugs that affect hemostasis such as nonsteroidal anti-inflammatory drugs, platelet inhibitors, and other anticoagulants; a history of traumatic or repeated epidural or spinal punctures; or a history of spinal deformity or spinal surgery increases the risk of epidural or spinal hematoma in patients receiving edoxaban.
    • Expect to receive another anticoagulant, as ordered, if edoxaban must be discontinued for reasons other than the presence of active bleeding or therapy is no longer needed. This is because premature discontinuation of edoxaban increases the risk of ischemic events.
    • Monitor the patient closely for bleeding. If present, notify the prescriber immediately because there is no antidote to reverse the anticoagulation effects of edoxaban, which may last for up to 24 hours after the last dose. Know that patients who take other drugs that affect hemostasis, such as aspirin and other antiplatelet agents, chronic use of nonsteroidal anti-inflammatory drugs, fibrinolytic therapy, or other antithrombotic drugs, are at increased risk for bleeding.
    • Know that the use of anticoagulants, including edoxaban, may increase the risk of bleeding in the fetus and neonate. Monitor neonate for bleeding if mother was taking edoxaban prior to birth.

    PATIENT TEACHING
    • Tell the patient that if she misses a dose of edoxaban, she should take the dose as soon as possible on the same day and resume the dosing for the next day at the normal time. However, if she forgets the dose until the next day, she should not double the dose to make up for the missed dose.
    • Inform patient unable to swallow tablets that edoxaban may be crushed and mixed with 2 to 3 ounces of water or mixed in applesauce and immediately taken by mouth.
    • Instruct patient on bleeding precautions. If bleeding occurs, tell her to report any unusual bleeding immediately to the prescriber.
    • Caution patient not to stop taking edoxaban without talking to her prescriber first.
    • Tell the patient to alert all healthcare providers and dentists that she is taking edoxaban and to consult the prescriber before taking any new drugs, including OTC drugs.
    • Stress is important for females of child-bearing age to notify the prescriber if pregnancy occurs or is suspected. This is because anticoagulants, including edoxaban, may increase the risk of bleeding in the fetus and neonate. Tell mother who took edoxaban during late pregnancy to watch neonate for bleeding.
    • Advise mothers that breastfeeding is not recommended during edoxaban therapy because of the potential risk of serious adverse reactions.
    WARNING Alert patient who is having neuraxial anesthesia or spinal puncture to immediately report signs and symptoms suggestive of epidural or spinal hematomas such as back pain, muscle weakness, numbness (especially in the lower limbs), stool or urine incontinence, and tingling.

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