edoxaban (e-dox-a-ban) Lixiana, Savaysa

 Indications

Reduction of stroke/systemic embolization (SE) risk associated

with nonvalvular atrial fibrillation (NVAF).

Action

Selective inhibitor of factor Xa. Does not inhibit platelet

aggregation directly, but does inhibit thrombin-induced

platelet aggregation. Decreases thrombin generation

and thrombus development. Therapeutic Effects:

Decreased thrombotic events associated with atrial fibrillation

including stroke and systemic embolization.

Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) after 5–10 days of parenteral anticoagulant.

Pharmacokinetics

Absorption: 62% absorbed following oral administration.

Distribution: Unknown.

Metabolism and Excretion: Minimal metabolism,

one metabolite is pharmacologically active. Excreted

mostly unchanged in urine.

Half-life: 10–14 hr.

TIME/ACTION PROFILE (anticoagulant effect)

ROUTE ONSET PEAK DURATION

PO unknown 1–2 hr 24 hr

Contraindications/Precautions

Contraindicated in: Active bleeding; CCr 95 mL/

min (peffectiveness); Concurrent use of other anticoagulants

or rifampin; Presence of mechanical heart

valves or severe mitral stenosis; Moderate to severe hepatic

impairment; Lactation: Discontinue edoxaban or

discontinue breast feeding.

Use Cautiously in: Elective/planned invasive/surgical

procedures (discontinue at least 24 hr prior top

risk of bleeding); Premature discontinuation (qrisk of

ischemic events); Neuroaxial anesthesia/spinal puncture

(qrisk of spinal/epidural hematoma and potential

paralysis); Renal impairment (dose reduction required

for CCr 15–50 mL/min); Deteriorating or improving

renal function (may require dose change); Body weight

60 kg (requires lower dose); OB: Use during pregnancy

only if potential benefit outweighs potential risk

to fetus; Pedi: Safe and effective use in children has not

been established.

Adverse Reactions/Side Effects

GI: abnormal liver function tests. Hemat: BLEEDING,

anemia.

Interactions

Drug-Drug:qrisk of bleeding with other anticoagulants,

aspirin, clopidogrel, ticagrelor, prasugrel,

fibrinolytics, NSAIDs, SNRIs, or SSRIs. Rifampin

maypblood levels and effectiveness and is

contraindicated. Concurrent use of P-gp inhibitors

including azithromycin, clarithromcyin, erythromycin,

itraconazole (oral), ketoconazole oral),

quinidine, or verapamilqblood levels and the risk

of bleeding (lower dose required).

Route/Dosage

Treatment of NVAF

PO (Adults): 60 mg once daily.

Renal Impairment

PO (Adults): CCr 15–50 mL/min—30 mg once

daily.

Treatment of DVT/PE

PO (Adults 60 kg): 60 mg once daily.

PO (Adults 60 kg or certain concurrent P-gp inhibitors):

30 mg once daily.

Renal Impairment

PO (Adults CCr 15–50 mL/min): 30 mg once daily.

Availability

Tablets: 15 mg, 30 mg, 60 mg.