Agent can cause major or fatal bleeding; Regular INR monitoring is necessary; drugs, dietary changes, and other factors affect INR levels (FDA)
Discontinuation in patients without adequate continuous anticoagulation increases the risk of stroke (FDA)
None to date
Discontinuing places patients at an increased risk of thrombotic events; Risk of spinal/epidural hematoma during neuraxial anesthesia/spinal puncture (FDA)
Variable, patient specific
Fixed, twice daily With dose reduction in two of the following patients: (per FDA) (1) Age ≥ 80 years (2) Weight ≤ 60 kg (3) Serum creatinine ≥1.5 mg/dL
Fixed, twice daily With dose reduction in patients with renal dysfunction (per FDA)
VTE prevention and nonvalvular AF: Fixed, once daily With dose reduction in patients with renal dysfunction (per FDA) VTE treatment: Fixed, twice daily 3 weeks then fixed, once daily Not to be used if ClCr <30 mL/min
36% unchanged drug* 33% as inactive metabolites Mostly via secretion not glomerular filtration
>90% (S-enantiomer is a substrate for 2C9 and 2C19 while R-enantiomer is a substrate for 1A1, 1A2, and 3A4 )
15% (primary substrate for CYP3A4; minor contributions by others, without active metabolites)
30% (substrate for CYP3A4, CYP2J2)
Dietary vitamin K
VTE prevention dose: does not specify AFIB: Take with evening meal VTE treatment: Take with food
Influence on routine coagulation assay
Thrombin time (TT)
Coagulation assay used to monitor efficacy
Clinically validated Reversal agent
Vitamin K, FFP, PCC, Factor VIIa, aPCC
EMA: European Medicines Agency; HC: Health Canada; FDA: U.S. Food and Drug Administration AF: Atrial Fibrillation; CYP: cytochrome P450; VKORC1: C1 subunit of the vitamin K epoxide reductase enzyme; FFP: Fresh Frozen Plasma; PCC: Prothrombin Complex Concentrate. ∧Does not bind to antithrombin.
#Rivaroxaban 15 mg tablet, if available, should be taken with food.
*Dose adjustment for level of renal dysfunction required.
+Potential source for drug-drug interactions—review full package insert for details.
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