rivaroxaban (Rx)

Brand and Other Names:Xarelto
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Dosing & Uses


Dosage Forms & Strengths


  • 2.5mg
  • 10mg
  • 15mg
  • 20mg

Deep Vein Thrombosis Prophylaxis for Hip or Knee Replacement Surgery

Indicated for prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE) in patients undergoing knee or hip replacement surgery

Start 6-10 hours after surgery once hemostasis has been established

Knee replacement: 10 mg PO qDay for 12 days

Hip replacement: 10 mg PO qDay for 35 days

Venous Thromboembolism Prophylaxis and Restricted Mobility

Indicated for prophylaxis of venous thromboembolism (VTE) and VTE related death during hospitalization and at discharge in adults admitted for an acute medical illness who are at risk for thromboembolic complications due to moderate or severe restricted mobility and other risk factors for VTE and not at high risk of bleeding

10 mg PO qDay, in hospital and after hospital discharge, for 31-39 days

Nonvalvular Atrial Fibrillation

To reduce the risk of stroke and systemic embolism

20 mg PO qDay

Deep Vein Thrombosis and/or Pulmonary Embolism Treatment

Indicated for treatment of existing DVT or PE

15 mg PO q12hr for 21 days, THEN 20 mg PO qDay

Reduction in risk of recurrence of DVT or PE

  • Indicated for reduction in risk of recurrence of DVT and/or PE in patients at continued risk for recurrent DVT and/or PE after completion of initial treatment lasting at least 6 months
  • 10 mg PO qDay, after at least 6 months of standard anticoagulant treatment

Reduction of Risk of Major Cardiovascular Events

In combination with aspirin, is indicated to reduce the risk of major cardiovascular events (cardiovascular [CV] death, myocardial infarction [MI] and stroke) in patients with chronic coronary artery disease (CAD) or peripheral artery disease (PAD)

2.5 mg PO BID, plus aspirin (75-100 mg) qDay

Dosage Modifications

Use with P-gp and Strong CYP3A4 inhibitors and inducers

  • Coadministration with combined P-gp and strong CYP3A inhibitors: Avoid use
  • Coadministration with combined P-gp and strong CYP3A inducers: Avoid use

Renal impairment (risk reduction of major cardiovascular events)

  • No dose adjustment needed based on CrCl
  • ESRD, not on dialysis: 2.5 mg BID is expected to give an exposure similar to that in patients with moderate renal impairment, whose efficacy and safety outcomes were similar to those with preserved renal function
  • ESRD on dialysis: No clinical outcome data available for use with aspirin; in patients with ESRD maintained on intermittent hemodialysis, administration of 2.5 mg BID resulted in concentrations and pharmacodynamic activity similar to those observed in moderate renal impaired patients in the COMPASS study

Renal impairment (treatment, risk reduction of recurrent DVT/PE, prophylaxis of DVT, VTE prophylaxis)

  • CrCl ≥30 mL/min: No dosage adjustment necessary
  • CrCl 15 to <30 mL/min: Limited clinical data; closely monitor and promptly evaluate any signs or symptoms of blood loss
  • CrCl <15 mL/min and ESRD on dialysis: No clinical data; avoid use
  • Discontinue in patients who develop acute renal failure during treatment

Renal impairment (nonvalvular AF)

  • CrCl >50 mL/min: No dosage adjustment necessary
  • CrCl 15-50 mL/min: 15 mg PO qDay
  • ESRD on intermittent renal dialysis: 15 mg/day

Hepatic impairment

  • Moderate (Child-Pugh B): AUC increases of 127% were observed; avoid use
  • Severe (Child-Pugh B or C) or with any hepatic disease associated with coagulopathy: Avoid use; no clinical data available

Dosing Considerations

Discontinuation for surgery or other procedures

  • Stop rivaroxaban at least 24 hr before procedure
  • Restart rivaroxaban after surgery/procedure as soon as adequate hemostasis is established
  • If unable to take oral medication following surgical intervention, consider administering a parenteral drug

Switching to rivaroxaban

  • From warfarin to rivaroxaban: Discontinue warfarin and start rivaroxaban as soon as INR <3
  • From anticoagulant other than warfarin (eg, low molecular weight heparin) to rivaroxaban: Start rivaroxaban 0-2 hr prior to next scheduled evening administration and omit administration of the other anticoagulant
  • From unfractionated heparin continuous infusion to rivaroxaban: Stop infusion and start rivaroxaban at the same time

Switching from rivaroxaban

  • From rivaroxaban to warfarin: No clinical data available; INR measurements during coadministration with warfarin may not be useful for determining appropriate dose of warfarin; one approach is to discontinue rivaroxaban and begin both a parenteral anticoagulant and warfarin at time the next scheduled dose of rivaroxaban
  • From rivaroxaban and transitional to rapid-onset anticoagulant: Discontinue rivaroxaban and give first dose of other anticoagulant (PO or parenteral) at the next scheduled rivaroxaban dose

Safety and efficacy not established



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            Adverse Effects


            Hematoma (<3%)

            Back pain (2.9%)

            Wound secretion (2.8%)

            Abdominal pain (2.7%)

            Dizziness (2.2%)

            Pruritus (2.1-2.2%)

            Pain in extremity (1.7%)

            Insomnia (1.6%)

            Anxiety (1.4%)

            Blister (1.4%)

            Fatigue (1.4%)

            Muscle spasm (1.3%)

            Syncope (1.2%)

            Muscle spasm (1.2%)

            Depression (1.2%)

            Major bleeding

            • Atrial fibrillation (6%)
            • DVT prophylaxis (<1%)
            • DVT treatment (1%)
            • VTE prophylaxis (0.7%)

            Postmarketing Reports

            Blood and lymphatic system disorders: Agranulocytosis, thrombocytopenia

            Gastrointestinal disorders: Retroperitoneal hemorrhage

            Hepatobiliary disorders: Jaundice, cholestasis, hepatitis (including hepatocellular injury)

            Immune system disorders: Hypersensitivity, anaphylactic reaction, anaphylactic shock, angioedema

            Nervous system disorders: Cerebral hemorrhage, subdural hematoma, epidural hematoma, hemiparesis

            Skin and SC tissue disorders: Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms (DRESS)



            Black Box Warnings

            Epidural or spinal hematomas

            • May occur in patients who are anticoagulated and are receiving neuraxial anesthesia or undergoing spinal puncture; consider the benefits and risks in anticoagulated patients who are candidates for neuraxial intervention; optimal timing between therapy administration and neuraxial procedures is not known
            • These hematomas may result in long-term or permanent paralysis; consider these risks when scheduling patients for spinal procedures
            • Factors increasing risk: Indwelling epidural catheters, coadministration with other drugs that affect hemostasis, such as non-steroidal anti-inflammatory drugs (NSAIDs), platelet inhibitors, other anticoagulants, history of traumatic or repeated epidural or spinal punctures, history of spinal deformity or spinal surgery
            • Monitor frequently for signs and symptoms of neurologic impairment; if neurologic compromise is noted, urgent treatment is necessary

            Premature discontinuation increases the risk of thrombotic events

            • Premature discontinuation of anticoagulants, including rivaroxaban, places patients at increased risk for thrombotic events
            • If anticoagulation with rivaroxaban must be discontinued for a reason other than pathologic bleeding, consider administering another anticoagulant



            Active pathological bleeding

            Patients who have had transcatheter aortic valve replacement (Tavr)


            Neuraxial anesthesia (see Black Box Warnings)

            Risk for thrombotic events increased with premature discontinuation (see Black Box Warnings)

            Safety and efficacy have not been studied in patients with other prosthetic heart valves or other valve procedures; use not recommended in patients with prosthetic heart valves

            Increases risk of bleeding and can cause serious and fatal bleeding; reports of major hemorrhages, including epidural hematomas, adrenal bleeding, and intracranial, gastrointestinal, and retinal hemorrhages; promptly evaluate S/S of blood loss and consider the need for blood replacement; discontinue with active pathological hemorrhage

            Not for use with the following conditions at increased risk of bleeding in patients requiring primary VTE prophylaxis; history of bronchiectasis, pulmonary cavitation, or pulmonary hemorrhage, active cancer (i.e. undergoing acute, in-hospital cancer treatment), active gastroduodenal ulcer in the three months prior to treatment, history of bleeding in the three months prior to treatment, or dual antiplatelet therapy

            Not recommended acutely as an alternative to unfractionated heparin in patients with PE who present with hemodynamic instability or who may receive thrombolysis or pulmonary embolectomy

            Do not remove an indwelling epidural or intrathecal catheter before at least 2 half-lives have elapsed (ie, 18 hr in patients aged 20-45 years and 26 hr in patients aged 60-76 years), after last administration; do not administer next dose earlier than 6 hr after removal of catheter; if traumatic puncture occurs, delay administration for 24 hr

            Periodically assess renal function as clinically indicated (ie, more frequently in situations in which renal function may decline) and adjust therapy accordingly; consider dose adjustment or discontinuation of therapy in patients who develop acute renal failure while on therapy

            Not recommended for use in patients with a history of thrombosis who are diagnosed with antiphospholipid syndrome (APS); for patients with APS (especially those who are triple positive [positive for lupus anticoagulant, anticardiolipin, and anti-beta 2-glycoprotein I antibodies]), treatment has been associated with an increased rate of recurrent thrombotic events compared with vitamin K antagonist therapy

            Use with caution in pregnant women and only if the potential benefit justifies the potential risk to the mother and fetus (see Pregnancy)

            Reversing anticoagulant effect

            • Use of procoagulant reversal agents, including prothrombin complex concentrate (PCC), activated prothrombin complex concentrate or recombinant factor VIIa, may be considered when reversal of anticoagulation needed because of life-threatening or uncontrolled bleeding
            • Clinical efficacy and safety has not been evaluated
            • Monitoring for anticoagulation effect of rivaroxaban using a clotting test (PT, INR or aPTT) or anti-factor Xa (FXa) activity not recommended

            Drug interaction overview

            • Rivaroxaban is a substrate of CYP3A4/5, CYP2J2, and the P-gp and ATP-binding cassette G2 (ABCG2) transporters
            • Avoid concomitant use of P-gp and strong CYP3A4 inhibitors (eg, ketoconazole, itraconazole, lopinavir/ritonavir, ritonavir, indinavir/ritonavir, conivaptan); may increase risk of bleeding
            • Caution with concomitant use of P-gp and weak or moderate CYP3A4 inhibitors (eg, erythromycin, azithromycin, diltiazem, verapamil, quinidine, ranolazine, dronedarone, amiodarone, felodipine, citalopram, escitalopram, fluoxetine, fluvoxamine, desvenlafaxine, venlafaxine)
            • Avoid concomitant use of P-gp and strong CYP3A4 inducers (eg, carbamazepine, phenytoin, rifampin, St. John’s wort); these drugs may decrease the systemic effects and efficacy of rivaroxaban and may increase risk of thromboembolic events
            • Concomitant use of other drugs that impair hemostasis increases risk of bleeding; these include aspirin, P2Y12 platelet inhibitors, other antithrombotic agents, fibrinolytic therapy, non-steroidal anti-inflammatory drugs (NSAIDs), selective serotonin reuptake inhibitors, and serotonin norepinephrine reuptake inhibitors
            • Clopidogrel: Avoid concomitant use unless the benefit outweighs the bleeding risk; change in bleeding time was found to be approximately twice the maximum increase seen with either drug alone

            Pregnancy & Lactation


            Limited available data in pregnant women are insufficient to inform a drug-associated risk of adverse developmental outcomes

            Use with caution in pregnant patients because of the potential for pregnancy related hemorrhage and/or emergent delivery; anticoagulant effect cannot be reliably monitored with standard laboratory testing

            Consider benefits and risks for the mother and possible risks to the fetus when prescribing to a pregnant woman

            Clinical considerations

            • Pregnancy is a risk factor for VTE and risk increases in women with inherited or acquired thrombophilias; pregnant women with thromboembolic disease have an increased risk of maternal complications (eg, pre-eclampsia); maternal thromboembolic disease increases the risk for intrauterine growth restriction, placental abruption, and early and late pregnancy loss
            • Based on pharmacologic activity of Factor Xa inhibitors and the potential to cross the placenta, bleeding may occur at any site in the fetus and/or neonate
            • All patients receiving anticoagulants, including pregnant women, are at risk for bleeding and this risk may be increased during labor or delivery; risk of bleeding should be balanced with the risk of thrombotic events when considering the use in this setting

            Reproductive potential

            • Females of reproductive potential requiring anticoagulation should discuss pregnancy planning
            • The risk of clinically significant uterine bleeding, potentially requiring gynecological surgical interventions, identified with oral anticoagulants should be assessed in females of reproductive potential and those with abnormal uterine bleeding


            Drug detected in human milk

            Insufficient data available to determine effects on breastfed child or on milk production; drug and/or its metabolites were present in milk of rats

            Consider developmental and health benefits of breastfeeding along with mother’s clinical need for therapy and any potential adverse effects on breastfed infant from therapy or from underlying maternal condition

            Pregnancy Categories

            A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA: Information not available.



            Mechanism of Action

            Factor Xa inhibitor that inhibits platelet activation by selectively blocking the active site of factor Xa without requiring a cofactor (eg, antithrombin III) for activity

            Blood coagulation cascade is dependent on the activation of factor X to factor Xa via the intrinsic and extrinsic pathways, which play a central role in the blood coagulation cascade

            Dose-dependent inhibition of factor Xa activity observed; antifactor Xa activity is also influenced by rivaroxaban; prolongs PT and aPTT and HepTest


            Bioavailability: 80-100%

            Peak plasma time: 2-4 hr

            AUC: 29-56% decrease when released in proximal small intestine compared with gastric absorption


            Protein bound: 92-95% (mainly albumin)

            Vd: 50 L


            Metabolized by oxidative degradation catalyzed by CYP3A4/5 and CYP2J2; also metabolized by hydrolysis

            Unchanged rivaroxaban is the predominant moiety in plasma with no major or active circulating metabolites (50% higher in patients of Japanese descent)

            Substrate of P-gp and ABCG2 (Bcrp) efflux transporter proteins


            Half-life: 5-9 hr; 11-13 hr (elderly)

            Total body clearance: 10 L/hr (following IV administration)

            Excretion: feces (21% as metabolites; 28% unchanged), urine (30% as metabolites; 36% unchanged)



            Oral Administration

            2.5 mg or 10 mg tablets: May take with or without food (bioavailability not significantly affected in fasted state)

            15 mg or 20 mg tablets: Take with food (bioavailability improves when taken with food)

            Patients unable to swallow whole tablets

            • Crush tablets and mix with applesauce immediately before use
            • Crushed 2.5-mg or 10-mg tablet: May take with or without food
            • Crushed 15-mg or 20-mg tablet: Administer dose immediately followed with food

            Feeding tube administration

            • Crush tablets and suspend in 50 mL of water and administered via NG or gastric feeding tube
            • Absorption dependent on site of drug release in the gastrointestinal tract (gastric vs small intestine); avoid administrating distal to the stomach which can result in reduced absorption and thereby, reduced drug exposure
            • When administering as a crushed tablet via a feeding tube, confirm gastric placement of tube
            • After administration of a crushed 15-mg or 20-mg tablet, dose should be immediately followed by enteral feeding

            Missed dose

            • 2.5 mg PO BID: If a dose is missed, take a single 2.5-mg dose as recommended at the next scheduled time
            • 15 mg PO BID: Take immediately to ensure intake of 30 mg/day; in this instance, two 15-mg tablets may be taken at once; continue with regular 15 mg q12hr on the following day
            • If taking 10, 15, or 20 mg PO qDay: Take missed dose immediately; do not double dose within the same day to make up for a missed dose


            Tablets: Store at room temperature, 25ºC (77ºF); excursions permitted to 15-30ºC (59-86ºF)

            Crushed tablets in water or applesauce: Store at room temperature, 25ºC (77ºF) for up to 4 hr





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            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.