rivaroxaban (Rx)

Brand and Other Names:Xarelto
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

tablet

  • 2.5mg
  • 10mg
  • 15mg
  • 20mg

Stroke Prophylaxis With Atrial Fibrillation

Indicated to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation

20 mg PO qDay with evening meal

Limited data on efficacy of rivaroxaban and warfarin in reducing the risk of stroke and systemic embolism when warfarin therapy is well-controlled

Renal impairment (atrial fibrillation)

  • CrCl >50 mL/min: No dosage adjustment required
  • CrCl <50 mL/min: Reduce dose to 15 mg PO qDay
  • AHA/ACC/HRS renal impairment recommendation
    • CrCl <15 mL/min or dialysis: Insufficient data; not recommended

AHA/ACC/HRS guidelines for atrial fibrillation

  • Class 1: For patients with AF or atrial flutter <48-hour duration and with high risk of stroke, IV heparin or LMWH, or administration of a factor Xa or direct thrombin inhibitor, is recommended as soon as possible before or immediately after cardioversion, followed by long-term anticoagulation therapy
  • Class IIa: For patients with AF or atrial flutter of ≥48-hr, or when the duration of AF is unknown, anticoagulation with warfarin (INR 2-3), a factor Xa inhibitor, or direct thrombin inhibitor is recommended for at least 3 weeks prior to and 4 weeks after cardioversion
  • Class IIb: For patients with AF or atrial flutter <48-hour duration who are at low thromboembolic risk, anticoagulation (IV heparin, LMWH, or a new oral anticoagulant) or no antithrombotic therapy may be considered for cardioversion, without the need for postcardioversion oral anticoagulation
  • For patients with nonvalvular AF unable to maintain a therapeutic INR level with warfarin, use of a direct thrombin or factor Xa inhibitor
  • Not recommended in patients with AF and end-stage CKD or on hemodialysis because of the lack of evidence from clinical trials regarding the balance of risks and benefits; warfarin or apixaban recommended
  • Circulation July 9, 2019

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 hr after surgery once hemostasis has been established

CrCl ≥15 mL/min: Knee replacement: 10 mg PO qDay for 12 days

CrCl ≥15 mL/min: Hip replacement: 10 mg PO qDay for 35 days

CrCl <15 mL/min: Avoid use

Venous Thromboembolism Prophylaxis for Restricted Mobility

Indicated for prophylaxis of venous thromboembolism (VTE) and VTE-related death during hospitalization and at discharge in acutely ill patients who are admitted and 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

CrCl ≥15 mL/min: 10 mg PO qDay, in hospital and after hospital discharge, for 31-39 days

CrCl <15 mL/min: Avoid use

DVT and/or PE Treatment

Indicated for treatment of existing DVT or PE

CrCl ≥15 mL/min: 15 mg PO q12hr for 21 days, THEN 20 mg PO qDay

CrCl <15 mL/min: Avoid use

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

CrCl ≥15 mL/min: 10 mg PO qDay, after at least 6 months of standard anticoagulant treatment

CrCl <15 mL/min: Avoid use

Risk Reduction of Major Cardiovascular Events

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

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

Renal considerations: No dose adjustment needed based on CrCl

Risk Reduction of Major Thrombotic Vascular Events

Indicated, in combination with aspirin, to reduce the risk of major thrombotic vascular events (MI, ischemic stroke, acute limb ischemia, and major amputation of a vascular etiology) in patients with peripheral artery disease (PAD), including those who have recently undergone a lower extremity revascularization procedure due to symptomatic PAD

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

Initiate once hemostasis has been established when starting therapy after successful lower extremity revascularization procedure

Renal considerations: No dose adjustment needed based on CrCl

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

  • See specific indications regarding necessary dosage modifications for renal impairment

Hepatic impairment

  • Moderate (Child-Pugh B): Avoid use; AUC increases of 127% were observed
  • Severe (Child-Pugh 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

Next:

Interactions

Interaction Checker

and rivaroxaban

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            Contraindicated (6)

            • betrixaban

              rivaroxaban, betrixaban. Either increases levels of the other by anticoagulation. Contraindicated. Therapeutic duplication; may use temporarily when switching anticoagulants.

            • defibrotide

              defibrotide increases effects of rivaroxaban by pharmacodynamic synergism. Contraindicated. Coadministration of defibrotide is contraindicated with antithrombotic/fibrinolytic drugs. This does not include use for routine maintenance or reopening of central venous lines.

            • mifepristone

              mifepristone increases toxicity of rivaroxaban by anticoagulation. Contraindicated.

            • omacetaxine

              omacetaxine increases toxicity of rivaroxaban by anticoagulation. Contraindicated.

            • prothrombin complex concentrate, human

              rivaroxaban, prothrombin complex concentrate, human. pharmacodynamic antagonism. Contraindicated.

            • vorapaxar

              vorapaxar increases toxicity of rivaroxaban by anticoagulation. Contraindicated.

            Serious - Use Alternative (24)

            • abametapir

              abametapir will increase the level or effect of rivaroxaban by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. For 2 weeks after abametapir application, avoid taking drugs that are CYP3A4 substrates. If not feasible, avoid use of abametapir.

            • apalutamide

              apalutamide will decrease the level or effect of rivaroxaban by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Coadministration of apalutamide, a strong CYP3A4 inducer, with drugs that are CYP3A4 substrates can result in lower exposure to these medications. Avoid or substitute another drug for these medications when possible. Evaluate for loss of therapeutic effect if medication must be coadministered. Adjust dose according to prescribing information if needed.

            • apixaban

              rivaroxaban and apixaban both increase anticoagulation. Avoid or Use Alternate Drug.

            • clarithromycin

              clarithromycin increases levels of rivaroxaban by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid concomitant use of rivaroxaban and combined Pgp and strong CYP3A4 inhibitors. Combination may lead to significant increases in rivaroxaban levels and increase bleeding risk; however, according to the manufacturer, although clarithromycin is a combined P-gp and strong CYP3A4 inhibitor, pharmacokinetic data suggests that no precautions are necessary with concomitant administration with rivaroxaban in patients with normal renal function as the change in exposure is unlikely to affect the bleeding risk; however, combination is to be avoided in patients with mild or moderately impaired renal function (CrCl 15-80 mL/min) .

            • cobicistat

              cobicistat will increase the level or effect of rivaroxaban by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid coadministration of cobicistat with rivaroxaban; may result in increased exposure of rivaroxaban and increased risk of bleeding

            • conivaptan

              conivaptan increases levels of rivaroxaban by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid concomitant use of rivaroxaban and combined Pgp and strong CYP3A4 inhibitors. Combination may lead to significant increases in rivaroxaban levels and increase bleeding risk.

            • dabrafenib

              dabrafenib will decrease the level or effect of rivaroxaban by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

            • edoxaban

              edoxaban, rivaroxaban. Either increases toxicity of the other by anticoagulation. Avoid or Use Alternate Drug. Both drugs have the potential to cause bleeding, monitor closely. Promptly evaluate any signs or symptoms of blood loss. Long-term concomitant treatment with edoxaban and other anticoagulants is not recommended. Short-term coadministration may be needed for patients transitioning to or from edoxaban.

            • enzalutamide

              enzalutamide will decrease the level or effect of rivaroxaban by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Contraindicated.

            • Factor X, human

              rivaroxaban will decrease the level or effect of Factor X, human by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Based on the mechanism of action, Factor X is likely to be counteracted by direct and indirect Factor Xa inhibitors.

            • fexinidazole

              fexinidazole will increase the level or effect of rivaroxaban by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Fexinidazole inhibits CYP3A4. Coadministration may increase risk for adverse effects of CYP3A4 substrates.

            • fondaparinux

              rivaroxaban, fondaparinux. Either increases effects of the other by anticoagulation. Contraindicated. Avoid concurrent use of rivaroxaban with other anticoagulants due to increased bleeding risk other than during therapeutic transition periods where patients should be observed closely. Monitor for signs/symptoms of blood loss.

            • fosphenytoin

              fosphenytoin will decrease the level or effect of rivaroxaban by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

            • idelalisib

              idelalisib will increase the level or effect of rivaroxaban by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Idelalisib is a strong CYP3A inhibitor; avoid coadministration with sensitive CYP3A substrates

            • indinavir

              indinavir increases levels of rivaroxaban by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid concomitant use of rivaroxaban and combined Pgp and strong CYP3A4 inhibitors. Combination may lead to significant increases in rivaroxaban levels and increase bleeding risk.

            • ivosidenib

              ivosidenib will decrease the level or effect of rivaroxaban by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid coadministration of sensitive CYP3A4 substrates with ivosidenib or replace with alternative therapies. If coadministration is unavoidable, monitor patients for loss of therapeutic effect of these drugs.

            • ketoconazole

              ketoconazole increases levels of rivaroxaban by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid concomitant use of rivaroxaban and combined Pgp and strong CYP3A4 inhibitors. Combination may lead to significant increases in rivaroxaban levels and increase bleeding risk.

            • lonafarnib

              lonafarnib will increase the level or effect of rivaroxaban by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid coadministration with sensitive CYP3A substrates. If coadministration unavoidable, monitor for adverse reactions and reduce CYP3A substrate dose in accordance with product labeling.

            • phenobarbital

              phenobarbital will decrease the level or effect of rivaroxaban by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Contraindicated.

            • posaconazole

              posaconazole will increase the level or effect of rivaroxaban by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

            • primidone

              primidone will decrease the level or effect of rivaroxaban by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Contraindicated.

            • ritonavir

              ritonavir increases levels of rivaroxaban by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid concomitant use of rivaroxaban and combined Pgp and strong CYP3A4 inhibitors. Combination may lead to significant increases in rivaroxaban levels and increase bleeding risk.

            • tucatinib

              tucatinib will increase the level or effect of rivaroxaban by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid concomitant use of tucatinib with CYP3A substrates, where minimal concentration changes may lead to serious or life-threatening toxicities. If unavoidable, reduce CYP3A substrate dose according to product labeling.

            • voxelotor

              voxelotor will increase the level or effect of rivaroxaban by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Voxelotor increases systemic exposure of sensitive CYP3A4 substrates. Avoid coadministration with sensitive CYP3A4 substrates with a narrow therapeutic index. Consider dose reduction of the sensitive CYP3A4 substrate(s) if unable to avoid.

            Monitor Closely (118)

            • abciximab

              rivaroxaban, abciximab. Either increases effects of the other by anticoagulation. Use Caution/Monitor. Avoid concurrent use of rivaroxaban with other anticoagulants due to increased bleeding risk other than during therapeutic transition periods where patients should be observed closely. Monitor for signs/symptoms of blood loss.

            • acalabrutinib

              acalabrutinib increases effects of rivaroxaban by anticoagulation. Use Caution/Monitor. Coadministration of acalabrutinib with antiplatelets or anticoagulants may further increase risk of hemorrhage. Monitor for signs of bleeding and consider the benefit-risk of withholding acalabrutinib for 3-7 days presurgery and postsurgery depending upon the type of surgery and the risk of bleeding.

            • alteplase

              rivaroxaban, alteplase. Either increases effects of the other by anticoagulation. Use Caution/Monitor. Avoid concurrent use of rivaroxaban with other anticoagulants due to increased bleeding risk other than during therapeutic transition periods where patients should be observed closely. Monitor for signs/symptoms of blood loss.

            • amiodarone

              amiodarone increases levels of rivaroxaban by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Patients with renal impairment receiving rivaroxaban with drugs that are combined P-gp and weak or moderate CYP3A4 inhibitors may have significant increases in exposure compared with patients with normal renal function and no inhibitor use, since both pathways of rivaroxaban elimination are affected. Since these increases may increase bleeding risk, use rivaroxaban in this situation only if the potential benefit justifies the potential risk.

            • anagrelide

              rivaroxaban, anagrelide. Either increases effects of the other by anticoagulation. Use Caution/Monitor. Avoid concurrent use of rivaroxaban with other anticoagulants due to increased bleeding risk other than during therapeutic transition periods where patients should be observed closely. Monitor for signs/symptoms of blood loss.

            • antithrombin alfa

              rivaroxaban, antithrombin alfa. Either increases effects of the other by anticoagulation. Use Caution/Monitor. Avoid concurrent use of rivaroxaban with other anticoagulants due to increased bleeding risk other than during therapeutic transition periods where patients should be observed closely. Monitor for signs/symptoms of blood loss.

            • antithrombin III

              rivaroxaban, antithrombin III. Either increases effects of the other by anticoagulation. Use Caution/Monitor. Avoid concurrent use of rivaroxaban with other anticoagulants due to increased bleeding risk other than during therapeutic transition periods where patients should be observed closely. Monitor for signs/symptoms of blood loss.

            • argatroban

              rivaroxaban, argatroban. Either increases effects of the other by anticoagulation. Use Caution/Monitor. Avoid concurrent use of rivaroxaban with other anticoagulants due to increased bleeding risk other than during therapeutic transition periods where patients should be observed closely. Monitor for signs/symptoms of blood loss.

            • aspirin

              aspirin, rivaroxaban. Either increases toxicity of the other by anticoagulation. Use Caution/Monitor. Both drugs have the potential to cause bleeding. The need for simultaneous use of low-dose aspirin (<100 mg/day) with anticoagulants are common for patients with cardiovascular disease, but may result in increased bleeding; monitor closely. Promptly evaluate any signs or symptoms of blood loss if treated concomitantly with low-dose aspirin. Avoid coadministration with chronic use of higher dose aspirin.

            • aspirin/citric acid/sodium bicarbonate

              aspirin/citric acid/sodium bicarbonate, rivaroxaban. Either increases toxicity of the other by anticoagulation. Use Caution/Monitor. The need for simultaneous use of low-dose aspirin and anticoagulant or antiplatelet agents are common for patients with cardiovascular disease; monitor closely.

              rivaroxaban, aspirin/citric acid/sodium bicarbonate. Other (see comment). Use Caution/Monitor. Comment: Aspirin are known to increase bleeding. Bleeding risk may be increased when aspirin is used concomitantly with rivaroxaban. Monitor for signs/symptoms of blood loss.

            • atazanavir

              atazanavir will increase the level or effect of rivaroxaban by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • azficel-T

              azficel-T, rivaroxaban. Other (see comment). Use Caution/Monitor. Comment: Coadministration with anticoagulants or antiplatelets may increase bruising or bleeding at biopsy and/or injection sites; concomitant use not recommended. Decisions regarding continued use or cessation of anticoagulants or antiplatelets should be made by a physician.

            • azithromycin

              azithromycin increases levels of rivaroxaban by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Patients with renal impairment receiving rivaroxaban with drugs that are combined P-gp and weak or moderate CYP3A4 inhibitors may have significant increases in exposure compared with patients with normal renal function and no inhibitor use, since both pathways of rivaroxaban elimination are affected. Since these increases may increase bleeding risk, use rivaroxaban in this situation only if the potential benefit justifies the potential risk.

            • bivalirudin

              rivaroxaban, bivalirudin. Either increases effects of the other by anticoagulation. Use Caution/Monitor. Avoid concurrent use of rivaroxaban with other anticoagulants due to increased bleeding risk other than during therapeutic transition periods where patients should be observed closely. Monitor for signs/symptoms of blood loss.

            • bosentan

              bosentan will decrease the level or effect of rivaroxaban by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • caplacizumab

              caplacizumab, rivaroxaban. Either increases effects of the other by anticoagulation. Use Caution/Monitor.

            • carbamazepine

              carbamazepine decreases levels of rivaroxaban by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Avoid concomitant use of rivaroxaban with drugs that are combined P-gp and strong CYP3A4 inducers. Consider increasing the rivaroxaban dose if these drugs must be coadministered.

            • celecoxib

              rivaroxaban, celecoxib. Other (see comment). Use Caution/Monitor. Comment: NSAIDs are known to increase bleeding. Bleeding risk may be increased when NSAIDs are used concomitantly with rivaroxaban. Monitor for signs/symptoms of blood loss.

            • cenobamate

              cenobamate will decrease the level or effect of rivaroxaban by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Increase dose of CYP3A4 substrate, as needed, when coadministered with cenobamate.

            • chloramphenicol

              chloramphenicol will increase the level or effect of rivaroxaban by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • cilostazol

              rivaroxaban, cilostazol. Either increases effects of the other by anticoagulation. Use Caution/Monitor. Avoid concurrent use of rivaroxaban with other anticoagulants due to increased bleeding risk other than during therapeutic transition periods where patients should be observed closely. Monitor for signs/symptoms of blood loss.

            • citalopram

              citalopram increases effects of rivaroxaban by pharmacodynamic synergism. Use Caution/Monitor. Combination may increase risk of bleeding.

            • clopidogrel

              rivaroxaban, clopidogrel. Other (see comment). Use Caution/Monitor. Comment: Avoid concurrent administration of clopidogrel with rivaroxaban unless the benefit outweighs the risk of increased bleeding. .

            • collagenase clostridium histolyticum

              rivaroxaban increases toxicity of collagenase clostridium histolyticum by anticoagulation. Use Caution/Monitor. Collagenase clostridium histolyticum has high incidence of ecchymosis/contusion at injection site; avoid concomitant anticoagulants (except for low-dose aspirin, ie, up to 150 mg/day).

            • crizotinib

              crizotinib increases levels of rivaroxaban by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

            • cyclosporine

              cyclosporine increases levels of rivaroxaban by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Cyclosporine, a moderate dual inhibitors of CYP3A4 and P-gp may increase the plasma concentrations of rivaroxaban, a P-gp and CYP3A4 substrate. This interaction is clinically significant in patients with with renal impairment based on simulated pharmacokinetic data.

            • dabigatran

              rivaroxaban, dabigatran. Either increases effects of the other by anticoagulation. Use Caution/Monitor. Avoid concurrent use of rivaroxaban with other anticoagulants due to increased bleeding risk other than during therapeutic transition periods where patients should be observed closely. Monitor for signs/symptoms of blood loss.

            • dalteparin

              rivaroxaban, dalteparin. Either increases effects of the other by anticoagulation. Use Caution/Monitor. Avoid concurrent use of rivaroxaban with other anticoagulants due to increased bleeding risk other than during therapeutic transition periods where patients should be observed closely. Monitor for signs/symptoms of blood loss.

            • darunavir

              darunavir increases levels of rivaroxaban by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Avoid concomitant use of rivaroxaban with known combined P-gp and strong CYP3A4 inhibitors.

            • desirudin

              rivaroxaban, desirudin. Either increases effects of the other by anticoagulation. Use Caution/Monitor. Avoid concurrent use of rivaroxaban with other anticoagulants due to increased bleeding risk other than during therapeutic transition periods where patients should be observed closely. Monitor for signs/symptoms of blood loss.

            • dexamethasone

              dexamethasone decreases levels of rivaroxaban by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Avoid concomitant use of rivaroxaban with drugs that are combined P-gp and strong CYP3A4 inducers. Consider increasing the rivaroxaban dose if these drugs must be coadministered.

            • diclofenac

              rivaroxaban, diclofenac. Other (see comment). Use Caution/Monitor. Comment: NSAIDs are known to increase bleeding. Bleeding risk may be increased when NSAIDs are used concomitantly with rivaroxaban. Monitor for signs/symptoms of blood loss.

            • diltiazem

              diltiazem increases levels of rivaroxaban by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Patients with renal impairment receiving rivaroxaban with drugs that are combined P-gp and weak or moderate CYP3A4 inhibitors may have significant increases in exposure compared with patients with normal renal function and no inhibitor use, since both pathways of rivaroxaban elimination are affected. Since these increases may increase bleeding risk, use rivaroxaban in this situation only if the potential benefit justifies the potential risk.

            • dipyridamole

              rivaroxaban, dipyridamole. Either increases effects of the other by anticoagulation. Use Caution/Monitor. Avoid concurrent use of rivaroxaban with other anticoagulants due to increased bleeding risk other than during therapeutic transition periods where patients should be observed closely. Monitor for signs/symptoms of blood loss.

            • dronedarone

              dronedarone increases levels of rivaroxaban by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Dronedarone also inhibits P-gp activity, which can further increase rivaroxaban serum levels; since both pathways of rivaroxaban elimination are affected, patients with renal impairment receiving rivaroxaban with drugs that are combined P-gp and moderate CYP3A4 inhibitors may have significant increases in exposure compared to patients with normal renal function; since the drug combination may increase bleeding risk, monitor closely.

            • efavirenz

              efavirenz will decrease the level or effect of rivaroxaban by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • elagolix

              elagolix decreases levels of rivaroxaban by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Elagolix is a weak-to-moderate CYP3A4 inducer. Monitor CYP3A substrates if coadministered. Consider increasing CYP3A substrate dose if needed.

            • encorafenib

              encorafenib, rivaroxaban. affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Encorafenib both inhibits and induces CYP3A4 at clinically relevant plasma concentrations. Coadministration of encorafenib with sensitive CYP3A4 substrates may result in increased toxicity or decreased efficacy of these agents.

            • enoxaparin

              rivaroxaban, enoxaparin. Either increases effects of the other by anticoagulation. Use Caution/Monitor. Avoid concurrent use of rivaroxaban with other anticoagulants due to increased bleeding risk other than during therapeutic transition periods where patients should be observed closely. Monitor for signs/symptoms of blood loss.

            • eptifibatide

              rivaroxaban, eptifibatide. Either increases effects of the other by anticoagulation. Use Caution/Monitor. Avoid concurrent use of rivaroxaban with other anticoagulants due to increased bleeding risk other than during therapeutic transition periods where patients should be observed closely. Monitor for signs/symptoms of blood loss.

            • erythromycin base

              erythromycin base increases levels of rivaroxaban by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Patients with renal impairment receiving rivaroxaban with drugs that are combined P-gp and weak or moderate CYP3A4 inhibitors may have significant increases in exposure compared with patients with normal renal function and no inhibitor use, since both pathways of rivaroxaban elimination are affected. Since these increases may increase bleeding risk, use rivaroxaban in this situation only if the potential benefit justifies the potential risk.

            • erythromycin ethylsuccinate

              erythromycin ethylsuccinate increases levels of rivaroxaban by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Patients with renal impairment receiving rivaroxaban with drugs that are combined P-gp and weak or moderate CYP3A4 inhibitors may have significant increases in exposure compared with patients with normal renal function and no inhibitor use, since both pathways of rivaroxaban elimination are affected. Since these increases may increase bleeding risk, use rivaroxaban in this situation only if the potential benefit justifies the potential risk.

            • erythromycin lactobionate

              erythromycin lactobionate increases levels of rivaroxaban by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Patients with renal impairment receiving rivaroxaban with drugs that are combined P-gp and weak or moderate CYP3A4 inhibitors may have significant increases in exposure compared with patients with normal renal function and no inhibitor use, since both pathways of rivaroxaban elimination are affected. Since these increases may increase bleeding risk, use rivaroxaban in this situation only if the potential benefit justifies the potential risk.

            • erythromycin stearate

              erythromycin stearate increases levels of rivaroxaban by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Patients with renal impairment receiving rivaroxaban with drugs that are combined P-gp and weak or moderate CYP3A4 inhibitors may have significant increases in exposure compared with patients with normal renal function and no inhibitor use, since both pathways of rivaroxaban elimination are affected. Since these increases may increase bleeding risk, use rivaroxaban in this situation only if the potential benefit justifies the potential risk.

            • escitalopram

              escitalopram increases effects of rivaroxaban by pharmacodynamic synergism. Use Caution/Monitor. Combination may increase risk of bleeding.

            • etodolac

              rivaroxaban, etodolac. Other (see comment). Use Caution/Monitor. Comment: NSAIDs are known to increase bleeding. Bleeding risk may be increased when NSAIDs are used concomitantly with rivaroxaban. Monitor for signs/symptoms of blood loss.

            • fedratinib

              fedratinib will increase the level or effect of rivaroxaban by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Adjust dose of drugs that are CYP3A4 substrates as necessary.

            • felodipine

              felodipine increases levels of rivaroxaban by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Patients with renal impairment receiving rivaroxaban with drugs that are combined P-gp and weak or moderate CYP3A4 inhibitors may have significant increases in exposure compared with patients with normal renal function and no inhibitor use, since both pathways of rivaroxaban elimination are affected. Since these increases may increase bleeding risk, use rivaroxaban in this situation only if the potential benefit justifies the potential risk.

            • fenoprofen

              rivaroxaban, fenoprofen. Other (see comment). Use Caution/Monitor. Comment: NSAIDs are known to increase bleeding. Bleeding risk may be increased when NSAIDs are used concomitantly with rivaroxaban. Monitor for signs/symptoms of blood loss.

            • fish oil triglycerides

              fish oil triglycerides will increase the level or effect of rivaroxaban by anticoagulation. Use Caution/Monitor. Prolonged bleeding reported in patients taking antiplatelet agents or anticoagulants and oral omega-3 fatty acids. Periodically monitor bleeding time in patients receiving fish oil triglycerides and concomitant antiplatelet agents or anticoagulants.

            • fluconazole

              fluconazole increases levels of rivaroxaban by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Patients with renal impairment receiving rivaroxaban with moderate CYP3A4 inhibitors may have significant increases in exposure compared with patients with normal renal function and no inhibitor use; increased may increase bleeding risk.

            • fluoxetine

              fluoxetine increases effects of rivaroxaban by pharmacodynamic synergism. Use Caution/Monitor. Combination may increase risk of bleeding.

            • flurbiprofen

              rivaroxaban, flurbiprofen. Other (see comment). Use Caution/Monitor. Comment: NSAIDs are known to increase bleeding. Bleeding risk may be increased when NSAIDs are used concomitantly with rivaroxaban. Monitor for signs/symptoms of blood loss.

            • fluvoxamine

              fluvoxamine will increase the level or effect of rivaroxaban by pharmacodynamic synergism. Use Caution/Monitor. May increase risk of bleeding

            • grapefruit

              grapefruit will increase the level or effect of rivaroxaban by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • hemin

              rivaroxaban, hemin. Either increases effects of the other by anticoagulation. Use Caution/Monitor. Hemin degradation product (ie, hematin) may produce coagulopathy (eg, thrombocytopenia, platelet degranulation) and cause mild anticoagulant effects.

            • heparin

              rivaroxaban, heparin. Either increases effects of the other by anticoagulation. Use Caution/Monitor. Avoid concurrent use of rivaroxaban with other anticoagulants due to increased bleeding risk other than during therapeutic transition periods where patients should be observed closely. Monitor for signs/symptoms of blood loss.

            • ibrutinib

              ibrutinib will increase the level or effect of rivaroxaban by anticoagulation. Use Caution/Monitor. Ibrutinib may increase the risk of hemorrhage in patients receiving antiplatelet or anticoagulant therapies and monitor for signs of bleeding.

            • ibuprofen

              rivaroxaban, ibuprofen. Other (see comment). Use Caution/Monitor. Comment: NSAIDs are known to increase bleeding. Bleeding risk may be increased when NSAIDs are used concomitantly with rivaroxaban. Monitor for signs/symptoms of blood loss.

            • ibuprofen IV

              rivaroxaban, ibuprofen IV. Other (see comment). Use Caution/Monitor. Comment: NSAIDs are known to increase bleeding. Bleeding risk may be increased when NSAIDs are used concomitantly with rivaroxaban. Monitor for signs/symptoms of blood loss.

            • icosapent

              icosapent, rivaroxaban. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Icosapent may prolong bleeding time; monitor periodically if coadministered with other drugs that affect bleeding.

            • imatinib

              imatinib, rivaroxaban. Either increases toxicity of the other by Other (see comment). Modify Therapy/Monitor Closely. Comment: Imatinib may cause thrombocytopenia; bleeding risk increased when imatinib is coadministered with anticoagulants, NSAIDs, platelet inhibitors, and thrombolytic agents; patients requiring anticoagulation while on imatinib should receive LMWH or unfractionated heparin instead of warfarin because of multiple interaction mechanisms of imatinib with warfarin.

            • indomethacin

              rivaroxaban, indomethacin. Other (see comment). Use Caution/Monitor. Comment: NSAIDs are known to increase bleeding. Bleeding risk may be increased when NSAIDs are used concomitantly with rivaroxaban. Monitor for signs/symptoms of blood loss.

            • istradefylline

              istradefylline will increase the level or effect of rivaroxaban by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Istradefylline 40 mg/day increased peak levels and AUC of CYP3A4 substrates in clinical trials. This effect was not observed with istradefylline 20 mg/day. Consider dose reduction of sensitive CYP3A4 substrates.

            • itraconazole

              itraconazole increases levels of rivaroxaban by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Avoid concomitant use of rivaroxaban and combined Pgp and strong CYP3A4 inhibitors. Combination may lead to significant increases in rivaroxaban levels and increase bleeding risk.

            • ketoprofen

              rivaroxaban, ketoprofen. Other (see comment). Use Caution/Monitor. Comment: NSAIDs are known to increase bleeding. Bleeding risk may be increased when NSAIDs are used concomitantly with rivaroxaban. Monitor for signs/symptoms of blood loss.

            • ketorolac

              rivaroxaban, ketorolac. Other (see comment). Use Caution/Monitor. Comment: NSAIDs are known to increase bleeding. Bleeding risk may be increased when NSAIDs are used concomitantly with rivaroxaban. Monitor for signs/symptoms of blood loss.

            • lapatinib

              lapatinib increases levels of rivaroxaban by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Patients with renal impairment receiving rivaroxaban with drugs that are combined P-gp and weak or moderate CYP3A4 inhibitors may have significant increases in exposure compared with patients with normal renal function and no inhibitor use, since both pathways of rivaroxaban elimination are affected. Since these increases may increase bleeding risk, use rivaroxaban in this situation only if the potential benefit justifies the potential risk.

            • letermovir

              letermovir increases levels of rivaroxaban by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • lopinavir

              lopinavir increases levels of rivaroxaban by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Avoid concomitant use of rivaroxaban and combined Pgp and strong CYP3A4 inhibitors. Combination may lead to significant increases in rivaroxaban levels and increase bleeding risk.

            • lorlatinib

              lorlatinib will decrease the level or effect of rivaroxaban by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • meclofenamate

              rivaroxaban, meclofenamate. Other (see comment). Use Caution/Monitor. Comment: NSAIDs are known to increase bleeding. Bleeding risk may be increased when NSAIDs are used concomitantly with rivaroxaban. Monitor for signs/symptoms of blood loss.

            • mefenamic acid

              rivaroxaban, mefenamic acid. Other (see comment). Use Caution/Monitor. Comment: NSAIDs are known to increase bleeding. Bleeding risk may be increased when NSAIDs are used concomitantly with rivaroxaban. Monitor for signs/symptoms of blood loss.

            • mefloquine

              mefloquine increases levels of rivaroxaban by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Patients with renal impairment receiving rivaroxaban with drugs that are combined P-gp and weak or moderate CYP3A4 inhibitors may have significant increases in exposure compared with patients with normal renal function and no inhibitor use, since both pathways of rivaroxaban elimination are affected. Since these increases may increase bleeding risk, use rivaroxaban in this situation only if the potential benefit justifies the potential risk.

            • melatonin

              melatonin increases effects of rivaroxaban by anticoagulation. Use Caution/Monitor. Melatonin may decrease prothrombin time.

            • meloxicam

              rivaroxaban, meloxicam. Other (see comment). Use Caution/Monitor. Comment: NSAIDs are known to increase bleeding. Bleeding risk may be increased when NSAIDs are used concomitantly with rivaroxaban. Monitor for signs/symptoms of blood loss.

            • mifepristone

              mifepristone will increase the level or effect of rivaroxaban by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. These drugs may be coadministered with caution when mifepristone given chronically for conditions, including Cushing's syndrome; increased serum concentrations of rivaroxaban possible

            • mitotane

              mitotane decreases levels of rivaroxaban by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Mitotane is a strong inducer of cytochrome P-4503A4; monitor when coadministered with CYP3A4 substrates for possible dosage adjustments.

            • nabumetone

              rivaroxaban, nabumetone. Other (see comment). Use Caution/Monitor. Comment: NSAIDs are known to increase bleeding. Bleeding risk may be increased when NSAIDs are used concomitantly with rivaroxaban. Monitor for signs/symptoms of blood loss.

            • nafcillin

              nafcillin will decrease the level or effect of rivaroxaban by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • naproxen

              rivaroxaban, naproxen. Other (see comment). Use Caution/Monitor. Comment: NSAIDs are known to increase bleeding. Bleeding risk may be increased when NSAIDs are used concomitantly with rivaroxaban. Monitor for signs/symptoms of blood loss.

            • nefazodone

              nefazodone will increase the level or effect of rivaroxaban by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • nelfinavir

              nelfinavir increases levels of rivaroxaban by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Avoid concomitant use of rivaroxaban and combined Pgp and strong CYP3A4 inhibitors. Combination may lead to significant increases in rivaroxaban levels and increase bleeding risk.

            • nicardipine

              nicardipine increases levels of rivaroxaban by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Avoid concomitant use of rivaroxaban and combined Pgp and strong CYP3A4 inhibitors. Combination may lead to significant increases in rivaroxaban levels and increase bleeding risk.

            • nilotinib

              nilotinib increases levels of rivaroxaban by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Patients with renal impairment receiving rivaroxaban with drugs that are combined P-gp and weak or moderate CYP3A4 inhibitors may have significant increases in exposure compared with patients with normal renal function and no inhibitor use, since both pathways of rivaroxaban elimination are affected. Since these increases may increase bleeding risk, use rivaroxaban in this situation only if the potential benefit justifies the potential risk.

            • nintedanib

              nintedanib increases effects of rivaroxaban by anticoagulation. Use Caution/Monitor. Nintedanib is a VEGFR inhibitor, and may increase the risk of bleeding; monitor patients on full anticoagulation therapy; monitor closely for bleeding and adjust therapy as needed .

            • oxaprozin

              rivaroxaban, oxaprozin. Other (see comment). Use Caution/Monitor. Comment: NSAIDs are known to increase bleeding. Bleeding risk may be increased when NSAIDs are used concomitantly with rivaroxaban. Monitor for signs/symptoms of blood loss.

            • paroxetine

              paroxetine increases effects of rivaroxaban by pharmacodynamic synergism. Use Caution/Monitor. Combination may increase risk of bleeding.

            • phenytoin

              phenytoin decreases levels of rivaroxaban by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Avoid concomitant use of rivaroxaban with drugs that are combined P-gp and strong CYP3A4 inducers. Consider increasing the rivaroxaban dose if these drugs must be coadministered.

            • piroxicam

              rivaroxaban, piroxicam. Other (see comment). Use Caution/Monitor. Comment: NSAIDs are known to increase bleeding. Bleeding risk may be increased when NSAIDs are used concomitantly with rivaroxaban. Monitor for signs/symptoms of blood loss.

            • prasugrel

              rivaroxaban, prasugrel. Either increases effects of the other by anticoagulation. Use Caution/Monitor. Avoid concurrent use of rivaroxaban with other anticoagulants due to increased bleeding risk other than during therapeutic transition periods where patients should be observed closely. Monitor for signs/symptoms of blood loss.

            • protein C concentrate

              rivaroxaban, protein C concentrate. Either increases effects of the other by anticoagulation. Use Caution/Monitor. Avoid concurrent use of rivaroxaban with other anticoagulants due to increased bleeding risk other than during therapeutic transition periods where patients should be observed closely. Monitor for signs/symptoms of blood loss.

            • quinidine

              quinidine increases levels of rivaroxaban by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Patients with renal impairment receiving rivaroxaban with drugs that are combined P-gp and weak or moderate CYP3A4 inhibitors may have significant increases in exposure compared with patients with normal renal function and no inhibitor use, since both pathways of rivaroxaban elimination are affected. Since these increases may increase bleeding risk, use rivaroxaban in this situation only if the potential benefit justifies the potential risk.

            • ranolazine

              ranolazine increases levels of rivaroxaban by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Patients with renal impairment receiving rivaroxaban with drugs that are combined P-gp and weak or moderate CYP3A4 inhibitors may have significant increases in exposure compared with patients with normal renal function and no inhibitor use, since both pathways of rivaroxaban elimination are affected. Since these increases may increase bleeding risk, use rivaroxaban in this situation only if the potential benefit justifies the potential risk.

            • reteplase

              rivaroxaban, reteplase. Either increases effects of the other by anticoagulation. Use Caution/Monitor. Avoid concurrent use of rivaroxaban with other anticoagulants due to increased bleeding risk other than during therapeutic transition periods where patients should be observed closely. Monitor for signs/symptoms of blood loss.

            • rifabutin

              rifabutin will decrease the level or effect of rivaroxaban by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • rifampin

              rifampin decreases levels of rivaroxaban by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Avoid concomitant use of rivaroxaban with drugs that are combined P-gp and strong CYP3A4 inducers. Consider increasing the rivaroxaban dose if these drugs must be coadministered.

            • rucaparib

              rucaparib will increase the level or effect of rivaroxaban by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Adjust dosage of CYP3A4 substrates, if clinically indicated.

            • saquinavir

              saquinavir increases levels of rivaroxaban by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Avoid concomitant use of rivaroxaban and combined Pgp and strong CYP3A4 inhibitors. Combination may lead to significant increases in rivaroxaban levels and increase bleeding risk.

            • saw palmetto

              saw palmetto increases toxicity of rivaroxaban by unspecified interaction mechanism. Use Caution/Monitor. May increase risk of bleeding.

            • sertraline

              sertraline increases effects of rivaroxaban by pharmacodynamic synergism. Use Caution/Monitor. Combination may increase risk of bleeding.

            • St John's Wort

              St John's Wort decreases levels of rivaroxaban by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Avoid concomitant use of rivaroxaban with drugs that are combined P-gp and strong CYP3A4 inducers. Consider increasing the rivaroxaban dose if these drugs must be coadministered.

            • stiripentol

              stiripentol, rivaroxaban. affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Stiripentol is a CYP3A4 inhibitor and inducer. Monitor CYP3A4 substrates coadministered with stiripentol for increased or decreased effects. CYP3A4 substrates may require dosage adjustment.

            • sulindac

              rivaroxaban, sulindac. Other (see comment). Use Caution/Monitor. Comment: NSAIDs are known to increase bleeding. Bleeding risk may be increased when NSAIDs are used concomitantly with rivaroxaban. Monitor for signs/symptoms of blood loss.

            • tamoxifen

              tamoxifen increases levels of rivaroxaban by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Patients with renal impairment receiving rivaroxaban with drugs that are combined P-gp and weak or moderate CYP3A4 inhibitors may have significant increases in exposure compared with patients with normal renal function and no inhibitor use, since both pathways of rivaroxaban elimination are affected. Since these increases may increase bleeding risk, use rivaroxaban in this situation only if the potential benefit justifies the potential risk.

            • tazemetostat

              tazemetostat will decrease the level or effect of rivaroxaban by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • tecovirimat

              tecovirimat will decrease the level or effect of rivaroxaban by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Tecovirimat is a weak CYP3A4 inducer. Monitor sensitive CYP3A4 substrates for effectiveness if coadministered.

            • tenecteplase

              rivaroxaban, tenecteplase. Either increases effects of the other by anticoagulation. Use Caution/Monitor. Avoid concurrent use of rivaroxaban with other anticoagulants due to increased bleeding risk other than during therapeutic transition periods where patients should be observed closely. Monitor for signs/symptoms of blood loss.

            • ticagrelor

              ticagrelor, rivaroxaban. Either increases effects of the other by anticoagulation. Use Caution/Monitor. Increased risk of bleeding during concomitant use of medications that increase potential for bleeding.

            • ticlopidine

              rivaroxaban, ticlopidine. Either increases effects of the other by anticoagulation. Use Caution/Monitor. Avoid concurrent use of rivaroxaban with other anticoagulants due to increased bleeding risk other than during therapeutic transition periods where patients should be observed closely. Monitor for signs/symptoms of blood loss.

            • tipranavir

              tipranavir will increase the level or effect of rivaroxaban by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • tirofiban

              rivaroxaban, tirofiban. Either increases effects of the other by anticoagulation. Use Caution/Monitor. Avoid concurrent use of rivaroxaban with other anticoagulants due to increased bleeding risk other than during therapeutic transition periods where patients should be observed closely. Monitor for signs/symptoms of blood loss.

            • tolmetin

              rivaroxaban, tolmetin. Other (see comment). Use Caution/Monitor. Comment: NSAIDs are known to increase bleeding. Bleeding risk may be increased when NSAIDs are used concomitantly with rivaroxaban. Monitor for signs/symptoms of blood loss.

            • vemurafenib

              vemurafenib increases levels of rivaroxaban by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

            • verapamil

              verapamil increases levels of rivaroxaban by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Verapamil also inhibits P-gp activity, which can further increase rivaroxaban serum levels; since both pathways of rivaroxaban elimination are affected, patients with renal impairment receiving rivaroxaban with drugs that are combined P-gp and moderate CYP3A4 inhibitors may increase exposure compared to patients with normal renal function; monitor for bleeding.

            • vortioxetine

              rivaroxaban, vortioxetine. Either increases effects of the other by anticoagulation. Use Caution/Monitor.

            • warfarin

              rivaroxaban, warfarin. Either increases effects of the other by anticoagulation. Use Caution/Monitor. Avoid concurrent use of rivaroxaban with other anticoagulants due to increased bleeding risk other than during therapeutic transition periods where patients should be observed closely. Monitor for signs/symptoms of blood loss.

            • zanubrutinib

              rivaroxaban, zanubrutinib. Either increases effects of the other by anticoagulation. Modify Therapy/Monitor Closely. Zanubrutinib-induced cytopenias increases risk of hemorrhage. Coadministration of zanubritinib with antiplatelets or anticoagulants may further increase this risk.

            Minor (1)

            • ribociclib

              ribociclib will increase the level or effect of rivaroxaban by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

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            Adverse Effects

            1-10%

            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)

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            Warnings

            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

            Contraindications

            Hypersensitivity

            Active pathological bleeding

            Patients who have had transcatheter aortic valve replacement (Tavr)

            Cautions

            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
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            Pregnancy & Lactation

            Pregnancy

            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

            Lactation

            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.

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            Pharmacology

            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

            Absorption

            Bioavailability: 80-100%

            Peak plasma time: 2-4 hr

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

            Distribution

            Protein bound: 92-95% (mainly albumin)

            Vd: 50 L

            Metabolism

            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

            Elimination

            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)

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            Administration

            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

            Storage

            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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            Images

            BRAND FORM. UNIT PRICE PILL IMAGE
            Xarelto DVT-PE Treatment 30-Day Starter oral
            -
            15 mg (42)- 20 mg (9) tablet
            Xarelto oral
            -
            10 mg tablet
            Xarelto oral
            -
            20 mg tablet
            Xarelto oral
            -
            15 mg tablet
            Xarelto oral
            -
            2.5 mg tablet

            Copyright © 2010 First DataBank, Inc.

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            Patient Handout

            Patient Education
            rivaroxaban oral

            RIVAROXABAN - ORAL

            (RIV-a-ROX-a-ban)

            COMMON BRAND NAME(S): Xarelto

            WARNING: Do not stop taking rivaroxaban unless directed by your doctor. If you stop taking this medication early, you have a higher risk of forming a serious blood clot (such as a stroke, blood clot in the legs/lungs). Your doctor may direct you to take a different "blood thinning" or antiplatelet medication to reduce your risk. Get medical help right away if you have weakness on one side of the body, trouble speaking, sudden vision changes, confusion, chest pain, trouble breathing, pain/warmth/swelling in the legs.People taking this medication may bleed near the spinal cord after certain spinal procedures. Bleeding in this area can cause paralysis that lasts a long time or could become permanent. Ask your doctor about the benefits and risks before any spinal procedure. The risk of bleeding may be higher if you have a deformed spine, or have had spinal procedures/surgery before (such as epidural catheter placement, difficult epidural/spinal puncture), or are taking other drugs that can cause bleeding/bruising (including antiplatelet drugs such as clopidogrel, "blood thinners" such as warfarin/enoxaparin, nonsteroidal anti-inflammatory drugs-NSAIDs such as ibuprofen). See also Drug Interactions section. Tell your doctor right away if you notice symptoms such as back pain, leg numbness/tingling/weakness, loss of control of the bowels or bladder (incontinence).

            USES: Rivaroxaban is used to prevent blood clots from forming due to a certain irregular heartbeat (atrial fibrillation) or after hip or knee replacement surgery. It is also used to prevent blood clots from forming in high-risk patients with limited mobility during their hospital stay and after discharge. In addition, rivaroxaban is used to treat blood clots (such as in deep vein thrombosis-DVT or pulmonary embolus-PE) and to prevent the blood clots from forming again.Rivaroxaban is an anticoagulant that works by blocking certain clotting proteins in your blood.

            HOW TO USE: Read the Medication Guide provided by your pharmacist before you start taking rivaroxaban and each time you get a refill. If you have any questions, ask your doctor or pharmacist.Take this medication by mouth as directed by your doctor. If you are taking this medication to prevent blood clots after knee or hip replacement surgery or during a hospital stay and after discharge, the dose is usually taken once a day. If you are taking this drug to prevent strokes and blood clots that may form due to an irregular heartbeat, the dose is usually taken once a day with the evening meal. If you are taking rivaroxaban to treat blood clots, the dose is usually taken twice a day for the first 3 weeks, and then once a day. To lower the risk of blood clots forming again, this medication is usually taken once a day. Carefully follow your doctor's directions. Do not increase your dose, take it more often, or stop taking it unless you are told to do so by your doctor.The 10 milligrams tablet may be taken with or without food. The 15 milligrams and 20 milligrams tablet should be taken with food. If you have any questions about how to take rivaroxaban, ask your doctor or pharmacist.If you are unable to swallow whole tablets, you may crush the tablet and mix it with applesauce. Eat the entire mixture right away. Do not prepare a supply for future use.If you are giving this medication through a tube into the stomach (nasogastric or gastric tube), ask your health care professional for detailed instructions on how to properly mix and give it.The dosage and length of treatment is based on your medical condition and response to treatment.Use this medication regularly to get the most benefit from it. To help you remember, take it at the same time(s) each day.

            SIDE EFFECTS: See also Warning section.Easy bruising or minor bleeding (such as nosebleed, bleeding from cuts) may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.This medication can cause serious bleeding if it affects your blood clotting proteins too much. Tell your doctor right away if you have any signs of serious bleeding, including: unusual pain/swelling/discomfort, unusual bruising, prolonged bleeding from cuts or gums, persistent/frequent nosebleeds, unusually heavy/prolonged menstrual flow, pink/dark urine, coughing up blood, vomit that is bloody or looks like coffee grounds, severe headache, dizziness/fainting, unusual or persistent tiredness/weakness, bloody/black/tarry stools, difficulty swallowing.Get medical help right away if you have any signs of very serious bleeding, including: vision changes, confusion, trouble speaking, weakness on one side of the body.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

            PRECAUTIONS: Before taking rivaroxaban, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, kidney disease, bleeding problems (such as bleeding of the stomach/intestines, bleeding in the brain), stroke, artificial heart valves, recent major injury/surgery, blood disorders (such as anemia, hemophilia, thrombocytopenia), frequent falls/injuries, certain eye problem (retinopathy), a certain clotting disorder (antiphospholipid syndrome), certain hereditary enzyme problems (such as galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption).It is important that all your doctors and dentists know that you take rivaroxaban. Before having surgery or any medical/dental procedures, tell your doctor or dentist that you are using this medication.This medication may cause stomach bleeding. Daily use of alcohol while using this medicine will increase your risk for stomach bleeding. Limit alcoholic beverages. Ask your doctor or pharmacist about how much alcohol you may safely drink.This medication can cause bleeding. To lower the chance of getting cut, bruised, or injured, use great caution with sharp objects like safety razors and nail cutters. Use an electric razor when shaving and a soft toothbrush when brushing your teeth. Avoid activities such as contact sports. If you fall or injure yourself, especially if you hit your head, contact your doctor right away. Your doctor may need to check you for hidden bleeding that could be serious.Older adults may be more sensitive to the side effects of this drug, especially bleeding.Tell your doctor if you are pregnant or if you plan to become pregnant. During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor before using this medication.This medication may pass into breast milk. Consult your doctor before breast-feeding.

            DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Some products that may interact with this drug include: mifepristone, other drugs that can cause bleeding/bruising (including antiplatelet drugs such as clopidogrel, "blood thinners" such as warfarin, enoxaparin), certain antidepressants (including SSRIs such as fluoxetine, SNRIs such as desvenlafaxine/venlafaxine).Other medications can affect the removal of rivaroxaban from your body, which may affect how rivaroxaban works. Examples include cobicistat, conivaptan, certain azole antifungals (itraconazole, ketoconazole, posaconazole), rifamycins (such as rifampin), HIV protease inhibitors (such as lopinavir, ritonavir), St. John's wort, drugs used to treat seizures (such as carbamazepine, phenytoin, phenobarbital), among others.Aspirin can increase the risk of bleeding when used with this medication. However, if your doctor has directed you to take low-dose aspirin for heart attack or stroke prevention (usually 81-162 milligrams a day), you should continue taking it unless your doctor instructs you otherwise. Ask your doctor or pharmacist for more details.

            OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: bloody/black/tarry stools, pink/dark urine, unusual/prolonged bleeding.

            NOTES: Do not share this medication with others.Laboratory and/or medical tests (such as hematocrit/hemoglobin, red blood cell count) may be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

            MISSED DOSE: If you are taking this medication once a day and miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.If you are taking this medication twice a day and miss a dose, take it as soon as you remember. If you missed the morning dose and it is near the time of the evening dose, you may take both doses together. Then take your next dose at the regular time.

            STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.Use/discard the crushed tablet mixture within 4 hours. (See also How to Use section.)Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

            MEDICAL ALERT: Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).

            Information last revised August 2021. Copyright(c) 2021 First Databank, Inc.

            IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

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            Formulary

            FormularyPatient Discounts

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            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            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.