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Xarelto
rivaroxaban
Black Box Warnings .
Tx Discontinuation
incr. thrombotic event and stroke risk when D/C rivaroxaban before completion of tx course; if must D/C rivaroxaban for reasons other than pathological bleeding or completion of tx course, consider administering another anticoagulant
Epidural/Spinal Hematoma Risk
epidural/spinal hematoma risk after neuraxial anesthesia or spinal puncture in anticoagulated pts; hematoma may result in long-term or permanent paralysis; incr. risk if indwelling epidural catheter use, concomitant use of drugs affecting hemostasis incl. NSAIDs, platelet inhibitors, or other anticoagulants, traumatic or repeated epidural or spinal puncture hx, spinal deformity, or spinal surgery hx; consider benefit vs. risk before neuraxial intervention in anticoagulated pts or planned anticoagulation for thromboprophylaxis; while optimal timing to minimize risk is unknown, delay epidural catheter removal >18h (for pts 60-76 yo, delay removal >26h) after last rivaroxaban dose and delay rivaroxaban >6h after catheter removal; delay rivaroxaban 24h if traumatic puncture occurs; monitor s/sx neurologic impairment, treat urgently if needed
Adult Dosing .
Dosage forms: TAB: 2.5 mg, 10 mg, 15 mg, 20 mg; SUSP: 1 mg per mL
thromboembolism/stroke prevention
- [20 mg PO qd]
- Info: for non-valvular atrial fibrillation w/o moderate-severe mitral stenosis or mechanical heart valve; to convert from UFH infusion, D/C UFH, then start rivaroxaban immediately; to convert from other anticoagulants, D/C other anticoagulant, then start rivaroxaban 0-2h before next scheduled evening dose; to convert from warfarin, D/C warfarin, then start rivaroxaban when INR <3; depending on bleeding risk, consider holding tx 1-2 days before surgery or invasive procedure if CrCl >30 or 2-5 days if CrCl <30; resume tx >24h postop; give w/ evening meal
DVT/PE tx
- [15 mg PO bid x21 days, then 20 mg PO qd]
- Info: to convert from UFH infusion, D/C UFH, then start rivaroxaban immediately; to convert from other anticoagulants, D/C other anticoagulant, then start rivaroxaban 0-2h before next scheduled dose; to convert from warfarin, D/C warfarin, then start rivaroxaban when INR <3; depending on bleeding risk, consider holding tx 1-2 days before surgery or invasive procedure if CrCl >30 or 2-5 days if CrCl <30; resume tx >24h postop; give 15 mg and 20 mg tabs w/ food
DVT/PE prophylaxis, recurrent
- [10 mg PO qd]
- Info: to convert from UFH infusion, D/C UFH, then start rivaroxaban immediately; to convert from other anticoagulants, D/C other anticoagulant, then start rivaroxaban 0-2h before next scheduled dose; to convert from warfarin, D/C warfarin, then start rivaroxaban when INR <3; depending on bleeding risk, consider holding tx 1-2 days before surgery or invasive procedure if CrCl >30 or 2-5 days if CrCl <30; resume tx >24h postop
DVT prophylaxis
- [hip replacement]
- Dose: 10 mg PO qd x35 days; Start: 6-10h postop once hemostasis established
- [knee replacement]
- Dose: 10 mg PO qd x12 days; Start: 6-10h postop once hemostasis established
VTE prophylaxis, acutely ill pts
- [10 mg PO qd]
- Info: for hospitalized pts w/ moderate-severe restricted mobility and other VTE risk factors, not at high bleeding risk; continue tx x31-39 days total incl. post-discharge
cardiovascular event risk reduction
- [2.5 mg PO bid]
- Info: for pts w/ CAD; give w/ aspirin 75-100 mg PO qd; to convert from UFH infusion, D/C UFH, then start rivaroxaban immediately; to convert from other anticoagulants, D/C other anticoagulant, then start rivaroxaban 0-2h before next scheduled dose; to convert from warfarin, D/C warfarin, then start rivaroxaban when INR <3
thrombotic event risk reduction
- [2.5 mg PO bid]
- Info: for pts w/ symptomatic peripheral arterial dz and w/ or w/o recent lower extremity revascularization; give w/ aspirin 75-100 mg PO qd; start once hemostasis established in pts w/ revascularization; to convert from UFH infusion, D/C UFH, then start rivaroxaban immediately; to convert from other anticoagulants, D/C other anticoagulant, then start rivaroxaban 0-2h before next scheduled dose; to convert from warfarin, D/C warfarin, then start rivaroxaban when INR <3
VTE prophylaxis, cardioversion (off-label)
- [afib/flutter duration <48h]
- Dose: 20 mg PO qd; Start: ASAP before or immediately after cardioversion; Info: for pts w/ CHA2DS2-VASc score >2; continue tx for at least 4wk after procedure; refer to ACC/AHA/HRS guidelines
- [afib/flutter duration >48h or unknown]
- Dose: 20 mg PO qd; Start: at least 3wk before cardioversion; Info: continue tx for at least 4wk after procedure; refer to ACC/AHA/HRS guidelines
renal dosing
- [thromboembolism/stroke prophylaxis]
- CrCl <51: 15 mg qd
- HD: 15 mg qd; no supplement after dialysis; PD: not defined
- [cardiovascular event risk reduction or thrombotic event risk reduction]
- renal impairment: no adjustment
- HD: no adjustment; no supplement; PD: not defined
- [VTE prophylaxis, cardioversion]
- CrCl 30-49: 15 mg qd; CrCl <30: not defined
- HD/PD: not defined
- [all other indications]
- CrCl <15: avoid use; Info: caution advised if CrCl 15-30
- HD/PD: avoid use
hepatic dosing
- [see below]
- Child-Pugh Class B or C: avoid use; coagulopathy-assoc. hepatic dz: avoid use
Peds Dosing .
- Dosage forms: TAB: 10 mg, 15 mg, 20 mg; SUSP: 1 mg per mL
venous thromboembolism tx
- [<18 yo, 2.6-2.9 kg]
- Dose: 0.8 mg PO tid; Start: after at least 5 days of parenteral anticoagulant tx; Info: cont. tx for at least 1mo in pts <2 yo w/ catheter-assoc. thrombosis, otherwise cont. tx for at least 3mo; to convert from UFH infusion, D/C UFH, then start rivaroxaban immediately; to convert from other anticoagulants, D/C other anticoagulant, then start rivaroxaban 0-2h before next scheduled dose; to convert from warfarin, D/C warfarin, then start rivaroxaban when INR <2.5; depending on bleeding risk, consider holding tx >24h before surgery or invasive procedure; resume tx once hemostasis established; give w/ food; use oral suspension only
- [<18 yo, 3-3.9 kg]
- Dose: 0.9 mg PO tid; Start: after at least 5 days of parenteral anticoagulant tx; Info: cont. tx for at least 1mo in pts <2 yo w/ catheter-assoc. thrombosis, otherwise cont. tx for at least 3mo; to convert from UFH infusion, D/C UFH, then start rivaroxaban immediately; to convert from other anticoagulants, D/C other anticoagulant, then start rivaroxaban 0-2h before next scheduled dose; to convert from warfarin, D/C warfarin, then start rivaroxaban when INR <2.5; depending on bleeding risk, consider holding tx >24h before surgery or invasive procedure; resume tx once hemostasis established; give w/ food; use oral suspension only
- [<18 yo, 4-4.9 kg]
- Dose: 1.4 mg PO tid; Start: after at least 5 days of parenteral anticoagulant tx; Info: cont. tx for at least 1mo in pts <2 yo w/ catheter-assoc. thrombosis, otherwise cont. tx for at least 3mo; to convert from UFH infusion, D/C UFH, then start rivaroxaban immediately; to convert from other anticoagulants, D/C other anticoagulant, then start rivaroxaban 0-2h before next scheduled dose; to convert from warfarin, D/C warfarin, then start rivaroxaban when INR <2.5; depending on bleeding risk, consider holding tx >24h before surgery or invasive procedure; resume tx once hemostasis established; give w/ food; use oral suspension only
- [<18 yo, 5-6.9 kg]
- Dose: 1.6 mg PO tid; Start: after at least 5 days of parenteral anticoagulant tx; Info: cont. tx for at least 1mo in pts <2 yo w/ catheter-assoc. thrombosis, otherwise cont. tx for at least 3mo; to convert from UFH infusion, D/C UFH, then start rivaroxaban immediately; to convert from other anticoagulants, D/C other anticoagulant, then start rivaroxaban 0-2h before next scheduled dose; to convert from warfarin, D/C warfarin, then start rivaroxaban when INR <2.5; depending on bleeding risk, consider holding tx >24h before surgery or invasive procedure; resume tx once hemostasis established; give w/ food; use oral suspension only
- [<18 yo, 7-7.9 kg]
- Dose: 1.8 mg PO tid; Start: after at least 5 days of parenteral anticoagulant tx; Info: cont. tx for at least 1mo in pts <2 yo w/ catheter-assoc. thrombosis, otherwise cont. tx for at least 3mo; to convert from UFH infusion, D/C UFH, then start rivaroxaban immediately; to convert from other anticoagulants, D/C other anticoagulant, then start rivaroxaban 0-2h before next scheduled dose; to convert from warfarin, D/C warfarin, then start rivaroxaban when INR <2.5; depending on bleeding risk, consider holding tx >24h before surgery or invasive procedure; resume tx once hemostasis established; give w/ food; use oral suspension only
- [<18 yo, 8-8.9 kg]
- Dose: 2.4 mg PO tid; Start: after at least 5 days of parenteral anticoagulant tx; Info: cont. tx for at least 1mo in pts <2 yo w/ catheter-assoc. thrombosis, otherwise cont. tx for at least 3mo; to convert from UFH infusion, D/C UFH, then start rivaroxaban immediately; to convert from other anticoagulants, D/C other anticoagulant, then start rivaroxaban 0-2h before next scheduled dose; to convert from warfarin, D/C warfarin, then start rivaroxaban when INR <2.5; depending on bleeding risk, consider holding tx >24h before surgery or invasive procedure; resume tx once hemostasis established; give w/ food; use oral suspension only
- [<18 yo, 9-9.9 kg]
- Dose: 2.8 mg PO tid; Start: after at least 5 days of parenteral anticoagulant tx; Info: cont. tx for at least 1mo in pts <2 yo w/ catheter-assoc. thrombosis, otherwise cont. tx for at least 3mo; to convert from UFH infusion, D/C UFH, then start rivaroxaban immediately; to convert from other anticoagulants, D/C other anticoagulant, then start rivaroxaban 0-2h before next scheduled dose; to convert from warfarin, D/C warfarin, then start rivaroxaban when INR <2.5; depending on bleeding risk, consider holding tx >24h before surgery or invasive procedure; resume tx once hemostasis established; give w/ food; use oral suspension only
- [<18 yo, 10-11.9 kg]
- Dose: 3 mg PO tid; Start: after at least 5 days of parenteral anticoagulant tx; Info: cont. tx for at least 1mo in pts <2 yo w/ catheter-assoc. thrombosis, otherwise cont. tx for at least 3mo; to convert from UFH infusion, D/C UFH, then start rivaroxaban immediately; to convert from other anticoagulants, D/C other anticoagulant, then start rivaroxaban 0-2h before next scheduled dose; to convert from warfarin, D/C warfarin, then start rivaroxaban when INR <2.5; depending on bleeding risk, consider holding tx >24h before surgery or invasive procedure; resume tx once hemostasis established; give w/ food; use oral suspension only
- [<18 yo, 12-29.9 kg]
- Dose: 5 mg PO bid; Start: after at least 5 days of parenteral anticoagulant tx; Info: cont. tx for at least 1mo in pts <2 yo w/ catheter-assoc. thrombosis, otherwise cont. tx for at least 3mo; to convert from UFH infusion, D/C UFH, then start rivaroxaban immediately; to convert from other anticoagulants, D/C other anticoagulant, then start rivaroxaban 0-2h before next scheduled dose; to convert from warfarin, D/C warfarin, then start rivaroxaban when INR <2.5; depending on bleeding risk, consider holding tx >24h before surgery or invasive procedure; resume tx once hemostasis established; give w/ food; use oral suspension only
- [<18 yo, 30-49.9 kg]
- Dose: 15 mg PO qd; Start: after at least 5 days of parenteral anticoagulant tx; Info: cont. tx for at least 1mo in pts <2 yo w/ catheter-assoc. thrombosis, otherwise cont. tx for at least 3mo; to convert from UFH infusion, D/C UFH, then start rivaroxaban immediately; to convert from other anticoagulants, D/C other anticoagulant, then start rivaroxaban 0-2h before next scheduled dose; to convert from warfarin, D/C warfarin, then start rivaroxaban when INR <2.5; depending on bleeding risk, consider holding tx >24h before surgery or invasive procedure; resume tx once hemostasis established; give w/ food
- [<18 yo, >50 kg]
- Dose: 20 mg PO qd; Start: after at least 5 days of parenteral anticoagulant tx; Info: cont. tx for at least 1mo in pts <2 yo w/ catheter-assoc. thrombosis, otherwise cont. tx for at least 3mo; to convert from UFH infusion, D/C UFH, then start rivaroxaban immediately; to convert from other anticoagulants, D/C other anticoagulant, then start rivaroxaban 0-2h before next scheduled dose; to convert from warfarin, D/C warfarin, then start rivaroxaban when INR <2.5; depending on bleeding risk, consider holding tx >24h before surgery or invasive procedure; resume tx once hemostasis established; give w/ food
venous thromboembolism prophylaxis, recurrent
- [<18 yo, 2.6-2.9 kg]
- Dose: 0.8 mg PO tid; Start: after at least 5 days of parenteral anticoagulant tx; Info: cont. tx for at least 1mo in pts <2 yo w/ catheter-assoc. thrombosis, otherwise cont. tx for at least 3mo; to convert from UFH infusion, D/C UFH, then start rivaroxaban immediately; to convert from other anticoagulants, D/C other anticoagulant, then start rivaroxaban 0-2h before next scheduled dose; to convert from warfarin, D/C warfarin, then start rivaroxaban when INR <2.5; depending on bleeding risk, consider holding tx >24h before surgery or invasive procedure; resume tx once hemostasis established; give w/ food; use oral suspension only
- [<18 yo, 3-3.9 kg]
- Dose: 0.9 mg PO tid; Start: after at least 5 days of parenteral anticoagulant tx; Info: cont. tx for at least 1mo in pts <2 yo w/ catheter-assoc. thrombosis, otherwise cont. tx for at least 3mo; to convert from UFH infusion, D/C UFH, then start rivaroxaban immediately; to convert from other anticoagulants, D/C other anticoagulant, then start rivaroxaban 0-2h before next scheduled dose; to convert from warfarin, D/C warfarin, then start rivaroxaban when INR <2.5; depending on bleeding risk, consider holding tx >24h before surgery or invasive procedure; resume tx once hemostasis established; give w/ food; use oral suspension only
- [<18 yo, 4-4.9 kg]
- Dose: 1.4 mg PO tid; Start: after at least 5 days of parenteral anticoagulant tx; Info: cont. tx for at least 1mo in pts <2 yo w/ catheter-assoc. thrombosis, otherwise cont. tx for at least 3mo; to convert from UFH infusion, D/C UFH, then start rivaroxaban immediately; to convert from other anticoagulants, D/C other anticoagulant, then start rivaroxaban 0-2h before next scheduled dose; to convert from warfarin, D/C warfarin, then start rivaroxaban when INR <2.5; depending on bleeding risk, consider holding tx >24h before surgery or invasive procedure; resume tx once hemostasis established; give w/ food; use oral suspension only
- [<18 yo, 5-6.9 kg]
- Dose: 1.6 mg PO tid; Start: after at least 5 days of parenteral anticoagulant tx; Info: cont. tx for at least 1mo in pts <2 yo w/ catheter-assoc. thrombosis, otherwise cont. tx for at least 3mo; to convert from UFH infusion, D/C UFH, then start rivaroxaban immediately; to convert from other anticoagulants, D/C other anticoagulant, then start rivaroxaban 0-2h before next scheduled dose; to convert from warfarin, D/C warfarin, then start rivaroxaban when INR <2.5; depending on bleeding risk, consider holding tx >24h before surgery or invasive procedure; resume tx once hemostasis established; give w/ food; use oral suspension only
- [<18 yo, 7-7.9 kg]
- Dose: 1.8 mg PO tid; Start: after at least 5 days of parenteral anticoagulant tx; Info: cont. tx for at least 1mo in pts <2 yo w/ catheter-assoc. thrombosis, otherwise cont. tx for at least 3mo; to convert from UFH infusion, D/C UFH, then start rivaroxaban immediately; to convert from other anticoagulants, D/C other anticoagulant, then start rivaroxaban 0-2h before next scheduled dose; to convert from warfarin, D/C warfarin, then start rivaroxaban when INR <2.5; depending on bleeding risk, consider holding tx >24h before surgery or invasive procedure; resume tx once hemostasis established; give w/ food; use oral suspension only
- [<18 yo, 8-8.9 kg]
- Dose: 2.4 mg PO tid; Start: after at least 5 days of parenteral anticoagulant tx; Info: cont. tx for at least 1mo in pts <2 yo w/ catheter-assoc. thrombosis, otherwise cont. tx for at least 3mo; to convert from UFH infusion, D/C UFH, then start rivaroxaban immediately; to convert from other anticoagulants, D/C other anticoagulant, then start rivaroxaban 0-2h before next scheduled dose; to convert from warfarin, D/C warfarin, then start rivaroxaban when INR <2.5; depending on bleeding risk, consider holding tx >24h before surgery or invasive procedure; resume tx once hemostasis established; give w/ food; use oral suspension only
- [<18 yo, 9-9.9 kg]
- Dose: 2.8 mg PO tid; Start: after at least 5 days of parenteral anticoagulant tx; Info: cont. tx for at least 1mo in pts <2 yo w/ catheter-assoc. thrombosis, otherwise cont. tx for at least 3mo; to convert from UFH infusion, D/C UFH, then start rivaroxaban immediately; to convert from other anticoagulants, D/C other anticoagulant, then start rivaroxaban 0-2h before next scheduled dose; to convert from warfarin, D/C warfarin, then start rivaroxaban when INR <2.5; depending on bleeding risk, consider holding tx >24h before surgery or invasive procedure; resume tx once hemostasis established; give w/ food; use oral suspension only
- [<18 yo, 10-11.9 kg]
- Dose: 3 mg PO tid; Start: after at least 5 days of parenteral anticoagulant tx; Info: cont. tx for at least 1mo in pts <2 yo w/ catheter-assoc. thrombosis, otherwise cont. tx for at least 3mo; to convert from UFH infusion, D/C UFH, then start rivaroxaban immediately; to convert from other anticoagulants, D/C other anticoagulant, then start rivaroxaban 0-2h before next scheduled dose; to convert from warfarin, D/C warfarin, then start rivaroxaban when INR <2.5; depending on bleeding risk, consider holding tx >24h before surgery or invasive procedure; resume tx once hemostasis established; give w/ food; use oral suspension only
- [<18 yo, 12-29.9 kg]
- Dose: 5 mg PO bid; Start: after at least 5 days of parenteral anticoagulant tx; Info: cont. tx for at least 1mo in pts <2 yo w/ catheter-assoc. thrombosis, otherwise cont. tx for at least 3mo; to convert from UFH infusion, D/C UFH, then start rivaroxaban immediately; to convert from other anticoagulants, D/C other anticoagulant, then start rivaroxaban 0-2h before next scheduled dose; to convert from warfarin, D/C warfarin, then start rivaroxaban when INR <2.5; depending on bleeding risk, consider holding tx >24h before surgery or invasive procedure; resume tx once hemostasis established; give w/ food; use oral suspension only
- [<18 yo, 30-49.9 kg]
- Dose: 15 mg PO qd; Start: after at least 5 days of parenteral anticoagulant tx; Info: cont. tx for at least 1mo in pts <2 yo w/ catheter-assoc. thrombosis, otherwise cont. tx for at least 3mo; to convert from UFH infusion, D/C UFH, then start rivaroxaban immediately; to convert from other anticoagulants, D/C other anticoagulant, then start rivaroxaban 0-2h before next scheduled dose; to convert from warfarin, D/C warfarin, then start rivaroxaban when INR <2.5; depending on bleeding risk, consider holding tx >24h before surgery or invasive procedure; resume tx once hemostasis established; give w/ food
- [<18 yo, >50 kg]
- Dose: 20 mg PO qd; Start: after at least 5 days of parenteral anticoagulant tx; Info: cont. tx for at least 1mo in pts <2 yo w/ catheter-assoc. thrombosis, otherwise cont. tx for at least 3mo; to convert from UFH infusion, D/C UFH, then start rivaroxaban immediately; to convert from other anticoagulants, D/C other anticoagulant, then start rivaroxaban 0-2h before next scheduled dose; to convert from warfarin, D/C warfarin, then start rivaroxaban when INR <2.5; depending on bleeding risk, consider holding tx >24h before surgery or invasive procedure; resume tx once hemostasis established; give w/ food
thromboembolism prophylaxis, post-Fontan procedure
- [2 yo and older, 7-7.9 kg]
- Dose: 1.1 mg PO bid; Info: to convert from UFH infusion, D/C UFH, then start rivaroxaban immediately; to convert from other anticoagulants, D/C other anticoagulant, then start rivaroxaban 0-2h before next scheduled dose; to convert from warfarin, D/C warfarin, then start rivaroxaban when INR <2.5; depending on bleeding risk, consider holding tx >24h before surgery or invasive procedure; resume tx once hemostasis established; use oral suspension only
- [2 yo and older, 8-9.9 kg]
- Dose: 1.6 mg PO bid; Info: to convert from UFH infusion, D/C UFH, then start rivaroxaban immediately; to convert from other anticoagulants, D/C other anticoagulant, then start rivaroxaban 0-2h before next scheduled dose; to convert from warfarin, D/C warfarin, then start rivaroxaban when INR <2.5; depending on bleeding risk, consider holding tx >24h before surgery or invasive procedure; resume tx once hemostasis established; use oral suspension only
- [2 yo and older, 10-11.9 kg]
- Dose: 1.7 mg PO bid; Info: to convert from UFH infusion, D/C UFH, then start rivaroxaban immediately; to convert from other anticoagulants, D/C other anticoagulant, then start rivaroxaban 0-2h before next scheduled dose; to convert from warfarin, D/C warfarin, then start rivaroxaban when INR <2.5; depending on bleeding risk, consider holding tx >24h before surgery or invasive procedure; resume tx once hemostasis established; use oral suspension only
- [2 yo and older, 12-19.9 kg]
- Dose: 2 mg PO bid; Info: to convert from UFH infusion, D/C UFH, then start rivaroxaban immediately; to convert from other anticoagulants, D/C other anticoagulant, then start rivaroxaban 0-2h before next scheduled dose; to convert from warfarin, D/C warfarin, then start rivaroxaban when INR <2.5; depending on bleeding risk, consider holding tx >24h before surgery or invasive procedure; resume tx once hemostasis established; use oral suspension only
- [2 yo and older, 20-29.9 kg]
- Dose: 2.5 mg PO bid; Info: to convert from UFH infusion, D/C UFH, then start rivaroxaban immediately; to convert from other anticoagulants, D/C other anticoagulant, then start rivaroxaban 0-2h before next scheduled dose; to convert from warfarin, D/C warfarin, then start rivaroxaban when INR <2.5; depending on bleeding risk, consider holding tx >24h before surgery or invasive procedure; resume tx once hemostasis established; use oral suspension only
- [2 yo and older, 30-49.9 kg]
- Dose: 7.5 mg PO qd; Info: to convert from UFH infusion, D/C UFH, then start rivaroxaban immediately; to convert from other anticoagulants, D/C other anticoagulant, then start rivaroxaban 0-2h before next scheduled dose; to convert from warfarin, D/C warfarin, then start rivaroxaban when INR <2.5; depending on bleeding risk, consider holding tx >24h before surgery or invasive procedure; resume tx once hemostasis established; use oral suspension only
- [2 yo and older, >50 kg]
- Dose: 10 mg PO qd; Info: to convert from UFH infusion, D/C UFH, then start rivaroxaban immediately; to convert from other anticoagulants, D/C other anticoagulant, then start rivaroxaban 0-2h before next scheduled dose; to convert from warfarin, D/C warfarin, then start rivaroxaban when INR <2.5; depending on bleeding risk, consider holding tx >24h before surgery or invasive procedure; resume tx once hemostasis established
renal dosing
- [<1 yo]
- Cr >97.5th percentile: avoid use; Info: see pkg insert for Cr reference values
- HD/PD: not defined
- [1 yo and older]
- eGFR <50: avoid use
- HD/PD: not defined
hepatic dosing
- [not defined]
Contraindications / Cautions .
- hypersensitivity to drug or ingredient
- bleeding, active major
- bleeding risk, high (VTE prophylaxis use in acutely ill pts)
- hepatic impairment, Child-Pugh Class B-C
- hepatic dz, coagulopathy-associated
- CrCl <15 (DVT prophylaxis, recurrent DVT prophylaxis, recurrent PE prophylaxis, DVT tx, or PE tx use)
- CrCl <15 (VTE prophylaxis use in acutely ill pts)
- acute PE w/ hemodynamic instability
- acute PE requiring thrombolysis
- acute PE requiring pulmonary embolectomy
- heart valve, prosthetic
- antiphospholipid syndrome
- pregnancy
- caution: female pts of reproductive potential
- caution: pts >65 yo
- caution: gestation <37 wk at birth (pts <6 mo)
- caution: oral feeding <10 days (pts <6 mo)
- caution: CrCl <51 (thromboembolism prevention or stroke prevention use)
- caution: CrCl 30-49 (VTE prophylaxis use in pts undergoing cardioversion)
- caution: CrCl 15-30 (DVT prophylaxis, recurrent DVT prophylaxis, recurrent PE prophylaxis, DVT tx, or PE tx use)
- caution: CrCl 15-30 (VTE prophylaxis use in acutely ill pts)
- caution: bleeding risk
- caution: epidural anesthesia use
- caution: spinal anesthesia use, concurrent
- caution: spinal puncture
Drug Interactions .
Overview
rivaroxaban
factor Xa inhibitor
Interaction Characteristics:
- CYP3A4 substrate
- P-gp substrate
- anticoagulant
Contraindicated
- defibrotide
- mifepristone
Avoid/Use Alternative
- abrocitinib
- adagrasib
- alteplase
- amiodarone
- anagrelide
- antithrombin
- apalutamide
- apixaban
- aprepitant
- argatroban
- asciminib
- atazanavir
- avacopan
- azithromycin
- belumosudil
- berotralstat
- bisoprolol
- bivalirudin
- bosentan
- brigatinib
- butalbital
- canagliflozin
- cannabidiol
- caplacizumab
- capmatinib
- captopril
- carbamazepine
- carvedilol
- cenobamate
- ceritinib
- chloramphenicol
- cimetidine
- ciprofloxacin
- clarithromycin
- clofazimine
- cobicistat
- collagenase clostridium histolyticum
- conivaptan
- crizotinib
- cyclosporine
- dabigatran
- dabrafenib
- dalteparin
- danazol
- danicopan
- danshen
- daridorexant
- darunavir
- dicloxacillin
- diltiazem
- diosmin
- dronedarone
- duvelisib
- edoxaban
- efavirenz
- elacestrant
- elagolix
- elexacaftor/tezacaftor/ivacaftor
- eliglustat
- enasidenib
- encorafenib
- enoxaparin
- entrectinib
- enzalutamide
- erdafitinib
- erythromycin
- etravirine
- fedratinib
- felodipine
- fexinidazole
- flibanserin
- fluconazole
- fluvoxamine
- fondaparinux
- fosamprenavir
- fosphenytoin
- fostamatinib
- futibatinib
- gilteritinib
- ginkgo
- glecaprevir
- grapefruit
- heparin
- ibritumomab tiuxetan
- ibrutinib
- idelalisib
- imatinib
- indomethacin
- isavuconazonium
- istradefylline
- itraconazole
- ivacaftor
- ivosidenib
- ketoconazole
- lapatinib
- lasmiditan
- ledipasvir
- lefamulin
- lenacapavir
- letermovir
- levacetylleucine
- levoketoconazole
- lifileucel
- lomitapide
- lonafarnib
- lopinavir/ritonavir
- lorlatinib
- lumacaftor/ivacaftor
- maribavir
- mavacamten
- mavorixafor
- milk thistle
- mirabegron
- mitapivat
- mitotane
- modafinil
- nafcillin
- naproxen
- nefazodone
- nelfinavir
- neratinib
- netupitant
- nifedipine
- nilotinib
- nirogacestat
- omacetaxine mepesuccinate
- osimertinib
- pacritinib
- paroxetine
- pentobarbital
- pexidartinib
- phenobarbital
- phenytoin
- pibrentasvir
- pirtobrutinib
- ponatinib
- posaconazole
- primidone
- propafenone
- quercetin
- quinidine (antiarrhythmic)
- quinidine (CYP2D6 inhibitor)
- quinine
- ranolazine
- repotrectinib
- reteplase
- ribociclib
- rifabutin
- rifampin
- rifapentine
- ritonavir
- rolapitant
- rucaparib
- sarecycline
- selpercatinib
- sorafenib
- sotagliflozin
- sotorasib
- sparsentan
- St. John's wort
- stiripentol
- suvorexant
- tacrolimus
- telmisartan
- temsirolimus
- tenecteplase
- tepotinib
- tezacaftor/ivacaftor
- ticagrelor
- tipranavir
- tolvaptan
- trazodone
- trimethoprim
- tucatinib
- turmeric
- uridine triacetate
- valbenazine
- vandetanib
- vanzacaftor/tezacaftor/deutivacaftor
- velpatasvir
- vemurafenib
- venetoclax
- verapamil
- vimseltinib
- voclosporin
- vorapaxar
- voriconazole
- voxilaprevir
- warfarin
- xanomeline
- zonisamide
Monitor/Modify Tx
- acalabrutinib
- ado-trastuzumab emtansine
- aducanumab
- afatinib
- anacaulase topical
- asparaginase
- aspirin
- avapritinib
- axitinib
- bevacizumab
- binimetinib
- brentuximab vedotin
- bromelain
- bromfenac ophthalmic
- cabazitaxel
- cabozantinib
- calaspargase
- cangrelor
- carfilzomib
- cefaclor
- cefadroxil
- cefazolin
- cefdinir
- cefepime
- cefixime
- cefotetan
- cefoxitin
- cefpodoxime
- cefprozil
- ceftazidime
- ceftriaxone
- cefuroxime axetil
- cefuroxime sodium
- celecoxib
- cephalexin
- cilostazol
- citalopram
- clopidogrel
- cysteamine
- daprodustat
- dasatinib
- deferasirox
- desvenlafaxine
- deuruxolitinib
- diclofenac
- diclofenac ophthalmic
- diclofenac topical
- diflunisal
- dimethyl fumarate
- dipyridamole
- diroximel fumarate
- donanemab
- duloxetine
- epoprostenol
- eptifibatide
- erlotinib
- escitalopram
- etodolac
- evening primrose oil
- fenoprofen
- fenugreek
- fluoxetine
- flurbiprofen
- flurbiprofen ophthalmic
- fruquintinib
- garlic
- gefitinib
- gemtuzumab ozogamicin
- hydrocortisone
- ibuprofen
- ibuprofen lysine
- icosapent ethyl
- iloprost inhaled
- ketoprofen
- ketorolac
- ketorolac ophthalmic
- lecanemab
- lenvatinib
- levomilnacipran
- magnesium salicylate
- meclofenamate
- mefenamic acid
- meloxicam
- methotrexate
- methyl salicylate topical
- milnacipran
- monomethyl fumarate
- mycophenolate mofetil
- mycophenolic acid
- nabumetone
- nattokinase
- nepafenac ophthalmic
- niacin (vitamin B3)
- nintedanib
- nusinersen
- omega-3-acid
- oxaliplatin
- oxaprozin
- pazopanib
- pegaspargase
- penicillin G
- pentosan polysulfate sodium
- pentoxifylline
- piperacillin
- piroxicam
- plasminogen, human
- porfimer
- pralsetinib
- prasugrel
- pretomanid
- ramucirumab
- ranibizumab
- regorafenib
- resveratrol
- salsalate
- saw palmetto
- selumetinib
- sertraline
- sirolimus albumin-bound
- sotatercept
- sugammadex
- sulindac
- sunitinib
- testosterone
- tirofiban
- tisotumab vedotin
- tivozanib
- tolmetin
- tovorafenib
- trametinib
- treprostinil
- upadacitinib
- vadadustat
- valproic acid
- venlafaxine
- vilazodone
- vinpocetine
- vortioxetine
- willow bark
- zanubrutinib
- ziv-aflibercept
Caution Advised
- meropenem
- oxcarbazepine
- vaborbactam
Adverse Reactions .
Serious Reactions
- bleeding, severe
- epidural hematoma
- spinal hematoma
- thrombocytopenia
- agranulocytosis
- hypersensitivity rxn
- Stevens-Johnson syndrome
- drug rxn w/ eosinophilia and systemic sx
- hepatitis
- nephropathy
Common Reactions
- bleeding
- extremity pain (peds pts)
- fatigue (peds pts)
- vomiting (peds pts)
- cough (peds pts)
- gastroenteritis (peds pts)
- pruritus
- back pain
- abdominal pain
- dizziness
Safety/Monitoring .
Monitoring Parameters
LFTs at baseline, then periodically; Cr at baseline, then q6-12mo if CrCl >50 or q3mo if CrCl <50; CBC; BP
Pregnancy/Lactation .
Pregnancy
Clinical Summary
avoid use during pregnancy; inadequate human data available; risk of maternal hemorrhage based on animal data and risk of fetal harm, incl. decr. fetal wt and embryo-fetal death, based on animal data at 4x MRHD; risk of maternal hemorrhage during delivery and fetal bleeding based on drug's mechanism of action
Lactation
Clinical Summary
weigh risk/benefit while breastfeeding; inadequate human data available, though risk of infant harm not expected based on drug properties; no human data available to assess effects on milk production
Pharmacology .
Metabolism: liver; CYP450: 2J2, 3A4/5 substrate
Excretion: urine 66% (36% unchanged), feces 28% (7% unchanged); Half-life: 5-9h, 11-13h (elderly), 1.6-4.2h (peds)
Subclass: Anticoagulants
Mechanism of Action
selectively blocks active site of factor Xa, inhibiting blood coagulation (factor Xa inhibitor)
Formulary .
No Formulary Selected
Manufacturer/Pricing .
Manufacturer: Janssen Pharmaceuticals, Inc.
DEA/FDA: Rx
Approximate Retail Price
from http://www.goodrx.com/xarelto
oral tablet:
- 2.5 mg (60 ea): $512.00
- 10 mg (30 ea): $512.00
- 15 mg (30 ea): $512.00
- 20 mg (30 ea): $512.00
oral kit:
- 15 mg and 20 mg (1 titration pack, 30 days): $864.00
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