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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 patients; hematoma may result in long-term or permanent paralysis; incr. risk if indwelling epidural catheter use, concomitant use of drugs affecting hemostasis including NSAIDs, platelet inhibitors, or other anticoagulants, traumatic or repeated epidural or spinal puncture history, spinal deformity, or spinal surgery history; consider benefit vs. risk before neuraxial intervention in anticoagulated patients or planned anticoagulation for thromboprophylaxis; while optimal timing to minimize risk is unknown, delay epidural catheter removal >18h (for patients 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 signs/symptoms of neurologic impairment, treat urgently if needed
Adult Dosing .
Dosage forms: TAB: 2.5 mg, 10 mg, 15 mg, 20 mg; TAB (DVT/PE tx 30-day starter pack): 15 mg x42 and 20 mg x9; SUSPENSION: 1 mg per mL
thromboembolism/stroke prevention
- [20 mg PO qd]
- Info: for non-valvular atrial fibrillation without 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; do not split tab, but may crush tab; give 20 mg tab with 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; do not split tab, but may crush tab; give 15 mg or 20 mg tab with 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; do not split tab, but may crush tab
DVT prophylaxis
- [hip replacement]
- Dose: 10 mg PO qd x35 days; Start: 6-10h postop once hemostasis established; Info: do not split tab, but may crush tab
- [knee replacement]
- Dose: 10 mg PO qd x12 days; Start: 6-10h postop once hemostasis established; Info: do not split tab, but may crush tab
VTE prophylaxis, acutely ill patients
- [10 mg PO qd]
- Info: for hospitalized patients with moderate-severe restricted mobility and other VTE risk factors, not at high bleeding risk; continue tx x31-39 days total including post-discharge; do not split tab, but may crush tab
cardiovascular event risk reduction
- [2.5 mg PO bid]
- Info: for patients with CAD; give with 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; do not split tab, but may crush tab
thrombotic event risk reduction
- [2.5 mg PO bid]
- Info: for patients with symptomatic peripheral arterial disease and with or without recent lower extremity revascularization; give with aspirin 75-100 mg PO qd; start once hemostasis established in patients with 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; do not split tab, but may crush tab
VTE prophylaxis, cardioversion (off-label)
- [afib/flutter duration <48h]
- Dose: 20 mg PO qd; Start: ASAP before or immediately after cardioversion; Info: for patients with CHA2DS2-VASc score >2; continue tx for at least 4wk after procedure; refer to ACC/AHA/HRS guidelines; do not split tab, but may crush tab; give 20 mg tab with evening meal
- [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; do not split tab, but may crush tab; give 20 mg tab with evening meal
renal dosing
- [thromboembolism/stroke prevention]
- 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-associated hepatic disease: avoid use
Peds Dosing .
- Dosage forms: TAB: 2.5 mg, 10 mg, 15 mg, 20 mg; SUSPENSION: 1 mg per mL
VTE 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: continue tx for at least 1mo in patients <2 yo with catheter-associated thrombosis, otherwise continue 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 with 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: continue tx for at least 1mo in patients <2 yo with catheter-associated thrombosis, otherwise continue 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 with 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: continue tx for at least 1mo in patients <2 yo with catheter-associated thrombosis, otherwise continue 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 with 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: continue tx for at least 1mo in patients <2 yo with catheter-associated thrombosis, otherwise continue 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 with 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: continue tx for at least 1mo in patients <2 yo with catheter-associated thrombosis, otherwise continue 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 with 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: continue tx for at least 1mo in patients <2 yo with catheter-associated thrombosis, otherwise continue 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 with 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: continue tx for at least 1mo in patients <2 yo with catheter-associated thrombosis, otherwise continue 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 with 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: continue tx for at least 1mo in patients <2 yo with catheter-associated thrombosis, otherwise continue 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 with 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: continue tx for at least 1mo in patients <2 yo with catheter-associated thrombosis, otherwise continue 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 with 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: continue tx for at least 1mo in patients <2 yo with catheter-associated thrombosis, otherwise continue 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; do not split tab, but may crush tab; give oral suspension or 15 mg tab with food
- [<18 yo, >50 kg]
- Dose: 20 mg PO qd; Start: after at least 5 days of parenteral anticoagulant tx; Info: continue tx for at least 1mo in patients <2 yo with catheter-associated thrombosis, otherwise continue 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; do not split tab, but may crush tab; give oral suspension or 20 mg tab with food
VTE 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: continue tx for at least 1mo in patients <2 yo with catheter-associated thrombosis, otherwise continue 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 with 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: continue tx for at least 1mo in patients <2 yo with catheter-associated thrombosis, otherwise continue 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 with 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: continue tx for at least 1mo in patients <2 yo with catheter-associated thrombosis, otherwise continue 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 with 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: continue tx for at least 1mo in patients <2 yo with catheter-associated thrombosis, otherwise continue 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 with 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: continue tx for at least 1mo in patients <2 yo with catheter-associated thrombosis, otherwise continue 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 with 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: continue tx for at least 1mo in patients <2 yo with catheter-associated thrombosis, otherwise continue 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 with 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: continue tx for at least 1mo in patients <2 yo with catheter-associated thrombosis, otherwise continue 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 with 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: continue tx for at least 1mo in patients <2 yo with catheter-associated thrombosis, otherwise continue 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 with 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: continue tx for at least 1mo in patients <2 yo with catheter-associated thrombosis, otherwise continue 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 with 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: continue tx for at least 1mo in patients <2 yo with catheter-associated thrombosis, otherwise continue 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; do not split tab, but may crush tab; give oral suspension or 15 mg tab with food
- [<18 yo, >50 kg]
- Dose: 20 mg PO qd; Start: after at least 5 days of parenteral anticoagulant tx; Info: continue tx for at least 1mo in patients <2 yo with catheter-associated thrombosis, otherwise continue 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; do not split tab, but may crush tab; give oral suspension or 20 mg tab with 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; do not split tab, but may crush tab
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 patients)
- hepatic impairment, Child-Pugh Class B-C
- hepatic disease, 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 patients)
- Cr >97.5th percentile (patients <1 yo)
- eGFR <50 (patients 1-17 yo)
- acute PE with hemodynamic instability
- acute PE requiring thrombolysis
- acute PE requiring pulmonary embolectomy
- heart valve, prosthetic
- antiphospholipid syndrome
- pregnancy
- caution: patients of childbearing potential
- caution: patients >65 yo
- caution: gestation <37 wk at birth (patients <6 mo)
- caution: oral feeding <10 days (patients <6 mo)
- caution: CrCl <51 (thromboembolism prevention or stroke prevention use)
- caution: CrCl 30-49 (VTE prophylaxis use in patients 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 patients)
- caution: bleeding risk
- caution: epidural anesthesia use
- caution: spinal anesthesia use
- caution: spinal puncture
Drug Interactions .
Overview
rivaroxaban
factor Xa inhibitor
Interaction Characteristics:
- CYP3A4 substrate
- BCRP substrate
- P-gp substrate
- anticoagulant
Contraindicated
Avoid/Use Alternative
Monitor/Modify Tx
Caution Advised
Adverse Reactions .
Serious Reactions
- bleeding, severe
- epidural hematoma
- spinal hematoma
- thrombocytopenia
- agranulocytosis
- hypersensitivity reaction
- Stevens-Johnson syndrome
- drug reaction with eosinophilia and systemic symptoms
- hepatitis
- nephropathy
- splenic rupture
Common Reactions
- bleeding
- extremity pain (peds patients)
- fatigue (peds patients)
- vomiting (peds patients)
- cough (peds patients)
- gastroenteritis (peds patients)
- 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 fetal harm, including decr. fetal wt and embryo-fetal death, based on animal data at 4x MRHD; risk of hemorrhage in pregnant patients 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: for rivaroxaban: liver; CYP450: 2J2, 3A4/5 substrate
Excretion: for rivaroxaban: 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
for rivaroxaban: selectively blocks active site of factor Xa, inhibiting blood coagulation (factor Xa inhibitor)
Formulary .
No Formulary Selected
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