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mechanism of action is Factor Xa Inhibitors [MoA]

Xarelto

(Rivaroxaban)

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Dosage & Administration

Nonvalvular Atrial Fibrillation

: 15 or 20 mg, once daily with food (

2.1 Recommended Dosage in Adults

Table 1: Recommended Dosage in Adults
Indication	Renal ConsiderationsCalculate CrCl based on actual weight. [See Warnings and Precautions (5.4) and Use in Specific Populations (8.6)]	Dosage	Food/TimingSee Clinical Pharmacology (12.3)
Reduction in Risk of Stroke in Nonvalvular Atrial Fibrillation	CrCl >50 mL/min	20 mg once daily	Take with evening meal
	CrCl ≤50 mL/minPatients with CrCl <30 mL/min were not studied, but administration of XARELTO is expected to result in serum concentrations of rivaroxaban similar to those in patients with moderate renal impairment (CrCl 30 to <50 mL/min) [see Use in Specific Populations (8.6)]	15 mg once daily	Take with evening meal
Treatment of DVT and/or PE	CrCl ≥15 mL/min	15 mg twice daily ▼ after 21 days, transition to ▼ 20 mg once daily	Take with food, at the same time each day
Treatment of DVT and/or PE	CrCl <15 mL/min	Avoid Use
Reduction in the Risk of Recurrence of DVT and/or PE in patients at continued risk for DVT and/or PE	CrCl ≥15 mL/min	10 mg once daily, after at least 6 months of standard anticoagulant treatment	Take with or without food
	CrCl <15 mL/min	Avoid Use
Prophylaxis of DVT Following:
* Hip Replacement Surgery See Dosage and Administration (2.4)	CrCl ≥15 mL/min	10 mg once daily for 35 days, 6–10 hours after surgery once hemostasis has been established	Take with or without food
	CrCl <15 mL/min	Avoid Use
* Knee Replacement Surgery	CrCl ≥15 mL/min	10 mg once daily for 12 days, 6–10 hours after surgery once hemostasis has been established	Take with or without food
* Knee Replacement Surgery	CrCl <15 mL/min	Avoid Use
Prophylaxis of VTE in Acutely Ill Medical Patients at Risk for Thromboembolic Complications Not at High Risk of Bleeding	CrCl ≥15 mL/min	10 mg once daily, in hospital and after hospital discharge, for a total recommended duration of 31 to 39 days	Take with or without food
	CrCl <15 mL/min	Avoid Use
Reduction of Risk of Major Cardiovascular Events (CV Death, MI, and Stroke) in CAD	No dose adjustment needed based on CrCl	2.5 mg twice daily , plus aspirin (75–100 mg) once daily	Take with or without food
Reduction of Risk of Major Thrombotic Vascular Events in PAD, Including Patients after Lower Extremity Revascularization due to Symptomatic PAD	No dose adjustment needed based on CrCl	2.5 mg twice daily , plus aspirin (75–100 mg) once daily. When starting therapy after a successful lower extremity revascularization procedure, initiate once hemostasis has been established.	Take with or without food

)

*

Treatment of DVT and/or PE

: 15 mg orally twice daily with food for the first 21 days followed by 20 mg orally once daily with food for the remaining treatment (

2.1 Recommended Dosage in Adults

Table 1: Recommended Dosage in Adults
Indication	Renal ConsiderationsCalculate CrCl based on actual weight. [See Warnings and Precautions (5.4) and Use in Specific Populations (8.6)]	Dosage	Food/TimingSee Clinical Pharmacology (12.3)
Reduction in Risk of Stroke in Nonvalvular Atrial Fibrillation	CrCl >50 mL/min	20 mg once daily	Take with evening meal
	CrCl ≤50 mL/minPatients with CrCl <30 mL/min were not studied, but administration of XARELTO is expected to result in serum concentrations of rivaroxaban similar to those in patients with moderate renal impairment (CrCl 30 to <50 mL/min) [see Use in Specific Populations (8.6)]	15 mg once daily	Take with evening meal
Treatment of DVT and/or PE	CrCl ≥15 mL/min	15 mg twice daily ▼ after 21 days, transition to ▼ 20 mg once daily	Take with food, at the same time each day
Treatment of DVT and/or PE	CrCl <15 mL/min	Avoid Use
Reduction in the Risk of Recurrence of DVT and/or PE in patients at continued risk for DVT and/or PE	CrCl ≥15 mL/min	10 mg once daily, after at least 6 months of standard anticoagulant treatment	Take with or without food
	CrCl <15 mL/min	Avoid Use
Prophylaxis of DVT Following:
* Hip Replacement Surgery See Dosage and Administration (2.4)	CrCl ≥15 mL/min	10 mg once daily for 35 days, 6–10 hours after surgery once hemostasis has been established	Take with or without food
	CrCl <15 mL/min	Avoid Use
* Knee Replacement Surgery	CrCl ≥15 mL/min	10 mg once daily for 12 days, 6–10 hours after surgery once hemostasis has been established	Take with or without food
* Knee Replacement Surgery	CrCl <15 mL/min	Avoid Use
Prophylaxis of VTE in Acutely Ill Medical Patients at Risk for Thromboembolic Complications Not at High Risk of Bleeding	CrCl ≥15 mL/min	10 mg once daily, in hospital and after hospital discharge, for a total recommended duration of 31 to 39 days	Take with or without food
	CrCl <15 mL/min	Avoid Use
Reduction of Risk of Major Cardiovascular Events (CV Death, MI, and Stroke) in CAD	No dose adjustment needed based on CrCl	2.5 mg twice daily , plus aspirin (75–100 mg) once daily	Take with or without food
Reduction of Risk of Major Thrombotic Vascular Events in PAD, Including Patients after Lower Extremity Revascularization due to Symptomatic PAD	No dose adjustment needed based on CrCl	2.5 mg twice daily , plus aspirin (75–100 mg) once daily. When starting therapy after a successful lower extremity revascularization procedure, initiate once hemostasis has been established.	Take with or without food

)

*

Reduction in the Risk of Recurrence of DVT and/or PE in patients at continued risk for DVT and/or PE

: 10 mg once daily with or without food, after at least 6 months of standard anticoagulant treatment (

2.1 Recommended Dosage in Adults

Table 1: Recommended Dosage in Adults
Indication	Renal ConsiderationsCalculate CrCl based on actual weight. [See Warnings and Precautions (5.4) and Use in Specific Populations (8.6)]	Dosage	Food/TimingSee Clinical Pharmacology (12.3)
Reduction in Risk of Stroke in Nonvalvular Atrial Fibrillation	CrCl >50 mL/min	20 mg once daily	Take with evening meal
	CrCl ≤50 mL/minPatients with CrCl <30 mL/min were not studied, but administration of XARELTO is expected to result in serum concentrations of rivaroxaban similar to those in patients with moderate renal impairment (CrCl 30 to <50 mL/min) [see Use in Specific Populations (8.6)]	15 mg once daily	Take with evening meal
Treatment of DVT and/or PE	CrCl ≥15 mL/min	15 mg twice daily ▼ after 21 days, transition to ▼ 20 mg once daily	Take with food, at the same time each day
Treatment of DVT and/or PE	CrCl <15 mL/min	Avoid Use
Reduction in the Risk of Recurrence of DVT and/or PE in patients at continued risk for DVT and/or PE	CrCl ≥15 mL/min	10 mg once daily, after at least 6 months of standard anticoagulant treatment	Take with or without food
	CrCl <15 mL/min	Avoid Use
Prophylaxis of DVT Following:
* Hip Replacement Surgery See Dosage and Administration (2.4)	CrCl ≥15 mL/min	10 mg once daily for 35 days, 6–10 hours after surgery once hemostasis has been established	Take with or without food
	CrCl <15 mL/min	Avoid Use
* Knee Replacement Surgery	CrCl ≥15 mL/min	10 mg once daily for 12 days, 6–10 hours after surgery once hemostasis has been established	Take with or without food
* Knee Replacement Surgery	CrCl <15 mL/min	Avoid Use
Prophylaxis of VTE in Acutely Ill Medical Patients at Risk for Thromboembolic Complications Not at High Risk of Bleeding	CrCl ≥15 mL/min	10 mg once daily, in hospital and after hospital discharge, for a total recommended duration of 31 to 39 days	Take with or without food
	CrCl <15 mL/min	Avoid Use
Reduction of Risk of Major Cardiovascular Events (CV Death, MI, and Stroke) in CAD	No dose adjustment needed based on CrCl	2.5 mg twice daily , plus aspirin (75–100 mg) once daily	Take with or without food
Reduction of Risk of Major Thrombotic Vascular Events in PAD, Including Patients after Lower Extremity Revascularization due to Symptomatic PAD	No dose adjustment needed based on CrCl	2.5 mg twice daily , plus aspirin (75–100 mg) once daily. When starting therapy after a successful lower extremity revascularization procedure, initiate once hemostasis has been established.	Take with or without food

)

*

Prophylaxis of DVT Following Hip or Knee Replacement Surgery

: 10 mg orally once daily with or without food (

2.1 Recommended Dosage in Adults

Table 1: Recommended Dosage in Adults
Indication	Renal ConsiderationsCalculate CrCl based on actual weight. [See Warnings and Precautions (5.4) and Use in Specific Populations (8.6)]	Dosage	Food/TimingSee Clinical Pharmacology (12.3)
Reduction in Risk of Stroke in Nonvalvular Atrial Fibrillation	CrCl >50 mL/min	20 mg once daily	Take with evening meal
	CrCl ≤50 mL/minPatients with CrCl <30 mL/min were not studied, but administration of XARELTO is expected to result in serum concentrations of rivaroxaban similar to those in patients with moderate renal impairment (CrCl 30 to <50 mL/min) [see Use in Specific Populations (8.6)]	15 mg once daily	Take with evening meal
Treatment of DVT and/or PE	CrCl ≥15 mL/min	15 mg twice daily ▼ after 21 days, transition to ▼ 20 mg once daily	Take with food, at the same time each day
Treatment of DVT and/or PE	CrCl <15 mL/min	Avoid Use
Reduction in the Risk of Recurrence of DVT and/or PE in patients at continued risk for DVT and/or PE	CrCl ≥15 mL/min	10 mg once daily, after at least 6 months of standard anticoagulant treatment	Take with or without food
	CrCl <15 mL/min	Avoid Use
Prophylaxis of DVT Following:
* Hip Replacement Surgery See Dosage and Administration (2.4)	CrCl ≥15 mL/min	10 mg once daily for 35 days, 6–10 hours after surgery once hemostasis has been established	Take with or without food
	CrCl <15 mL/min	Avoid Use
* Knee Replacement Surgery	CrCl ≥15 mL/min	10 mg once daily for 12 days, 6–10 hours after surgery once hemostasis has been established	Take with or without food
* Knee Replacement Surgery	CrCl <15 mL/min	Avoid Use
Prophylaxis of VTE in Acutely Ill Medical Patients at Risk for Thromboembolic Complications Not at High Risk of Bleeding	CrCl ≥15 mL/min	10 mg once daily, in hospital and after hospital discharge, for a total recommended duration of 31 to 39 days	Take with or without food
	CrCl <15 mL/min	Avoid Use
Reduction of Risk of Major Cardiovascular Events (CV Death, MI, and Stroke) in CAD	No dose adjustment needed based on CrCl	2.5 mg twice daily , plus aspirin (75–100 mg) once daily	Take with or without food
Reduction of Risk of Major Thrombotic Vascular Events in PAD, Including Patients after Lower Extremity Revascularization due to Symptomatic PAD	No dose adjustment needed based on CrCl	2.5 mg twice daily , plus aspirin (75–100 mg) once daily. When starting therapy after a successful lower extremity revascularization procedure, initiate once hemostasis has been established.	Take with or without food

)

*

Prophylaxis of VTE in Acutely Ill Medical Patients at Risk for Thromboembolic Complications Not at High Risk of Bleeding

: 10 mg once daily, with or without food, in hospital and after hospital discharge for a total recommended duration of 31 to 39 days (

2.1 Recommended Dosage in Adults

Table 1: Recommended Dosage in Adults
Indication	Renal ConsiderationsCalculate CrCl based on actual weight. [See Warnings and Precautions (5.4) and Use in Specific Populations (8.6)]	Dosage	Food/TimingSee Clinical Pharmacology (12.3)
Reduction in Risk of Stroke in Nonvalvular Atrial Fibrillation	CrCl >50 mL/min	20 mg once daily	Take with evening meal
	CrCl ≤50 mL/minPatients with CrCl <30 mL/min were not studied, but administration of XARELTO is expected to result in serum concentrations of rivaroxaban similar to those in patients with moderate renal impairment (CrCl 30 to <50 mL/min) [see Use in Specific Populations (8.6)]	15 mg once daily	Take with evening meal
Treatment of DVT and/or PE	CrCl ≥15 mL/min	15 mg twice daily ▼ after 21 days, transition to ▼ 20 mg once daily	Take with food, at the same time each day
Treatment of DVT and/or PE	CrCl <15 mL/min	Avoid Use
Reduction in the Risk of Recurrence of DVT and/or PE in patients at continued risk for DVT and/or PE	CrCl ≥15 mL/min	10 mg once daily, after at least 6 months of standard anticoagulant treatment	Take with or without food
	CrCl <15 mL/min	Avoid Use
Prophylaxis of DVT Following:
* Hip Replacement Surgery See Dosage and Administration (2.4)	CrCl ≥15 mL/min	10 mg once daily for 35 days, 6–10 hours after surgery once hemostasis has been established	Take with or without food
	CrCl <15 mL/min	Avoid Use
* Knee Replacement Surgery	CrCl ≥15 mL/min	10 mg once daily for 12 days, 6–10 hours after surgery once hemostasis has been established	Take with or without food
* Knee Replacement Surgery	CrCl <15 mL/min	Avoid Use
Prophylaxis of VTE in Acutely Ill Medical Patients at Risk for Thromboembolic Complications Not at High Risk of Bleeding	CrCl ≥15 mL/min	10 mg once daily, in hospital and after hospital discharge, for a total recommended duration of 31 to 39 days	Take with or without food
	CrCl <15 mL/min	Avoid Use
Reduction of Risk of Major Cardiovascular Events (CV Death, MI, and Stroke) in CAD	No dose adjustment needed based on CrCl	2.5 mg twice daily , plus aspirin (75–100 mg) once daily	Take with or without food
Reduction of Risk of Major Thrombotic Vascular Events in PAD, Including Patients after Lower Extremity Revascularization due to Symptomatic PAD	No dose adjustment needed based on CrCl	2.5 mg twice daily , plus aspirin (75–100 mg) once daily. When starting therapy after a successful lower extremity revascularization procedure, initiate once hemostasis has been established.	Take with or without food

)

*

CAD or PAD

: 2.5 mg orally twice daily with or without food, in combination with aspirin (75–100 mg) once daily (

2.1 Recommended Dosage in Adults

Table 1: Recommended Dosage in Adults
Indication	Renal ConsiderationsCalculate CrCl based on actual weight. [See Warnings and Precautions (5.4) and Use in Specific Populations (8.6)]	Dosage	Food/TimingSee Clinical Pharmacology (12.3)
Reduction in Risk of Stroke in Nonvalvular Atrial Fibrillation	CrCl >50 mL/min	20 mg once daily	Take with evening meal
	CrCl ≤50 mL/minPatients with CrCl <30 mL/min were not studied, but administration of XARELTO is expected to result in serum concentrations of rivaroxaban similar to those in patients with moderate renal impairment (CrCl 30 to <50 mL/min) [see Use in Specific Populations (8.6)]	15 mg once daily	Take with evening meal
Treatment of DVT and/or PE	CrCl ≥15 mL/min	15 mg twice daily ▼ after 21 days, transition to ▼ 20 mg once daily	Take with food, at the same time each day
Treatment of DVT and/or PE	CrCl <15 mL/min	Avoid Use
Reduction in the Risk of Recurrence of DVT and/or PE in patients at continued risk for DVT and/or PE	CrCl ≥15 mL/min	10 mg once daily, after at least 6 months of standard anticoagulant treatment	Take with or without food
	CrCl <15 mL/min	Avoid Use
Prophylaxis of DVT Following:
* Hip Replacement Surgery See Dosage and Administration (2.4)	CrCl ≥15 mL/min	10 mg once daily for 35 days, 6–10 hours after surgery once hemostasis has been established	Take with or without food
	CrCl <15 mL/min	Avoid Use
* Knee Replacement Surgery	CrCl ≥15 mL/min	10 mg once daily for 12 days, 6–10 hours after surgery once hemostasis has been established	Take with or without food
* Knee Replacement Surgery	CrCl <15 mL/min	Avoid Use
Prophylaxis of VTE in Acutely Ill Medical Patients at Risk for Thromboembolic Complications Not at High Risk of Bleeding	CrCl ≥15 mL/min	10 mg once daily, in hospital and after hospital discharge, for a total recommended duration of 31 to 39 days	Take with or without food
	CrCl <15 mL/min	Avoid Use
Reduction of Risk of Major Cardiovascular Events (CV Death, MI, and Stroke) in CAD	No dose adjustment needed based on CrCl	2.5 mg twice daily , plus aspirin (75–100 mg) once daily	Take with or without food
Reduction of Risk of Major Thrombotic Vascular Events in PAD, Including Patients after Lower Extremity Revascularization due to Symptomatic PAD	No dose adjustment needed based on CrCl	2.5 mg twice daily , plus aspirin (75–100 mg) once daily. When starting therapy after a successful lower extremity revascularization procedure, initiate once hemostasis has been established.	Take with or without food

)

*

Pediatric Patients:

See dosing recommendations in the Full Prescribing Information (

2.2 Recommended Dosage in Pediatric Patients

Treatment of Venous Thromboembolism and Reduction in Risk of Recurrent Venous Thromboembolism in Pediatric Patients

Table 2: Recommended Dosage in Pediatric Patients Birth to Less than 18 Years for Treatment of and Reduction in Risk of Recurrent VTEInitiate XARELTO treatment following at least 5 days of initial parenteral anticoagulation therapy.^,Patients <6 months of age should meet the following criteria: at birth were at least 37 weeks of gestation, have had at least 10 days of oral feeding, and weigh ≥2.6 kg at the time of dosing.
Dosage Form	Body Weight	1 mg XARELTO = 1 mL Suspension
		Dosage			Total Daily DoseAll doses should be taken with feeding or with food since exposures match that of 20 mg daily dose in adults.
		Once a DayOnce a day: approximately 24 hours apart; 2 times a day: approximately 12 hours apart; 3 times a day: approximately 8 hours apart	2 Times a Day	3 Times a Day
Oral Suspension Only	2.6 kg to 2.9 kg			0.8 mg	2.4 mg
	3 kg to 3.9 kg			0.9 mg	2.7 mg
	4 kg to 4.9 kg			1.4 mg	4.2 mg
	5 kg to 6.9 kg			1.6 mg	4.8 mg
	7 kg to 7.9 kg			1.8 mg	5.4 mg
	8 kg to 8.9 kg			2.4 mg	7.2 mg
	9 kg to 9.9 kg			2.8 mg	8.4 mg
	10 kg to 11.9 kg			3 mg	9 mg
	12 kg to 29.9 kg		5 mg		10 mg
Oral Suspension or Tablets	30 kg to 49.9 kg	15 mg			15 mg
Oral Suspension or Tablets	≥50 kg	20 mg			20 mg

Dosing of XARELTO was not studied and therefore dosing cannot be reliably determined in the following patient populations. Its use is therefore not recommended in children less than 6 months of age with any of the following:

* Less than 37 weeks of gestation at birth
* Less than 10 days of oral feeding
* Body weight of less than 2.6 kg.

To increase absorption, all doses should be taken with feeding or with food.

Monitor the child's weight and review the dose regularly, especially for children below 12 kg. This is to ensure a therapeutic dose is maintained.

All pediatric patients (except <2 years old with catheter-related thrombosis):

Therapy with XARELTO should be continued for at least 3 months in children with thrombosis. Treatment can be extended up to 12 months when clinically necessary. The benefit of continued therapy beyond 3 months should be assessed on an individual basis taking into account the risk for recurrent thrombosis versus the potential risk of bleeding.

Pediatric patients <2 years old with catheter-related thrombosis:

Therapy with XARELTO should be continued for at least 1 month in children less than 2 years old with catheter-related thrombosis. Treatment can be extended up to 3 months when clinically necessary. The benefit of continued therapy beyond 1 month should be assessed on an individual basis taking into account the risk for recurrent thrombosis versus the potential risk of bleeding.

Thromboprophylaxis in Pediatric Patients with Congenital Heart Disease after the Fontan Procedure

Table 3: Recommended Dosage for Thromboprophylaxis in Pediatric Patients with Congenital Heart Disease
Dosage Form	Body Weight	1 mg XARELTO = 1 mL Suspension
		Dosage		Total Daily DoseAll doses can be taken with or without food since exposures match that of 10 mg daily dose in adults.
		Once a DayOnce a day: approximately 24 hours apart; 2 times a day: approximately 12 hours apart.	2 Times a Day
Oral Suspension Only	7 kg to 7.9 kg		1.1 mg	2.2 mg
	8 kg to 9.9 kg		1.6 mg	3.2 mg
	10 kg to 11.9 kg		1.7 mg	3.4 mg
	12 kg to 19.9 kg		2 mg	4 mg
	20 kg to 29.9 kg		2.5 mg	5 mg
	30 kg to 49.9 kg	7.5 mg		7.5 mg
Oral Suspension or Tablets	≥50 kg	10 mg		10 mg

Administration in Pediatric Patients

Food Effect:

For the treatment of VTE in children, the dose should be taken with food to increase absorption.

For thromboprophylaxis after Fontan procedure, the dose can be taken with or without food.

Vomit or Spit up:

If the patient vomits or spits up the dose within 30 minutes after receiving the dose, a new dose should be given. However, if the patient vomits more than 30 minutes after the dose is taken, the dose should not be re-administered and the next dose should be taken as scheduled. If the patient vomits or spits up the dose repeatedly, the caregiver should contact the child's doctor right away.

Tablets:

XARELTO tablet must not be split in an attempt to provide a fraction of a tablet dose.

For children unable to swallow 10, 15, or 20 mg whole tablets, XARELTO oral suspension should be used. XARELTO 2.5 mg tablets are not recommended for use in pediatric patients

[see Use in Specific Populations (8.4)]

Use in Renal Impairment in Pediatric Patients

Patients 1 Year of Age or Older

* Mild renal impairment (eGFR: 50 to ≤ 80 mL/min/1.73 m²): No dose adjustment is required.
* Moderate or severe renal impairment (eGFR: <50 mL/min/1.73 m²): avoid use, as limited clinical data are available.

Estimated glomerular filtration rate (eGFR) can be done using the updated Schwartz formula, eGFR (Schwartz) = (0.413 × height in cm)/serum creatinine in mg/dL, if serum creatinine (SCr) is measured by an enzymatic creatinine method that has been calibrated to be traceable to isotope dilution mass spectrometry (IDMS).

If SCr is measured with routine methods that have not been recalibrated to be traceable to IDMS (e.g., the traditional Jaffé reaction), the eGFR should be obtained from the original Schwartz formula: eGFR (mL/min/1.73 m²) = k * height (cm)/SCr (mg/dL), where k is proportionality constant:

* k = 0.55 in children 1 year to 13 years
* k = 0.55 in girls > 13 and < 18 years
* k = 0.70 in boys > 13 and < 18 years

Patients Less than 1 Year of Age

Determine renal function using serum creatinine. Avoid use of XARELTO in pediatric patients younger than 1 year with serum creatinine results above 97.5^thpercentile, as no clinical data are available.

Table 4: Reference Values of Serum Creatinine in Pediatric Patients <1 Year of Age
Age	97.5^thPercentile of Creatinine (mg/dL)	97.5^thPercentile of Creatinine (µmol/L)
Week 2	0.52	46
Week 3	0.46	41
Week 4	0.42	37
Month 2	0.37	33
Month 3	0.34	30
Month 4–6	0.34	30
Month 7–9	0.34	30
Month 10–12	0.36	32

)

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Xarelto Prescribing Information

WARNING: (A) PREMATURE DISCONTINUATION OF XARELTO INCREASES THE RISK OF THROMBOTIC EVENTS, (B) SPINAL/EPIDURAL HEMATOMA

See full prescribing information for complete boxed warning.

(A) Premature discontinuation of XARELTO increases the risk of thrombotic events

Premature discontinuation of any oral anticoagulant, including XARELTO, increases the risk of thrombotic events. To reduce this risk, consider coverage with another anticoagulant if XARELTO is discontinued for a reason other than pathological bleeding or completion of a course of therapy. (

2.2 Recommended Dosage in Pediatric Patients

Treatment of Venous Thromboembolism and Reduction in Risk of Recurrent Venous Thromboembolism in Pediatric Patients

Table 2: Recommended Dosage in Pediatric Patients Birth to Less than 18 Years for Treatment of and Reduction in Risk of Recurrent VTEInitiate XARELTO treatment following at least 5 days of initial parenteral anticoagulation therapy.^,Patients <6 months of age should meet the following criteria: at birth were at least 37 weeks of gestation, have had at least 10 days of oral feeding, and weigh ≥2.6 kg at the time of dosing.
Dosage Form	Body Weight	1 mg XARELTO = 1 mL Suspension
		Dosage			Total Daily DoseAll doses should be taken with feeding or with food since exposures match that of 20 mg daily dose in adults.
		Once a DayOnce a day: approximately 24 hours apart; 2 times a day: approximately 12 hours apart; 3 times a day: approximately 8 hours apart	2 Times a Day	3 Times a Day
Oral Suspension Only	2.6 kg to 2.9 kg			0.8 mg	2.4 mg
	3 kg to 3.9 kg			0.9 mg	2.7 mg
	4 kg to 4.9 kg			1.4 mg	4.2 mg
	5 kg to 6.9 kg			1.6 mg	4.8 mg
	7 kg to 7.9 kg			1.8 mg	5.4 mg
	8 kg to 8.9 kg			2.4 mg	7.2 mg
	9 kg to 9.9 kg			2.8 mg	8.4 mg
	10 kg to 11.9 kg			3 mg	9 mg
	12 kg to 29.9 kg		5 mg		10 mg
Oral Suspension or Tablets	30 kg to 49.9 kg	15 mg			15 mg
Oral Suspension or Tablets	≥50 kg	20 mg			20 mg

Less than 37 weeks of gestation at birth
Less than 10 days of oral feeding
Body weight of less than 2.6 kg.

To increase absorption, all doses should be taken with feeding or with food.

Monitor the child's weight and review the dose regularly, especially for children below 12 kg. This is to ensure a therapeutic dose is maintained.

All pediatric patients (except <2 years old with catheter-related thrombosis):

Pediatric patients <2 years old with catheter-related thrombosis:

Thromboprophylaxis in Pediatric Patients with Congenital Heart Disease after the Fontan Procedure

Table 3: Recommended Dosage for Thromboprophylaxis in Pediatric Patients with Congenital Heart Disease
Dosage Form	Body Weight	1 mg XARELTO = 1 mL Suspension
		Dosage		Total Daily DoseAll doses can be taken with or without food since exposures match that of 10 mg daily dose in adults.
		Once a DayOnce a day: approximately 24 hours apart; 2 times a day: approximately 12 hours apart.	2 Times a Day
Oral Suspension Only	7 kg to 7.9 kg		1.1 mg	2.2 mg
	8 kg to 9.9 kg		1.6 mg	3.2 mg
	10 kg to 11.9 kg		1.7 mg	3.4 mg
	12 kg to 19.9 kg		2 mg	4 mg
	20 kg to 29.9 kg		2.5 mg	5 mg
	30 kg to 49.9 kg	7.5 mg		7.5 mg
Oral Suspension or Tablets	≥50 kg	10 mg		10 mg

Administration in Pediatric Patients

Food Effect:

For the treatment of VTE in children, the dose should be taken with food to increase absorption.

For thromboprophylaxis after Fontan procedure, the dose can be taken with or without food.

Vomit or Spit up:

Tablets:

XARELTO tablet must not be split in an attempt to provide a fraction of a tablet dose.

For children unable to swallow 10, 15, or 20 mg whole tablets, XARELTO oral suspension should be used. XARELTO 2.5 mg tablets are not recommended for use in pediatric patients

[see Use in Specific Populations (8.4)]

Use in Renal Impairment in Pediatric Patients

Patients 1 Year of Age or Older

Mild renal impairment (eGFR: 50 to ≤ 80 mL/min/1.73 m²): No dose adjustment is required.
Moderate or severe renal impairment (eGFR: <50 mL/min/1.73 m²): avoid use, as limited clinical data are available.

k = 0.55 in children 1 year to 13 years
k = 0.55 in girls > 13 and < 18 years
k = 0.70 in boys > 13 and < 18 years

Patients Less than 1 Year of Age

Table 4: Reference Values of Serum Creatinine in Pediatric Patients <1 Year of Age
Age	97.5^thPercentile of Creatinine (mg/dL)	97.5^thPercentile of Creatinine (µmol/L)
Week 2	0.52	46
Week 3	0.46	41
Week 4	0.42	37
Month 2	0.37	33
Month 3	0.34	30
Month 4–6	0.34	30
Month 7–9	0.34	30
Month 10–12	0.36	32

2.3 Switching to and from XARELTO

Switching from Warfarin to XARELTO

- When switching patients from warfarin to XARELTO, discontinue warfarin and start XARELTO as soon as the International Normalized Ratio (INR) is below 3.0 in adults and below 2.5 in pediatric patients to avoid periods of inadequate anticoagulation.

Switching from XARELTO to Warfarin –

Adults:

No clinical trial data are available to guide converting patients from XARELTO to warfarin. XARELTO affects INR, so INR measurements made during coadministration with warfarin may not be useful for determining the appropriate dose of warfarin. One approach is to discontinue XARELTO and begin both a parenteral anticoagulant and warfarin at the time the next dose of XARELTO would have been taken.

Pediatric Patients:

To ensure adequate anticoagulation during the transition from XARELTO to warfarin, continue XARELTO for at least 2 days after the first dose of warfarin. After 2 days of co-administration, an INR should be obtained prior to the next scheduled dose of XARELTO. Co-administration of XARELTO and warfarin is advised to continue until the INR is ≥ 2.0.

Once XARELTO is discontinued, INR testing may be done reliably 24 hours after the last dose.

Switching from XARELTO to Anticoagulants other than Warfarin

- For adult and pediatric patients currently taking XARELTO and transitioning to an anticoagulant with rapid onset, discontinue XARELTO and give the first dose of the other anticoagulant (oral or parenteral) at the time that the next XARELTO dose would have been taken

[see Drug Interactions (7.4)]

Switching from Anticoagulants other than Warfarin to XARELTO -

For adult and pediatric patients currently receiving an anticoagulant other than warfarin, start XARELTO 0 to 2 hours prior to the next scheduled administration of the drug (e.g., low molecular weight heparin or non-warfarin oral anticoagulant) and omit administration of the other anticoagulant. For unfractionated heparin being administered by continuous infusion, stop the infusion and start XARELTO at the same time.

5.1 Increased Risk of Thrombotic Events after Premature Discontinuation

Premature discontinuation of any oral anticoagulant, including XARELTO, in the absence of adequate alternative anticoagulation increases the risk of thrombotic events. An increased rate of stroke was observed during the transition from XARELTO to warfarin in clinical trials in atrial fibrillation patients. If XARELTO is discontinued for a reason other than pathological bleeding or completion of a course of therapy, consider coverage with another anticoagulant

[see Dosage and Administration (2.3, 2.4)and Clinical Studies (14.1)]

14.1 Stroke Prevention in Nonvalvular Atrial Fibrillation

The evidence for the efficacy and safety of XARELTO was derived from

ivaroxaban

nce-daily oral direct factor Xa inhibition

ompared with vitamin

antagonist for the prevention of stroke and

mbolism

rial in

trial

ibrillation (ROCKET AF) [NCT00403767], a multi-national, double-blind study comparing XARELTO (at a dose of 20 mg once daily with the evening meal in patients with CrCl >50 mL/min and 15 mg once daily with the evening meal in patients with CrCl 30 to 50 mL/min) to warfarin (titrated to INR 2.0 to 3.0) to reduce the risk of stroke and non-central nervous system (CNS) systemic embolism in patients with nonvalvular atrial fibrillation (AF). Patients had to have one or more of the following additional risk factors for stroke:

a prior stroke (ischemic or unknown type), transient ischemic attack (TIA) or non-CNS systemic embolism, or
2 or more of the following risk factors:
- age ≥75 years,
- hypertension,
- heart failure or left ventricular ejection fraction ≤35%, or
- diabetes mellitus

ROCKET AF was a non-inferiority study designed to demonstrate that XARELTO preserved more than 50% of warfarin's effect on stroke and non-CNS systemic embolism as established by previous placebo-controlled studies of warfarin in atrial fibrillation.

A total of 14264 patients were randomized and followed on study treatment for a median of 590 days. The mean age was 71 years and the mean CHADS₂score was 3.5. The population was 60% male, 83% Caucasian, 13% Asian and 1.3% Black. There was a history of stroke, TIA, or non-CNS systemic embolism in 55% of patients, and 38% of patients had not taken a vitamin K antagonist (VKA) within 6 weeks at time of screening. Concomitant diseases of patients in this study included hypertension 91%, diabetes 40%, congestive heart failure 63%, and prior myocardial infarction 17%. At baseline, 37% of patients were on aspirin (almost exclusively at a dose of 100 mg or less) and few patients were on clopidogrel. Patients were enrolled in Eastern Europe (39%); North America (19%); Asia, Australia, and New Zealand (15%); Western Europe (15%); and Latin America (13%). Patients randomized to warfarin had a mean percentage of time in the INR target range of 2.0 to 3.0 of 55%, lower during the first few months of the study.

In ROCKET AF, XARELTO was demonstrated non-inferior to warfarin for the primary composite endpoint of time to first occurrence of stroke (any type) or non-CNS systemic embolism [HR (95% CI): 0.88 (0.74, 1.03)], but superiority to warfarin was not demonstrated. There is insufficient experience to determine how XARELTO and warfarin compare when warfarin therapy is well-controlled.

Table 19 displays the overall results for the primary composite endpoint and its components.

Table 19: Primary Composite Endpoint Results in ROCKET AF Study (Intent-to-Treat Population)
	XARELTO		Warfarin		XARELTO vs. Warfarin
Event	N=7081 n (%)	Event Rate (per 100 Pt-yrs)	N=7090 n (%)	Event Rate (per 100 Pt-yrs)	Hazard Ratio (95% CI)
Primary Composite EndpointThe primary endpoint was the time to first occurrence of stroke (any type) or non-CNS systemic embolism. Data are shown for all randomized patients followed to site notification that the study would end.	269 (3.8)	2.1	306 (4.3)	2.4	0.88 (0.74, 1.03)
Stroke	253 (3.6)	2.0	281 (4.0)	2.2
Hemorrhagic StrokeDefined as primary hemorrhagic strokes confirmed by adjudication in all randomized patients followed up to site notification	33 (0.5)	0.3	57 (0.8)	0.4
Ischemic Stroke	206 (2.9)	1.6	208 (2.9)	1.6
Unknown Stroke Type	19 (0.3)	0.2	18 (0.3)	0.1
Non-CNS Systemic Embolism	20 (0.3)	0.2	27 (0.4)	0.2

Figure 4 is a plot of the time from randomization to the occurrence of the first primary endpoint event in the two treatment arms.

Figure 4: Time to First Occurrence of Stroke (any type) or Non-CNS Systemic Embolism by Treatment Group (Intent-to-Treat Population)

Referenced Image

Figure 5 shows the risk of stroke or non-CNS systemic embolism across major subgroups.

Note: The figure above presents effects in various subgroups all of which are baseline characteristics and all of which were pre-specified (diabetic status was not pre-specified in the subgroup, but was a criterion for the CHADS2 score). The 95% confidence limits that are shown do not take into account how many comparisons were made, nor do they reflect the effect of a particular factor after adjustment for all other factors. Apparent homogeneity or heterogeneity among groups should not be over-interpreted.

Figure 5: Risk of Stroke or Non-CNS Systemic Embolism by Baseline Characteristics in ROCKET AFData are shown for all randomized patients followed to site notification that the study would end.(Intent-to-Treat Population)

Referenced Image

The efficacy of XARELTO was generally consistent across major subgroups.

The protocol for ROCKET AF did not stipulate anticoagulation after study drug discontinuation, but warfarin patients who completed the study were generally maintained on warfarin. XARELTO patients were generally switched to warfarin without a period of coadministration of warfarin and XARELTO, so that they were not adequately anticoagulated after stopping XARELTO until attaining a therapeutic INR. During the 28 days following the end of the study, there were 22 strokes in the 4637 patients taking XARELTO vs. 6 in the 4691 patients taking warfarin.

Few patients in ROCKET AF underwent electrical cardioversion for atrial fibrillation. The utility of XARELTO for preventing post-cardioversion stroke and systemic embolism is unknown.

Figure 4

Figure 5

)

(B) Spinal/epidural hematoma

Epidural or spinal hematomas have occurred in patients treated with XARELTO who are receiving neuraxial anesthesia or undergoing spinal puncture. These hematomas may result in long-term or permanent paralysis. (

5.2 Risk of Bleeding

XARELTO increases the risk of bleeding, including in any organ, and can cause serious or fatal bleeding. In deciding whether to prescribe XARELTO to patients at increased risk of bleeding, the risk of thrombotic events should be weighed against the risk of bleeding.

Promptly evaluate any signs or symptoms of blood loss and consider the need for blood replacement. Discontinue XARELTO in patients with active pathological hemorrhage. The terminal elimination half-life of rivaroxaban is 5 to 9 hours in healthy subjects aged 20 to 45 years.

Concomitant use of other drugs that impair hemostasis increases the risk of bleeding. These include aspirin, P2Y₁₂platelet inhibitors, dual antiplatelet therapy, other antithrombotic agents, fibrinolytic therapy, non-steroidal anti-inflammatory drugs (NSAIDs)

[see Drug Interactions (7.4)]

, selective serotonin reuptake inhibitors, and serotonin norepinephrine reuptake inhibitors.

Concomitant use of drugs that are known combined P-gp and strong CYP3A inhibitors increases rivaroxaban exposure and may increase bleeding risk

[see Drug Interactions (7.2)]

Risk of Hemorrhage in Acutely Ill Medical Patients at High Risk of Bleeding

Acutely ill medical patients with the following conditions are at increased risk of bleeding with the use of XARELTO for 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. XARELTO is not for use for primary VTE prophylaxis in these hospitalized, acutely ill medical patients at high risk of bleeding.

Reversal of Anticoagulant Effect

An agent to reverse the anti-factor Xa activity of rivaroxaban is available. Because of high plasma protein binding, rivaroxaban is not dialyzable

[see Clinical Pharmacology (12.3)]

. Protamine sulfate and vitamin K are not expected to affect the anticoagulant activity of rivaroxaban. Use of procoagulant reversal agents, such as prothrombin complex concentrate (PCC), activated prothrombin complex concentrate or recombinant factor VIIa, may be considered but has not been evaluated in clinical efficacy and safety studies. Monitoring for the anticoagulation effect of rivaroxaban using a clotting test (PT, INR or aPTT) or anti-factor Xa (FXa) activity is not recommended.

5.3 Spinal/Epidural Anesthesia or Puncture

When neuraxial anesthesia (spinal/epidural anesthesia) or spinal puncture is employed, patients treated with anticoagulant agents for prevention of thromboembolic complications are at risk of developing an epidural or spinal hematoma which can result in long-term or permanent paralysis

[see Boxed Warning]

To reduce the potential risk of bleeding associated with the concurrent use of XARELTO and epidural or spinal anesthesia/analgesia or spinal puncture, consider the pharmacokinetic profile of XARELTO

[see Clinical Pharmacology (12.3)]

. Placement or removal of an epidural catheter or lumbar puncture is best performed when the anticoagulant effect of XARELTO is low; however, the exact timing to reach a sufficiently low anticoagulant effect in each patient is not known.

An indwelling epidural or intrathecal catheter should not be removed before at least 2 half-lives have elapsed (i.e., 18 hours in young patients aged 20 to 45 years and 26 hours in elderly patients aged 60 to 76 years), after the last administration of XARELTO

[see Clinical Pharmacology (12.3)]

. The next XARELTO dose should not be administered earlier than 6 hours after the removal of the catheter. If traumatic puncture occurs, delay the administration of XARELTO for 24 hours.

Should the physician decide to administer anticoagulation in the context of epidural or spinal anesthesia/analgesia or lumbar puncture, monitor frequently to detect any signs or symptoms of neurological impairment, such as midline back pain, sensory and motor deficits (numbness, tingling, or weakness in lower limbs), bowel and/or bladder dysfunction. Instruct patients to immediately report if they experience any of the above signs or symptoms. If signs or symptoms of spinal hematoma are suspected, initiate urgent diagnosis and treatment including consideration for spinal cord decompression even though such treatment may not prevent or reverse neurological sequelae.

6.2 Postmarketing Experience

The following adverse reactions have been identified during post-approval use of XARELTO. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Blood and lymphatic system disorders:

agranulocytosis, thrombocytopenia

Hepatobiliary disorders:

jaundice, cholestasis, hepatitis (including hepatocellular injury)

Immune system disorders:

hypersensitivity, anaphylactic reaction, anaphylactic shock, angioedema

Nervous system disorders:

hemiparesis

Renal disorders:

Anticoagulant-related nephropathy

Respiratory, thoracic and mediastinal disorders:

Eosinophilic pneumonia

Skin and subcutaneous tissue disorders:

Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms (DRESS)

Injury, poisoning and procedural complications:

Atraumatic splenic rupture

)

Monitor patients frequently for signs and symptoms of neurological impairment and if observed, treat urgently. Consider the benefits and risks before neuraxial intervention in patients who are or who need to be anticoagulated. (

5.3 Spinal/Epidural Anesthesia or Puncture

[see Boxed Warning]

To reduce the potential risk of bleeding associated with the concurrent use of XARELTO and epidural or spinal anesthesia/analgesia or spinal puncture, consider the pharmacokinetic profile of XARELTO

[see Clinical Pharmacology (12.3)]

. The next XARELTO dose should not be administered earlier than 6 hours after the removal of the catheter. If traumatic puncture occurs, delay the administration of XARELTO for 24 hours.

)

Warnings and Precautions (

5.2 Risk of Bleeding

[see Drug Interactions (7.4)]

, selective serotonin reuptake inhibitors, and serotonin norepinephrine reuptake inhibitors.

Concomitant use of drugs that are known combined P-gp and strong CYP3A inhibitors increases rivaroxaban exposure and may increase bleeding risk

[see Drug Interactions (7.2)]

Risk of Hemorrhage in Acutely Ill Medical Patients at High Risk of Bleeding

Reversal of Anticoagulant Effect

An agent to reverse the anti-factor Xa activity of rivaroxaban is available. Because of high plasma protein binding, rivaroxaban is not dialyzable

[see Clinical Pharmacology (12.3)]

)

06/2025

XARELTO is a factor Xa inhibitor indicated:

to reduce risk of stroke and systemic embolism in nonvalvular atrial fibrillation (

1.1 Reduction of Risk of Stroke and Systemic Embolism in Nonvalvular Atrial Fibrillation
XARELTO is indicated to reduce the risk of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation.
There are limited data on the relative effectiveness of XARELTO and warfarin in reducing the risk of stroke and systemic embolism when warfarin therapy is well-controlled
[see Clinical Studies (14.1)].
)
for treatment of deep vein thrombosis (DVT) (

1.2 Treatment of Deep Vein Thrombosis
XARELTO is indicated for the treatment of deep vein thrombosis (DVT).
)
for treatment of pulmonary embolism (PE) (

1.3 Treatment of Pulmonary Embolism
XARELTO is indicated for the treatment of pulmonary embolism (PE).
)
for reduction in the risk of recurrence of DVT or PE (

1.4 Reduction in the Risk of Recurrence of Deep Vein Thrombosis and/or Pulmonary Embolism
XARELTO is indicated for the reduction in the risk of recurrence of DVT and/or PE in adult patients at continued risk for recurrent DVT and/or PE after completion of initial treatment lasting at least 6 months.
)
for the prophylaxis of DVT, which may lead to PE in patients undergoing knee or hip replacement surgery (

1.5 Prophylaxis of Deep Vein Thrombosis Following Hip or Knee Replacement Surgery
XARELTO is indicated for the prophylaxis of DVT, which may lead to PE in adult patients undergoing knee or hip replacement surgery.
)
for prophylaxis of venous thromboembolism (VTE) in acutely ill medical patients (

1.6 Prophylaxis of Venous Thromboembolism in Acutely Ill Medical Patients at Risk for Thromboembolic Complications Not at High Risk of Bleeding
XARELTO is indicated for the prophylaxis of venous thromboembolism (VTE) and VTE related death during hospitalization and post hospital discharge in adult patients admitted for an acute medical illness who are at risk for thromboembolic complications due to moderate or severe restricted mobility and other risk factors for VTE and not at high risk of bleeding
[see Warnings and Precautions (5.2)and Clinical Studies (14.5)]
.
)
to reduce the risk of major cardiovascular events in patients with coronary artery disease (CAD) (

1.7 Reduction of Risk of Major Cardiovascular Events in Patients with Coronary Artery Disease (CAD)
XARELTO, in combination with aspirin, is indicated to reduce the risk of major cardiovascular events (cardiovascular death, myocardial infarction, and stroke) in adult patients with coronary artery disease.
)
to reduce the risk of major thrombotic vascular events in patients with peripheral artery disease (PAD), including patients after recent lower extremity revascularization due to symptomatic PAD (

1.8 Reduction of Risk of Major Thrombotic Vascular Events in Patients with Peripheral Artery Disease (PAD), Including Patients after Lower Extremity Revascularization due to Symptomatic PAD
XARELTO, in combination with aspirin, is indicated to reduce the risk of major thrombotic vascular events (myocardial infarction, ischemic stroke, acute limb ischemia, and major amputation of a vascular etiology) in adult patients with PAD, including patients who have recently undergone a lower extremity revascularization procedure due to symptomatic PAD.
)
for treatment of VTE and reduction in the risk of recurrent VTE in pediatric patients from birth to less than 18 years (

1.9 Treatment of Venous Thromboembolism and Reduction in Risk of Recurrent Venous Thromboembolism in Pediatric Patients
XARELTO is indicated for the treatment of venous thromboembolism (VTE) and the reduction in the risk of recurrent VTE in pediatric patients from birth to less than 18 years after at least 5 days of initial parenteral anticoagulant treatment.
)
for thromboprophylaxis in pediatric patients 2 years and older with congenital heart disease after the Fontan procedure (

1.10 Thromboprophylaxis in Pediatric Patients with Congenital Heart Disease after the Fontan Procedure
XARELTO is indicated for thromboprophylaxis in pediatric patients aged 2 years and older with congenital heart disease who have undergone the Fontan procedure.
)

Nonvalvular Atrial Fibrillation

: 15 or 20 mg, once daily with food (

2.1 Recommended Dosage in Adults

Table 1: Recommended Dosage in Adults
Indication	Renal ConsiderationsCalculate CrCl based on actual weight. [See Warnings and Precautions (5.4) and Use in Specific Populations (8.6)]	Dosage	Food/TimingSee Clinical Pharmacology (12.3)
Reduction in Risk of Stroke in Nonvalvular Atrial Fibrillation	CrCl >50 mL/min	20 mg once daily	Take with evening meal
	CrCl ≤50 mL/minPatients with CrCl <30 mL/min were not studied, but administration of XARELTO is expected to result in serum concentrations of rivaroxaban similar to those in patients with moderate renal impairment (CrCl 30 to <50 mL/min) [see Use in Specific Populations (8.6)]	15 mg once daily	Take with evening meal
Treatment of DVT and/or PE	CrCl ≥15 mL/min	15 mg twice daily ▼ after 21 days, transition to ▼ 20 mg once daily	Take with food, at the same time each day
Treatment of DVT and/or PE	CrCl <15 mL/min	Avoid Use
Reduction in the Risk of Recurrence of DVT and/or PE in patients at continued risk for DVT and/or PE	CrCl ≥15 mL/min	10 mg once daily, after at least 6 months of standard anticoagulant treatment	Take with or without food
	CrCl <15 mL/min	Avoid Use
Prophylaxis of DVT Following:
Hip Replacement Surgery See Dosage and Administration (2.4)	CrCl ≥15 mL/min	10 mg once daily for 35 days, 6–10 hours after surgery once hemostasis has been established	Take with or without food
Hip Replacement Surgery See Dosage and Administration (2.4)	CrCl <15 mL/min	Avoid Use
Knee Replacement Surgery	CrCl ≥15 mL/min	10 mg once daily for 12 days, 6–10 hours after surgery once hemostasis has been established	Take with or without food
Knee Replacement Surgery	CrCl <15 mL/min	Avoid Use
Prophylaxis of VTE in Acutely Ill Medical Patients at Risk for Thromboembolic Complications Not at High Risk of Bleeding	CrCl ≥15 mL/min	10 mg once daily, in hospital and after hospital discharge, for a total recommended duration of 31 to 39 days	Take with or without food
	CrCl <15 mL/min	Avoid Use
Reduction of Risk of Major Cardiovascular Events (CV Death, MI, and Stroke) in CAD	No dose adjustment needed based on CrCl	2.5 mg twice daily , plus aspirin (75–100 mg) once daily	Take with or without food
Reduction of Risk of Major Thrombotic Vascular Events in PAD, Including Patients after Lower Extremity Revascularization due to Symptomatic PAD	No dose adjustment needed based on CrCl	2.5 mg twice daily , plus aspirin (75–100 mg) once daily. When starting therapy after a successful lower extremity revascularization procedure, initiate once hemostasis has been established.	Take with or without food

)

Treatment of DVT and/or PE

: 15 mg orally twice daily with food for the first 21 days followed by 20 mg orally once daily with food for the remaining treatment (

2.1 Recommended Dosage in Adults

Table 1: Recommended Dosage in Adults
Indication	Renal ConsiderationsCalculate CrCl based on actual weight. [See Warnings and Precautions (5.4) and Use in Specific Populations (8.6)]	Dosage	Food/TimingSee Clinical Pharmacology (12.3)
Reduction in Risk of Stroke in Nonvalvular Atrial Fibrillation	CrCl >50 mL/min	20 mg once daily	Take with evening meal
	CrCl ≤50 mL/minPatients with CrCl <30 mL/min were not studied, but administration of XARELTO is expected to result in serum concentrations of rivaroxaban similar to those in patients with moderate renal impairment (CrCl 30 to <50 mL/min) [see Use in Specific Populations (8.6)]	15 mg once daily	Take with evening meal
Treatment of DVT and/or PE	CrCl ≥15 mL/min	15 mg twice daily ▼ after 21 days, transition to ▼ 20 mg once daily	Take with food, at the same time each day
Treatment of DVT and/or PE	CrCl <15 mL/min	Avoid Use
Reduction in the Risk of Recurrence of DVT and/or PE in patients at continued risk for DVT and/or PE	CrCl ≥15 mL/min	10 mg once daily, after at least 6 months of standard anticoagulant treatment	Take with or without food
	CrCl <15 mL/min	Avoid Use
Prophylaxis of DVT Following:
Hip Replacement Surgery See Dosage and Administration (2.4)	CrCl ≥15 mL/min	10 mg once daily for 35 days, 6–10 hours after surgery once hemostasis has been established	Take with or without food
Hip Replacement Surgery See Dosage and Administration (2.4)	CrCl <15 mL/min	Avoid Use
Knee Replacement Surgery	CrCl ≥15 mL/min	10 mg once daily for 12 days, 6–10 hours after surgery once hemostasis has been established	Take with or without food
Knee Replacement Surgery	CrCl <15 mL/min	Avoid Use
Prophylaxis of VTE in Acutely Ill Medical Patients at Risk for Thromboembolic Complications Not at High Risk of Bleeding	CrCl ≥15 mL/min	10 mg once daily, in hospital and after hospital discharge, for a total recommended duration of 31 to 39 days	Take with or without food
	CrCl <15 mL/min	Avoid Use
Reduction of Risk of Major Cardiovascular Events (CV Death, MI, and Stroke) in CAD	No dose adjustment needed based on CrCl	2.5 mg twice daily , plus aspirin (75–100 mg) once daily	Take with or without food
Reduction of Risk of Major Thrombotic Vascular Events in PAD, Including Patients after Lower Extremity Revascularization due to Symptomatic PAD	No dose adjustment needed based on CrCl	2.5 mg twice daily , plus aspirin (75–100 mg) once daily. When starting therapy after a successful lower extremity revascularization procedure, initiate once hemostasis has been established.	Take with or without food

)

Reduction in the Risk of Recurrence of DVT and/or PE in patients at continued risk for DVT and/or PE

: 10 mg once daily with or without food, after at least 6 months of standard anticoagulant treatment (

2.1 Recommended Dosage in Adults

Table 1: Recommended Dosage in Adults
Indication	Renal ConsiderationsCalculate CrCl based on actual weight. [See Warnings and Precautions (5.4) and Use in Specific Populations (8.6)]	Dosage	Food/TimingSee Clinical Pharmacology (12.3)
Reduction in Risk of Stroke in Nonvalvular Atrial Fibrillation	CrCl >50 mL/min	20 mg once daily	Take with evening meal
	CrCl ≤50 mL/minPatients with CrCl <30 mL/min were not studied, but administration of XARELTO is expected to result in serum concentrations of rivaroxaban similar to those in patients with moderate renal impairment (CrCl 30 to <50 mL/min) [see Use in Specific Populations (8.6)]	15 mg once daily	Take with evening meal
Treatment of DVT and/or PE	CrCl ≥15 mL/min	15 mg twice daily ▼ after 21 days, transition to ▼ 20 mg once daily	Take with food, at the same time each day
Treatment of DVT and/or PE	CrCl <15 mL/min	Avoid Use
Reduction in the Risk of Recurrence of DVT and/or PE in patients at continued risk for DVT and/or PE	CrCl ≥15 mL/min	10 mg once daily, after at least 6 months of standard anticoagulant treatment	Take with or without food
	CrCl <15 mL/min	Avoid Use
Prophylaxis of DVT Following:
Hip Replacement Surgery See Dosage and Administration (2.4)	CrCl ≥15 mL/min	10 mg once daily for 35 days, 6–10 hours after surgery once hemostasis has been established	Take with or without food
Hip Replacement Surgery See Dosage and Administration (2.4)	CrCl <15 mL/min	Avoid Use
Knee Replacement Surgery	CrCl ≥15 mL/min	10 mg once daily for 12 days, 6–10 hours after surgery once hemostasis has been established	Take with or without food
Knee Replacement Surgery	CrCl <15 mL/min	Avoid Use
Prophylaxis of VTE in Acutely Ill Medical Patients at Risk for Thromboembolic Complications Not at High Risk of Bleeding	CrCl ≥15 mL/min	10 mg once daily, in hospital and after hospital discharge, for a total recommended duration of 31 to 39 days	Take with or without food
	CrCl <15 mL/min	Avoid Use
Reduction of Risk of Major Cardiovascular Events (CV Death, MI, and Stroke) in CAD	No dose adjustment needed based on CrCl	2.5 mg twice daily , plus aspirin (75–100 mg) once daily	Take with or without food
Reduction of Risk of Major Thrombotic Vascular Events in PAD, Including Patients after Lower Extremity Revascularization due to Symptomatic PAD	No dose adjustment needed based on CrCl	2.5 mg twice daily , plus aspirin (75–100 mg) once daily. When starting therapy after a successful lower extremity revascularization procedure, initiate once hemostasis has been established.	Take with or without food

)

Prophylaxis of DVT Following Hip or Knee Replacement Surgery

: 10 mg orally once daily with or without food (

2.1 Recommended Dosage in Adults

Table 1: Recommended Dosage in Adults
Indication	Renal ConsiderationsCalculate CrCl based on actual weight. [See Warnings and Precautions (5.4) and Use in Specific Populations (8.6)]	Dosage	Food/TimingSee Clinical Pharmacology (12.3)
Reduction in Risk of Stroke in Nonvalvular Atrial Fibrillation	CrCl >50 mL/min	20 mg once daily	Take with evening meal
	CrCl ≤50 mL/minPatients with CrCl <30 mL/min were not studied, but administration of XARELTO is expected to result in serum concentrations of rivaroxaban similar to those in patients with moderate renal impairment (CrCl 30 to <50 mL/min) [see Use in Specific Populations (8.6)]	15 mg once daily	Take with evening meal
Treatment of DVT and/or PE	CrCl ≥15 mL/min	15 mg twice daily ▼ after 21 days, transition to ▼ 20 mg once daily	Take with food, at the same time each day
Treatment of DVT and/or PE	CrCl <15 mL/min	Avoid Use
Reduction in the Risk of Recurrence of DVT and/or PE in patients at continued risk for DVT and/or PE	CrCl ≥15 mL/min	10 mg once daily, after at least 6 months of standard anticoagulant treatment	Take with or without food
	CrCl <15 mL/min	Avoid Use
Prophylaxis of DVT Following:
Hip Replacement Surgery See Dosage and Administration (2.4)	CrCl ≥15 mL/min	10 mg once daily for 35 days, 6–10 hours after surgery once hemostasis has been established	Take with or without food
Hip Replacement Surgery See Dosage and Administration (2.4)	CrCl <15 mL/min	Avoid Use
Knee Replacement Surgery	CrCl ≥15 mL/min	10 mg once daily for 12 days, 6–10 hours after surgery once hemostasis has been established	Take with or without food
Knee Replacement Surgery	CrCl <15 mL/min	Avoid Use
Prophylaxis of VTE in Acutely Ill Medical Patients at Risk for Thromboembolic Complications Not at High Risk of Bleeding	CrCl ≥15 mL/min	10 mg once daily, in hospital and after hospital discharge, for a total recommended duration of 31 to 39 days	Take with or without food
	CrCl <15 mL/min	Avoid Use
Reduction of Risk of Major Cardiovascular Events (CV Death, MI, and Stroke) in CAD	No dose adjustment needed based on CrCl	2.5 mg twice daily , plus aspirin (75–100 mg) once daily	Take with or without food
Reduction of Risk of Major Thrombotic Vascular Events in PAD, Including Patients after Lower Extremity Revascularization due to Symptomatic PAD	No dose adjustment needed based on CrCl	2.5 mg twice daily , plus aspirin (75–100 mg) once daily. When starting therapy after a successful lower extremity revascularization procedure, initiate once hemostasis has been established.	Take with or without food

)

Prophylaxis of VTE in Acutely Ill Medical Patients at Risk for Thromboembolic Complications Not at High Risk of Bleeding

: 10 mg once daily, with or without food, in hospital and after hospital discharge for a total recommended duration of 31 to 39 days (

2.1 Recommended Dosage in Adults

Table 1: Recommended Dosage in Adults
Indication	Renal ConsiderationsCalculate CrCl based on actual weight. [See Warnings and Precautions (5.4) and Use in Specific Populations (8.6)]	Dosage	Food/TimingSee Clinical Pharmacology (12.3)
Reduction in Risk of Stroke in Nonvalvular Atrial Fibrillation	CrCl >50 mL/min	20 mg once daily	Take with evening meal
	CrCl ≤50 mL/minPatients with CrCl <30 mL/min were not studied, but administration of XARELTO is expected to result in serum concentrations of rivaroxaban similar to those in patients with moderate renal impairment (CrCl 30 to <50 mL/min) [see Use in Specific Populations (8.6)]	15 mg once daily	Take with evening meal
Treatment of DVT and/or PE	CrCl ≥15 mL/min	15 mg twice daily ▼ after 21 days, transition to ▼ 20 mg once daily	Take with food, at the same time each day
Treatment of DVT and/or PE	CrCl <15 mL/min	Avoid Use
Reduction in the Risk of Recurrence of DVT and/or PE in patients at continued risk for DVT and/or PE	CrCl ≥15 mL/min	10 mg once daily, after at least 6 months of standard anticoagulant treatment	Take with or without food
	CrCl <15 mL/min	Avoid Use
Prophylaxis of DVT Following:
Hip Replacement Surgery See Dosage and Administration (2.4)	CrCl ≥15 mL/min	10 mg once daily for 35 days, 6–10 hours after surgery once hemostasis has been established	Take with or without food
Hip Replacement Surgery See Dosage and Administration (2.4)	CrCl <15 mL/min	Avoid Use
Knee Replacement Surgery	CrCl ≥15 mL/min	10 mg once daily for 12 days, 6–10 hours after surgery once hemostasis has been established	Take with or without food
Knee Replacement Surgery	CrCl <15 mL/min	Avoid Use
Prophylaxis of VTE in Acutely Ill Medical Patients at Risk for Thromboembolic Complications Not at High Risk of Bleeding	CrCl ≥15 mL/min	10 mg once daily, in hospital and after hospital discharge, for a total recommended duration of 31 to 39 days	Take with or without food
	CrCl <15 mL/min	Avoid Use
Reduction of Risk of Major Cardiovascular Events (CV Death, MI, and Stroke) in CAD	No dose adjustment needed based on CrCl	2.5 mg twice daily , plus aspirin (75–100 mg) once daily	Take with or without food
Reduction of Risk of Major Thrombotic Vascular Events in PAD, Including Patients after Lower Extremity Revascularization due to Symptomatic PAD	No dose adjustment needed based on CrCl	2.5 mg twice daily , plus aspirin (75–100 mg) once daily. When starting therapy after a successful lower extremity revascularization procedure, initiate once hemostasis has been established.	Take with or without food

)

CAD or PAD

: 2.5 mg orally twice daily with or without food, in combination with aspirin (75–100 mg) once daily (

2.1 Recommended Dosage in Adults

Table 1: Recommended Dosage in Adults
Indication	Renal ConsiderationsCalculate CrCl based on actual weight. [See Warnings and Precautions (5.4) and Use in Specific Populations (8.6)]	Dosage	Food/TimingSee Clinical Pharmacology (12.3)
Reduction in Risk of Stroke in Nonvalvular Atrial Fibrillation	CrCl >50 mL/min	20 mg once daily	Take with evening meal
	CrCl ≤50 mL/minPatients with CrCl <30 mL/min were not studied, but administration of XARELTO is expected to result in serum concentrations of rivaroxaban similar to those in patients with moderate renal impairment (CrCl 30 to <50 mL/min) [see Use in Specific Populations (8.6)]	15 mg once daily	Take with evening meal
Treatment of DVT and/or PE	CrCl ≥15 mL/min	15 mg twice daily ▼ after 21 days, transition to ▼ 20 mg once daily	Take with food, at the same time each day
Treatment of DVT and/or PE	CrCl <15 mL/min	Avoid Use
Reduction in the Risk of Recurrence of DVT and/or PE in patients at continued risk for DVT and/or PE	CrCl ≥15 mL/min	10 mg once daily, after at least 6 months of standard anticoagulant treatment	Take with or without food
	CrCl <15 mL/min	Avoid Use
Prophylaxis of DVT Following:
Hip Replacement Surgery See Dosage and Administration (2.4)	CrCl ≥15 mL/min	10 mg once daily for 35 days, 6–10 hours after surgery once hemostasis has been established	Take with or without food
Hip Replacement Surgery See Dosage and Administration (2.4)	CrCl <15 mL/min	Avoid Use
Knee Replacement Surgery	CrCl ≥15 mL/min	10 mg once daily for 12 days, 6–10 hours after surgery once hemostasis has been established	Take with or without food
Knee Replacement Surgery	CrCl <15 mL/min	Avoid Use
Prophylaxis of VTE in Acutely Ill Medical Patients at Risk for Thromboembolic Complications Not at High Risk of Bleeding	CrCl ≥15 mL/min	10 mg once daily, in hospital and after hospital discharge, for a total recommended duration of 31 to 39 days	Take with or without food
	CrCl <15 mL/min	Avoid Use
Reduction of Risk of Major Cardiovascular Events (CV Death, MI, and Stroke) in CAD	No dose adjustment needed based on CrCl	2.5 mg twice daily , plus aspirin (75–100 mg) once daily	Take with or without food
Reduction of Risk of Major Thrombotic Vascular Events in PAD, Including Patients after Lower Extremity Revascularization due to Symptomatic PAD	No dose adjustment needed based on CrCl	2.5 mg twice daily , plus aspirin (75–100 mg) once daily. When starting therapy after a successful lower extremity revascularization procedure, initiate once hemostasis has been established.	Take with or without food

)

Pediatric Patients:

See dosing recommendations in the Full Prescribing Information (

2.2 Recommended Dosage in Pediatric Patients

Treatment of Venous Thromboembolism and Reduction in Risk of Recurrent Venous Thromboembolism in Pediatric Patients

Table 2: Recommended Dosage in Pediatric Patients Birth to Less than 18 Years for Treatment of and Reduction in Risk of Recurrent VTEInitiate XARELTO treatment following at least 5 days of initial parenteral anticoagulation therapy.^,Patients <6 months of age should meet the following criteria: at birth were at least 37 weeks of gestation, have had at least 10 days of oral feeding, and weigh ≥2.6 kg at the time of dosing.
Dosage Form	Body Weight	1 mg XARELTO = 1 mL Suspension
		Dosage			Total Daily DoseAll doses should be taken with feeding or with food since exposures match that of 20 mg daily dose in adults.
		Once a DayOnce a day: approximately 24 hours apart; 2 times a day: approximately 12 hours apart; 3 times a day: approximately 8 hours apart	2 Times a Day	3 Times a Day
Oral Suspension Only	2.6 kg to 2.9 kg			0.8 mg	2.4 mg
	3 kg to 3.9 kg			0.9 mg	2.7 mg
	4 kg to 4.9 kg			1.4 mg	4.2 mg
	5 kg to 6.9 kg			1.6 mg	4.8 mg
	7 kg to 7.9 kg			1.8 mg	5.4 mg
	8 kg to 8.9 kg			2.4 mg	7.2 mg
	9 kg to 9.9 kg			2.8 mg	8.4 mg
	10 kg to 11.9 kg			3 mg	9 mg
	12 kg to 29.9 kg		5 mg		10 mg
Oral Suspension or Tablets	30 kg to 49.9 kg	15 mg			15 mg
Oral Suspension or Tablets	≥50 kg	20 mg			20 mg

Less than 37 weeks of gestation at birth
Less than 10 days of oral feeding
Body weight of less than 2.6 kg.

To increase absorption, all doses should be taken with feeding or with food.

Monitor the child's weight and review the dose regularly, especially for children below 12 kg. This is to ensure a therapeutic dose is maintained.

All pediatric patients (except <2 years old with catheter-related thrombosis):

Pediatric patients <2 years old with catheter-related thrombosis:

Thromboprophylaxis in Pediatric Patients with Congenital Heart Disease after the Fontan Procedure

Table 3: Recommended Dosage for Thromboprophylaxis in Pediatric Patients with Congenital Heart Disease
Dosage Form	Body Weight	1 mg XARELTO = 1 mL Suspension
		Dosage		Total Daily DoseAll doses can be taken with or without food since exposures match that of 10 mg daily dose in adults.
		Once a DayOnce a day: approximately 24 hours apart; 2 times a day: approximately 12 hours apart.	2 Times a Day
Oral Suspension Only	7 kg to 7.9 kg		1.1 mg	2.2 mg
	8 kg to 9.9 kg		1.6 mg	3.2 mg
	10 kg to 11.9 kg		1.7 mg	3.4 mg
	12 kg to 19.9 kg		2 mg	4 mg
	20 kg to 29.9 kg		2.5 mg	5 mg
	30 kg to 49.9 kg	7.5 mg		7.5 mg
Oral Suspension or Tablets	≥50 kg	10 mg		10 mg

Administration in Pediatric Patients

Food Effect:

For the treatment of VTE in children, the dose should be taken with food to increase absorption.

For thromboprophylaxis after Fontan procedure, the dose can be taken with or without food.

Vomit or Spit up:

Tablets:

XARELTO tablet must not be split in an attempt to provide a fraction of a tablet dose.

For children unable to swallow 10, 15, or 20 mg whole tablets, XARELTO oral suspension should be used. XARELTO 2.5 mg tablets are not recommended for use in pediatric patients

[see Use in Specific Populations (8.4)]

Use in Renal Impairment in Pediatric Patients

Patients 1 Year of Age or Older

Mild renal impairment (eGFR: 50 to ≤ 80 mL/min/1.73 m²): No dose adjustment is required.
Moderate or severe renal impairment (eGFR: <50 mL/min/1.73 m²): avoid use, as limited clinical data are available.

k = 0.55 in children 1 year to 13 years
k = 0.55 in girls > 13 and < 18 years
k = 0.70 in boys > 13 and < 18 years

Patients Less than 1 Year of Age

Table 4: Reference Values of Serum Creatinine in Pediatric Patients <1 Year of Age
Age	97.5^thPercentile of Creatinine (mg/dL)	97.5^thPercentile of Creatinine (µmol/L)
Week 2	0.52	46
Week 3	0.46	41
Week 4	0.42	37
Month 2	0.37	33
Month 3	0.34	30
Month 4–6	0.34	30
Month 7–9	0.34	30
Month 10–12	0.36	32

)

2.5 mg tablets: Round, light yellow, and film-coated with a triangle pointing down above a "2.5" marked on one side and "Xa" on the other side
10 mg tablets: Round, light red, biconvex and film-coated with a triangle pointing down above a "10" marked on one side and "Xa" on the other side
15 mg tablets: Round, red, biconvex, and film-coated with a triangle pointing down above a "15" marked on one side and "Xa" on the other side
20 mg tablets: Triangle-shaped, dark red, and film-coated with a triangle pointing down above a "20" marked on one side and "Xa" on the other side
For oral suspension: white to off-white granules; once reconstituted, provide flavored white to off-white opaque liquid with a concentration of 1 mg/mL.

Renal impairment: Avoid or adjust dose (

8.6 Renal Impairment
In pharmacokinetic studies, compared to healthy adult subjects with normal creatinine clearance, rivaroxaban exposure increased by approximately 44 to 64% in adult subjects with renal impairment. Increases in pharmacodynamic effects were also observed
[see Clinical Pharmacology (12.3)]
.
Nonvalvular Atrial Fibrillation
Patients with Chronic Kidney Disease not on Dialysis
In the ROCKET AF trial, patients with CrCl 30 to 50 mL/min were administered XARELTO 15 mg once daily resulting in serum concentrations of rivaroxaban and clinical outcomes similar to those in patients with better renal function administered XARELTO 20 mg once daily. Patients with CrCl <30 mL/min were not studied, but administration of XARELTO 15 mg once daily is expected to result in serum concentrations of rivaroxaban similar to those in patients with moderate renal impairment
[see Clinical Pharmacology (12.3)]
.
Patients with End-Stage Renal Disease on Dialysis
Clinical efficacy and safety studies with XARELTO did not enroll patients with end-stage renal disease (ESRD) on dialysis. In patients with ESRD maintained on intermittent hemodialysis, administration of XARELTO 15 mg once daily will result in concentrations of rivaroxaban and pharmacodynamic activity similar to those observed in the ROCKET AF study
[see Clinical Pharmacology (12.2, 12.3)]
. It is not known whether these concentrations will lead to similar stroke reduction and bleeding risk in patients with ESRD on dialysis as was seen in ROCKET AF.
Treatment of DVT and/or PE and Reduction in the Risk of Recurrence of DVT and/or PE
In the EINSTEIN trials, patients with CrCl values <30 mL/min at screening were excluded from the studies, but administration of XARELTO is expected to result in serum concentrations of rivaroxaban similar to those in patients with moderate renal impairment (CrCl 30 to <50 mL/min)
[see Clinical Pharmacology (12.3)].
Observe closely and promptly evaluate any signs or symptoms of blood loss in patients with CrCl 15 to <30 mL/min. Avoid the use of XARELTO in patients with CrCl <15 mL/min.
Prophylaxis of DVT Following Hip or Knee Replacement Surgery
The combined analysis of the RECORD 1–3 clinical efficacy studies did not show an increase in bleeding risk for patients with CrCl 30 to 50 mL/min and reported a possible increase in total venous thromboemboli in this population. In the RECORD 1–3 trials, patients with CrCl values <30 mL/min at screening were excluded from the studies, but administration of XARELTO 10 mg once daily is expected to result in serum concentrations of rivaroxaban similar to those in patients with moderate renal impairment (CrCl 30 to <50 mL/min)
[see Clinical Pharmacology (12.3)].
Observe closely and promptly evaluate any signs or symptoms of blood loss in patients with CrCl 15 to <30 mL/min. Avoid the use of XARELTO in patients with CrCl <15 mL/min.
Prophylaxis of Venous Thromboembolism in Acutely Ill Medical Patients at Risk for Thromboembolic Complications Not at High Risk of Bleeding
Patients with CrCl values <30 mL/min at screening were excluded from the MAGELLAN study. In patients with CrCl <30 mL/min a dose of XARELTO 10 mg once daily is expected to result in serum concentrations of rivaroxaban similar to those in patients with moderate renal impairment (CrCl 30 to <50 mL/min)
[see Clinical Pharmacology (12.3)]
. Observe closely and promptly evaluate any signs or symptoms of blood loss in patients with CrCl 15 to <30 mL/min. Avoid use of XARELTO in patients with CrCl <15 mL/min.
Reduction of Risk of Major Cardiovascular Events in Patients with CAD and Reduction of Risk of Major Thrombotic Vascular Events in Patients with PAD, Including Patients After Recent Lower Extremity Revascularization due to Symptomatic PAD
Patients with Chronic Kidney Disease not on Dialysis
Patients with a CrCl <15 mL/min at screening were excluded from COMPASS and VOYAGER, and limited data are available for patients with a CrCl of 15 to 30 mL/min. In patients with CrCl <30 mL/min, a dose of 2.5 mg XARELTO twice daily is expected to give an exposure similar to that in patients with moderate renal impairment (CrCl 30 to <50 mL/min)
[see Clinical Pharmacology (12.3)]
, whose efficacy and safety outcomes were similar to those with preserved renal function.
Patients with End-Stage Renal Disease on Dialysis
No clinical outcome data is available for the use of XARELTO with aspirin in patients with ESRD on dialysis since these patients were not enrolled in COMPASS or VOYAGER. In patients with ESRD maintained on intermittent hemodialysis, administration of XARELTO 2.5 mg twice daily will result in concentrations of rivaroxaban and pharmacodynamic activity similar to those observed in moderate renal impaired patients in the COMPASS study
[see Clinical Pharmacology (12.2, 12.3)]
. It is not known whether these concentrations will lead to similar CV risk reduction and bleeding risk in patients with ESRD on dialysis as was seen in COMPASS.
Pediatric Use
No dosage adjustment is required in patients 1 year of age or older with mild renal impairment (eGFR 50 to ≤ 80 mL/min/1.73 m²). There are limited clinical data in pediatric patients 1 year or older with moderate or severe renal impairment (eGFR <50 mL/min/1.73 m²); therefore, avoid the use of XARELTO in these patients.
There are no clinical data in pediatric patients younger than 1 year with serum creatinine results above 97.5^thpercentile; therefore, avoid the use of XARELTO in these patients
[see Dosage and Administration (2.2)]
.
)
Hepatic impairment: Avoid use in Child-Pugh B and C hepatic impairment or hepatic disease associated with coagulopathy (

8.7 Hepatic Impairment
In a pharmacokinetic study, compared to healthy adult subjects with normal liver function, AUC increases of 127% were observed in adult subjects with moderate hepatic impairment (Child-Pugh B).
The safety or PK of XARELTO in patients with severe hepatic impairment (Child-Pugh C) has not been evaluated
[see Clinical Pharmacology (12.3)]
.
Avoid the use of XARELTO in patients with moderate (Child-Pugh B) and severe (Child-Pugh C) hepatic impairment or with any hepatic disease associated with coagulopathy.
No clinical data are available in pediatric patients with hepatic impairment.
)

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