Xarelto

XARELTO- rivaroxaban tablet, film coated
Cardinal Health 107, LLC

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. Consider these risks when scheduling patients for spinal procedures. Factors that can increase the risk of developing epidural or spinal hematomas in these patients include:

•

use of indwelling epidural catheters

•

concomitant use of other drugs that affect hemostasis, such as non-steroidal anti-inflammatory drugs (NSAIDs), platelet inhibitors, other anticoagulants

•

a history of traumatic or repeated epidural or spinal punctures

•

a history of spinal deformity or spinal surgery

•

optimal timing between the administration of XARELTO and neuraxial procedures is not known

[see Warnings and Precautions (5.2, 5.3) and Adverse Reactions (6.2)].

Monitor patients frequently for signs and symptoms of neurological impairment. If neurological compromise is noted, urgent treatment is necessary [see Warnings and Precautions (5.3)].

Consider the benefits and risks before neuraxial intervention in patients anticoagulated or to be anticoagulated for thromboprophylaxis [see Warnings and Precautions (5.3)].

1 INDICATIONS AND USAGE

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 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)].

1.2 Treatment of Deep Vein Thrombosis

XARELTO is indicated for the treatment of deep vein thrombosis (DVT).

1.3 Treatment of Pulmonary Embolism

XARELTO is indicated for the treatment of pulmonary embolism (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 patients at continued risk for recurrent DVT and/or PE after completion of initial treatment lasting at least 6 months.

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 patients undergoing knee or hip replacement surgery.

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)].

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 patients with coronary artery disease.

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 patients with PAD, including patients who have recently undergone a lower extremity revascularization procedure due to symptomatic PAD.

2 DOSAGE AND ADMINISTRATION

2.1 Recommended Dosage

Table 1: Recommended Dosage

Indication	Renal Considerations *	Dosage	Food/Timing †
* Calculate CrCl based on actual weight. [See Warnings and Precautions (5.4) and Use in Specific Populations (8.6)] † See Clinical Pharmacology (12.3) ‡ Patients 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)] § See Dosage and Administration (2.3)
Reduction in Risk of Stroke in Nonvalvular Atrial Fibrillation	CrCl >50 mL/min	20 mg once daily	Take with evening meal
	CrCl ≤50 mL/min ‡	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
	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:
1. Hip Replacement Surgery §	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
	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.	Take with or without food
		When starting therapy after a successful lower extremity revascularization procedure, initiate once hemostasis has been established.