Xarelto

XARELTO- rivaroxaban tablet, film coated
Cardinal Health.

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

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. If anticoagulation with 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 (2.2, 2.3), Warnings and Precautions (5.1), and Clinical Studies (14.1)].
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 (14.1) ].

1.7 Reduction of Risk of Major Cardiovascular Events in Patients with Chronic Coronary Artery Disease (CAD) or Peripheral Artery Disease (PAD)

XARELTO, in combination with aspirin, is indicated to reduce the risk of major cardiovascular events (cardiovascular (CV) death, myocardial infarction (MI) and stroke) in patients with chronic coronary artery disease (CAD) or peripheral artery disease (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

1.
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 Chronic CAD or 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

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