What is the recommended dose and duration of Xarelto (rivaroxaban) for Deep Vein Thrombosis (DVT) prophylaxis in inpatient settings?

From the Guidelines

Xarelto (rivaroxaban) is recommended at a dose of 10 mg once daily for DVT prophylaxis in inpatient settings, as supported by the most recent and highest quality study 1. The medication should be initiated at least 6-10 hours after surgery once hemostasis has been established, and continued throughout the hospitalization period. For most medical patients, the duration is usually 6-14 days, while surgical patients often require 10-35 days of prophylaxis depending on the type of surgery and individual risk factors. Some key points to consider when using Xarelto for DVT prophylaxis include:

• Renal function should be assessed before initiating therapy, as dose adjustments may be necessary for patients with impaired kidney function 1.
• Patients should be monitored for signs of bleeding, which is the primary adverse effect.
• Xarelto should not be used in patients with active bleeding, severe renal impairment, or those taking strong CYP3A4 and P-glycoprotein inhibitors. The medication works by directly inhibiting Factor Xa, a key component in the blood clotting cascade, thereby reducing thrombin generation and clot formation. It is essential to take Xarelto with food at approximately the same time each day to maintain consistent blood levels. Overall, the use of Xarelto for DVT prophylaxis in inpatient settings is supported by recent guidelines and studies, and its efficacy and safety profile make it a suitable option for preventing venous thromboembolism in hospitalized patients 1.

From the FDA Drug Label

Advise patients for initial treatment of DVT and/or PE to take XARELTO 15 mg or 20 mg tablets with food at approximately the same time every day [see Dosage and Administration (2. 1)] . Advise patients who are at a continued risk of recurrent DVT and/or PE after at least 6 months of initial treatment, to take XARELTO 10 mg once daily with or without food [see Dosage and Administration (2.1)].

The recommended dose of Xarelto for DVT prophylaxis in inpatient settings is not explicitly stated in the provided drug label. However, for the treatment of DVT, the initial dose is 15 mg or 20 mg tablets with food, and after at least 6 months of initial treatment, the dose is 10 mg once daily.

• The duration of Xarelto for DVT prophylaxis in inpatient settings is not mentioned in the label.
• The label does provide information on the treatment of DVT, but it does not directly address prophylaxis in inpatient settings 2.

From the Research

DVT Prophylaxis with Xarelto (Rivaroxaban) in Inpatient Settings

• The recommended dose and duration of Xarelto (rivaroxaban) for Deep Vein Thrombosis (DVT) prophylaxis in inpatient settings is not explicitly stated in the provided studies.
• However, according to the studies, rivaroxaban is used for the prevention of venous thromboembolism (VTE) in adult patients after total hip replacement (THR) or total knee replacement (TKR) surgery at a dose of 10 mg once daily 3.
• In patients with acute iliofemoral DVT, rivaroxaban is used as maintenance therapy at a dose of 20 mg once daily, with early switching from low-molecular-weight heparin (LMWH) being effective and safe 4.
• The efficacy and safety of rivaroxaban for thromboprophylaxis in major orthopedic surgery have been compared with fondaparinux, with rivaroxaban showing superior efficacy and lower rates of severe bleeding 5.
• In patients with chronic kidney disease, the approved dosages of rivaroxaban can be used for the treatment and prevention of VTE and for prophylaxis of DVT after hip or knee replacement surgery, with no increase in the incidence of major bleeding 6.
• The clinical development program for the treatment and prevention of VTE as well as prophylaxis of DVT excluded patients with creatinine clearance (CrCl) < 30 mL/min, but a limited number of patients with severe renal impairment were enrolled, with efficacy outcomes not meaningfully different from those of patients with higher levels of renal function 6.

Key Findings

• Rivaroxaban is effective and safe for DVT prophylaxis in inpatient settings, with a recommended dose of 10 mg once daily for patients undergoing THR or TKR surgery 3.
• Early switching from LMWH to rivaroxaban is effective and safe for acute iliofemoral DVT 4.
• Rivaroxaban shows superior efficacy and lower rates of severe bleeding compared to fondaparinux for thromboprophylaxis in major orthopedic surgery 5.
• Patients with chronic kidney disease can use the approved dosages of rivaroxaban for DVT prophylaxis, with no increase in major bleeding 6.