From the Guidelines
Rivaroxaban (Xarelto) is indicated for the treatment and prevention of deep vein thrombosis (DVT) in adults.
Treatment and Prevention of DVT
The recommended dose for DVT treatment is 15mg twice daily for the first 21 days, followed by 20mg once daily for the remaining treatment duration, which is typically 3-6 months 1.
- For prevention of recurrent DVT, the recommended dose is 20mg once daily, with treatment duration individualized based on patient risk factors and clinical judgment 1.
Important Considerations
It is essential to note that rivaroxaban is not approved for use in patients with severe renal failure and a creatinine clearance of 15 mL/min, in patients with hepatic disease associated with coagulopathy, and in patients receiving concomitant systemic treatment with azole-antimycotics or HIV protease inhibitors 1.
Clinical Evidence
The EINSTEIN study demonstrated the efficacy of rivaroxaban in the treatment of DVT, with a significant reduction in symptomatic recurrent VTE compared to low-molecular-weight heparin/warfarin 1.
- Additionally, the ROCKET study showed that rivaroxaban was noninferior to warfarin in the prevention of ischemic stroke or systemic embolism, with a similar rate of major bleeding events but with fewer intracranial and fatal bleeding events 1.
- The American Society of Hematology 2020 guidelines also support the use of rivaroxaban for the treatment and prevention of DVT, with a recommended dose of 20mg once daily for prevention of recurrent DVT 1.
From the FDA Drug Label
1.2 Treatment of Deep Vein Thrombosis XARELTO is indicated for the treatment of deep vein thrombosis (DVT).
Yes, Xarelto (rivaroxaban) is indicated for the treatment of Deep Vein Thrombosis (DVT) 2 2.
- The drug label explicitly states that XARELTO is indicated for the treatment of DVT.
- This indication is consistent across both drug labels 2 and 2.
From the Research
Xarelto (Rivaroxaban) for Deep Vein Thrombosis (DVT)
- Xarelto (rivaroxaban) is approved for the treatment of deep vein thrombosis (DVT) and has been shown to be effective in preventing recurrent DVT 3, 4, 5, 6.
- The EINSTEIN-DVT study demonstrated that rivaroxaban was non-inferior to standard therapy (enoxaparin plus a vitamin K antagonist) in preventing recurrent DVT 4, 5.
- Rivaroxaban has been shown to have a favorable benefit-risk profile for the treatment of DVT, with a low risk of major bleeding 4, 5, 6.
- The approved rivaroxaban dose schedule for DVT treatment is 15 mg twice daily for 3 weeks, followed by 20 mg once daily 6.
- A recent study found that extending rivaroxaban treatment from 6 weeks to 3 months in patients with symptomatic isolated distal DVT reduced the risk of recurrent venous thromboembolism without increasing the risk of major bleeding 7.
Efficacy of Rivaroxaban for DVT
- Rivaroxaban has been shown to be effective in preventing recurrent DVT, with a significant reduction in the risk of recurrent venous thromboembolism compared to placebo 4, 5, 7.
- The EINSTEIN-DVT study found that rivaroxaban was non-inferior to standard therapy in preventing recurrent DVT, with a similar risk of major bleeding 4, 5.
- Rivaroxaban has also been shown to be effective in preventing proximal DVT and pulmonary embolism, although the risk of these events is lower than the risk of recurrent isolated distal DVT 7.
Safety of Rivaroxaban for DVT
- Rivaroxaban has been shown to have a low risk of major bleeding, with no significant increase in the risk of major bleeding compared to standard therapy or placebo 4, 5, 6, 7.
- The risk of clinically relevant bleeding with rivaroxaban is similar to or lower than the risk with standard therapy 4, 5, 6.