NPS news : Rivaroxaban (Xarelto) for treatment of deep vein thrombosis and pulmonary embolism, and for prevention of venous thromboembolism recurrence

    Aug , 01  2103


    Reference :

    • An alternative to INR-adjusted warfarin with initial heparin for the treatment of symptomatic DVT (without symptomatic PE) or PE.
            Efficacy and safety were studied in people with acute, symptomatic proximal DVT without PE, and in people with acute symptomatic PE with or without DVT, over 3, 6 or 12 months.
    • Rivaroxaban is non-inferior to enoxaparin plus warfarin for preventing VTE (DVT or PE) recurrence.
            In trials VTE recurrence, major or clinically relevant non-major bleeding, and mortality were similar with rivaroxaban compared with enoxaparin plus either warfarin or acenocoumarol.a
    • For initial treatment of acute DVT or PE the dose is rivaroxaban 15 mg twice a day for the first 3 weeks then 20 mg once a day.
                Continue treatment for as long as the risk of VTE recurrence persists, balancing benefits and harms and patient preference.        
    • For continuing treatment in people with a history of VTE the dose is 20 mg once a day.
            In trials rivaroxaban reduced recurrence of VTE in these people, but increased incidence of bleeding compared with placebo.
    • There is no antidote to the anticoagulant effects of rivaroxaban and no readily available and validated method of monitoring its activity in a primary care setting.
            Routine coagulation monitoring is not possible but routine clinical monitoring is essential. Advise patients to seek urgent medical attention for unexplained bruising, blood in the urine or black stools.
    • Bleeding risk may be higher in people with renal impairment.
            Very few people with renal impairment were included in trials. Do not use in people with severe renal impairment (CrCl < 30 mL/min).
    aAcenocoumarol is not marketed in Australia.