Active Ingredient: Rivaroxaban
Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults. (See section 4.4 for haemodynamically unstable PE patients.)
For this indication, competent medicine agencies globally authorize below treatments:
Oral
20 - 30 mg
From 10 To 15 mg 2 time(s) per day every day
30 mg
20 mg
The recommended dose for the initial treatment of acute DVT or PE is 15 mg twice daily for the first three weeks followed by 20 mg once daily for the continued treatment and prevention of recurrent DVT and PE.
Short duration of therapy (at least 3 months) should be considered in patients with DVT or PE provoked by major transient risk factors (i.e. recent major surgery or trauma). Longer duration of therapy should be considered in patients with provoked DVT or PE not related to major transient risk factors, unprovoked DVT or PE, or a history of recurrent DVT or PE.
When extended prevention of recurrent DVT and PE is indicated (following completion of at least 6 months therapy for DVT or PE), the recommended dose is 10 mg once daily. In patients in whom the risk of recurrent DVT or PE is considered high, such as those with complicated comorbidities, or who have developed recurrent DVT or PE on extended prevention with rivaroxaban 10 mg once daily, a dose of rivaroxaban 20 mg once daily should be considered.
The duration of therapy and dose selection should be individualised after careful assessment of the treatment benefit against the risk for bleeding.
| Time period | Dosing schedule | Total daily dose | |
|---|---|---|---|
| Treatment and prevention of recurrent DVT and PE | Day 1-21 | 15 mg twice daily | 30 mg |
| Day 22 onwards | 20 mg once daily | 20 mg | |
| Prevention of recurrent DVT and PE | Following completion of at least 6 months therapy for DVT or PE | 10 mg once daily or 20 mg once daily | 10 mg or 20 mg |
The 4-week treatment initiation pack of rivaroxaban is dedicated to patients who will transition from 15 mg twice daily to 20 mg once daily from Day 22 onwards. For patients with moderate or severe renal impairment where the decision has been taken for 15 mg once daily from Day 22 onwards, other pack sizes only containing 15 mg film-coated tablets are available.
If a dose is missed during the 15 mg twice daily treatment phase (day 1-21), the patient should take rivaroxaban immediately to ensure intake of 30 mg rivaroxaban per day. In this case two 15 mg tablets may be taken at once. The patient should continue with the regular 15 mg twice daily intake as recommended on the following day.
If a dose is missed during the once daily treatment phase, the patient should take rivaroxaban immediately, and continue on the following day with the once daily intake as recommended. The dose should not be doubled within the same day to make up for a missed dose.
For patients treated for DVT, PE and prevention of recurrence, VKA treatment should be stopped and rivaroxaban therapy should be initiated once the International Normalised Ratio (INR) is ≤2.5. When converting patients from VKAs to rivaroxaban, INR values will be falsely elevated after the intake of rivaroxaban. The INR is not valid to measure the anticoagulant activity of rivaroxaban, and therefore should not be used.
There is a potential for inadequate anticoagulation during the transition from rivaroxaban to VKA. Continuous adequate anticoagulation should be ensured during any transition to an alternate anticoagulant. It should be noted that rivaroxaban can contribute to an elevated INR.
In patients converting from rivaroxaban to VKA, VKA should be given concurrently until the INR is ≥2.0. For the first two days of the conversion period, standard initial dosing of VKA should be used followed by VKA dosing, as guided by INR testing. While patients are on both rivaroxaban and VKA the INR should not be tested earlier than 24 hours after the previous dose but prior to the next dose of rivaroxaban. Once rivaroxaban is discontinued INR testing may be done reliably at least 24 hours after the last dose.
For patients currently receiving a parenteral anticoagulant, discontinue the parenteral anticoagulant and start rivaroxaban 0 to 2 hours before the time that the next scheduled administration of the parenteral medicinal product (e.g. low molecular weight heparins) would be due or at the time of discontinuation of a continuously administered parenteral medicinal product (e.g. intravenous unfractionated heparin).
Give the first dose of parenteral anticoagulant at the time the next rivaroxaban dose would be taken.
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