Rivaroxaban (PE Treatment)

SCOPE: this is the page's primary indication and route - treatment of acute pulmonary embolism in adults, by mouth. VERBATIM UK SPC 4.2: '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.' Its dosing table: 'Day 1-21: 15 mg twice daily, total daily dose 30 mg. Day 22 onwards: 20 mg once daily, total daily dose 20 mg.' DURATION: '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.' EXTENDED PREVENTION: '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.' MISSED DOSE: '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.' SWITCHING FROM A VKA: 'For patients treated for DVT, PE and prevention of recurrence, VKA treatment should be stopped and Rivaroxaban therapy should be initiated once the INR is <= 2.5.' A '4 weeks treatment initiation pack' exists to support the day-21 switch from 15 mg to 20 mg. NO MAXIMUM DOSE with an explicit ceiling cue appears anywhere in either fetched label for this indication, so maxDose is left empty rather than inferred from the 30 mg total daily dose.

NO PAEDIATRIC DOSE IS PUBLISHED HERE. UK SPC 4.2, verbatim: 'The safety and efficacy of Rivaroxaban 10mg tablets in children aged 0 to 18 years have not been established. No data are available. Therefore, Rivaroxaban 10mg tablets are not recommended for use in children below 18 years of age.' The US label does establish a paediatric VTE indication - section 8.4: 'The safety and effectiveness of XARELTO have been established in pediatric patients from birth to less than 18 years for the treatment of VTE and the reduction in risk of recurrent VTE' - but its paediatric dosing table (section 2.2) was corrupted and truncated in the fetched text, so the actual figures were not retrieved. The regimen is body-weight-banded, not per-kilogram: UK SPC 4.8 describes it as a 'Body weight-adjusted dose to achieve a similar exposure as that observed in adults treated for DVT with 20 mg rivaroxaban once daily', so no per-kg value can be published and the weight calculator is deliberately left inactive. US label 8.4 also warns: 'XARELTO was not studied and therefore dosing cannot be reliably determined or recommended in children less than 6 months who were less than 37 weeks of gestation at birth; had less than 10 days of oral feeding, or had a body weight of less than 2.6 kg.' A 1 mg/mL oral suspension exists (US label section 3). Seek specialist paediatric haematology advice and verify every figure against a children's formulary.