Rivaroxaban (Xarelto)

Background

Doses

For Xarelto 15 and 20 mg film-coated tablets:

Prevention of stroke and systemic embolism in adult patients with non-valvular AF with one or more risk factors, such as CCF, ↑BP, age ≥75 years, DM, prior stroke or TIA
Treatment of DVT and PE and prevention of recurrent DVT and PE in adults
Prevention of stroke and systemic embolism - the recommended dose is 20 mg once daily, which is also the recommended maximum dose
Therapy with Rivaroxaban (Xarelto ®) should be continued long term provided the benefit of prevention of stroke and systemic embolism outweighs the risk of bleeding
If a dose is missed the patient should take Xarelto 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
Treatment of DVT, treatment of PE and prevention of recurrent DVT and PE - 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, as indicated in the table below

	Dosing schedule	Maximum daily dose
Day 1 - 21	15 mg twice daily	30 mg
Day 22 and onwards	20 mg once daily	20 mg

The duration of therapy 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 Xarelto immediately to ensure intake of 30 mg Xarelto 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 (day 22 and onwards), the patient should take Xarelto 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

Converting anticoagulants

converting from Vitamin K Antagonists (VKA) to Xarelto

For patients treated for prevention of stroke and systemic embolism, VKA treatment should be stopped and Xarelto therapy should be initiated when the INR is ≤3
For patients treated for DVT, PE and prevention of recurrence, VKA treatment should be stopped and Xarelto therapy should be initiated once the INR is ≤2.5
When converting patients from VKAs to Xarelto, INR values will be falsely elevated after the intake of Xarelto
The INR is not valid to measure the anticoagulant activity of Xarelto, and therefore should not be used

Converting from Xarelto to Vitamin K antagonists (VKA)

In patients converting from Xarelto 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 Xarelto and VKA the INR should not be tested earlier than 24 hours after the previous dose but prior to the next dose of Xarelto. Once Xarelto is discontinued INR testing may be done reliably at least 4 hours after the last dose

Converting from parenteral anticoagulants to Xarelto

For patients currently receiving a parenteral anticoagulant, Xarelto should be started 0 to 2 hours before the time of the next scheduled administration of the parenteral medicinal product (e.g. low molecular weight heparins) or at the time of discontinuation of a continuously administered parenteral medicinal product e.g. intravenous unfractionated heparin)

Converting from Xarelto to parenteral anticoagulants

Give the first dose of parenteral anticoagulant at the time the next Xarelto dose would be taken

Special populations

Renal impairment

Xarelto is to be used with caution in these patients
Please check BNF or medicines.ie

Hepatic impairment

Rivaroxaban is contraindicated in patients with hepatic disease associated with coagulopathy and clinically relevant bleeding risk including cirrhotic patients with Child Pugh B and C

Elderly population

No dose adjustment

Body weight

No dose adjustment

Gender

No dose adjustment

Children

Xarelto® in children has specific (indications)

Low dose Rivaroxaban

Rivaroxaban has a 2.5mg q12h dose available (Indications). It has recently become available on the MMP under a Managed Access Program (MAP), (details). This 2.5mg bd dose is not a precribing error but used in some, with low-dose ASA for the prevention of major adverse cardiovascular events in CAD and PAD.

Thrombophlebitis

The use of Rivaroxaban in the management of thrombphlebitis (NB dose = 10mg od x6/52) is off license but we believe the evidence supports it's use in patients with high risk thrombophlebitis. More on thrombophlebitis.

Rivaroxaban (Xarelto ®)