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Xarelto® in Practice Q&A
Answers to frequently asked questions about Xarelto
Xarelto is an oral, once-daily direct Factor Xa inhibitor for:
Stroke prevention in adults with NVAF
Treatment of PE and treatment of DVT in adults, prevention of recurrent DVT in adults
Treatment of VTE and prevention of recurrent VTE in children 0–17 years old after at least 5 days of initial parenteral anticoagulation
Prevention of atherothrombotic events in adult patients after ACS
Prevention of venous thromboembolism in adult patients undergoing elective hip or knee replacement surgery
With the introduction of any new therapeutic option, there are often questions regarding its use in clinical practice. These answers to some commonly asked questions are designed to provide further guidance to the physician about the appropriate use of Xarelto.
If the answer to your question is not addressed here, please contact Bayer.
What is the evidence to support the use of Xarelto in NVAF patients undergoing PCI with stenting?
In PIONEER AF-PCI, Xarelto signi cantly reduced clinically signi cant bleeding in NVAF patients undergoing PCI with stenting.1 The Xarelto 15 mg OD dose in addition to a P2Y12 inhibitor for a maximum of 12 months post PCI with stent placement has already been adopted in clinical practice.
Xarelto is the only NOAC that is recommended speci cally in the focused update of the 2017 ESC Guidelines for DAPT in patients with an indication for an OAC with a IIb/B recommendation based on the PIONEER AF-PCI results.1,2
Can my NVAF patients without renal impairment be treated with a reduced dose of NOAC if I consider them to be vulnerable?
In a retrospective analysis of 14,865 patients from a US administrative database, Yao et al concluded that NOAC underdosing is associated with a higher risk of stroke without any advantages for patient.3
The study found that, among the 13,392 patients with no renal indication for dose reduction, 13.3% were potentially underdosed.3
Suboptimal stroke protection from inappropriate NOAC dosing has no advantages for patient’s safety. There was no statistically significant relationship between dose reduction and risk of stroke or bleeding in patients who received Xarelto.3
Which dose of Xarelto should be used for extended VTE treatment, for each of my PE/DVT patients?
Ideally, adult PE/ DVT patients should be assessed for individual risk at month 6 and children after 3 months of Xarelto treatment.4 After 6 months, you have the option to reduce the dose of Xarelto to 10 mg once daily. In patients in whom the risk of recurrent VTE is considered high, like those patients with complicated comorbidities or who have developed recurrent VTE, (while on 10 mg OD) a dose of Xarelto 20 mg once daily should be considered. This dosing choice is unique to Xarelto.
In children with VTE, dosing is based on their individual body weight, and should be adjusted if the child is on Xarelto for an extended period of time.4 Please see the Xarelto dosing guide for more information.4 There is no data available in children to support a dose reduction after 6 months treatment.
How should the dose of Xarelto be modified for patients on extended prevention who have experienced recurrent VTE?
From month 6 onwards, the dosage of Xarelto should be increased back to 20 mg OD in adults patients if they experienced recurrent VTE while on Xarelto 10 mg OD.4
Do I need to adjust the dose of Xarelto in patients with renal impairment?
Xarelto is eliminated via both the faecal and the renal pathway, with two thirds metabolised by the liver and one third of active drug eliminated unchanged via the kidneys. Xarelto does not require any dose adjustments in patients with mild renal impairment (CrCl 50–80 ml/min). Xarelto should be used with caution in patients with severe renal impairment (CrCl 15–29 ml/min), and renal impairment concomitantly receiving other medicinal products which increase rivaroxaban plasma concentrations.4 Xarelto has not been studied in the patient population with a creatinine clearance <15 ml/min and its use is not recommended in this patient population.4
There is limited data in children with VTE with renal impairment.4 No dose adjustment is required for children 1 year or older with mild renal impairment [glomerular filtration rate 50–80 mL/min/1.73 m2]. As no clinical data is available, Xarelto is not recommended in children 1 year or older with moderate or severe renal impairment [glomerular filtration rate < 50 mL/min/1.73 m2]. Xarelto is not recommended in children younger than 1 year with serum creatinine results above 97.5th percentile.4
Rivaroxaban clearance is decreased with increasing renal impairment.5 Consequently, and based on the Phase 3 study (ROCKET AF), a dose reduction is recommended for SPAF (20 mg OD to 15 mg OD) in patients with moderate renal impairment [CrCl 30–49 ml/min] and severe renal impairment [CrCl 15–29 ml/min]. For VTE patients with moderate [CrCl 30–49 ml/min] or severe renal impairment [CrCl15–29 ml/min] a dose reduction (20 mg OD to 15 mg OD) can be considered if the bleeding risk outweighs the thrombotic risk. No dose adjustment is necessary in patients taking Xarelto 10 mg OD or 2.5 mg BID.
Why is no routine coagulation monitoring required?
Rivaroxaban shows consistent, dose dependent plasma levels across a range of patient populations. With a fixed dose, a wide therapeutic window, few drug interactions, and predictable pharmacodynamics, no routine monitoring of coagulation parameters is required.4,6
Factor Xa activity closely correlates with the plasma concentration. The prothrombin time (PT) varies in a linear dose-dependent fashion with plasma levels of Xarelto.4
Rivaroxaban shows consistent, dose dependent plasma levels across a range of patient populations.
The Anti- Factor Xa Chromogenic Assay4 and the Prothrombin Time11 (PT), using Neoplastin Plus as reagent, have been identi ed as suitable coagulation tests for rivaroxaban using validated rivaroxaban calibrators and controls.4
The PK profile of rivaroxaban including timing of last drug intake, Cmax and Ctrough has to be taken into account when interpreting results of these tests.4,7
The Anti- Factor Xa Chromogenic Assay accurately estimates rivaroxaban plasma concentration. The PT is prolonged in concentration-dependent fashion,4,8 and in proportion to the increase in anti-Xa activity,9 but the change in PT is smaller and much overlaps within different dose regimens and Cmax/Ctrough levels.9
AF, atrial brillation; ALT, alanine aminotransferase; aPTT, activated partial thromboplastin time; BID, twice daily; CI, con dence interval; DAPT, dual antiplatelet therapy; DVT, deep vein thrombosis; HR, hazard ratio; INR, international normalised ratio; NOAC, non-vitamin K antagonist oral anticoagulant; NVAF, non-valvular atrial brillation; OAC, oral anticoagulant; OD, once daily; PCI, percutaneous coronary intervention; PE, pulmonary embolism; PT, prothrombin time; ULN, upper limit of normal; VTE, venous thromboembolism.
