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DOSING GUIDE
PRACTICAL MANAGEMENT
PRESCRIBING INFORMATION

The Treatment Choice Today, Confidently Protecting Your Patients Tomorrow1–8

Treatment of PE/DVT and prevention of recurrent VTE

Xarelto® is indicated for the treatment of pulmonary embolism (PE) ,deep vein thrombosis (DVT) and prevention of recurrence in adults1

 

Xarelto is indicated for the treatment of venous thromboembolism (VTE) and prevention of VTE recurrence children aged less than 18 years after at least 5 days of initial parenteral anticoagulation1

Protection starts with getting to know your patient

Rose VTE Bio

The more you know someone, the more you can focus on what matters

Rose VTE Bio second image

How do you protect what matters for your patients with VTE ?

Protect what matters most with fast and effective PE clot resolution

Einstein PE

88% of patients who received Xarelto experienced complete or partial clot resolution following 21 days of treatment2

 

Clot resolution following 21 days of Xarelto 15 mg BID*,2

Clot resolution

Overall rates of clot resolution were comparable between Xarelto and enoxaparin.2

 

Treat your patients with long-term protection in mind

Patients in the EINSTEIN PE study experienced consistent efficacy compared with enoxaparin/ VKA with significantly reduced rates of major bleeding3

Einstein PE 3

Recurrent symptomatic VTE 3

Recurrent symptomatic VTE

Rate of major bleeding3

Rate of major bleeding

* Pre-defined safety analysis of the EINSTEIN PE study incolving 347 patients with scan-confirmed PE who received a follow-up CT or Q-scan after 21 days of anticoagulant therapy. Three patients with symptomatic worsening and confirmed recurrent PE were excluded from this analysis.2

† Primary endpoint.

‡ Standard therapy was defined as enoxaparin 1.0 mg/kg BID and either warfarin or acenocoumarol.

§ In the EINSTEIN pooled analysis, overall rates of clinically relevant bleeding were comparable between Xarelto and enoxaparin.4

‖ RRR was calculated as 1-HR (HR: 0.49; 95% CI: 0.31–0.79).

Proven protection from the comfort of their own home

Protect your patients against recurrent VTE without the need for in-hospital treatment5

HoT-PE VTE

Outcomes following 3 months of treatment with Xarelto at home5

Outcomes following 3 months

Look after the life ahead for your patients with VTE

Provide your patients with long-term protection against recurrent VTE , with a choice of dosing that suits their individual needs1,6

Provide your patients with long-term protection against recurrent VTE

Recurent symptomatic VTE *,6

Recurent symptomatic VTE
Experience major bleeding

* All study participants were required to have completed 6 to 12 months of anticoagulation therapy prior to enrolment.

† Primary efficacy outcome was recurrent, symptomatic VTE .

‡  RRR was calculated as 1-HR.

Your patients with cancer-associated thrombosis (CAT) deserve protection that’s backed by studies in more than 7000 people just like them7-11

Let your patients with CAT focus on what matters by protecting them against a devastating VTE recurrence7

Select D VTE

Cumulative recurrent VTE at 6 months*,7

Cumulative recurrent VTE at 6 months

Bleeding outcomes at 6 months7

Bleeding outcomes at 6 months

Protect your patients without adding to their treatment burden12

Xarelto is the only NOAC with studies dedicated to assessing quality of life in patients with CAT7,12-14

Xarelto in the only NOAC VTE
Cosimo vte

Patient-reported outcomes associated with switching to Xarelto for the treatment of VTE in patients with active cancer12

 

Improvement from baseline in ACTS Burdens subscale after switch to Xarelto‡,12

Improvement from baseline in ACTS Burdens

* Primary efficacy outcome was VTE recurrence including symptomatic VTE and incidental PE .

† Fatal bleeding was included as part of major bleeding.

‡ An increase in ACTS Burdens score indicates a decrease in burden (and increase in treatment satisfaction) associated with anti-clot therapy.

§ Primary outcome.

‖ 100% of patients from the ACTS analysis set for week 4, month 3 and month 6 were included in the pairwise analysis of mean scores.

Xarelto is recommended by the ESC for your patients with VTE, including those with active cancer

Provide your patients with guideline recommended protection against recurrent VTE 15

 

ESC 2019 guidelines15

ESC-2019 guidelines table 1
ESC-2019 guidelines table 2

The recommendation for use in patients with cancer is supported by multiple international guidelines:16-18

  • ASCO
  • ISTH
  • ITAC

People like Rose need a dosing regimen that’s right for them

Tailored, once daily dosing means that you can protect your patients with the right dose at the right time1,19

Injection free vte
Daily dosing VTE

* For patients in which 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 OD. 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 Xarelto 10 mg OD, a dose of Xarelto 20 mg OD should be considered.

ACTS, anti-clot treatment scale; ASCO, American Society of Clinical Oncology; ARR, absolute risk reduction; BID, twice daily; CAT, cancer-associated thrombosis ; CI, confidence interval; CT, computed tomography; DVT , deep vein thrombosis; ESC, European Society of Cardiology; HR, hazard raio; ISTH, International Society of Thrombosis and Haemostasis; ITAC, The International Initiative on Thrombosis and Cancer; LMWH , low moecular weight heparin; OD, once daily; PE , pumonary embolism; RRR , relative risk reduction; VKA , vitamin K antagonist; VTE , venous thromboembolism.

References

  • Bayer AG. Xarelto® (rivaroxaban) Summary of Product Characteristics. Available at: https://www.ema.europa.eu/documents/product-information/xarelto-epar-product-information_en.pdf. Return to content
  • Van Es, Douma RA, Kamphuisen PW et al. Clot resolution after 3 weeks of anticolagulant treatment for pulmonary embolism: comparison of computed tomography and perfusion scintigraphy. J Thromb Haemost. 2013;11:679–685. Return to content
  • Buller HR, Prins MH, Lensing AWA et al. Oral rivaroxaban for the treatment of symptomatic pulmonary embolism. N Engl J Med. 2019;366:1287–1297. Return to content
  • Prins M, Lensing AWA, Bauersachs R et al. Oral rivaroxaban versus standard therapy for the treatment of symptomatic venous thromboembolism: a pooled analysis of the EINSTEIN-DVT and PE randomized studies. Thrombosis J. 2013;11(1):21–31. Return to content
  • Barco S, Schmidtmann I, Ageno W et al. Early discharge and home treatment of patients with low-risk pulmonary embolism with the oral factor Xa inhibitor rivaroxaban; an international multicentre single-arm clinical trial. Eur Heart J. 2020;41:509–518. Return to content
  • Weitz JI, Lensing AWA, Prins MH et al. Rivaroxaban or aspirin for extended treatment of venous thromboembolism. N Engl J Med. 2017;376:1211–1222. Return to content
  • Young AM, Marshal A, Thirlwall J et al. Comparison of an oral factor Xa inhibitor with low molecular weight heparin in patients with cancer with venous thromboembolism: Results of a randomized trial (SELECT-D). J Clin Oncol. 2018;36:2017–2023. Return to content
  • Prins MH, Lensing AWA, Brighton TA et al. Oral rivaroxaban versus enoxaparin with vitamin K antagonist for the treatment of symptomatic venous thromboembolism in patients with cancer (EINSTEIN-DVT and EINSTEIN-PE): a pooled subgroup analysis of two randomised controlled trials. Lancet Haematol. 2014;1:e37–e46. Return to content
  • Streiff MB, Milentijevic D, McCrae K et al. Effectiveness and safety of anticoagulants for the treatment of venous thromboembolism in patients with cancer. Am J Hematol. 2018;93:664–671. Return to content
  • Ageno W, Mantovani LG, Haas S et al. Subgroup analysis of patients with cancer in XALIA: A noninterventional study of Rivaroxaban versus standard anticoagulation for VTE. TH Open. 2017;1:e33–e42. Return to content
  • Bach M and Bauersachs R. Spotlight on advances in VTE management: CALLISTO and EINSTEIN CHOICE. Thromb Haemost. 2016;116(Suppl 2):S24–S32. Return to content
  • Cohen AT, et al. Patient-reported outcomes associated with switching to rivaroxaban for the treatment of venous thromboembolism in patients with active cancer. Poster 1774P presented at the European Society of Medical Oncology (ESMO) congress, 27 September – 1 October 2019, Barcelona, Spain. Return to content
  • Cohen AT, Maraveyaa A, Beyer-Westendorf J et al. COSIMO – patients with active cancer changing to rivaroxaban for the treatment and prevention of recurrent venous thromboembolism: a non-interventional study. Thromb J. 2018;16:21. Return to content
  • Marshall A, Levine M, Hill C et al. Treatment of cancer-associated venous thromboembolism: 12-month outcomes of the placebo versus rivaroxaban randomization of the SELECT-D Trial (SELECT-D: 12m). J Thromb Haemost. 2020;18:905–915. Return to content
  • Konstantinides SV, Meyer G, Becattini C et al. 2019 ESC Guidelines for the diagnosis and management of acute pulmonary embolism developed in collaboration with the European Respiratory Society (ERS). Eur Heart J. 2020;41:543–603. Return to content
  • Khorana AA, Noble S, Lee AYY et al. Role of direct oral anticoagulants in the treatment of cancer-associated venous thromboembolism: guidance from the SSC of the ISTH. J Thromb Haemost. 2018;16:1891–1894. Return to content
  • Key NS, Khorana AA, Kuderer NM et al. Venous Thromboembolism Prophylaxis and Treatment in Patients With Cancer: ASCO Clinical Practice Guideline Update. J Clin Oncol. 2020;38:496–520. Return to content
  • Farge D, Frere C, Connors JM et al. 2019 international clinical practice guidelines for the treatment and prophylaxis of venous thromboembolism in patients with cancer. Lancet Oncol. 2019;e566–e581. Return to content
  • Limone BL, Hernandez A, Michalak D et al. Timing of recurrent venous thromboembolism early after the index event: A meta-analysis of randomized controlled trials. Thromb Res. 2013;132:420–426. Return to content

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This website contains information on Xarelto (rivaroxaban) which is based on the Summary of Product Characteristics (SPC) as approved by the European Commission. It is intended to provide information to an international audience outside the USA and UK.

Last updated on 30/03/2020