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, deep vein thrombosis and prevention of recurrence in adults1

Effective VTE VTE
Venous thromboembolism (= VTE). A disease process beginning with a blood clot occurring within the venous system, including deep vein thrombosis and pulmonary embolism.
treatment in Patients with Comorbidities, Halving the Risk of Major Bleeding, vs enoxaparin/VKA VKA
Vitamin K antagonist (= VKA). An anticoagulant that inhibits multiple steps in the blood clotting process. Administered orally, the dose varies by patient, and regular monitoring and dose adjustment are required. Vitamin K antagonists have interactions with food and other drugs. Due to the many limitations of this drug, many of those who are treated are outside of the required target INR range, which can be the cause for increased bleeding or a greater risk of stroke.
1

Consistent safety in patients with moderate renal impairment, active cancer, previous VTE VTE
Venous thromboembolism (= VTE). A disease process beginning with a blood clot occurring within the venous system, including deep vein thrombosis and pulmonary embolism.
and in those who are frail1,2,3

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Xarelto provides effective treatment against recurrent VTE VTE
Venous thromboembolism (= VTE). A disease process beginning with a blood clot occurring within the venous system, including deep vein thrombosis and pulmonary embolism.
, with the reassurance of only 1% risk of major bleedinga,1
EINSTEIN-DVT and PE trials: Xarelto provides effective treatment against recurrent VTE

aDemonstrated major bleeding event rate in EINSTEIN PE PE
Pulmonary embolism (= PE). A potentially fatal condition caused by a blood clot blocking a vessel in the lung: usually the clot originates from a DVT in the legs. PE can result in permanent lung damage.
/DVT DVT
Deep vein thrombosis (= DVT). A blood clot in a deep vein, usually resulting from damage to the vein or blood flow slowing down or stopping. Usually DVTs are found in the leg, but can also be in the arm. Distal DVTs are found in deep veins of the calf, and are the most common type of DVT. Proximal DVTs are found in the legs above the calf muscle up to the waist.
. bPrimary efficacy outcome was recurrent, symptomatic VTE. cRRR RRR
Relative risk reduction (= RRR). Proportion of the control group experiencing a given outcome minus the proportion of the treatment group experiencing the outcome, divided by the proportion of the control group experiencing the outcome.
was calculated as 1–HR HR
Hazard ratio (= HR). This is a measure of how often a particular event happens in one group compared to how often it happens in another group, over time.
by Bayer.

 
XALIA reaffirms the EINSTEIN efficacy and safety profile of Xarelto in the real world4
XALIA study reaffirms the EINSTEIN efficacy and safety profile of Xarelto in the real world

bPrimary efficacy outcome was recurrent, symptomatic VTE. dInitial treatment with unfractionated heparin, low-molecular-weight heparin or fondaparinux usually overlapping with and followed by a VKA VKA
Vitamin K antagonist (= VKA). An anticoagulant that inhibits multiple steps in the blood clotting process. Administered orally, the dose varies by patient, and regular monitoring and dose adjustment are required. Vitamin K antagonists have interactions with food and other drugs. Due to the many limitations of this drug, many of those who are treated are outside of the required target INR range, which can be the cause for increased bleeding or a greater risk of stroke.
.

 
In EINSTEIN PE/DVT, Xarelto reduced the risk of major bleeding:1–3
  • In patients with moderate renal impairment, by 77% vs enoxaparin/VKA2
  • In patients with active cancer, by 58% vs enoxaparin/VKA3
  • In frail patients, by 73% vs enoxaparin/VKA1
In EINSTEIN-PE – the only PE-specific clinical study of any NOAC:
  • Only 1% of patients on Xarelto experienced major bleedinge,5

 

In PE/DVT patients with renal impairment, Xarelto demonstrated lower major bleeding vs enoxaparin/VKAf,2
In PE/DVT patients with renal impairment, Xarelto demonstrated lower major bleeding vs Enoxaparin + VKA

bPrimary efficacy outcome was recurrent, symptomatic VTE. cRRR was calculated as 1–HR by Bayer. fNormal renal function: CrCl ≥80 ml/min. Mild renal impairment: CrCl 50–79 ml/min. Moderate renal impairment: CrCl 30–49 ml/min. Xarelto is to be used with caution in patients with CrCl 15–29 ml/min. Xarelto is not recommended for patients with CrCl <15 ml/min.

  • Choose Xarelto for your patients with renal impairment – approved for patients with CrCl >15 ml/ming,6

 

In CAT patients, Xarelto demonstrated effective VTE protection with a superior safety profile vs enoxaparin/VKAh,3
In CAT patients, Xarelto demonstrated effective VTE protection with a superior safety profile vs enoxaparin/VKA

bPrimary efficacy outcome was recurrent, symptomatic VTE. cRRR was calculated as 1–HR by Bayer. hSubgroup analysis of patients with cancer enrolled in the EINSTEIN-PE and EINSTEIN-DVT randomised controlled trials. iITT ITT
Intention-to-treat (= ITT) analysis. This is an assessment of the people taking part in a clinical trial, based on the group they were initially allocated to. This is regardless of whether or not they dropped out of the study or fully adhered to the treatment or switched to an alternative treatment. Intention-to-treat analyses are often used to assess clinical effectiveness because they reflect actual clinical practice as not everyone adheres to the treatment. In addition, the treatment people receive may be changed according to how their condition responds to it.
population: N=8,281; patients with active cancer, n=655. jSafety population: N=8,246; patients with active cancer, n=651.

  • Xarelto is the only NOAC without a warning in the EU SmPC in patients with active cancer6,7,8,9

 

In Frail Patients, Major Bleeding was Reduced by 73%, vs enoxaparin/VKAk,1
In Frail PE/DVT Patients, Xarelto significantly reduced major bleeding compared with Enoxaparin + VKA

bPrimary efficacy outcome was recurrent, symptomatic VTE. cRRR was calculated as 1–HR by Bayer.
kFrail patients are defined as having one or more of the following criteria: age >75 years, renal impairment (CrCl <50 ml/min) or low body weight (≤50 kg).

Xarelto is to be used with caution in patients with creatinine clearance 15–29 ml/min. In the EINSTEIN pooled analysis, overall rates of clinically relevant bleeding were comparable between Xarelto and enoxaparin + VKA.1

  • Choose Xarelto for your patients with renal impairment – approved for patients with CrCl >15 ml/ming,6

 

In PE Patients, Xarelto more than Halves the Risk of Major Bleeding, vs enoxaparin/VKA5
In PE Patients, Xarelto more than Halves the Risk of Major Bleeding, vs enoxaparin/VKA

In the EINSTEIN pooled analysis, overall rates of clinically relevant bleeding were comparable between Xarelto and enoxaparin + VKA.1
bPrimary efficacy outcome was recurrent, symptomatic VTE. cRRR was calculated as 1–HR by Bayer.

  • Choose Xarelto for your PE patients, with the reassurance that it is the only NOAC with a PE-specific clinical study5

 

In Patients with Previous VTE, Recurrent VTE was Reduced by 55%, vs enoxaparin/VKA1
In Patients with Previous VTE, Recurrent VTE was Reduced by 55% using Xarelto, vs enoxaparin/VKA

EINSTEIN pooled analysis: primary efficacy outcome was non-inferior to standard of care1
In the EINSTEIN pooled analysis, overall rates of clinically relevant bleeding were comparable between Xarelto and enoxaparin + VKA.1

  • To prevent recurrent events, choose Xarelto for patients with a history of VTE.

eIn the EINSTEIN pooled analysis, overall rates of clinically relevant bleeding were comparable between Xarelto and enoxaparin + VKA.
gRefer to Xarelto SmPC for full guidance.

The Only NOAC Where You Have a Dosing Choice in VTE VTE
Venous thromboembolism (= VTE). A disease process beginning with a blood clot occurring within the venous system, including deep vein thrombosis and pulmonary embolism.
Extended Treatment6

Up to 40% of patients may suffer recurrent VTE VTE
Venous thromboembolism (= VTE). A disease process beginning with a blood clot occurring within the venous system, including deep vein thrombosis and pulmonary embolism.
. Extended treatment should be considered9

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Xarelto is Superior in the Reduction of Recurrent VTE VTE
Venous thromboembolism (= VTE). A disease process beginning with a blood clot occurring within the venous system, including deep vein thrombosis and pulmonary embolism.
and as Safe as aspirinl,10
Xarelto is Superior in the Reduction of Recurrent VTE and as Safe as aspirin

bPrimary efficacy outcome was recurrent, symptomatic VTE. cRRR RRR
Relative risk reduction (= RRR). Proportion of the control group experiencing a given outcome minus the proportion of the treatment group experiencing the outcome, divided by the proportion of the control group experiencing the outcome.
was calculated as 1–HR HR
Hazard ratio (= HR). This is a measure of how often a particular event happens in one group compared to how often it happens in another group, over time.
by Bayer. lFor VTE extended treatment. mNo events after Day 360 up to Day 480.

  • Extend treatment in your PE PE
    Pulmonary embolism (= PE). A potentially fatal condition caused by a blood clot blocking a vessel in the lung: usually the clot originates from a DVT in the legs. PE can result in permanent lung damage.
    /DVT DVT
    Deep vein thrombosis (= DVT). A blood clot in a deep vein, usually resulting from damage to the vein or blood flow slowing down or stopping. Usually DVTs are found in the leg, but can also be in the arm. Distal DVTs are found in deep veins of the calf, and are the most common type of DVT. Proximal DVTs are found in the legs above the calf muscle up to the waist.
    patients, with the reassurance of <1% major bleeding, observed in the EINSTEIN CHOICE
 
Consistent reassurance that less than 1% of patients experienced major bleeding with Xarelton,1,4,10,11
Consistent reassurance that less than 1% of patients experienced major bleeding with Xarelto

nIn the EINSTEIN programme and XALIA study. oResults are not intended for direct comparison with clinical trials because the real-world studies were observational trials. Difference in study designs, patient populations, definitions of safety or efficacy outcomes, as well as data collection methods, make it difficult to make comparisons either with clinical trials or with each other.

Simple to start, Xarelto is the only NOAC where you have the flexibility of tailoring dosage in extended PE PE
Pulmonary embolism (= PE). A potentially fatal condition caused by a blood clot blocking a vessel in the lung: usually the clot originates from a DVT in the legs. PE can result in permanent lung damage.
/DVT DVT
Deep vein thrombosis (= DVT). A blood clot in a deep vein, usually resulting from damage to the vein or blood flow slowing down or stopping. Usually DVTs are found in the leg, but can also be in the arm. Distal DVTs are found in deep veins of the calf, and are the most common type of DVT. Proximal DVTs are found in the legs above the calf muscle up to the waist.
treatment6

Flexible dosing options for patients with previous VTE VTE
Venous thromboembolism (= VTE). A disease process beginning with a blood clot occurring within the venous system, including deep vein thrombosis and pulmonary embolism.
who require extended treatment6

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Flexibility of tailoring dosage with Xarelto in extended PE/DVT treatment

Xarelto 15 mg and 20 mg has to be taken with food to ensure high (80–100%) bioavailability and absorption6
pWhile on Xarelto 10 mg once daily.

VTE VTE
Venous thromboembolism (= VTE). A disease process beginning with a blood clot occurring within the venous system, including deep vein thrombosis and pulmonary embolism.
, venous thromboembolism; VKA VKA
Vitamin K antagonist (= VKA). An anticoagulant that inhibits multiple steps in the blood clotting process. Administered orally, the dose varies by patient, and regular monitoring and dose adjustment are required. Vitamin K antagonists have interactions with food and other drugs. Due to the many limitations of this drug, many of those who are treated are outside of the required target INR range, which can be the cause for increased bleeding or a greater risk of stroke.
, vitamin K antagonist; NOAC, non-vitamin K antagonist oral anticoagulant anticoagulant
Anticoagulant drugs are used to treat and prevent blood clots. Sometimes referred to as ‘blood thinners’.
; PE PE
Pulmonary embolism (= PE). A potentially fatal condition caused by a blood clot blocking a vessel in the lung: usually the clot originates from a DVT in the legs. PE can result in permanent lung damage.
, pulmonary embolism; DVT DVT
Deep vein thrombosis (= DVT). A blood clot in a deep vein, usually resulting from damage to the vein or blood flow slowing down or stopping. Usually DVTs are found in the leg, but can also be in the arm. Distal DVTs are found in deep veins of the calf, and are the most common type of DVT. Proximal DVTs are found in the legs above the calf muscle up to the waist.
, deep vein thrombosis thrombosis
Formation of a clot inside a blood vessel.
; RRR RRR
Relative risk reduction (= RRR). Proportion of the control group experiencing a given outcome minus the proportion of the treatment group experiencing the outcome, divided by the proportion of the control group experiencing the outcome.
, relative risk reduction; ARR, absolute risk reduction; HR HR
Hazard ratio (= HR). This is a measure of how often a particular event happens in one group compared to how often it happens in another group, over time.
, hazard ratio; CI, confidence interval; CrCl, creatinine clearance; OD, once daily; EXT, extension; ITT ITT
Intention-to-treat (= ITT) analysis. This is an assessment of the people taking part in a clinical trial, based on the group they were initially allocated to. This is regardless of whether or not they dropped out of the study or fully adhered to the treatment or switched to an alternative treatment. Intention-to-treat analyses are often used to assess clinical effectiveness because they reflect actual clinical practice as not everyone adheres to the treatment. In addition, the treatment people receive may be changed according to how their condition responds to it.
, intention-to-treat.