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Information for:

UK & IRELAND HEALTHCARE PROFESSIONALS

Click here if you are a healthcare professional and would like more information on Pradaxa® (dabigatran etexilate)


Information intended for:

PATIENTS PRESCRIBED PRADAXA®/ MEMBERS OF THE PUBLIC IN THE UK & IRELAND

Click here for more information on Pradaxa®


PC-GB -101423 V1 August 2020

Pradaxa®(dabigatran etexilate):
Summary of key information

What is Pradaxa®(dabigatran etexilate)?

Pradaxa® (dabigatran etexilate) is a non–vitamin K antagonist oral anticoagulant (NOAC) and is a direct inhibitor of thrombin.1,2​​​​​​​

Pradaxa® (dabigatran etexilate) packaging: 75 mg, 110 mg and 150 mg
Pradaxa® (dabigatran etexilate) packaging: 75 mg, 110 mg and 150 mg

What is Pradaxa® used for?

Pradaxa® is indicated for the prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (NVAF) with one or more risk factors such as:1,2


Pradaxa® is also indicated for:

  • Primary prevention of venous thromboembolism (VTE) following total knee replacement surgery in adults2,3
  • Primary prevention of VTE following total hip replacement surgery in adults2,3
  • Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) in adults1,2
  • Prevention of recurrent DVT and PE in adults1,2

How does Pradaxa® prevent the formation of blood clots?

All anticoagulants ultimately exert their effects by inhibiting thrombin, directly or indirectly. Pradaxa® is the only NOAC that directly inhibits thrombin. In contrast, other NOACs, also known as DOACs (direct oral anticoagulants), exert their anticoagulant effects by inhibiting Factor Xa, a molecule in the coagulation cascade that converts small amounts of prothrombin to thrombin.

Dabigatran is a potent, competitive reversible direct thrombin inhibitor which specifically and selectively binds to both free and fibrin-bound thrombin. Since thrombin enables the conversion of fibrinogen into fibrin during the coagulation cascade, its inhibition prevents the development of thrombus. 1-3 As a reversible inhibitor, dabigatran dissociates from thrombin, leaving a small amount of free, enzymatically active thrombin available for normal haemostasis.4

Pradaxa® (dabigatran etexilate) mechanism of action
Pradaxa is a direct thrombin inhibitor

Practicalities of prescribing Pradaxa® for stroke prevention in patients with NVAF

Simple dosing and administration

Pradaxa® is available in 150mg and 110mg hard shell capsules and is the only NOAC that gives you the flexibility to select the appropriate dose for each patient based on your assessment of their thromboembolic and bleeding risks. This means you can prescribe a lower dose if you are concerned your patient may have an increased risk of bleeding.*1,2,5 This flexibility allows you to choose the right dose for the right patient for stroke prevention in NVAF.

Pradaxa® is available nationally

Pradaxa® is available for you to prescribe locally. This means that if your NVAF patient is at risk of stroke and systemic embolism and you think that Pradaxa® is the right treatment, it is available for use, in line with NICE recommendations and SMC advice.6,7

Pradaxa® is the NOAC with the lowest daily cost

Pradaxa® has the lowest daily cost compared to the other NOACs (rivaroxaban, apixaban and edoxaban), costing only £51.00 per month or £1.70 per day, compared with up to £57.00 per month or £1.90 per day for the other NOACs.8

Pradaxa® SmPCs and risk minimisation materials

Before prescribing Pradaxa®, you should refer to the SmPC, which you can access at the links below:

For UK Healthcare professionals

For IRE Healthcare professionals

You can also access the current Pradaxa® Prescriber Guides online via the links above. The Prescriber Guides provide recommendations for the use of Pradaxa® in order to minimise the risk of bleeding. In particular it is aimed at increasing awareness about the potential risk of bleeding during treatment with Pradaxa® and providing guidance on how to manage that risk.

Pradaxa (dabigatran etexilate) Prescriber Guide (SPAF/DVT/PE)
Pradaxa (dabigatran etexilate) Prescriber Guide (SPAF/DVT/PE)
Abbreviations

DVT: deep vein thrombosis

NVAF: non-valvular atrial fibrillation

NYHA: New York Heart Association

PE: pulmonary embolism

SmPC: summary of product characteristics

VTE: venous thromboembolism

 

References
  1. Pradaxa® 110mg hard capsules Summary of Product Characteristics.
  2. Pradaxa® 150mg hard capsules Summary of Product Characteristics.
  3. Pradaxa® 75mg hard capsules Summary of Product Characteristics.
  4. Stangier J. Clin Pharmacokinet 2008;47(5):285-295.
  5. Rubboli A. Eur J Intern Med 2019;62:e11-e12.
  6. SMC Advice (672/11). Dabigatran etexilate 110mg and 150mg hard capsules (Pradaxa®). Published August 2011. 
  7. NICE Technology Appraisal Guidance (TA249). Dabigatran etexilate for the prevention of stroke and systemic embolism in atrial fibrillation. Published March 2012. 
  8. MIMS.co.uk (accessed August2020).
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