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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) dosing and administration
for stroke prevention in NVAF

Simple, flexible dosing at your discretion

Pradaxa® (dabigatran etexilate) is available in 110mg and 150mg hard capsules and is the only NOAC that gives you the flexibility to select the appropriate dose for your individual patient based on your assessment of their bleeding risk. A reduced Pradaxa® dose can be used at your discretion if you are concerned your patient may have an increased risk of bleeding.1–3

Selecting the correct Pradaxa®
dose for your NVAF patients

Selecting the correct Pradaxa® (dabigatran etexilate) dose for your NVAF patients
Selecting the correct Pradaxa® dose for your NVAF patients

*Examples of increased bleeding risk may include: the patient is 75–80 years old; suffering from gastritis, oesophagitis or gastroesophageal reflux; has moderate renal impairment (CrCL 30-50mL/min). For further details of factors which may increase the bleeding risk please refer to the Summary of Product Characteristics. Pradaxa® is contraindicated in patients with severe renal impairment (CrCL <30mL/min).2,3

Renal function should be assessed by calculating the creatinine clearance (CrCL) prior to initiation of treatment. Pradaxa® is contraindicated in patients with severe renal impairment (i.e. CrCL <30mL/min).2,3 Prior to prescribing Pradaxa® please ensure that you have assessed the patient's risk of stroke, risk of bleeding and their renal function. These will help you determine the patient's suitability for Pradaxa® and the appropriate dose for them.2,3

Are your patients getting
the most appropriate NOAC dose?

The 2018 European Heart Rhythm Association Practical Guide on the use of NOACs in patients with atrial fibrillation advises that whenever possible, the tested standard doses of NOACs should be used. The Guidance adds that NOAC dose reductions should align with the criteria investigated in phase III trials, and should consider patient age, weight, renal function, co-morbidities and drug-drug interactions.4

NOAC dosing can be challenging particularly when individualising treatment.4 Indeed, findings from a population-based cross-sectional study of patients starting NOAC therapy in UK primary care showed that while the majority of patients were prescribed a daily dose in line with the approved EU drug label, inappropriate underdosing was more than twice as common among patients starting on apixaban than those starting on rivaroxaban or Pradaxa®.5

Dose recommendations by
patient characteristics for
stroke prevention in atrial fibrillation2,3

Prior to prescribing Pradaxa® please ensure that you have assessed the patient's risk of stroke, risk of bleeding and their renal function. These will help you determine the patient's suitability for Pradaxa® and the appropriate dose for them.2,3

Renal function should be assessed by calculating the creatinine clearance (CrCL) prior to initiation of treatment, to exclude patients with severe renal impairment (CrCL <30 ml/min).2,3

Patient characteristic

150mg b.d.*

110mg b.d

Contraindicated

Renal function

CrCL >50 mL/min

CrCl 30-50 mL/min

consider reduction

consider reduction

CrCl <30 mL/min

x

Patient age

<75 years

75-80 years

consider reduction

consider reduction

>80 years

Patient weight

<50kg

consider reduction

consider reduction

>50kg

Concomitant medications

Verapamil


 

Amiodarone

Medicines that may impair haemostasis

consider reduction

consider reduction

Strong P-gp inhibitors: systemic ketoconazole, cyclosporine, itraconazole, dronedarone and the fixed-dose combination glecaprevir/pibrentasvir

x

Previous medical history

Patients with gastritis, oesophagitis or gastroesophageal reflux

consider reduction

consider reduction

History of bleeding

consider reduction

consider reduction

Frequent falls

consider reduction

consider reduction

Other factors that may increase risk of bleeding§

consider reduction

consider reduction

*150mg b.d. may be selected for patients displaying the below characteristics in the absence of them meeting other criteria for dose reduction

Examples include: aspirin and other platelet aggregation inhibitors such as clopidogrel, non-steriodal anti-inflammatory drugs (NSAIDs), selective serotonin re-uptake inhibitors (SSRIs), selective serotonin norepinephrine re-uptake inhibitors (SNRIs).

Patients who have active clinically significant bleeding, or lesions or conditions considered a significant risk factor for major bleeding are contraindicated from taking Pradaxa 

§For further details of factors which may increase the bleeding risk please refer to the Summary of Product Characteristics. 

Initiating your patients on Pradaxa®

Pradaxa® has rapid onset of action, with maximum plasma concentrations
achieved within 0.5 ‒ 2 hours after administration.2,3,7 

New patient

Initiate Pradaxa®2,3

Switching from warfarin

Discontinue warfarin, initiate Pradaxa® once INR is below 2.02,3

Switching from aspirin or clopidogrel

Discontinue aspirin or clopidogrel (unless combination therapy is deemed necessary), and initiate Pradaxa®4

For patients who need triple antithrombotic therapy with aspirin and clopidogrel, Pradaxa® 110mg b.d. should be selected to optimise the risk-benefit ratio.6

For patients who need dual antithrombotic therapy with clopidogrel, guidelines recommend Pradaxa® 150mg b.d. to reduce the risk of ischaemic events (unless the patient meets the criteria for dose reduction)6

Switching from another NOAC

Discontinue the other NOAC; initiate Pradaxa® when the next dose of the initial NOAC is due4

Switching from a parenteral anticoagulant

Start Pradaxa® 2 hours before the next dose of the alternate therapy would be due, or at the time of discontinuation in case of continuous treatment2,3

Instructing your patients
on how to take Pradaxa®

Please advise your patients to swallow Pradaxa® whole with a glass of water to facilitate delivery of this medicine to their stomach. It’s also important that your patients are aware that they must not break, chew or open the capsules before swallowing since this may increase their risk of bleeding. Pradaxa® can be taken with or without food.2,3

How to take Pradaxa®

One capsule twice a day2,3

Pradaxa® should be taken with water2,3. Taking with food may help dyspepsia symptoms.8

Take at roughly the same time each day and 12 hours apart

A forgotten Pradaxa® dose may still be taken up to 6 hours prior to the next scheduled dose. From 6 hours prior to the next scheduled dose onwards, the missed dose should be omitted.2,3

What to do in case of an overdose

Taking an overdose of Pradaxa® exposes patients to an increased risk of bleeding. If a patient has taken more than the recommended dose or an overdose is suspected, coagulation tests can help to determine the bleeding risk. In the event of bleeding complications, Pradaxa® treatment must be discontinued and the source of bleeding investigated. Depending on the clinical situation appropriate supportive treatment, such as surgical haemostasis and blood volume replacement, should be undertaken at the prescriber's discretion. For emergency situations when rapid reversal of the anticoagulant effect of Pradaxa is required, the specific reversal agent (Praxbind®) is available . For further information, please refer to the Summary of Product Characteristics.2,3

Pradaxa® doses for indications
other than NVAF

Pradaxa® has several other indications. These indications, along with their
respective recommended Pradaxa® dose, are as follows:2,3,7

Recommended Dose 

Duration of dosing

Dose reduction recommendations

Prevention of venous thromboembolism (VTE) following elective knee replacement surgery in adults 3,7

110mg on the day of surgery (1-4 hours after surgery is completed)*

then

220mg once daily
(taken as 2 x 110mg capsules) starting on the first day after surgery

10 days 
(starting from the first day after surgery)

75mg on the day of surgery (1-4 hours after surgery is completed)*

then

150mg once daily (taken as 2x 75mg capsules) for patients:

  • With moderate renal impairment (CrCL 30–50ml/min)
  • Who receive concomitant verapamil, amiodarone or quinidine
  • Aged ≥75 years

75mg once daily should be considered for patients with moderate renal impairment (CrCL 30–50ml/min) AND receive concomitant verapamil

Prevention of venous thromboembolism (VTE) following elective hip replacement surgery in adults 3,7

28–35 days 
(starting from the first day after surgery)

Treatment and prevention of deep vein thrombosis (DVT) and pulmonary embolism (PE) in adults† 2,3

150mg twice daily

Individualised after careful assessment of the treatment benefit against the risk for bleeding

Short duration of therapy (at least 3 months) should be based on transient risk factors (e.g. recent surgery, trauma, immobilisation) and longer durations should be based on permanent risk factors or idiopathic DVT or PE.

110mg twice daily for patients:

  • Aged ≥80 years
  • Who receive concomitant verapamil

Consider reducing dose to 110mg twice daily based on individual assessment of thromboembolic and bleeding risk for patients:

  • Aged 75–80 years
  • With moderate renal impairment (CrCL 30–50 ml/min)
  • With gastritis, esophagitis or gastroesophageal reflux
  • At increased risk of bleeding‡ 

*For both surgeries, if haemostasis is not secured, initiation of treatment should be delayed. If treatment is not started on the day of surgery, then treatment should be initiated with 2 capsules once daily.

Treatment should be initiated after treatment with a parenteral anticoagulant for ≥5 days.

‡ For further details of factors which may increase the bleeding risk please refer to the Summary of Product Characteristics.

For more information on the dosing and administration of Pradaxa® for these indications, please refer to the Summary of Product Characteristics.


Abbreviations

AF — atrial fibrillation

CrCL —  creatinine clearance calculated using the Cockroft-Gault formula.

DVT — deep vein thrombosis

EU — European Union

HCP — healthcare professional

INR — International Normalised Ratio

NOAC — non-Vitamin K antagonist oral anticoagulant

NVAF — non-valvular atrial fibrillation

PE —  pulmonary embolism

VTE —  venous thromboembolism

References
  1. Rubboli A. Eur J Intern Med 2019;62:e11–e12.
  2. Pradaxa® 150mg hard capsules Summary of Product Characteristics.
  3. Pradaxa® 110mg hard capsules Summary of Product Characteristics.
  4. Steffel J, et al. Eur Heart J 2018; 39: 1330–1393.
  5. Garcia Rodriguez LA, et al. BMJ Open. 2019 Sep 20;9(9):e03134
  6. Lip GYH, et al. Europace 2019;21;192-193.
  7. Pradaxa® 75mg hard capsules Summary of Product Characteristics. 
  8. Ezekowitz MD, et al. Europace 2016;18(7):973‒978.
PC-GB-100831 V1 | August 2020

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