Dabigatran

Green-G

Brand Name(s):Pradaxa

Indication:Stroke prevention and systemic embolism prevention in adult patients with non-valvular atrial fibrillation with one or more risk factors.

Rationale:

Considered:Nov-08

Review Date:Jul-24

Comments:
Drug Safety Update
Direct-acting oral anticoagulants (DOACs): increased risk of recurrent thrombotic events in patients with antiphospholipid syndrome
June 19
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NICE CG 180 The Management of AF: Information can be found at:http://www.nice.org.uk/guidance/CG180
June 2014
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Risk of haemorrhage
Prescribers should note guidance issued by MHRA regarding risk of serious haemorrhage with the new oral anticoagulant drugs (NOAC’s). Guidance contains updated information on contraindications and warnings for use.

MHRA guidance available at: http://www.mhra.gov.uk/home/groups/pl-p/documents/drugsafetymessage/con321961.pdf
Issued October 2013

Because of the risk of haemorrhage, dabigatran is contraindicated in a range of clinical conditions where the patient is at significant risk of major bleeding (listed in the main article). Dabigatran is also now contraindicated with dronedarone, and with the use of other anticoagulant agents, except when switching therapy to or from dabigatran, or with the use of unfractionated heparin for maintenance of venous or arterial catheter patency.

In addition, as exposure to dabigatran is substantially increased in patients with renal insufficiency, renal function should be assessed in all patients before starting dabigatran and at least once a year in patients older than 75 years or those with a suspected decline in renal function.

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MHRA Drug Safety UpdateVolume 5 Issue 12 July 2012

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Please refer to local Formulary http://medicinesmanagement.doncasterpct.nhs.uk/page.asp?cpath=103

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Dabigatran etexilate for the prevention of stroke and systemic embolism in atrial fibrillation
Dabigatran etexilate is recommended as an option for the prevention of stroke and systemic embolism within its licensed indication, that is, in people with nonvalvular atrial fibrillation with one or more of the following risk factors:
previous stroke, transient ischaemic attack or systemic embolism
left ventricular ejection fraction below 40%
symptomatic heart failure of New York Heart Association (NYHA) class 2 or above
age 75 years or older
age 65 years or older with one of the following: diabetes mellitus, coronary artery disease or hypertension.
The decision about whether to start treatment with dabigatran etexilate should be made after an informed discussion between the clinician and the person about the risks and benefits of dabigatran etexilate compared with warfarin. For people who are taking warfarin, the potential risks and benefits of switching to dabigatran etexilate should be considered in light of their level of international normalised ratio (INR) control. Dabigatran etexilate for the prevention of stroke and systemic embolism in atrial fibrillation
NICE technology appraisal guidance 249
Issued: March 2012

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NICE TA 157
Dabigatran etexilate for the prevention of venous thromboembolism after hip or knee replacement surgery in adults September 2008