Dabigatran etexilate

Articles · Medicine Compliance Aid Stability · Lactation Safety Information · New Medicines ·


Safety in Lactation: Drugs for thromboembolic disorders

Additional information relating to breastfeeding To be used in conjunction with individual drug entries for specific information and guidance. Oral anticoagulants The coumarin anticoagulants, warfarin… Abciximab Acenocoumarol Alteplase Apixaban Argatroban Aspirin Cardiovascular system disorders Clopidogrel Dabigatran etexilate Dalteparin Dipyridamole Edoxaban Enoxaparin Epoprostenol Eptifibatide Fondaparinux Heparin Phenindione Prasugrel Rivaroxaban Safety in Lactation Ticagrelor Tinzaparin Urokinase Warfarin

Medicine Compliance Aid Stability

Pradaxa · Boehringer Ingelheim

Boehringer Ingelheim
Capsules 75mg, 110mg, 150mg
R2 · Red 2 · Drug is not suitable for CAs due to theoretical reasons that cannot be mitigated.
Very sensitive to moisture so should be left in individual foil wrapping.
9th November 2015

Lactation Safety Information

Direct thrombin inhibitor
Very limited published evidence of safety indicates low levels in milk
Minimal absorption from the infant’s GI tract expected due to low oral bioavailability
Monitor infant for bleeding and bruising
13th August 2020

New Medicines

Pradaxa · Venous thromboembolism (VTE) from birth to <18 years of age


Licence extension / variation
Boehringer Ingelheim
Boehringer Ingelheim

Development and Regulatory status

Pre-registration (Filed)
Pre-registration (Filed)
Phase III Clinical Trials
Aug 20 · Currently pre-registration in EU. Has been filed using the centralised procedure; estimated CHMP opinion in Oct 20 [8].


Thrombin inhibitor
The incidence of VTE is 1-2 per 1,000 of the population and the risk increases with age. One in 20 people will have a VTE at some time in their life. Approximately half of patients presenting with VTE have been hospitalised in the previous eight weeks [2].
Venous thromboembolism (VTE) from birth to <18 years of age

Trial or other data

Nov 19 · Boehringer completes the PII PIII Diversity (NCT01895777) trial [7].
Dec 18 · PIII Diversity trial is still recruiting subjects, with an estimated primary completion date of January 2020 [6].
Nov 17 · The PIII Diversity trial estimated primary completion date changed to 5 Nov 2018 [5]
Jan 17 · The PIII Diversity trial (NCT01895777) is ongoing and still recruiting participants, with an estimated primary completion date of June 2018 [4]
Jan 16 · PIII development is ongoing with the open-label (NCT01895777) still recruiting subjects. The estimated final data collection date for the primary outcome measure is March 2018 [3].
Jul 13 · NCT01895777 This is an open-label, randomized, active-controlled, multi-centre PIII non-inferiority study in 270 children from birth to < 18 years of age to assess the efficacy and safety of dabigatran vs standard of care (LMWH or vitamin K antagonists) for treatment of VTE. The study will also assess the appropriateness of the proposed dabigatran doses for use in paediatric patients using three different formulations (capsules, pellets and oral liquid formulation). The co-primary outcomes are: A combined endpoint of complete thrombus resolution plus freedom from recurrent VTE plus freedom from mortality related to VTE, and freedom from major bleeding events, both at 12 weeks. The study starts Sep 13 and is due to complete Mar 18 [1].