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Articles

Small volume intramuscular injections in people taking oral anticoagulants

11 May 2022Advice and a summary of the issues and evidence for healthcare professionals with concerns about use of IM injections in people taking oral anticoagulants

Using oral anticoagulants in breastfeeding women

2 November 2021Thromboembolic disease management whilst breastfeeding is challenging. Warfarin is the preferred choice. Guidance on using DOACs is also provided.

Using COVID-19 vaccines in patients with anticoagulation and bleeding disorders

7 January 2021Information on use of the vaccine in patients who are receiving anticoagulants or have a bleeding disorder is given below.

Non-vitamin K antagonist oral anticoagulants (NOACs): Is it safe to take them with herbal medicines?

26 March 2020There is a lack of scientific evidence of the safety and efficacy of herbal medicines together with an under-reporting and underestimation of adverse effects. Interactions…

Direct Acting Oral Anticoagulants (DOACs) in Renal Impairment: Practice Guide to Dosing Issues

5 March 2020Choosing the correct dose of an anticoagulant is important to ensure that the patient receives the benefits in terms of reduction of thrombo-embolic events whilst…
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Medicine Compliance Aid Stability

PradaxaBoehringer Ingelheim

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

Lactation Safety Information

Caution
Warfarin, Rivaroxaban
Direct thrombin inhibitor
Very limited published evidence of safety indicates negligible levels in milk
Minimal absorption from the infant’s GI tract expected due to low oral bioavailability
Monitor infant for bleeding and bruising
1 November 2021

New Medicines

PradaxaVenous thromboembolism (VTE) from birth to <18 years of age - oral solution and coated granules formulations

Information

Pradaxa
Licence extension / variation and new formulation
Boehringer Ingelheim
Boehringer Ingelheim

Development and Regulatory status

Approved (Licensed)
Approved (Licensed)
Approved (Licensed)
Jan 22Pradaxa 75mg, 110mg and 150mg capsules are also licensed in the UK for the treatment of VTE and prevention of recurrent VTE in paediatric patients from birth to less than 18 years of age (licence change was approved by MHRA in Jan 21, but updated SPC made available this month). Pradaxa capsules can be used in adults and paediatric patients aged 8 years or older who are able to swallow the capsules whole. Pradaxa coated granules can be used in children aged less than 12 years as soon as the child is able to swallow soft food. Pradaxa powder and solvent for oral solution should only be used in children aged less than 1 year [14].
Nov 21MHRA approves Pradaxa 6.25 mg/mL powder and solvent for oral solution and Pradaxa 20 mg coated granules (and 30 mg, 40 mg, 50 mg, 110 mg, 150 mg) for treatment of venous thromboembolic events (VTE) and prevention of recurrent VTE in paediatric patients from birth to less than 18 years of age. Pradaxa powder and solvent for oral solution should not be used in patients aged 1 year or older [13].
Jun 21Approval is for oral pellets to treat children age 3 months to <12 years and for capsules to treat patients age ≥8 years, with VTE after parenteral anticoagulation for ≥5 days, and also for prevention of recurrent clots in those who have completed treatment for their first VTE [11].
Jun 21Approved in US for only children 3 months to less than 12 years old [10].
Jan 21Licence change and new formulations approved in EU [12].
Nov 20Recommended for EU approval by CHMP - the additional indication is "Treatment of VTE and prevention of recurrent VTE in paediatric patients from birth to less than 18 years of age." Indications for all dose forms now include "For age appropriate dose forms, see section 4.2." A contra-indication of "eGFR <50 mL/min/1.73m2 in paediatric patients" is added for all dose forms, and new dose forms of an oral liquid plus oral coated granules in a range of strengths have been licensed [8].
Aug 20Currently pre-registration in EU. Has been filed using the centralised procedure; estimated CHMP opinion in Oct 20 [8].

Category

Thrombin inhibitor, in an oral solution and oral granules
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 - oral solution and coated granules formulations
Oral

Trial or other data

Dec 20Diversity RCT (n=328) found age/weight adjusted dabigatran non-inferior to standard of care (LMWH/unfractionated heparin/vit K antagonists/fondaparinux) for the composite efficacy endpoint of thrombus resolution, & no recurrent VTE or VTE-death: 42%vs 46%; p<0.0001) [9].
Nov 19Boehringer completes the PII PIII Diversity (NCT01895777) trial [7].
Dec 18PIII Diversity trial is still recruiting subjects, with an estimated primary completion date of January 2020 [6].
Nov 17The PIII Diversity trial estimated primary completion date changed to 5 Nov 2018 [5]
Jan 17The PIII Diversity trial (NCT01895777) is ongoing and still recruiting participants, with an estimated primary completion date of June 2018 [4]
Jan 16PIII 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 13NCT01895777 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].

Evidence based evaluations