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Pediatric dosing guidance for the direct oral anticoagulant dabigatran

Pediatric dosing guidance for the direct oral anticoagulant dabigatran
Dabigatran oral pellets*
Dosing for infants and toddlers <2 years old		 Dabigatran oral pellets*
Dosing for children ≥2 years old		 Dabigatran oral capsules*
(an option for patients ≥8 years old who can swallow pills)
Patient's age Patient's weight Dabigatran dose Patient's weight Dabigatran dose Patient's weight Dabigatran dose
3 to <4 months 3 to <4 kg 30 mg twice daily 7 to <9 kg 70 mg twice daily 11 to <16 kg 75 mg twice daily
4 to <7 kg 40 mg twice daily 9 to <11 kg 90 mg twice daily 16 to <26 kg 110 mg twice daily
7 to <9 kg 50 mg twice daily 11 to <13 kg 110 mg twice daily 26 to <41 kg 150 mg twice daily
4 to <5 months 3 to <4 kg 30 mg twice daily 13 to <16 kg 140 mg twice daily 41 to <61 kg 185 mg twice daily
4 to <7 kg 40 mg twice daily 16 to <21 kg 170 mg twice daily 61 to <81 kg 220 mg twice dailyΔ
7 to <9 kg 60 mg twice daily 21 to <41 kg 220 mg twice daily ≥81 kg 260 mg twice dailyΔ
5 to <6 months 3 to <4 kg 30 mg twice daily ≥41 kg 260 mg twice daily    
4 to <5 kg 40 mg twice daily        
5 to <7 kg 50 mg twice daily        
7 to <11 kg 60 mg twice daily        
6 to <9 months 4 to <5 kg 40 mg twice daily        
5 to <7 kg 50 mg twice daily        
7 to <9 kg 60 mg twice daily        
9 to <11 kg 80 mg twice daily        
11 to <13 kg 100 mg twice daily        
9 to <11 months 4 to <5 kg 40 mg twice daily        
5 to <7 kg 50 mg twice daily        
7 to <9 kg 70 mg twice daily        
9 to <11 kg 80 mg twice daily        
11 to <16 kg 100 mg twice daily        
11 to <18 months 5 to <7 kg 50 mg twice daily        
7 to <9 kg 70 mg twice daily        
9 to <11 kg 90 mg twice daily        
11 to <13 kg 100 mg twice daily        
13 to <21 kg 140 mg twice daily        
18 months to <2 years 5 to <7 kg 50 mg twice daily        
7 to <9 kg 70 mg twice daily        
9 to <11 kg 90 mg twice daily        
11 to <13 kg 110 mg twice daily        
13 to <21 kg 140 mg twice daily        
21 to <26 kg 180 mg twice daily        
The dosing guidance in this table is for the treatment or secondary prevention of VTE in patients with normal kidney function. Patients should receive at least 5 days of parenteral anticoagulant therapy (eg, with LMWH or UFH) prior to transitioning to dabigatran. There are limited data available on use of dabigatran in patients with renal insufficiency. Dabigatran should not be used in patients with significant renal insufficiency (ie, estimated glomerular filtration rate <50 mL/minute). The dosing guidance for dabigatran as presented in this table differs slightly from the package label, in that some age group categories were combined if the dose was the same.
VTE: venous thrombosis and thromboembolism; LMWH: low molecular weight heparin; UFH: unfractionated heparin.
* Dabigatran is available in 2 different dosing forms for use in pediatric patients: oral pellets and oral capsules. The dosing forms are not interchangeable on a mg-for-mg basis, due to differences in bioavailability. Use caution when selecting the dosing form and dose. Combining dosing forms to achieve the total dose is not recommended.
¶ For administration of dabigatran oral pellets, the dose can be mixed into an ounce of apple juice or soft food (eg, apple sauce, mashed bananas). Oral pellets should not be mixed with milk, milk products, or soft foods containing milk.
Δ The suggested doses for adolescent patients weighing >60 kg are substantially higher than the usual treatment dose for adult patients, which is 150 mg twice daily. The pediatric dosing guidance summarized above is taken from the pediatric DIVERSITY trial and is based upon the Hayton model, which applies to renally eliminated drugs and considers the maturation of renal function parameters (eg, glomerular filtration, tubular secretion, renal plasma flow). The efficacy of the adult dosing regimen (150 mg twice daily) was established in clinical trials that largely enrolled patients >40 years old. Young adults with normal kidney function likely require higher doses compared with older patients. However, the optimal dose for this population is uncertain.
References:
  1. US Food and Drug Administration. Prescribing information: Pradaxa (dabigatran etexilate) oral pellets. 2021. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/214358s000lbl.pdf (Accessed on November 5, 2021).
  2. US Food and Drug Administration. Prescribing information: Pradaxa (dabigatran etexilate) capsules. 2021. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022512s041lbl.pdf (Accessed on November 5, 2021).
  3. Halton J, Brandão LR, Luciani M, et al. Dabigatran etexilate for the treatment of acute venous thromboembolism in children (DIVERSITY): a randomised, controlled, open-label, phase 2b/3, non-inferiority trial. Lancet Haematol 2021; 8:e22.
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