Active Ingredient: Dabigatran
Treatment of VTE in paediatric patients from birth to less than 18 years of age.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Regimen A: In case that patient weight is ≥ 11 kg and patient weight is ≤ 13 kg and patient age in years is ≥ 8 and patient age in years is ≤ 9, oral, 75 milligrams dabigatran, 2 times daily.
Regimen B: In case that patient weight is ≥ 13 kg and patient weight is ≤ 16 kg and patient age in years is ≥ 8 and patient age in years is ≤ 11, oral, 110 milligrams dabigatran, 2 times daily.
Regimen C: In case that patient weight is ≥ 16 kg and patient weight is ≤ 21 kg and patient age in years is ≥ 8 and patient age in years is ≤ 14, oral, 110 milligrams dabigatran, 2 times daily.
Regimen D: In case that patient weight is ≥ 21 kg and patient weight is ≤ 26 kg and patient age in years is ≥ 8 and patient age in years is ≤ 16, oral, 150 milligrams dabigatran, 2 times daily.
Regimen E: In case that patient weight is ≥ 26 kg and patient weight is ≤ 31 kg and patient age in years is ≥ 8 and patient age in years is ≤ 18, oral, 150 milligrams dabigatran, 2 times daily.
Regimen F: In case that patient weight is ≥ 31 kg and patient weight is ≤ 41 kg and patient age in years is ≥ 8 and patient age in years is ≤ 18, oral, 185 milligrams dabigatran, 2 times daily.
Regimen G: In case that patient weight is ≥ 41 kg and patient weight is ≤ 51 kg and patient age in years is ≥ 8 and patient age in years is ≤ 18, oral, 220 milligrams dabigatran, 2 times daily.
Regimen H: In case that patient weight is ≥ 51 kg and patient weight is ≤ 61 kg and patient age in years is ≥ 8 and patient age in years is ≤ 18, oral, 260 milligrams dabigatran, 2 times daily.
Regimen I: In case that patient weight is ≥ 61 kg and patient weight is ≤ 71 kg and patient age in years is ≥ 8 and patient age in years is ≤ 18, oral, 300 milligrams dabigatran, 2 times daily.
Regimen J: In case that patient weight is ≥ 71 kg and patient weight is ≤ 81 kg and patient age in years is ≥ 8 and patient age in years is ≤ 18, oral, 300 milligrams dabigatran, 2 times daily.
Regimen K: In case that patient weight is ≥ 81 kg and patient age in years is ≥ 10 and patient age in years is ≤ 18, oral, 300 milligrams dabigatran, 2 times daily.
For the treatment of VTE in paediatric patients, treatment should be initiated following treatment with a parenteral anticoagulant for at least 5 days. For prevention of recurrent VTE, treatment should be initiated following previous treatment.
Dabigatran etexilate should be taken twice daily, one dose in the morning and one dose in the evening, at approximately the same time every day. The dosing interval should be as close to 12 hours as possible.
The recommended dose of dabigatran etexilate is based on the patient’s weight and age as shown in the following table. The dose should be adjusted according to weight and age as treatment progresses.
For weight and age combinations not listed in the dosing table no dosing recommendation can be provided.
Single and total daily dabigatran etexilate doses in milligrams (mg) by weight in kilograms (kg) and age in years of the patient:
| Weight /age combinations | Single dose in mg | Total daily dose in mg | |
|---|---|---|---|
| Weight in kg | Age in years | ||
| 11 to <13 | 8 to <9 | 75 | 150 |
| 13 to <16 | 8 to <11 | 110 | 220 |
| 16 to <21 | 8 to <14 | 110 | 220 |
| 21 to <26 | 8 to <16 | 150 | 300 |
| 26 to <31 | 8 to <18 | 150 | 300 |
| 31 to <41 | 8 to <18 | 185 | 370 |
| 41 to <51 | 8 to <18 | 220 | 440 |
| 51 to <61 | 8 to <18 | 260 | 520 |
| 61 to <71 | 8 to <18 | 300 | 600 |
| 71 to <81 | 8 to <18 | 300 | 600 |
| >81 | 10 to <18 | 300 | 600 |
Prior to the initiation of treatment, the estimated glomerular filtration rate (eGFR) should be estimated using the Schwartz formula (method used for creatinine assessment to be checked with local lab).
Treatment with dabigatran etexilate in paediatric patients with eGFR <50 mL/min/1.73m² is contraindicated.
Patients with an eGFR ≥50 mL/min/1.73m² should be treated with the dose according to the table above.
While on treatment, renal function should be assessed in certain clinical situations when it is suspected that the renal function could decline or deteriorate (such as hypovolemia, dehydration, and with certain co-medications, etc).
The duration of therapy should be individualised based on the benefit risk assessment.
A forgotten dabigatran etexilate 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. A double dose to make up for missed individual doses must never be taken.
Dabigatran etexilate treatment should not be discontinued without medical advice. Patients or their caregivers should be instructed to contact the treating physician if the patient develops gastrointestinal symptoms such as dyspepsia.
Dabigatran etexilate treatment to parenteral anticoagulant:
It is recommended to wait 12 hours after the last dose before switching from dabigatran etexilate to a parenteral anticoagulant.
Parenteral anticoagulants to dabigatran etexilate:
The parenteral anticoagulant should be discontinued and dabigatran etexilate should be started 0-2 hours prior to the time that the next dose of the alternate therapy would be due, or at the time of discontinuation in case of continuous treatment (e.g. intravenous Unfractionated Heparin (UFH)).
Dabigatran etexilate treatment to Vitamin K antagonists (VKA):
Patients should start VKA 3 days before discontinuing dabigatran etexilate. Because dabigatran etexilate can impact the international normalised ratio (INR), the INR will better reflect VKA’s effect only after dabigatran etexilate has been stopped for at least 2 days. Until then, INR values should be interpreted with caution.
VKA to dabigatran etexilate:
The VKA should be stopped. Dabigatran etexilate can be given as soon as the INR is <2.0.
It can be taken with or without food.
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