Recurrent venous thromboembolism

Active Ingredient: Dabigatran

Indication for Dabigatran

Population group: only minors (0 - 18 years old)
Therapeutic intent: Preventive action

Prevention of recurrent VTE in paediatric patients from birth to less than 18 years of age.

For this indication, competent medicine agencies globally authorize below treatments:

75-300 mg 2 times daily based on the patient's weight and age

For:

Dosage regimens

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.

Detailed description

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

Assessment of renal function prior to and during treatment

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).

Duration of use

The duration of therapy should be individualised based on the benefit risk assessment.

Missed dose

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.

Discontinuation of dabigatran etexilate

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.

Switching

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.

Dosage considerations

It can be taken with or without food.

Active ingredient

Dabigatran

Dabigatran etexilate is a small molecule prodrug which does not exhibit any pharmacological activity. After oral administration, dabigatran etexilate is rapidly absorbed and converted to dabigatran by esterase-catalysed hydrolysis in plasma and in the liver. Dabigatran is a potent, competitive, reversible direct thrombin inhibitor and is the main active principle in plasma.

Read more about Dabigatran

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