Dabigatran

Generic name
Dabigatran
Brand name
ATC Code
B01AE07
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Dabigatran

Dosages
Side effects in children
Warnings & precautions in children
Contra-indications in children

Interactions
PK
Renal impairment
References

Pharmacokinetics in children

No information is present at this moment.

dose recommendation of formulary compared to licensed use (on-label versus off-label)

No information is present at this moment.

Available formulations

No information is present at this moment.

Dosages

Treatment of venous thrombo-embolic events (VTE) and prevention of recurrent venous thrombo-embolic events (VTE)
  • Oral
    • Capsule, hard
      • 8 years up to 18 years

        • Dabigatran etexilate:

          Weight Dose
          11 to 13 kg 150 mg/day in 2 doses
          13 to 21 kg 220 mg/day in 2 doses
          21 to 31 kg 300 mg/day in 2 doses
          31 to 41 kg 370 mg/day in 2 doses
          41 to 51 kg 440 mg/day in 2 doses
          51 to 61 kg 520 mg/day in 2 doses
          ≥ 61 kg 600 mg/day in 2 doses
    • Granules
      • 2.5 up to 3 kg

        • Dabigatran etexilate:

          4-5 months 40 mg/day in 2 doses
      • 3 up to 4 kg

        • Dabigatran etexilate:

          3-6 months 40 mg/day in 2 doses
      • 4 up to 5 kg

        • Dabigatran etexilate:

          1-3 months 40 mg/day in 2 doses
          3-8 months 60 mg/day in 2 doses
          8-10 months 80 mg/day in 2 doses
      • 5 up to 7 kg

        • Dabigatran etexilate:

          0-1 months 40 mg/day in 2 doses
          1-5 months 60 mg/day in 2 doses
          5-8 months 80 mg/day in 2 doses
          8-24 months 100 mg/day in 2 doses
      • 7 up to 9 kg

        • Dabigatran etexilate:

          3-4 months 80 mg/day in 2 doses
          4-9 months 100 mg/day in 2 doses
          9-24 months 120 mg/day in 2 doses
          2 years-4 years 140 mg/day in 2 doses
      • 9 up to 11 kg

        • Dabigatran etexilate:

          5-6 months 100 mg/day in 2 doses
          6-11 months 120 mg/day in 2 doses
          11-18 months 140 mg/day in 2 doses
          18 months - 7 years 160 mg/day in 2 doses
      • 11 up to 13 kg

        • Dabigatran etexilate:

          8-10 months 140 mg/day in 2 doses
          10-18 months 160 mg/day in 2 doses
          18-30 months 200 mg/day in 2 doses
          30 months-9 years 220 mg/day in 2 doses
      • 13 up to 16 kg

        • Dabigatran etexilate:

          10-11 months 160 mg/day in 2 doses
          11-18 months 200 mg/day in 2 doses
          18-24 months 220 mg/day in 2 doses
          24 months-12 years 280 mg/day in 2 doses
      • 16 up to 21 kg

        • Dabigatran etexilate:

          1-2 years 220 mg/day in 2 doses
          2-12 years 280 mg/day in 2 doses
      • 21 up to 26 kg

        • Dabigatran etexilate:

          1,5-2 years 280 mg/day in 2 doses
          2-12 years 360 mg/day in 2 doses
      • 26 up to 31 kg

        • Dabigatran etexilate:

          2,5-12 years 360 mg/day in 2 doses
      • 31 up to 41 kg

        • Dabigatran etexilate:

          2,5-12 years 440 mg/day in 2 doses
      • 41 up to 51 kg

        • Dabigatran etexilate:

          4-12 years 520 mg/day in 2 doses
      • ≥ 51 kg

        • Dabigatran etexilate:

          5-12 years 600 mg/day in 2 doses
CAUTION:
  • Route of administration not applicable
    • 0 years up to 18 years

      • Start oral treatment only after at least 5 days of parenteral anticoagulation.

Renal impaiment in children > 3 months

Adjustment in renal impairment as specified:

GFR 50-80 ml/min/1.73 m2
Dose adjustment not needed
GFR 30-50 ml/min/1.73 m2
Do not use
GFR 10-30 ml/min/1.73 m2
Do not use
GFR < 10 ml/min/1.73 m2
Do not use

The complete list of all undesirable drug reactions can be found in the national Summary of Product Characteristics (SmPC) – click here

Side effects in children

Common (1-10%): Anemia, thrombocytopenia, rash, urticaria, hematoma, epistaxis, diarrhea, dyspepsia, nausea, gastroesophageal reflux disease, vomiting, increased liver enzymes, alopecia

Uncommon (0.1-1%): decreased hemoglobin, decreased hematocrit, neutropenia, hypersensitivity, pruritus, intracranial haemorrhage, haemoptosis, gastrointestinal haemorrhage, abdominal pain, rectal haemorrhage, gastroesophagitis, dysphagia, increased ALT and / or AST, hyperbilirubinaemia, skin haemorrhage, genitourinary haemorrhage including haematuria, traumatic haemorrhage.

Further reported: agranulocytosis, anaphylactic reaction, angioedema, bronchospasm, other haemorrhages, gastrointestinal ulcer, including
esophageal ulcers, haemarthrosis,abnormal hepatic function (test)

The complete list of all contra-indications can be found in the national Summary of Product Characteristics (SmPC) – click here

Contra-indications in children

  • eGFR <50 mL/min/1.73m2 in paediatric patients

The complete list of all warnings and precautions can be found in the national Summary of Product Characteristics (SmPC) – click here

Warnings & precautions in children

Start treatment of VTE with oral dabigatran only after treatment with a parenteral anticoagulant for at least 5 days.

For certain very specific pediatric patients, e.g. patients with small bowel disease where absorption may be impaired, the use of an anticoagulant with parenteral route should be considered.

Discontinuation rules before invasive or surgical procedures for paediatric patients:
Renal function (eGFR in ml/min/1,73 m2) > 80: Stop dabigatran 24 hours before elective surgery
Renal function (eGFR in ml/min/1,73 m2) > 50–80: Stop dabigatran 2 days before elective surgery
Renal function (eGFR in ml/min/1,73 m2) < 50: These patients have not been studied

[EPAR Pradaxa]

Interactions

The complete list of all interactions can be found in the national Summary of Product Characteristics (SmPC) – click here

ANTITHROMBOTIC AGENTS

This pages provides a list of drugs from the same ATC class for comparison. This does not necessarily mean that these drugs are interchangeable.

Vitamin K antagonists
B01AA07
B01AA04
Heparin group
B01AB04
B01AB09
B01AB05
B01AB01
B01AB06
B01AB10
Platelet aggregation inhibitors excl. heparin
B01AC06
B01AC04
B01AC09
Enzymes
B01AD02
B01AD01
B01AD04
Direct factor Xa inhibitors
B01AF02
B01AF01

Reference

  1. Boehringer Ingelheim International GmbH, SmPC Pradaxa (EU/1/08/442/001-017) Rev 38, 127-07-2022, www.ema.europa.eu

Changes

Therapeutic Drug Monitoring


Overdose