Recurrent deep vein thrombosis and pulmonary embolism

Active Ingredient: Dabigatran

Indication for Dabigatran

Population group: only adults (18 years old or older)
Therapeutic intent: Preventive action

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

150 mg twice daily

For:

Dosage regimens

Oral, 150 milligrams dabigatran, 2 times daily.

Detailed description

Dose recommendations for DVT and PE:

 Dose recommendation
Prevention of recurrent DVT,
and PE in adults (DVT/PE)
300 mg dabigatran etexilate taken as one 150 mg
capsule twice daily following treatment with a
parenteral anticoagulant for at least 5 days
Dose reduction recommended
Patients aged ≥80 yearsdaily dose of 220 mg dabigatran etexilate taken as one
110 mg capsule twice daily
Patients who receive concomitant verapamil
Dose reduction for consideration
Patients between 75-80 yearsdaily dose of dabigatran etexilate of 300 mg or 220 mg
should be selected based on an individual assessment
of the thromboembolic risk and the risk of bleeding
Patients with moderate renal impairment
(CrCL 30-50 mL/min)
Patients with gastritis, esophagitis or
gastroesophageal reflux
Other patients at increased risk of bleeding

For DVT/PE the recommendation for the use of dabigatran 220 mg taken as one 110 mg capsule twice daily is based on pharmacokinetic and pharmacodynamic analyses and has not been studied in this clinical setting.

In case of intolerability to dabigatran, patients should be instructed to immediately consult their treating physician in order to be switched to alternate acceptable treatment options for DVT/PE. Assessment of renal function prior to and during dabigatran treatment

Assessment of renal function prior to and during dabigatran treatment

In all patients and especially in the elderly (>75 years), as renal impairment may be frequent in this age group:

  • Renal function should be assessed by calculating the creatinine clearance (CrCL) prior to initiation of treatment with dabigatran to exclude patients with severe renal impairment (i.e. CrCL <30 mL/min).
  • Renal function should also be assessed when a decline in renal function is suspected during treatment (e.g. hypovolaemia, dehydration, and in case of concomitant use of certain medicinal products).

Additional requirements in patients with mild to moderate renal impairment and in patients aged over 75 years:

  • Renal function should be assessed during treatment with dabigatran at least once a year or more frequently as needed in certain clinical situations when it is suspected that the renal function could decline or deteriorate (e.g. hypovolaemia, dehydration, and in case of concomitant use of certain medicinal products).

The method to be used to estimate renal function (CrCL in mL/min) is the Cockcroft-Gault method.

Duration of use

Duration of use for DVT/PE:

IndicationDuration of use
DVT/PEThe duration of therapy should be individualised after careful assessment of the treatment benefit against the risk for bleeding.
Short duration of therapy (at least 3 months) should be based on transient risk factors (e.g. recent surgery, trauma, immobilisation) and longer durations should be based on permanent risk factors or idiopathic DVT or PE.

Missed dose

A forgotten dabigatran dose may still be taken up to 6 hours prior to the next scheduled dose. From 6 hours prior to the next scheduled dose on, the missed dose should be omitted.

No double dose should be taken to make up for missed individual doses.

Discontinuation of dabigatran

dabigatran treatment should not be discontinued without medical advice. Patients should be instructed to contact the treating physician if they develop gastrointestinal symptoms such as dyspepsia.

Switching

dabigatran treatment to parenteral anticoagulant:

It is recommended to wait 12 hours after the last dose before switching from dabigatran to a parenteral anticoagulant.

Parenteral anticoagulants to dabigatran:

The parenteral anticoagulant should be discontinued and dabigatran 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 treatment to Vitamin K antagonists (VKA):

The starting time of the VKA should be adjusted based on CrCL as follows:

  • CrCL ≥50 mL/min, VKA should be started 3 days before discontinuing dabigatran.
  • CrCL ≥30-<50 mL/min, VKA should be started 2 days before discontinuing dabigatran.

Because dabigatran can impact the International Normalized Ratio (INR), the INR will better reflect VKA’s effect only after dabigatran has been stopped for at least 2 days. Until then, INR values should be interpreted with caution.

VKA to dabigatran:

The VKA should be stopped. dabigatran 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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