Posology (SPAF, DVT/PE)

Prevention of stroke and SEE in adult patients with NVAF with one or more risk factors (SPAF)

The recommended daily dose of Averodab is 300 mg taken as one 150 mg capsule twice daily. Therapy should be continued long term.

Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT, and PE in adults (DVT/PE)

The recommended daily dose of Averodab is 300 mg taken as one 150 mg capsule twice daily following treatment with a parenteral anticoagulant for at least 5 days. The 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

SPAF, DVT/PE

For the following groups the recommended daily dose of dabigatran etexilate is 220 mg taken as one 110 mg capsule twice daily:

• Patients aged 80 years or above
• Patients who receive concomitant verapamil
• For the following groups the daily 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 between 75-80 years
• • Patients with moderate renal impairment
• • Patients with gastritis, esophagitis or gastroesophageal reflux
• • Other patients at increased risk of bleeding
• For DVT/PE the recommendation for the use of dabigatran etexilate 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.
• See further down .
• 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 prevention of stroke and SEE associated with atrial fibrillation or for DVT/PE.
• Elderly (SPAF, DVT/PE)
• Patients between 75-80 years should be treated with a daily dose of 300 mg taken as one 150 mg capsule twice daily. A dose of dabigatran etexilate 220 mg taken as one 110 mg capsule twice daily can be individually considered, at the discretion of the physician, when the thromboembolic risk is low and the bleeding risk is high .
• Patients aged 80 years or above should be treated with a daily dose of dabigatran etexilate 220 mg taken as one 110 mg capsule twice daily due to the increased risk of bleeding in this population.

• Patients at risk of bleeding (SPAF, DVT/PE)
• Patients with an increased bleeding risk should be closely monitored clinically (looking for signs of bleeding or anaemia). Dose adjustment should be decided at the discretion of the physician, following assessment of the potential benefit and risk to an individual patient. A coagulation test may help to identify patients with an increased bleeding risk caused by excessive dabigatran exposure. When excessive dabigatran exposure is identified in patients at high risk of bleeding, a dose of dabigatran etexilate 220 mg taken as one 110 mg capsule twice daily is recommended. When clinically relevant bleeding occurs, treatment should be interrupted.
• For subjects with gastritis, esophagitis, or gastroesophageal reflux, the dose of dabigatran etexilate 220 mg taken as one 110 mg capsule twice daily may be considered due to the elevated risk of major gastro-intestinal bleeding .
• Assessment of renal function (SPAF, DVT/PE)
• In all patients:
• • Renal function should be assessed by calculating the creatinine clearance (CrCL) prior to initiation of treatment with Averodab to exclude patients with severe renal impairment (i.e. CrCL < 30 mL/min). Averodab is contraindicated in patients with severe renal impairment
• • 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 Averodab 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 used to estimate renal function (CrCL in mL/min) during the clinical development of Averodab was the Cockgroft-Gault method .