Pradaxa

Pradaxa Dosage/Direction for Use

dabigatran

Manufacturer:

Boehringer Ingelheim

Distributor:

DKSH
Full Prescribing Info
Dosage/Direction for Use
Adults: Primary prevention of Venous Thromboembolism (pVTEp) events in adult patients who have undergone elective knee replacement surgery: The recommended dose of PRADAXA is 220 mg once daily taken as 2 capsules of 110 mg. Treatment should be initiated orally within 1 - 4 hours of completed surgery with a single capsule (110 mg) and continuing with 2 capsules once daily thereafter for a total of 10 days.
Primary prevention of Venous Thromboembolism (pVTEp) events in adult patients who have undergone elective hip replacement surgery: The recommended dose of PRADAXA is 220 mg once daily taken as 2 capsules of 110 mg. Treatment should be initiated orally within 1 - 4 hours of completed surgery with a single capsule (110 mg) and continuing with 2 capsules once daily thereafter for a total of 28-35 days.
For both surgeries, if haemostasis is not secured, initiation of treatment should be delayed. If treatment is not started on the day of surgery then treatment should be initiated with 2 capsules once daily.
Reduction of the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation (SPAF): The recommended daily dose of PRADAXA is 300 mg taken orally as 150 mg hard capsules twice daily. Therapy should be continued life-long.
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 PRADAXA 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 (see Precautions). 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 PRADAXA 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 PRADAXA 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 PRADAXA 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 prevention of stroke and SEE associated with atrial fibrillation or for DVT/PE.
Special patient populations: Renal impairment: Renal function should be assessed by calculating the creatinine clearance (CrCl) prior to initiation of treatment with PRADAXA to exclude patients for treatment with severe renal impairment (i.e. CrCl < 30ml/min). There are no data to support use in patients with severe renal impairment (< 30 mL/min creatinine clearance); treatment in this population with PRADAXA is not recommended (see Contraindications).
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 comedications, etc).
Dabigatran can be dialysed; there is limited clinical experience to demonstrate the utility of this approach in clinical studies.
Primary prevention of venous thromboembolism events in adult patients who have undergone elective hip replacement surgery or total knee replacement surgery (pVTEp): In patients with moderate renal impairment (creatinine clearance 30-50 ml/min), there is limited clinical experience. These patients should be treated with caution. The recommended dose is 150 mg taken once daily as 2 capsules of 75 mg (see Precautions).
Treatment with PRADAXA should be initiated orally within 1 - 4 hours of completed surgery with a single capsule of 75 mg and continuing with 2 capsules of 75 mg once daily thereafter for a total of 10 days (following knee replacement surgery) or 28-35 days (following hip replacement surgery).
For both surgeries, if haemostasis is not secured, initiation of treatment should be delayed. If treatment is not started on the day of surgery then treatment should be initiated with 2 capsules once daily.
Reduction of the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation (SPAF): In patients with moderate renal impairment (CrCl 30-50ml/min) the renal function should be assessed at least once a year.
No dose adjustment necessary, patients should be treated with a daily dose of 300 mg taken orally as 150 mg hard capsules twice daily.
Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT, and PE in adults (DVT/PE): Treatment with PRADAXA in patients with severe renal impairment (CrCL < 30 mL/min) is contraindicated.
No dose adjustment is necessary in patients with mild renal impairment (CrCL 50 - ≤ 80 mL/min). For patients with moderate renal impairment (CrCL 30-50 mL/min) the recommended dose of PRADAXA is also 300 mg taken as one 150 mg capsule twice daily. However, for patients with high risk of bleeding, a dose reduction of PRADAXA to 220 mg taken as one 110 mg capsule twice daily should be considered. Close clinical surveillance is recommended in patients with renal impairment.
Elderly: Pharmacokinetic studies in older subjects demonstrate an increase in drug exposure in those patients with age-related decline of renal function.
See also Renal impairment as previously mentioned.
Primary prevention of venous thromboembolism events in adult patients who have undergone elective hip replacement surgery or total knee replacement surgery (pVTEp): As renal impairment may be frequent in the elderly (>75 years), renal function should be assessed by calculating the creatinine clearance (CrCl) prior to initiation of treatment with PRADAXA to exclude patients for treatment with severe renal impairment (i.e. CrCl < 30ml/min). The renal function should also 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 comedications, etc).
In elderly patients (> 75 years) there is limited clinical experience. These patients should be treated with caution. The recommended dose is 150 mg taken once daily as 2 capsules of 75 mg (see Precautions).
After knee replacement surgery treatment should be initiated orally within 1 - 4 hours of completed surgery with a single capsule and continuing with 2 capsules once daily thereafter for a total of 10 days.
After hip replacement surgery treatment should be initiated orally within 1 - 4 hours of completed surgery with a single capsule and continuing with 2 capsules once daily thereafter for a total of 28-35 days.
Reduction of the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation (SPAF): As renal impairment may be frequent in the elderly (>75 years), renal function should be assessed by calculating the creatinine clearance (CrCl) prior to initiation of treatment with PRADAXA to exclude patients for treatment with severe renal impairment (i.e. CrCl < 30ml/min). The renal function should also be assessed at least once a year in patients treated with PRADAXA or more frequently as needed in certain clinical situations when it is suspected that the renal function could decline or deteriorate (such as hypovolemia, dehydration, and with certain comedications, etc).
Patients aged 80 years and above should be treated with a dose of 220 mg of PRADAXA daily, taken orally as one 110 mg capsule twice a day.
Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT, and PE in adults (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 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 220 mg taken as one 110 mg capsule twice daily due to the increased risk of bleeding in this population.
As renal impairment may be frequent in the elderly (>75 years), renal function should be assessed by calculating the CrCL prior to initiation of treatment with PRADAXA to exclude patients with severe renal impairment (i.e. CrCL < 30 mL/min). The renal function should also be assessed at least once a year in patients treated with PRADAXA or more frequently as needed in certain clinical situations when it is suspected that the renal function could decline or deteriorate (such as hypovolemia, dehydration, and with certain comedications, etc).
Weight: Given the available clinical and kinetic data no adjustment is necessary (see Pharmacology: Pharmacokinetics under Actions), but close clinical surveillance is recommended in patients with a body weight < 50 kg (see Precautions).
Gender: Given the available clinical and kinetic data, no dose adjustment is necessary.
Concomitant use of PRADAXA with strong P-glycoprotein inhibitors, e.g. amiodarone, quinidine or verapamil: Primary prevention of venous thromboembolic events in adult patients who have undergone elective total hip replacement surgery or total knee replacement surgery (pVTEp): Dosing should be reduced to PRADAXA 150 mg taken once daily as 2 capsules of 75 mg in patients who concomitantly receive PRADAXA and amiodarone, quinidine or verapamil (see Interactions).
Treatment initiation with verapamil should be avoided in patients who have undergone elective total hip replacement surgery or total knee replacement surgery who are already treated with PRADAXA.
Simultaneous initiation of treatment with PRADAXA and verapamil should also be avoided.
Treatment with PRADAXA should be initiated orally within 1 - 4 hours of completed surgery with a single capsule of 75 mg and continuing with 2 capsules of 75 mg once daily thereafter for a total of 10 days (following knee replacement surgery) or 28-35 days (following hip replacement surgery). For both surgeries, if haemostasis is not secured, initiation of treatment should be delayed. If treatment is not started on the day of surgery then treatment should be initiated with 2 capsules once daily.
Reduction of the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation (SPAF): No dose adjustment is necessary for concomitant use of amiodarone or quinidine.
Dosing should be reduced to 220 mg taken as one 110 mg capsule twice daily in patients who receive concomitantly dabigatran etexilate and verapamil. In this situation PRADAXA and verapamil should be taken at the same time.
Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT, and PE in adults (DVT/PE): No dose adjustment is necessary for concomitant use of amiodarone or quinidine.
Dosing should be reduced to 220 mg taken as one 110 mg capsule twice daily in patients who receive concomitantly dabigatran etexilate and verapamil. In this situation PRADAXA and verapamil should be taken at the same time.
Patients at risk of bleeding: Reduction of the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation (SPAF): The presence of the following factors may increase the risk of bleeding: e.g. age ≥ 75 years, moderate renal impairment (30-50 ml CrCL/min), concomitant treatment with strong P-gp inhibitors (see Pharmacology: Pharmacokinetics: PK in specific populations under Actions), antiplatelets or previous gastro-intestinal bleed (see Precautions). For patients with one or more than one of these risk factors, a reduced daily dose of 220 mg given as 110 mg twice daily may be considered at the discretion of the physician.
Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT, and PE in adults (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 (see Precautions) 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 reduced dose of 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 220 mg taken as one 110 mg capsule twice daily may be considered due to the elevated risk of major gastro-intestinal bleeding.
Hepatic impairment: Patients with elevated liver enzymes > 2 upper limit of normal (ULN) were excluded in the main trials. No treatment experience is available for this subpopulation of patients, and therefore the use of PRADAXA is not recommended in this population. Hepatic impairment or liver disease expected to have any impact on survival is contraindicated.
Post-surgical patients with an increased risk for bleeding: PRADAXA should be resumed/started after the invasive procedure or surgical intervention as soon as possible provided the clinical situation allows and adequate haemostasis has been established.
Patients at risk for bleeding or patients at risk of overexposure, notably patients with moderate renal impairment (creatinine clearance 30 - 50 ml/min), should be treated with caution (see Precautions and Pharmacology: Pharmacodynamics under Actions).
Children and adolescents: pVTEp and SPAF: PRADAXA has not been investigated in patients < 18 years of age. Treatment of children with PRADAXA is therefore not recommended.
DVT/PE: PRADAXA is under investigation in patients < 18 years.
The safety and efficacy in children has not yet been established. Treatment of children with PRADAXA is therefore not recommended.
Switching from PRADAXA treatment to parenteral anticoagulant: pVTEp: It is recommended to wait 24 hours after the last dose before switching from PRADAXA to a parenteral anticoagulant (see Interactions).
SPAF and DVT/PE: It is recommended to wait 12 hours after the last dose before switching from PRADAXA to a parenteral anticoagulant.
Switching from parenteral anticoagulants treatment to PRADAXA: PRADAXA should be given 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 UFH).
Switching from Vit. K antagonists to PRADAXA: SPAF and DVT/PE: The Vit. K antagonist should be stopped. PRADAXA can be given as soon as the INR is < 2.0.
Switching from PRADAXA to Vit. K antagonists (VKA): SPAF and DVT/PE: The starting time of the VKA should be adjusted according to the patient's CrCL as follows: CrCL ≥ 50 ml/min, start VKA 3 days before discontinuing dabigatran etexilate.
CrCL ≥ 30-< 50 ml/min, start VKA 2 days before discontinuing dabigatran etexilate.
Because PRADAXA can impact the International Normalized Ratio (INR), the INR will better reflect VKA's effect only after PRADAXA has been stopped for at least 2 days. Until then, INR values should be interpreted with caution.
Cardioversion: SPAF and DVT/PE: Patients can stay on PRADAXA while being cardioverted.
Catheter ablation for atrial fibrillation: SPAF: Catheter ablation can be conducted in patients on 150 mg twice daily PRADAXA treatment. PRADAXA treatment does not need to be interrupted (see Pharmacology under Actions).
Percutaneous coronary intervention (PCI) with stenting: SPAF: Patients with non valvular atrial fibrillation who undergo a PCI with stenting can be treated with PRADAXA in combination with antiplatelets after haemostasis is achieved (see Pharmacology under Actions).
Missed dose: pVTEp: Continue with your remaining daily doses of PRADAXA at the same time of the next day. Do not take a double dose to make up for missed individual doses.
SPAF and DVT/PE: A forgotten PRADAXA 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.
Do not take a double dose to make up for missed individual doses.
Method of administration: PRADAXA can be taken with or without food. PRADAXA should be swallowed as a whole with a glass of water, to facilitate delivery to the stomach.
Patients should be instructed not to open the capsule as this may increase the risk of bleeding.
Instruction For Use/Handling: When removing a hard capsule from the blister, please note the following instructions: Tear off one individual blister from the blister card along the perforated line.
Peel off the backing foil and remove the capsule.
The capsule should not be pushed through the blister foil.
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