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PRADAXA is a brand name for Dabigatran Etexilate. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Treatment of venous thromboembolic events (VTE) and prevention of recurrent VTE in paediatric patients from the time the child is able to swallow soft food to less than 18 years of age. For age appropriate dose forms, see section 4.2.
Verbatim from this product's MHRA label. Tap a section to expand.
Posology Pradaxa coated granules can be used in children aged less than 12 years as soon as the child is able to swallow soft food. Pradaxa capsules can be used in adults and paediatric patients aged 8 years or older who are able to swallow the capsules whole.
When changing between the formulations, the prescribed dose may need to be altered. The dose stated in the relevant dosing table of a formulation should be prescribed based on the weight and age of the child. For the treatment of VTE in paediatric patients, treatment should be initiated following treatment with a parenteral anticoagulant for at least 5 days.
For prevention of recurrent VTE, treatment should be initiated following previous treatment. Dabigatran etexilate coated granules 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 coated granules is based on the patient’s weight and age as shown in tables 1 and 2. The dose should be adjusted according to weight and age as treatment progresses.
For weight and age combinations not listed in the dosing tables no dosing recommendation can be provided.
Table 1:
Single and total daily dabigatran etexilate doses in milligrams (mg) for patients aged less than 12 months. The doses depend on weight in kilograms (kg) and age in months of the patient. 5 to < 3 4 to < 5 20 40 3 to < 4 3 to < 6 20 40 1 to < 3 20 40 3 to < 8 30 60 4 to < 5 8 to < 10 40 80 0 to < 1 20 40 1 to < 5 30 60 5 to < 8 40 80 5 to < 7 8 to < 12 50 100 3 to < 4 40 80 4 to < 9 50 100 7 to < 9 9 to < 12 60 120 5 to < 6 50 100 6 to < 11 60 120 9 to < 11 11 to < 12 70 140 8 to < 10 70 14011 to < 13 10 to < 12 80 160 10 to < 11 80 16013 to < 16 11 to < 12 100 200 Convenient sachet combinations to achieve the single doses recommended in the dosing table are provided below.
Other combinations are possible. 20 mg: One 20 mg sachet 60 mg: Two 30 mg sachets 30 mg: One 30 mg sachet 70 mg: One 30 mg plus one 40 mg sachet 40 mg: One 40 mg sachet 80 mg: Two 40 mg sachets 50 mg: One 50 mg sachet 100 mg: Two 50 mg sachets Table 2: Single and total daily dabigatran etexilate doses in milligrams (mg) for patients aged 1 year to less than 12 years.
Summary of the safety profile Dabigatran etexilate has been evaluated in clinical trials overall in approximately 64 000 patients; thereof approximately 35 000 patients were treated with dabigatran etexilate. 108). In total, 328 paediatric patients had been treated with dabigatran etexilate.
The patients received age and weight adjusted doses of an age-appropriate formulation of dabigatran etexilate. Overall, the safety profile in children is expected to be the same as in adults. In total, 26 % of paediatric patients treated with dabigatran etexilate for VTE and for prevention of recurrent VTE experienced adverse reactions.
Tabulated list of adverse reactions Table 8 shows the adverse reactions identified from the studies in the treatment of VTE and prevention of recurrent VTE in paediatric patients. They are ranked under headings of System Organ Class (SOC) and frequency using the following convention: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1 000 to < 1/100), rare (≥ 1/10 000 to < 1/1 000), very rare (< 1/10 000), not known (cannot be estimated from the available data).
Table 8:
Adverse reactions Frequency SOC / Preferred term. treatment of VTE and prevention of recurrent VTE in paediatric patients Blood and lymphatic system disorders Anaemia Common Haemoglobin decreased Uncommon Thrombocytopenia Common Haematocrit decreased Uncommon Neutropenia Uncommon Agranulocytosis Not known Immune system disorder Drug hypersensitivity Uncommon Rash Common Pruritus Uncommon Anaphylactic reaction Not known Angioedema Not known Urticaria Common Bronchospasm Not known Nervous system disorders Intracranial haemorrhage Uncommon Vascular disorders Haematoma Common Haemorrhage Not known Respiratory, thoracic and mediastinal disorders Epistaxis Common Haemoptysis Uncommon Gastrointestinal disorders Gastrointestinal haemorrhage Uncommon Abdominal pain Uncommon Diarrhoea Common Dyspepsia Common Nausea Common Rectal haemorrhage Uncommon Haemorrhoidal haemorrhage Not known Gastrointestinal ulcer, including oesophageal ulcer Not known Gastroesophagitis Uncommon Gastroesophageal reflux disease Common Vomiting Common Dysphagia Uncommon Hepatobiliary disorders Hepatic function abnormal / Liver function Test abnormal Not known Alanine aminotransferase increased Uncommon Aspartate aminotransferase increased Uncommon Hepatic enzyme increased Common Hyperbilirubinaemia Uncommon Skin and subcutaneous tissue disorder Skin haemorrhage Uncommon Alopecia Common Musculoskeletal and connective tissue disorders Haemarthrosis Not known Renal and urinary disorders Genitourological haemorrhage, including haematuria Uncommon General disorders and administration site conditions Injection site haemorrhage Not known Catheter site haemorrhage Not known Injury, poisoning and procedural complications Traumatic haemorrhage Uncommon Incision site haemorrhage Not known Description of selected adverse reactions Bleeding reactions Due to the pharmacological mode of action, the use of dabigatran etexilate may be associated with an increased risk of occult or overt bleeding from any tissue or organ.
Haemorrhagic risk Dabigatran etexilate should be used with caution in conditions with an increased risk of bleeding or with concomitant use of medicinal products affecting haemostasis by inhibition of platelet aggregation. Bleeding can occur at any site during therapy.
An unexplained fall in haemoglobin and/or haematocrit or blood pressure should lead to a search for a bleeding site. The efficacy and safety of the specific reversal agent idarucizumab used for adult patients in situations of life-threatening or uncontrolled bleeding, when rapid reversal of the anticoagulation effect of dabigatran is required, have not been established in paediatric patients.
Haemodialysis can remove dabigatran. 9). Use of platelet aggregation inhibitors such as clopidogrel and acetylsalicylic acid (ASA) or non steroidal antiinflammatory drugs (NSAID), as well as the presence of esophagitis, gastritis or gastroesophageal reflux increase the risk of GI bleeding.
Risk factors Table 3 summarises factors which may increase the haemorrhagic risk.
Table 3:
Risk factors which may increase the haemorrhagic risk. g. 5). 9. 5), which significantly increase the risk of major bleeding requires a careful benefit-risk assessment. Dabigatran etexilate should only be given if the benefit outweighs bleeding risks.
1). In these patients, dabigatran etexilate should only be given if the expected benefit outweighs bleeding risks. Close clinical surveillance Close observation for signs of bleeding or anaemia is recommended throughout the treatment period, especially if risk factors are combined (see table 3 above).
5). 5). Discontinuation of dabigatran etexilate Patients who develop acute renal failure must discontinue dabigatran etexilate. When severe bleedings occur, treatment must be discontinued and the source of bleeding investigated. The efficacy and safety of the specific reversal agent (idarucizumab) to dabigatran have not been established in paediatric patients.
73 m2 in paediatric patients • Active clinically significant bleeding • Lesion or condition, if considered a significant risk factor for major bleeding. g. unfractionated heparin (UFH), low molecular weight heparins (enoxaparin, dalteparin etc), heparin derivatives (fondaparinux etc), oral anticoagulants (warfarin, rivaroxaban, apixaban etc) except under specific circumstances.
5). 1).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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The doses depend on weight in kilograms (kg) and age in years of the patient. 5 to < 12 220 440 41 to < 51 4 to < 12 260 520 51 to < 61 5 to < 12 300 600 61 to < 71 6 to < 12 300 600 71 to < 81 7 to < 12 300 600 > 81 10 to < 12 300 600 Convenient sachet combinations to achieve the single doses recommended in the dosing table are provided below.
Other combinations are possible. 50 mg: One 50 mg sachet 140 mg: One 30 mg plus one 110 mg sachet 60 mg: Two 30 mg sachets 180 mg: One 30 mg plus one 150 mg sachet 70 mg: One 30 mg plus one 40 mg sachet 220 mg: Two 110 mg sachets 80 mg: Two 40 mg sachets 260 mg: One 110 mg plus one 150 mg sachet 100 mg: Two 50 mg sachets 300 mg: Two 150 mg sachets 110 mg: One 110 mg sachet 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).
3). 73 m2 should be treated with the dose according to tables 1 and 2. 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. If a dose has only been taken partially, there should be no attempt to administer a second dose at that time-point, and the next dose should be taken as scheduled approximately 12 hours later.
Discontinuation of dabigatran etexilate Dabigatran etexilate treatment should not be discontinued without medical advice. 8). 5). g. 5).
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 signs, symptoms, and severity (including fatal outcome) will vary according to the location and degree or extent of the bleeding and/or anaemia. g. gastrointestinal, genitourinary) were seen more frequently during long term dabigatran etexilate treatment compared with VKA treatment.
Thus, in addition to adequate clinical surveillance, laboratory testing of haemoglobin/haematocrit is of value to detect occult bleeding. g. 4 Haemorrhagic risk). Haemorrhagic complications may present as weakness, paleness, dizziness, headache or unexplained swelling, dyspnoea, and unexplained shock.
Known bleeding complications such as compartment syndrome and acute renal failure due to hypoperfusion and anticoagulant-related nephropathy in patients with predisposing risk factors have been reported for dabigatran etexilate. Therefore, the possibility of haemorrhage is to be considered in evaluating the condition in any anticoagulated patient.
9 %) a minor bleeding event. 2 %). Major or severe bleeding, regardless of location, may lead to disabling, life-threatening or even fatal outcomes. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store
Haemodialysis can remove dabigatran. Laboratory coagulation parameters Although this medicinal product does not in general require routine anticoagulant monitoring, the measurement of dabigatran related anticoagulation may be helpful to detect excessive high exposure to dabigatran in the presence of additional risk factors.
1). The international normalised ratio (INR) test is unreliable in patients on dabigatran etexilate and false positive INR elevations have been reported. Therefore, INR tests should not be performed. Coagulation test thresholds at trough for paediatric patients that may be associated with an increased risk of bleeding are not known.
Use of fibrinolytic medicinal products for the treatment of acute ischemic stroke The use of fibrinolytic medicinal products for the treatment of acute ischemic stroke may be considered if the patient presents with a dTT, ECT or aPTT not exceeding the upper limit of normal (ULN) according to the local reference range.
Surgery and interventions Patients on dabigatran etexilate who undergo surgery or invasive procedures are at increased risk for bleeding. Therefore, surgical interventions may require the temporary discontinuation of dabigatran etexilate.
Caution should be exercised when treatment is temporarily discontinued for interventions and anticoagulant monitoring is warranted. 2). This should be considered in advance of any procedures. 1) may help to determine whether haemostasis is still impaired.
Emergency surgery or urgent procedures Dabigatran etexilate should be temporarily discontinued. The efficacy and safety of the specific reversal agent (idarucizumab) to dabigatran have not been established in paediatric patients. Haemodialysis can remove […]