Page 8 - P4304.1-V102_PS Magazine - Oct 24 (PRINT)

Dabigatran Etexilate Hard Capsules method should be used to estimate renal function (CrCL in mL/min). catheter ablation for atrial fibrillation; hepatic impairment or liver haemostasis may be required consider stopping Dabigatran Etexilate
Switching Dabigatran texilate treatment to Vitamin K antagonists disease expected to have any impact on survival; concomitant Accord 2-4 days before surgery. See SmPC for discontinuation rules
(VKA): the starting time of the VKA should be adjusted based on CrCL. treatment with the following strong P-gp inhibitors: systemic before invasive procedures. Spinal anaesthesia/epidural anaesthesia/
CrCL ≥ 50 mL/min, start VKA 3 days before discontinuing Dabigatran ketoconazole, cyclosporine, itraconazole, dronedarone and the fixed- lumbar puncture: procedures such as spinal anaesthesia may require
110mg x 10 pack, 110mg x 60 pack & 150mg x 60 pack Etexilate Accord. CrCL ≥ 30-< 50 mL/min, start VKA 2 days before dose combination glecaprevir/pibrentasvir; prosthetic heart valves complete haemostatic function. Risk of spinal or epidural haematoma
discontinuing Dabigatran Etexilate Accord. Because Dabigatran requiring anticoagulant treatment.
may be increased in cases of traumatic or repeated puncture and by
etexilate can impact the INR, the INR will better reflect VKA’s effect Warnings and Precautions: Haemorrhagic risk: use with caution in the prolonged use of epidural catheters. After removal of a catheter,
only after Dabigatran etexilate has been stopped for at least 2 days. conditions with an increased risk of bleeding or with concomitant use an interval of at least 2 hours should elapse before the administration
Until then, INR values should be interpreted with caution. VKA to of medicinal products affecting haemostasis by inhibition of platelet of the first dose of Dabigatran Etexilate Accord. Patients require
Dabigatran Etexilate Accord: the VKA should be stopped. Dabigatran aggregation. Bleeding can occur at any site during therapy. An frequent observation for neurological signs and symptoms of spinal
Etexilate Accord can be given as soon as the INR is < 2.0. Cardioversion unexplained fall in haemoglobin and/or haematocrit or blood or epidural haematoma. Postoperative phase: treatment should be
(SPAF): patients can stay on Dabigatran Etexilate Accord while being pressure should lead to a search for a bleeding site. In situations of resumed / started after the invasive procedure or surgical intervention
cardioverted. Catheter ablation for atrial fibrillation (SPAF): no data life-threatening or uncontrolled bleeding, when rapid reversal of the as soon as possible provided the clinical situation allows and
available for Dabigatran Etexilate Accord treatment. Percutaneous anticoagulation effect of dabigatran is required, the specific reversal adequate haemostasis has been established. Treat with caution in
coronary intervention (PCI) with stenting (SPAF): patients with non agent idarucizumab is available. The efficacy and safety of patients at risk for bleeding or at risk of overexposure, notably
valvular atrial fibrillation who undergo a PCI with stenting can be idarucizumab have not been established in paediatric patients. patients with CrCL 30-50 mL/min. Patients at high surgical mortality
treated with Dabigatran Etexilate Accord in combination with Haemodialysis can remove dabigatran. For adult patients, fresh risk and with intrinsic risk factors for thromboembolic events: limited
antiplatelets after haemostasis is achieved. Patients at risk of bleeding: whole blood or fresh frozen plasma, coagulation factor concentration efficacy and safety data available. Treat with caution. Hip fracture
these patients should be closely monitored clinically (looking for (activated or non-activated), recombinant factor VIIa or platelet surgery: no data. Treatment is not recommended. Hepatic impairment:
signs of bleeding or anaemia). Dose adjustment decided at the concentrates are other possible options. Risk factors: risk factors not recommended in patients with elevated liver enzymes > 2 ULN.
discretion of the physician, following assessment of the potential comprise co-medication with platelet aggregation inhibitors such as Hepatic impairment or liver disease expected to have any impact on
benefit and risk to an individual patient. A coagulation test may help clopidogrel and acetylsalicylic acid (ASA) or non steroidal anti- survival is contraindicated. Interaction with P-gp inducers:
to identify patients with an increased bleeding risk caused by inflammatory drugs (NSAID), as well as the presence of esophagitis, Concomitant administration is expected to result in decreased
Product Presentation Dabigatran Etexilate Hard Capsules excessive dabigatran exposure. If identified, a reduced dose of 220 mg gastritis or gastroesophageal reflux (see SmPC for risk factors which dabigatran plasma concentrations and should be avoided. Patients
taken as one 110 mg capsule twice daily is recommended. When may increase the haemorrhagic risk). Precautions and management of
Livery Accord Accord Accord clinically relevant bleeding occurs, treatment should be interrupted. the haemorrhagic risk: Benefit-risk assessment: the presence of with antiphospholipid syndrome: not recommended for patients with
a history of thrombosis who are diagnosed with antiphospholipid
Strength 110mg 110mg 150mg For subjects with gastritis, esophagitis, or gastroesophageal reflux, a lesions, conditions, procedures and/or pharmacological treatment syndrome. For patients that are triple positive (for lupus
dose reduction may be considered due to the elevated risk of major (NSAIDs, antiplatelets, SSRIs and SNRIs), which significantly increase anticoagulant, anticardiolipin antibodies, and anti–beta
Pack Size 10 60 60 gastro-intestinal bleeding. Renal impairment: contraindicated in the risk of major bleeding requires a careful benefit-risk assessment. 2¬glycoprotein I antibodies), treatment with DOACs could be
Product Format hard capsule hard capsule hard capsule patients with CrCL < 30 mL/min. No dose adjustment is necessary in Dabigatran Etexilate Accord should only be given if the benefit associated with increased rates of recurrent thrombotic events
patients with CrCL 50- ≤ 80 mL/min. For patients with CrCL 30-50 outweighs bleeding risks. Limited clinical data are available for
Legal Category POM POM POM mL/min the recommended dose is 300 mg (one 150 mg capsule twice paediatric patients with risk factors, including patients with active compared with vitamin K antagonist therapy. Myocardial Infarction
(MI): In clinical studies with dabigatran etexilate there was an
Pack Dimensions (HxWxD) 86mmx148mmx26mm 86mmx148mmx68mm 86mmx148mmx68mm daily). For patients with high risk of bleeding, a dose reduction to 220 meningitis, encephalitis and intracranial abscess (see SPC section increase in relative risk or higher reported rate of MI compared to
mg (one 110 mg capsule twice daily) should be considered. Close 5.1). Dabigatran etexilate should only be given if the expected benefit
Shelf Life 36 months 36 months 36 months clinical surveillance is recommended. Concomitant use of Dabigatran outweighs bleeding risks. Close clinical surveillance: close observation warfarin (please see SPC for details). Active Cancer Patients (DVT/PE,
paediatric VTE): efficacy and safety have not been established. There
PIP Code 540-1302 540-1336 540-1344 Etexilate Accord with mild to moderate P-glycoprotein (P-gp) inhibitors: for signs of bleeding or anaemia is recommended throughout the is limited data on efficacy and safety for paediatric patients with
no dose adjustment necessary for concomitant use of amiodarone or treatment period, especially if risk factors are combined. Exercise
EAN Code 505556577304 5055565787311 5055565787328 quinidine. Dose reductions recommended for patients who receive caution when Dabigatran Etexilate Accord is co-administered with active cancer. Paediatric population: for patients with small bowel
disease where absorption may be affected, use of an anticoagulant
concomitantly verapamil. In this situation Dabigatran Etexilate verapamil, amiodarone, quinidine or clarithromycin (P-gp inhibitors), with parenteral route of administration should be considered.
Accord and verapamil should be taken at the same time. Weight: no in the occurrence of bleeding, notably in patients having a mild to
Prescribing Information: Dabigatran Etexilate Accord 75mg, 110mg, 150mg hard capsules dose adjustment necessary but close clinical surveillance is moderate renal impairment. Close observation for signs of bleeding is Excipients: this medicine contains less than 1 mmol sodium (23 mg)
per capsule, that is to say essentially ‘sodium free’. Dabigatran
Please refer to the Summary of Product Characteristics (SmPC) before prescribing. recommended in patients with a body weight < 50 kg. Gender: no recommended in patients concomitantly treated with NSAIDs. Etexilate Accord has no or negligible influence on the ability to drive
dose adjustment necessary. Paediatric population: no relevant use in Discontinuation of Dabigatran Etexilate Accord: discontinue in patients
the paediatric population for the indication of prevention of stroke who develop acute renal failure and when severe bleeding occurs (the and use machines.
Pregnancy & Lactation: Women of childbearing potential: should
Presentation: Each hard capsule contains dabigatran etexilate (CrCL in mL/min) use the Cockcroft-Gault method. In all patients dabigatran etexilate. Because dabigatran etexilate can impact the and systemic embolism in patients with NVAF. Missed dose: continue source of bleeding must be investigated). The specific reversal agent
mesilate equivalent to 75mg, 110mg or 150mg of dabigatran (especially > 75 years, as renal impairment may be frequent in this International Normalised Ratio (INR), the INR will better reflect VKA’s with the remaining daily doses of Dabigatran Etexilate Accord at the idarucizumab may be considered in adult patients. Use of proton- avoid pregnancy during treatment with Dabigatran Etexilate
Accord. Pregnancy: should not be used during pregnancy unless
etexilate. age group): assess renal function prior to initiation of treatment to effect only after dabigatran etexilate has been stopped for at least 2 same time of the next day. A forgotten dose may still be taken up to 6 pump inhibitors: a proton-pump inhibitor (PPI) can be considered to clearly necessary. There is limited amount of data from the use of
Indications: 75mg and 110mg: primary prevention of venous exclude patients with severe renal impairment (CrCL < 30 mL/min). days. Until then, INR values should be interpreted with caution. hours prior to the next scheduled dose. From 6 hours prior to the next prevent GI bleeding. For paediatric patients, local labelling
thromboembolic events (VTE) in adult patients who have undergone Renal function should also be assessed when a decline in renal Prevention of stroke and systemic embolism in adult patients with NVAF scheduled dose onwards, the missed dose should be omitted. A recommendations for PPIs should be followed. Laboratory coagulation Dabigatran Etexilate Accord in pregnant women. The potential risk for
humans is unknown. Breast-feeding: no clinical data of the effect of
elective total hip replacement surgery or total knee replacement function is suspected during treatment (e.g. hypovolaemia, with one or more risk factors (SPAF). Treatment of DVT and PE, and double dose to make up for missed individual doses must never be parameters: although Dabigatran Etexilate Accord does not require
surgery. 75mg, 110mg, 150mg: treatment of VTE and prevention of dehydration, concomitant use of certain medicinal products). Renal prevention of recurrent DVT, and PE in adults (DVT/PE): Dose taken. routine anticoagulant monitoring, the measurement of dabigatran dabigatran on infants during breast-feeding. Breast-feeding should
recurrent VTE in paediatric patients from birth to less than 18 years of impairment: contraindicated in patients with severe renal impairment recommendations for SPAF, DVT and PE: prevention of stroke and Discontinuation of Dabigatran Etexilate Accord: treatment should related anticoagulation may be helpful to detect excessive high be discontinued during treatment with Dabigatran Etexilate Accord.
age. 110mg and 150mg: prevention of stroke and systemic embolism (CrCL < 30 mL/min). A dose reduction is recommended in patients systemic embolism in adult patients with NVAF with one or more risk not be discontinued without medical advice. Patients should exposure to dabigatran in the presence of additional risk factors. Fertility: no human data available.
in adult patients with non-valvular atrial fibrillation (NVAF), with with moderate renal impairment (CrCL 30-50 mL/min). Concomitant factors (SPAF): 300 mg (one 150 mg capsule twice daily). Treatment of be instructed to contact the treating physician if they develop Diluted thrombin time (dTT), ecarin clotting time (ECT) and activated Adverse Events include: Adverse events which could be
one or more risk factors, such as prior stroke or transient ischemic use of Dabigatran Etexilate Accord with mild to moderate P-glycoprotein DVT and PE, and prevention of recurrent DVT, and PE in adults (DVT/ gastrointestinal symptoms such as dyspepsia. Switching: Dabigatran partial thromboplastin time (aPTT) may provide useful information considered serious: anaemia, thrombocytopenia, neutropenia,
attack (TIA); age ≥ 75 years; heart failure (NYHA Class ≥ II); diabetes (P-gp) inhibitors: dosing should be reduced. Dabigatran Etexilate PE): 300 mg (one 150 mg capsule twice daily) following treatment Etexilate Accord to parenteral anticoagulant: it is recommended to (see SmPC). Interpret results with caution due to inter-test variability. agranulocytosis, drug hypersensitivity, anaphylactic reaction,
mellitus; hypertension. Treatment of deep vein thrombosis (DVT) and Accord should be taken at the same time as these medicinal products. with a parenteral anticoagulant for at least 5 days. Dose reduction wait 12 – 24 hrs (see SmPC for specific treatment regimen) after The INR test is unreliable in patients on Dabigatran Etexilate Accord angioedema, intracranial haemorrhage, haematoma, haemorrhage,
pulmonary embolism (PE), and prevention of recurrent DVT and PE In patients with moderate renal impairment and concomitantly recommended: patients aged ≥80 years and patients receiving the last dose of Dabigatran Etexilate Accord before switching to a and false positive INR elevations have been reported. INR tests should gastrointestinal haemorrhage, rectal haemorrhage, gastrointestinal
in adults. treated with verapamil, a dose reduction to 75 mg daily should be concomitant verapamil: 220 mg daily (one 110 mg capsule twice parenteral anticoagulant. Parenteral anticoagulants to Dabigatran not be performed. Use of fibrinolytic medicinal products for the ulcer, including oesophageal ulcer, hyperbilirubinaemia,
Dosage and Administration: posology: for use in adult and considered. Elderly: for patients > 75 years, a dose reduction is daily). Dose reduction for consideration: patients between 75-80 years, Etexilate Accord: the parenteral anticoagulant should be discontinued. treatment of acute ischemic stroke: may be considered if the patient haemarthrosis, genitourological haemorrhage, including
paediatric patients aged 8 years or older who are able to swallow the recommended. Weight: no adjustment is necessary, close clinical patients with moderate renal impairment (CrCL 30-50 mL/min), Dabigatran Etexilate Accord should then be started 0-2 hrs (see SmPC presents with a dTT, ECT or aPTT not exceeding the upper limit of haematuria, traumatic haemorrhage. Other Common adverse events:
capsules whole. Other formulations are available for use in children surveillance is recommended. Gender: no dose adjustment. Paediatric gastritis, esophagitis or gastroesophageal reflux, patients at increased for specific treatment regimen) before the next dose of the parenteral normal (ULN) according to the local reference range. Surgery and haemoglobin decreased, rash, urticaria, epistaxis, abdominal pain,
(see SmPC). When changing between formulations, the prescribed population: no relevant use for the indication of primary prevention of risk of bleeding: a daily dose of 300 mg or 220 mg should be selected anticoagulant would be due, or at the time of discontinuation in case interventions: patients who undergo surgery or invasive procedures diarrhoea, dyspepsia, nausea, dysphagia, hepatic function abnormal/
dose may need to be altered. The dose stated in the relevant dosing VTE in patients who have undergone elective total hip replacement based on an individual assessment of the thromboembolic risk and of continuous treatment (e.g. intravenous Unfractionated Heparin are at increased risk for bleeding. Surgical interventions may require liver function test abnormal, skin haemorrhage, gastroesophageal
table of a formulation should be prescribed for the age and weight of surgery or total knee replacement surgery. Treatment of VTE and the risk of bleeding. In case of intolerability to Dabigatran Etexilate (UFH)). Method of administration: for oral use. The capsules can be the temporary discontinuation of Dabigatran Etexilate Accord. reflux disease, vomiting, hepatic enzyme increased, alopecia. See
the child. Primary prevention of venous thromboembolism (VTE) in prevention of recurrent VTE in paediatric patients: treatment should be Accord, patients should immediately consult their treating physician taken with or without food and should be swallowed whole with a Exercise caution when treatment is temporarily discontinued for SmPC for details of other adverse events.
orthopaedic surgery: Patients following elective knee replacement initiated following treatment with a parenteral anticoagulant for at in order to be switched to alternate acceptable treatment options for glass of water, to facilitate delivery to the stomach. Instruct patients interventions and anticoagulant monitoring is warranted. Clearance Presentation and Price:
surgery or patients following elective hip replacement surgery; least 5 days. For prevention of recurrent VTE, treatment should be prevention of stroke and systemic embolism associated with atrial not to open the capsule as this may increase the risk of bleeding. of dabigatran in patients with renal insufficiency may take longer. 75mg x 10 £7.65, 75mg x 60 £45.90, 110mg x 10 £7.65,
treatment initiation on the day of surgery 1 4 hours after completed initiated following previous treatment. Dabigatran etexilate capsules fibrillation or for DVT/PE. Duration of use in the indications SPAF, DVT Contraindications: hypersensitivity to the active substance or to This should be considered in advance of any procedures. A coagulation 110mg x 60 £45.90, 150mg x 60 £45.90.
surgery: 110 mg (single 110 mg capsule). Maintenance dose starting should be taken twice daily; in the morning and the evening, at and PE: SPAF: continue therapy long term. DVT/PE: duration of any of the excipients; severe renal impairment (CrCL < 30 mL/min); test may help to determine whether haemostasis is still impaired. Legal Category: POM
on the first day after surgery: 220 mg once daily (2 capsules of 110 approximately the same time each day. The dosing interval should be therapy should be individualised after careful assessment of the eGFR <50 mL/min/1.73m in paediatric patients; active clinically Emergency surgery or urgent procedures: temporarily discontinue Further information is available from:
2
mg). Duration of maintenance dose: 10 days (knee replacement as close to 12 hours as possible. Dose recommendation is based on the treatment benefit against the risk for bleeding. Short duration of significant bleeding; lesion or condition, if considered a significant Dabigatran Etexilate Accord. When required, the specific reversal Accord-UK Ltd, Whiddon Valley, Barnstaple,
surgery) or 28 35 days (hip replacement surgery). Dose reduction patient’s age and weight (see SmPC) and should be adjusted therapy (3+ months) should be based on transient risk factors (e.g. risk factor for major bleeding. This may include current or recent agent, idarucizumab is available for adult patients. Haemodialysis can Devon, EX32 8NS.
recommended in patients with moderate renal impairment according to age and weight as treatment progresses. Assessment of recent surgery, trauma, immobilisation). Longer durations should be gastrointestinal ulceration, presence of malignant neoplasms at high remove dabigatran. Reversing dabigatran therapy exposes patients to Marketing Authorisation Numbers:
(creatinine clearance (CrCL 30-50 mL/min)); patients who receive renal function prior to and during treatment: prior to the initiation of based on permanent risk factors or idiopathic DVT or PE. Assessment risk of bleeding, recent brain or spinal injury, recent brain, spinal the thrombotic risk of their underlying disease. Dabigatran Etexilate PLGB 20075/1415, 1416, 1417
concomitant verapamil, amiodarone, quinidine; patients aged 75 or treatment, the estimated glomerular filtration rate (eGFR) should be of renal function prior to and during treatment: renal function should or ophthalmic surgery, recent intracranial haemorrhage, known Accord treatment can be re-initiated 24 hours after administration of Date of PI Preparation: December 2023
above. Treatment initiation on the day of surgery 1 4 hours after estimated using the Schwartz formula. Treatment is contraindicated be assessed in all patients especially in the elderly (> 75 years), as or suspected oesophageal varices, arteriovenous malformations, idarucizumab, if the patient is clinically stable and adequate Document Number: UK-05596
completed surgery: 75 mg (single 75 mg capsule). Maintenance dose in paediatric patients with eGFR <50 mL/min/1.73m . Patients with renal impairment may be frequent in this age group. CrCL should be vascular aneurysms or major intraspinal or intracerebral vascular haemostasis has been achieved. Subacute surgery/interventions:
2
starting on the first day after surgery: 150 mg once daily (2 capsules an eGFR ≥50 mL/min/1.73m should be treated as per the patient’s calculated prior to initiation of treatment to exclude patients with abnormalities; concomitant treatment with any other anticoagulants temporarily discontinue Dabigatran Etexilate Accord. If possible, Adverse events should be reported.
2
of 75 mg). Duration of maintenance dose: 10 days (knee replacement age and weight (see SmPC). During treatment, renal function should severe renal impairment (CrCL < 30 mL/min). Renal function should e.g. unfractionated heparin (UFH), low molecular weight heparins delay surgery / intervention until at least 12 hours after the last dose. Reporting forms and information can be found at
surgery) or 28 35 days (hip replacement surgery) (See SmPC). If be assessed when it is suspected that the renal function could decline also be assessed when a decline in renal function is suspected during (enoxaparin, dalteparin etc), heparin derivatives (fondaparinux etc), If surgery cannot be delayed the risk of bleeding may be increased. www.mhra.gov.uk/yellowcard
haemostasis is not secured, initiation of treatment should be delayed. or deteriorate (such as hypovolemia, dehydration or with certain co- treatment (e.g. hypovolaemia, dehydration, concomitant use of oral anticoagulants (warfarin, rivaroxaban, apixaban etc) except This risk of bleeding should be weighed against the urgency of Adverse events should also be reported to
If treatment is not started on the day of surgery then treatment medications). Duration of therapy should be individualised based on certain medicinal products). In patients with mild to moderate renal under specific circumstances. These are switching anticoagulant intervention. Elective surgery: discontinue Dabigatran Etexilate Accord Accord-UK LTD on 01271 385257 or
should be initiated with 2 capsules once daily. Assessment of renal the benefit risk assessment. Switching Dabigatran etexilate treatment impairment and in patients aged over 75 years, renal function should therapy, when UFH is given at doses necessary to maintain an open at least 24 hours before invasive / surgical procedures. Patients at email medinfo@accord-healthcare.com
function prior to and during treatment: to estimate renal function to Vitamin K antagonists (VKA): start VKA 3 days before discontinuing be assessed at least once a year as needed. The Cockcroft-Gault central venous or arterial catheter or when UFH is given during higher risk of bleeding or in major surgery where complete
UK-05837 | Date of Preparation: February 2024 UK-05837 | Date of Preparation: February 2024
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10/09/2024 17:02:12
P4304.1-V102_PS Magazine - Oct 24 FINAL VERSION.indd 8
P4304.1-V102_PS Magazine - Oct 24 FINAL VERSION.indd 8 10/09/2024 17:02:12