Page 5 - P4304.1-V98_PS-Magazine-June 2024 PRINT READY
P. 5

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
               or call us on 01904 558 350                                                                           5 5

                                                                                                                 22/05/2024   13:53:28
         P4304.1-V98_PS-Magazine-June 2024.indd   5                                                              22/05/2024   13:53:28
         P4304.1-V98_PS-Magazine-June 2024.indd   5
   1   2   3   4   5   6   7   8   9   10