NWMIC Medicines FAQ. New oral anticoagulants (NOACs) and management of dental patients - Dabigatran, rivaroxaban and apixaban.

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1 NWMIC Medicines FAQ New oral anticoagulants (NOACs) and management of dental patients - Date prepared: May 2013, updated November 2013 Summary In primary care; Consider liaising with the local hospital dental department. Some units may actively wish to gain experience managing patients on NOACs. Some units may have acquired hands on experience that they would be willing to share. If stopping dabigatran/rivaroxaban/apixaban periprocedure, always inform/liaise with the clinician managing anticoagulation. Renal function should be established for patients taking dabigatran. Follow advice of the relevant SmPC. If planning to extract without stopping dabigatran/rivaroxaban/apixaban If using a local anaesthetic use an infiltration or intraligamentary injection where possible. Maximise the time since last dabigatran/rivaroxaban/apixaban dose. Ensure that all local measures applicable to warfarin are carried out. The first dose post-procedure should not be taken until haemostasis is established and at least 4 hours post-procedure. Advice should be given to the patient verbally and in writing about the normal post-procedural course and measures to be taken in case of bleeding. It is essential that this advice includes who to contact after hours if bleeding develops. Go to the following information in the document: Dosing advice and half-life data Dabigatran Rivaroxaban Apixaban SmPC perioperative advice Dabigatran Rivaroxaban Apixaban Published information/guidance Belgian Society of Thrombosis and Haemostasis Dabigatran Rivaroxban European Heart Rhythm Association - Practical guide on the use of new oral anticoagulants in patients with non-valvular atrial fibrillation RE-LY - Peri-Procedural Bleeding and Thromboembolic Events with Dabigatran Compared to Warfarin: Results from the RE-LY Randomized Trial NICE CKS Anticoagulation oral. Management, surgery and dental treatment Clinical Pharmacist - How to support patients taking new oral anticoagulant medicines Unpublished guidance Glasgow Dental Hospital, Andrew Brewer NHS Tayside Integrated Dental Service Local Guidance References

2 Background There is little information on which to base advice for dentists who need to perform extractions for patients who are taking long-term NOACs. Answer Dosing advice and half-life data Dabigatran A direct thrombin inhibitor. Dabigatran was licensed for stroke prevention in AF in August Also licensed for prevention of venous thromboembolic events (VTE) following hip or knee surgery. Dose (AF): 150mg twice daily (110mg twice daily if >80 years old, at high risk of bleeding or taking verapamil.) Half-life: hours (normal renal function), 15 hours (GFR >50 and < 80), 18 hours (GFR >30 and <50) and 27 hours (GFR <30) Rivaroxaban A direct inhibitor of activated Factor Xa. Licensed for stroke prevention in AF and treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults in November 2011 and acute coronary syndrome in May Also licensed for prevention of venous thromboembolic events (VTE) following hip or knee surgery. Dose (AF): 20mg once daily Half-life: 5-9 hours (young), hours (elderly) Apixaban A direct inhibitor of activated Factor Xa. Licensed for stroke prevention in AF in December Also licensed for prevention of venous thromboembolic events (VTE) following hip or knee surgery. Dose (AF): 5mg twice daily (2.5mg twice daily if >80 years and < 60kg). Half-life: 12 hours Advice in Summaries of Product Characteristics General perioperative advice is included in the three NOAC SmPCs: Dabigatran (Pradaxa) 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. Clearance of dabigatran in patients with renal insufficiency may take longer. This should be considered in advance of any procedures. In such cases a coagulation test may help to determine whether haemostasis is still impaired. Preoperative phase Table 3 summarizes discontinuation rules before invasive or surgical procedures. Renal function (CrCL in ml/min) Estimated half-life (hours) Stop dabigatran before elective surgery High risk of bleeding or major surgery Standard risk 80 ~ 13 2 days before 24 hours before 50-< 80 ~ days before 1-2 days before 30-< 50 ~ 18 4 days before 2-3 days before (> 48 hours)

3 If an acute intervention is required, dabigatran etexilate should be temporarily discontinued. A surgery / intervention should be delayed if possible until at least 12 hours after the last dose. If surgery cannot be delayed the risk of bleeding may be increased. This risk of bleeding should be weighed against the urgency of intervention. Dabigatran SmPC interpretation for dental procedures If you assume that dental extractions are classed as standard risk dabigatran needs to be discontinued, duration dictated by renal function. Resume treatment after complete haemostasis is achieved. If dental extractions are lower than standard risk maybe no doses need to be omitted. Without the practical experience of dentists it is not possible to make this assessment. Rivaroxaban (Xarelto) Dosing recommendations before and after invasive procedures and surgical intervention If an invasive procedure or surgical intervention is required, Xarelto should be stopped at least 24 hours before the intervention, if possible and based on the clinical judgement of the physician. If the procedure cannot be delayed the increased risk of bleeding should be assessed against the urgency of the intervention. Xarelto should be restarted after the invasive procedure or surgical intervention as soon as possible provided the clinical situation allows and adequate haemostasis has been established. Rivaroxaban SmPC interpretation for dental procedures For invasive dental procedures e.g. extractions, the last dose of rivaroxaban should be taken at least 24 hours before the procedure and restarted when haemostasis is established. Apixaban (Eliquis) Surgery and invasive procedures Eliquis should be discontinued at least 48 hours prior to elective surgery or invasive procedures with a moderate or high risk of bleeding. This includes interventions for which the probability of clinically significant bleeding cannot be excluded or for which the risk of bleeding would be unacceptable. Eliquis should be discontinued at least 24 hours prior to elective surgery or invasive procedures with a low risk of bleeding. This includes interventions for which any bleeding that occurs is expected to be minimal, non-critical in its location or easily controlled. If surgery or invasive procedures cannot be delayed, appropriate caution should be exercised, taking into consideration an increased risk of bleeding. This risk of bleeding should be weighed against the urgency of intervention. Apixaban should be restarted after the invasive procedure or surgical intervention as soon as possible provided the clinical situation allows and adequate haemostasis has been established. Apixaban SmPC interpretation for dental procedures Apixaban should be discontinued 24 hours before dental procedures even for those classed as low risk and associated with minimal bleeding. Apixaban should be restarted as soon as possible after the procedure provided adequate haemostasis has been established. Published information/guidance 1. Belgian Society of Thrombosis and Haemostasis a. Practical guide dabigatran, Guidance for use in particular situations [1] Dental interventions Dabigatran should not necessarily be discontinued for dental interventions like extraction of one to three teeth, periodontal surgery, incision of an abscess or positioning of implants. The bleeding risk needs to be balanced against the thromboembolic risk. In such cases, the following precautions have to be taken:

4 The procedure should ideally be performed 12 hours after last dosing The procedure needs to be done with the least possible trauma After extraction, the wound should be sutured The patient can only leave the clinic when bleeding has completely stopped [The patient should rinse his mouth gently with 10 ml of tranexamic acid 5%, four times a day for five days]* The patient should be instructed verbally and in writing about the normal postprocedural course and the measures to be taken in case of bleeding The patient has to contact his dentist in case of bleeding that does not stop spontaneously The dentist (or his/her colleague) has to be accessible after hours. *It is not possible to prescribe tranexamic acid mouthwash on an NHS prescription; private prescriptions may be expensive to fill. If the decision is to discontinue, dabigatran should be stopped 24h prior to tooth extraction or other dental procedure. It should be resumed as soon as haemostasis is achieved. For more extensive interventions, the patient should be referred to a maxillofacial surgeon. Management of anticoagulation can then be guided by the Pradaxa SmPC. b. Rivaroxaban: A Practical Guide [2] Minor interventions without significant bleeding risk For minor interventions without significant bleeding risk e.g. dental interventions such as extraction of one to three teeth, periodontal surgery, incision of an abscess or positioning of implants - the bleeding risk needs to be balanced against the thromboembolic risk. When to interrupt rivaroxaban? Rivaroxaban interruption may not be required for superficial interventions. It is advised to allow a time window of at least 18 hours between the last dose of rivaroxaban and the scheduled procedure. Alternatively allow a time window of at least 24 hours between the last dose of rivaroxaban and the intervention. 2. European Heart Rhythm Association - Practical guide on the use of new oral anticoagulants in patients with non-valvular atrial fibrillation [3]: Patients undergoing a planned surgical intervention or ablation When to stop the new oral anticoagulants? Patient characteristics (kidney function, age, history of bleeding complications, concomitant medication) and surgical factors should be taken into account if discontinuing/restarting the drug. When an intervention carries no clinically important bleeding risk and/or when adequate local haemostasis is possible, e.g. some dental procedures, the procedure can be performed at trough concentration of the NOAC (i.e. 12 or 24 hours after the last dose, depending on twice or once daily dosing) but should not be performed at peak concentration. It may be more practical to have the intervention scheduled 18 to 24 hours after the last dose, and then restart 6 hours later, i.e. with skipping one dose for a twice daily NOAC. The patient should only leave the clinic when the bleeding has completely stopped. The patient should be given instructions about what to expect post procedure and the measures to be taken in case of bleeding, i.e. to contact the physician or dentist in case of bleeding that does not stop spontaneously. The physician or dentist (or an informed colleague) has to be accessible in such case. [For dental procedures, the patient could rinse the mouth gently with 10 ml of tranexamic acid 5%, four times a day for 5 days - It is not possible to prescribe tranexamic acid mouthwash on an NHS prescription; private prescriptions may be expensive to fill]. Classification of elective surgical interventions according to bleeding risk Interventions not necessarily requiring discontinuation of anticoagulation: Dental interventions Extraction of one to three teeth Periodontal surgery Incision of abscess Implant positioning

5 When to restart the new oral anticoagulants? For procedures with immediate and complete haemostasis, the NOAC can be resumed 6 8 hours after the intervention. Maximal anticoagulation effect of the NOACs will be achieved within 2 hours of ingestion. 3. Peri-Procedural Bleeding and Thromboembolic Events with Dabigatran Compared to Warfarin: Results from the RE-LY Randomized Trial [4] An analysis of RE-LY trial data compared peri-procedural bleeding risk of patients treated with dabigatran and warfarin. Although the RE-LY trial was not specifically designed to evaluate periprocedural bleeding, participants had details of peri-operative management of their anticoagulation prospectively recorded if procedures were required. Of 4,591 patients who underwent at least one invasive procedure 10.0% were dental procedures. The RE-LY protocol recommended stopping dabigatran 24 hours prior to a procedure or surgery. Unfortunately no specific data were published about the outcome for patients requiring dental procedures, or any other specific procedure. 4. NICE Clinical Knowledge Summaries Anticoagulation oral Management [5] [CKS recommendations are based on the SmPCs and the guidance published by the European Heart Rhythm Association [3]]. Patients needing to have surgery or any other invasive procedure, including dental procedures, may need to temporarily stop taking their anticoagulant. The decision to stop the anticoagulant and when to stop it will depend on the patient s risk of having a thromboembolic event and the bleeding risk associated with the procedure. Bleeding risk assessment Treatments with 'no clinically important bleeding risk include: Dental interventions such as; extraction of 1 to 3 teeth, periodontal surgery, incision of abscess and implant positioning. Minor surgery (e.g. abscess incision and small dermatologic excisions). Treatments with 'low bleeding risk' include: Endoscopy with biopsy. Treatments with 'high bleeding risk' include: Thoracic surgery. Abdominal surgery. Major orthopaedic surgery. Dabigatran Should dabigatran be stopped before planned surgery or dental treatment? For procedures associated with no clinically important bleeding risk the procedure can be performed: Just before the next dose of dabigatran is due, or Approximately hours after the last dose of dabigatran was taken (dabigatran should be restarted 6 hours later). This means one dose of dabigatran may be missed. For dental procedures, consider prescribing tranexamic acid 5% mouth wash; instruct the person to use 10 ml as a mouth wash four times a day for 5 days. For procedures with a low bleeding risk, dabigatran should be stopped 24 hours before the procedure. If the person has renal impairment, dabigatran may need to be stopped 36 (Creatinine clearance [CrCl] ml/min) or 48 hours (CrCl ml/min) before the intervention. For procedures with a high bleeding risk, dabigatran should be stopped 48 hours before the procedure. If the person has renal impairment, dabigatran may need to be stopped 72 (CrCl ml/min) or 96 hours (CrCl 30 50mL/min) before the intervention.

6 Rivaroxaban For procedures associated with no clinically important bleeding risk the procedure can be performed: Just before the next dose of rivaroxaban is due, or Approximately hours after the last dose of rivaroxaban was taken and rivaroxaban should be restarted 6 hours later. For dental procedures, consider prescribing tranexamic acid 5% mouthwash; instruct the person to use 10 ml as a mouthwash four times a day for 5 days. For procedures with a low bleeding risk, rivaroxaban should be stopped 24 hours before the procedure. If the person has a creatinine clearance between ml/min rivaroxaban should be stopped 36 hours before the procedure. For procedures that with a high bleeding risk, rivaroxaban should be stopped 48 hours before the procedure. Apixaban For procedures associated with no clinically important bleeding risk the procedure can be performed: Just before the next dose of apixaban is due or Approximately hours after the last dose of apixaban was taken (apixaban should be restarted 6 hours later). This means one dose of apixaban may be missed. For dental procedures, consider prescribing tranexamic acid 5% mouthwash; instruct the person to use 10 ml as a mouth wash four times a day for 5 days. For procedures with a low bleeding risk, apixaban should be stopped 24 hours before the procedure. If the person has a creatinine clearance (CrCl) between ml/min, apixaban should be stopped 36 hours before the procedure. For procedures with a high bleeding risk, apixaban should be stopped 48 hours before the procedure. 5. How to support patients taking new oral anticoagulant medicines - Clinical Pharmacist [6] [The authors of this paper are a consultant haematologist and an anticoagulant pharmacist] Dental procedures Routine check-ups or having fillings by a dentist do not usually require anticoagulant cessation. Manufacturers do not offer any specific advice for dental extractions or cleaning by a hygienist; however, if we consider tooth extractions to be low- or standard-risk surgery, then anticoagulation should be stopped one day before the procedure. An alternative, theoretical approach is to perform the procedure when plasma levels of the NOAC are at a trough this approach could be especially suitable for patients who are at a high risk of stroke. Such patients should arrange to have their procedure first thing in the morning and: For apixaban and dabigatran, omit the morning dose and recommence with the evening dose if bleeding has resolved For rivaroxaban, withhold the dose that morning and take it later in the day (within 12 hours) if bleeding has resolved. Unpublished guidance 1. Glasgow Dental Hospital, Andrew Brewer [7] DENTAL TREATMENT There are no published papers at present but the following suggestions are based on best available information. No effect in providing the following: Prosthodontics Conservation Endodontics

7 Hygiene Phase Therapy Orthodontics However, it is recommended these procedures are undertaken around hours after the last dose of dabigatran or apixaban (or hours after rivaroxaban). Local Anaesthetic A local anaesthetic containing a vasoconstrictor should be used, unless contra-indicated. Where possible use an infiltration or intraligamentary injection. If there is no alternative and an inferior alveolar nerve block is used, the injection should be administered slowly using an aspirating technique. May affect the following: Extractions Minor Oral Surgery Periodontal Surgery Biopsies If the patient requires treatment which cannot be delayed until the treatment is finished, as in short term prophylaxis, the following guidance may be useful. If possible, omit the dose before treatment and perform the treatment as near to the next dose as practical [if significant renal impairment, 2 prior doses of dabigatran may need to be omitted]. Haemostasis should be obtained using the usual local measures which may include the use of oxidised cellulose and sutures. Monitor the patient until haemostasis has been achieved. The next dose of anticoagulant should be delayed until 4h post procedure. 2. NHS Tayside Integrated Dental Service Local Guidance, April 2012, Dental Management of Patients Taking Oral Anticoagulant Drugs. [8] New anticoagulants that do not require regular blood test monitoring - Rivaroxaban/dabigatran Dental Management - No pre-operative testing required. - For all extractions, scaling etc. Proceed without altering the drug regime. Multiple extractions and surgical procedures are considered safe for patients continuing to take these anticoagulant drugs. When practical, however, the number of teeth to be extracted at a single visit should be limited to 3-4 teeth and it is advisable to assess the extent of bleeding after the extraction of the first tooth. (There is an approximate 1:10,000 risk of stroke, per day, in patients with atrial fibrillation without anticoagulant therapy). - For patients with a prosthetic valve or other device in place, consult the cardiologist for advice. - For patients on short courses of anticoagulant post orthopaedic surgery, delay any elective treatment until the patient is recovered. - For emergency treatment in such patients, consult the orthopaedic surgery team before proceeding. - Where a patient taking these drugs presents with a post-operative haemorrhage, contact the Haematology Department for advice. References 1. Prof. Dr. Hein Heidbüchel et al. Practical guide dabigatran: Guidance for use in particular situations. Version 2.0 (January 2013). Belgian Society of Thrombosis and Haemostasis January% pdf (accessed May 2013). 2. Prof. Dr. Hein Heidbüchel et al. Rivaroxaban: A Practical Guide (July 2012). Belgian Society of Thrombosis and Haemostasis (accessed May 2013) 3. Heidbüchel H. et al. European Heart Rhythm Association Practice guide on the use of new oral anticoagulants in patients with non-valvular atrial fibrillation. Europace 2013; 15:

8 4. Healey J S. et al. Peri-Procedural Bleeding and Thromboembolic Events with Dabigatran Compared to Warfarin: Results from the RE-LY Randomized Trial. Circulation 2012; 126: (Accessed May 2013) 5. NICE Clinical Knowledge Summaries Anticoagulation oral Management (Accessed November 2013) 6. Bhandal S and Pattinson J. How to support patients taking new oral anticoagulant medicines. Clinical Pharmacist 2013; 5: Management of patients requiring dental treatment who are taking the newly introduced oral anticoagulants. Andrew Brewer, personal communication, Oral & Maxillofacial Surgery Department, The Royal Infirmary, Glasgow. April Dental Management of Patients Taking Oral Anticoagulant Drugs, NHS Tayside Integrated Dental Service Local Guidance, April (accessed May 2013) Disclaimer NWMIC Medicines FAQs are intended for healthcare professionals and reflect UK practice. Each FAQ relates only to the clinical scenario described. FAQs are believed to accurately reflect medical literature at the time of writing. The authors of FAQs are not responsible for the content of external websites and links are made available solely to indicate their potential usefulness. You must use your judgement to determine the accuracy and relevance of the information they contain. This document cannot be used for commercial or marketing purposes. Prepared by Checked by Christine Randall. Medicines Information Pharmacist. Name. Medicines Information Pharmacist. North West Medicines Information Centre, 70 Pembroke Place, Liverpool. L69 3GF. Telephone Fax Search strategy Review date NWMIC MiDatabank project number 156 May 2015

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