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References: 1. Boehringer Ingelheim. Pradaxa®


2. Boehringer Ingelheim. Praxbind® Summary of Product Characteristics. 3. Schiele F, et al. Blood 2013;121(18):3554–3562. 4. Sarich


Summary of Product Characteristics. TC, et al. Am Heart J


2015;169(6):751–757. 5. Pollack CV, et al. N Engl J Med 2015;373(6):511–520. 6. Graham DJ, et al. Circulation 2015;131:157–164. 7. Connolly SJ, et al. N Engl J Med 2009;361:1139–1151. 8. Connolly SJ, et al. N Engl J Med 2010; 363:1875–1876. 9. Connolly SJ, et al. N Engl J Med 2014;371:1464–1465.


Prescribing Information (UK) PRAXBIND® for for


procedures; in (idarucizumab) 2.5 g/50 mL, solution


injection/infusion. Vials containing 2.5 g idarucizumab in 50 mL solution injection/infusion. Indication: Praxbind is a specifi c reversal agent for


dabigatran and is indicated in adult patients treated with Pradaxa (dabigatran etexilate) when rapid reversal of its anticoagulant effects is required: for emergency surgery/urgent


life-threatening or uncontrolled bleeding. Dose


and Administration: Restricted to hospital use only. Recommended dose is 5 g (2 x 2.5 g/ 50 mL), administered intravenously as two consecutive infusions over 5 to 10 minutes each or as a bolus injection. Administration of a second 5 g dose may be considered in the following situations: recurrence of clinically relevant bleeding together with prolonged clotting times; if potential re-bleeding would be life-threatening and prolonged clotting times are observed; patients require a second emergency surgery/ urgent procedure and have prolonged clotting times. Restarting antithrombotic therapy: If the patient is clinically stable and adequate haemostasis has been achieved following administration of Praxbind, Pradaxa (dabigatran etexilate) treatment can be re-initiated after 24 hours; other antithrombotic therapy (e.g. low-molecular weight heparin) can be started at any time. No dose adjustment is required in patients with renal or hepatic impairment or in elderly patients aged 65 years and above. Safety and effi cacy in children below the age of 18 years have not yet been established. Contraindications: None. Warnings and Precautions: Idarucizumab binds specifi cally to dabigatran and reverses its anticoagulant effect. It will not reverse the effects of other anticoagulants. Treatment can be used in conjunction with medically appropriate standard supportive


measures.


In patients with known hypersensitivity (e.g. anaphylactoid reaction)


to


idarucizumab or to any of the excipients the risk of using Praxbind needs to be weighed cautiously against the potential benefi t of the emergency treatment, discontinue use if an anaphylactic reaction or other serious reaction occurs. The recommended dose of Praxbind contains 4 g sorbitol as an excipient. In patients with hereditary fructose intolerance, parenteral administration of sorbitol has been associated with reports of hypoglycaemia, hypophosphatemia, metabolic acidosis, increase in uric acid, acute liver failure with breakdown of excretory and synthetic function, and death. Consequently, in these patients the risk of treatment with Praxbind must be weighed against the potential benefi t, and if Praxbind is administered intensifi ed medical care during and within 24 hours of exposure is required. Reversing dabigatran therapy exposes patients to the thrombotic risk of their underlying disease. To reduce this risk resumption of anticoagulant therapy should be considered as soon as medically appropriate. Contains 2.2 mmol (50 mg) sodium per dose. Praxbind causes transient proteinuria which is not indicative of renal damage but which should be taken into account for urine testing. Interactions: No formal interaction studies have been performed. Based on pharmacokinetic properties and high specifi city in binding to dabigatran clinically relevant interactions with other medicinal products are considered unlikely. Fertility, Pregnancy and Lactation: There are no data for use in pregnant women. Praxbind may be used during pregnancy, if the expected clinical benefi t outweighs the potential risks. There are no data on the effect on fertility. It is unknown whether idarucizumab is excreted in human milk. Undesirable effects: No adverse reactions have been identifi ed. Pack sizes and NHS price: Carton containing 2 vials £2,400. Legal category: POM MA numbers: EU/1/15/1056/001 Marketing Authorisation Holder: Boehringer Ingelheim International GmbH, Binger Str. 173, D-55216 Ingelheim am Rhein, Germany. Prescribers should consult the Summary of Product Characteristics for full prescribing information. Prepared in November 2015


Prescribing Information (SPAF - UK) PRADAXA® (dabigatran etexilate) Capsules containing 110 mg or 150 mg dabigatran etexilate (as mesilate) Action: Direct


thrombin inhibitor Indication: Prevention of stroke and systemic embolism in adult patients with non-valvular atrial fi brillation with one or more risk factors, such as prior stroke, or transient ischaemic attack; age ≥ 75 years; heart failure (NYHA Class ≥ II); diabetes mellitus; hypertension Dose and Administration: Renal function should be assessed by calculating CrCL prior to initiation to exclude patients with severe renal impairment (CrCL < 30 mL/min). Recommended daily dose 300 mg taken as one 150 mg capsule twice daily. Therapy should be continued long term. In case of intolerability to dabigatran, patients should be instructed to immediately consult their doctor. For patients aged 80 years or above, or those receiving concomitant verapamil, the recommended daily dose is Pradaxa 220 mg taken as 110 mg twice daily. Pradaxa and verapamil should be taken at the same time. For the following patient groups, the daily dose of 300 mg or 220 mg should be selected based on an individual assessment of the thromboembolic risk and risk of bleeding: aged 75 – 80 years; with moderate renal impairment (CrCL 30-50 mL/min); with gastritis, oesophagitis or gastroesophageal refl ux; other risk of increased bleeding. Close clinical surveillance is recommended in patients with renal impairment. Use is contraindicated in patients with severe renal impairment (CrCL < 30 mL/min). In all patients assess renal function by calculating CrCL prior to initiation to exclude patients with severe renal impairment. Renal function should also be assessed when a decline in renal function is suspected. Additionally in patients > 75 years or with mild to moderate renal impairment, renal function should also be assessed at least once a year or more frequently as needed in certain clinical situations when it is suspected that the renal function could decline or deteriorate. Patients with an increased risk of bleeding: closely monitor clinically looking for signs of bleeding or anaemia. A coagulation test may help identify increased risk patients. No dose adjustment required but close clinical surveillance in patients < 50 kg. Not recommended if liver enzymes > 2 Upper Limit of Normal (ULN). If switching from Pradaxa to parenteral anticoagulant wait 12 hours after the last dose of Pradaxa; if switching from parenteral anticoagulant


to Pradaxa discontinue the parenteral anticoagulant and start Pradaxa 0 2 hours prior to the time that the next dose of the alternate therapy would be


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