Drug Action
Idarucizumab is a humanised monoclonal antibody fragment that binds specifically to dabigatran and its metabolites, thereby reversing the anticoagulant effect.
PDF page 151
Loading InternPractice…
Drug reference
Idarucizumab is a humanised monoclonal antibody fragment that binds specifically to dabigatran and its metabolites, thereby reversing the anticoagulant effect.
PDF page 151
Rapid reversal of dabigatran for emergency procedures, or in life-threatening or uncontrolled bleeding (specialist supervision in hospital) ▶BY INTRAVENOUS INJECTION, OR BY INTRAVENOUS INFUSION ▶Adult: 5 g, followed by 5 g if required
PDF page 151
Risk of thrombosis CAUTIONS, FURTHER INFORMATION Manufacturer advises to consider re-starting anticoagulant therapy as soon as medically appropriate to reduce the risk of thrombosis. Dabigatran can be re-started 24 hours after administration of idarucizumab; other anticoagulant therapy can be started at any time.
PDF page 151
Scottish Medicines Consortium (SMC) decisions SMC No. 1178/16 The Scottish Medicines Consortium has advised (September 2016) that idarucizumab (Praxbind ®) is accepted for use within NHS Scotland for adults treated with dabigatran etexilate when rapid reversal of its anticoagulant effects is required for emergency surgery/urgent procedures or in life-threatening or uncontrolled bleeding.
PDF page 151
Manufacturer advises use only if potential benefit outweighs risk—no information available.
PDF page 151
Manufacturer advises that one dose of Praxbind ® is administered as either two consecutive intravenous infusions, each given over 5–10 minutes, or as a bolus injection. l HANDLING AND STORAGE Manufacturer advises store in a refrigerator at 2–8°C.
PDF page 151
There can be variation in the licensing of different medicines containing the same drug. Solution for infusion EXCIPIENTS: May contain Polysorbates, sorbitol ELECTROLYTES: May contain Sodium ▶Praxbind (Boehringer Ingelheim Ltd) A Idarucizumab 50 mg per 1 ml Praxbind 2.5g/50ml solution for infusion vials | 2 vial P £2,400.00 (Hospital only) ANTITHROMBOTIC DRUGS › ANTIPLATELET DRUGS Antiplatelet drugs Overview Antiplatelet drugs decrease platelet aggregation and inhibit thrombus formation in the arterial circulation, because in faster-flowing vessels, thrombi are composed mainly of platelets with little fibrin. g Use of aspirin p. 130 in primary prevention of cardiovascular disease, in patients with or without diabetes, or hypertension, is not recommended. Long-term use of low- dose aspirin is recommended in patients with established cardiovascular disease (secondary prevention); h unduly high blood pressure must be controlled before aspirin is given. If the patient is at a high risk of gastro-intestinal bleeding, a proton pump inhibitor can be added. For full guidance on the assessment and prevention of cardiovascular disease risk, see Cardiovascular disease risk assessment and prevention p. 201. Aspirin is given following coronary bypass surgery. It is also used in atrial fibrillation, for intermittent claudication, for stable angina and acute coronary syndromes, for use following placement of coronary stents and for use in stroke. Clopidogrel p. 131 is used for the prevention of atherothrombotic events in patients with a history of Cardiovascular system symptomatic ischaemic disease (e.g. ischaemic stroke). g In patients with non-ST elevation acute coronary syndromes, clopidogrel, should be given for three months in addition to long-term low-dose aspirin. In patients with ST elevation acute coronary syndromes, clopidogrel, should be given up to four weeks in addition to long-term low-dose aspirin. h Clopidogrel is also used, in combination with low-dose aspirin, for the prevention of atherothrombotic and thromboembolic events in patients with atrial fibrillation (and at least one risk factor for a vascular event), and for whom warfarin sodium p. 150 is unsuitable. Use of clopidogrel with aspirin increases the risk of bleeding. Clopidogrel monotherapy may be an alternative when aspirin is contra-indicated, for example in patients with aspirin hypersensitivity, or when aspirin is not tolerated despite the addition of a proton pump inhibitor. Dipyridamole p. 132 is used by mouth as an adjunct to oral anticoagulation for prophylaxis of thromboembolism associated with prosthetic heart valves. Modified-release preparations are licensed for secondary prevention of ischaemic stroke and transient ischaemic attacks. Prasugrel p. 228, in combination with aspirin, is licensed for the prevention of atherothrombotic events in patients with acute coronary syndrome undergoing percutaneous coronary intervention; the combination is usually given for up to 12 months. Ticagrelor p. 228, in combination with aspirin, is licensed for the prevention of atherothrombotic events in patients with acute coronary syndrome; the combination is usually given for up to 12 months. Cangrelor p. 222, in combination with aspirin, is licensed for the reduction of thrombotic cardiovascular events in patients with coronary artery disease undergoing percutaneous coronary intervention (PCI) who have not received treatment with oral clopidogrel, prasugrel or ticagrelor prior to the procedure and in whom oral therapy with these drugs is not suitable. Cangrelor is to be used under expert supervision only. Antiplatelet drugs and coronary stents Patients selected for percutaneous coronary intervention, with the placement of a coronary stent, will require dual antiplatelet therapy with aspirin and either cangrelor, clopidogrel, prasugrel, or ticagrelor [unlicensed]. Aspirin therapy should continue indefinitely. g Following percutaneous coronary intervention in patients with stable angina, clopidogrel is recommended in addition to aspirin for at least 1 month after placement of a bare-metal stent, and for at least 6 months if a drug-eluting stent is used. h Clopidogrel should not be discontinued prematurely in patients with a drug-eluting stent—there is an increased risk of stent thrombosis as a result of the eluted drug slowing the re-endothelialisation process. Patients considered to be at high-risk of developing late stent thrombosis with a drug- eluting stent may require a longer duration of treatment with clopidogrel combined with aspirin. Prasugrel or ticagrelor are alternatives to clopidogrel in certain patients undergoing percutaneous coronary intervention. Glycoprotein IIb/IIIa inhibitors Glycoprotein IIb/IIIa inhibitors prevent platelet aggregation by blocking the binding of fibrinogen to receptors on platelets. Abciximab is a monoclonal antibody which binds to glycoprotein IIb/IIIa receptors and to other related sites; it is licensed as an adjunct to heparin (unfractionated) p. 143 and aspirin for the prevention of ischaemic complications in high-risk patients undergoing percutaneous transluminal coronary intervention. Abciximab should be used once only (to avoid additional risk of thrombocytopenia). Eptifibatide p. 223 (in combination with heparin (unfractionated) and aspirin) and tirofiban p. 223 (in combination with heparin (unfractionated), aspirin, and clopidogrel) also inhibit glycoprotein IIb/IIIa Cardiovascular system receptors; they are licensed for use to prevent early myocardial infarction in patients with unstable angina or non-ST-segment-elevation myocardial infarction. Tirofiban is also licensed for use in combination with heparin (unfractionated), aspirin, and clopidogrel, for the reduction of major cardiovascular events in patients with ST-segment elevation myocardial infarction intended for primary percutaneous coronary intervention. Abciximab, eptifibatide and tirofiban should be used by specialists only. Epoprostenol p. 123 is also used to inhibit platelet aggregation during renal dialysis when heparins are unsuitable or contra-indicated. Advanced Pharmacy Services Patients taking antiplatelet drugs may be eligible for the New Medicines Service / Medicines Use Review service provided by a community pharmacist. For further information, see Advanced Pharmacy Services in Medicines optimisation p. 18.
PDF pages 151, 152
5 g, followed by 5 g if required
First-line fragment. Read the complete Indications and Dose section above.
PDF page 151