Company: Boehringer Ingelheim Ltd.
Legal category: Prescription. Hospital only. Sport permitted.
Active ingredient: Idarucizumab 2.5g/50ml.
Description: Solution for injection/infusion.
Presentation: 2 x 50ml vials, €3000.00.
Indications: Reversal of anticoagulant effects of dabigatran in emergency surgery/urgent procedures or in life-threatening or uncontrolled bleeding.
Pharmacology: Idarucizumab is a humanised monoclonal antibody fragment (Fab) that binds to dabigatran with very high affinity, approximately 300-fold more potent than the binding affinity of dabigatran for thrombin. Idarucizumab potently and specifically binds to dabigatran and its metabolites and neutralises their anticoagulant effect.
Dosage: Adult: 5g (2 x 2.5g/50ml) administered intravenously as two consecutive infusions over 5-10 minutes each or as bolus injection. A second 5g dose may be considered in patients with prolonged clotting times and (a) recurrence of clinically relevant bleeding or (b) if potential re-bleeding would be life-threatening or (c) patients require a second emergency surgery/urgent procedure. Resume anticoagulant therapy as soon as medically appropriate (i.e. patient is stable and has adequate haemostasis); dabigatran can be re-initiated after 24 hours, other antithrombotics (e.g. low-molecular weight heparin) can be started at any time. Elderly: As per adults. Children: Under 18 years, not recommended.
Contraindications: None.
Special precautions: Does not reverse effects of other anticoagulants. Hypersensitivity to idarucizumab or to any of the excipients (assess risk/benefit). Discontinue immediately if anaphylactic reaction or other serious allergic reaction occurs. Recurrence of plasma concentrations of unbound dabigatran and concomitant prolongation of clotting tests may occur up to 24 hours after administration in some patients. Causes transient proteinuria. Pregnancy (assess risk/benefit). Contains sorbitol, sodium.
Drug interactions: None known.
Adverse drug reactions: None known.
Full prescribing information and references available from Boehringer Ingelheim Ltd. Telephone: (01) 295 9620. E-mail: medinfo.bra@boehringer-ingelheim.com