Anticoagulant Reversal — Dabigatran Pregnancy: There are no available data in pregnant women to inform a drug-associated risk of major birth defects or miscarriage, and animal reproductive and developmental studies have not been conducted; it is not known whether idarucizumab can cause foetal harm or affect reproductive capacity. Give to a pregnant woman only if clearly needed (US labelling §8.1).

Idarucizumab

Brand names: Praxbind

Idarucizumab is a humanised monoclonal antibody fragment given intravenously as a specific reversal agent for the direct thrombin inhibitor dabigatran, used in life-threatening or uncontrolled bleeding or before urgent surgery.

Auto-extracted from the source labelling — not yet independently clinician-verified. These values were distilled from the UK SPC (or the US label where noted) but have not had a clinician sign-off. Confirm against the current SmPC before prescribing.

Adult dose

Dose: 5 g, provided as two separate vials each containing 2.5 g/50 mL idarucizumab

Route: Intravenous use only — give the 5 g dose (2 vials, each 2.5 g) either as two consecutive infusions, or as a bolus injection by injecting both vials consecutively one after another via syringe. Do not mix with other medicinal products. A pre-existing intravenous line may be used, but must be flushed with sterile 0.9% sodium chloride injection before infusion, and no other infusion should be administered in parallel via the same intravenous access.

Frequency: Single 5 g dose

Max: Not stated. There is limited data to support administration of an additional 5 g of idarucizumab.

SOURCE: no UK SPC was fetched in this bundle (providers.emc is null) — this draft is distilled from the US PRAXBIND prescribing information and must be verified against the UK SPC. PREPARATION: ensure aseptic handling; inspect visually for particulate matter and discoloration before administration; once the solution has been removed from the vial, administration should begin promptly, and solution in vials may be stored at room temperature 25°C but must be used within 6 hours. RE-DOSING: in a limited number of patients, coagulation parameters (for example activated partial thromboplastin time) were elevated between 12 and 24 hours after administration of 5 g idarucizumab — in patients with elevated coagulation parameters and reappearance of clinically relevant bleeding, or who require a second emergency surgery/urgent procedure, an additional 5 g dose may be considered. RESTARTING ANTITHROMBOTIC THERAPY: reversing dabigatran exposes patients to the thrombotic risk of their underlying disease, so resumption of anticoagulant therapy should be considered as soon as medically appropriate; dabigatran (Pradaxa) treatment can be initiated 24 hours after administration of idarucizumab. Idarucizumab is a specific reversal agent for dabigatran with no impact on the effect of other anticoagulant or antithrombotic therapies, and can be used in conjunction with standard supportive measures as medically appropriate. EXCIPIENT: contains sorbitol — risk of serious adverse reactions in patients with hereditary fructose intolerance. PAEDIATRIC: safety and effectiveness have not been established in paediatric patients — no paediatric dose exists; verify against a children's formulary and the local protocol.

Dose auto-extracted from US FDA prescribing information (openFDA / DailyMed) — cross-check; US labelling may differ from UK — not yet clinician-verified. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

None stated — the US label section 4 Contraindications reads 'None'

Side effects

Headache — the most frequently reported adverse reaction in 5% or more of healthy volunteers
Constipation and nausea — the most frequently reported adverse reactions in 5% or more of treated patients
Thromboembolic events — reversing dabigatran exposes patients to the thrombotic risk of their underlying disease
Hypersensitivity reactions — discontinue administration and evaluate
Serious adverse reactions in patients with hereditary fructose intolerance due to the sorbitol excipient

Clinical monograph

How it works

It binds dabigatran and its acylglucuronide metabolites with very high affinity, neutralising their anticoagulant effect almost immediately and far more avidly than dabigatran binds thrombin.

Prescribing in practice

It reverses only dabigatran and confers no benefit against other anticoagulants, so confirm the patient is on dabigatran before use.
Reversal removes anticoagulation and re-exposes the patient to their underlying thrombotic risk, so resumption of antithrombotic therapy should be considered once clinically appropriate.
Re-elevation of clotting parameters can occur after the initial dose, and a hereditary fructose intolerance caution applies because of the sorbitol excipient.

Monitoring

Monitor clinical bleeding and, where available, dabigatran-sensitive coagulation assays to confirm reversal and detect any rebound.

Counselling the patient

Explain to the team that this is an emergency reversal agent specific to dabigatran.
Discuss when and how anticoagulation will be restarted to manage the underlying thrombotic risk.
Report any recurrence of bleeding after treatment.

Evidence & guidelines

The RE-VERSE AD study supported rapid reversal of dabigatran anticoagulation with idarucizumab.

Reference: Pollack et al. RE-VERSE AD (NEJM 2017); SPC Praxbind; NICE guidance; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Curated clinical cross-links plus same-class fallbacks.

Calculators

Pathways