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Dabigatran reversal agent (specific antidote) Pregnancy: No available data on use in pregnant women; animal reproductive and developmental studies have not been conducted. Should be given to a pregnant woman only if clearly needed (§8.1).

Idarucizumab (Praxbind)

Brand names: Praxbind

Idarucizumab (Praxbind) is a humanised monoclonal antibody fragment used as a specific reversal agent for the direct oral anticoagulant dabigatran in life-threatening or uncontrolled bleeding or before urgent surgery or procedures.

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
Route: Intravenous use only — as two consecutive infusions, or as a bolus injection by injecting both vials consecutively one after another via syringe
Frequency: Single 5 g dose
US label §2.1/§2.3 (specific reversal agent for dabigatran). There is limited data to support administration of an additional 5 g dose; §5.2 notes that 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. A pre-existing intravenous line may be used but must be flushed with sterile 0.9% sodium chloride injection prior to infusion; no other infusion should be administered in parallel via the same access, and idarucizumab must not be mixed with other medicinal products. Once removed from the vial, administration should begin promptly (solution may be stored at room temperature but must be used within 6 hours). Restarting antithrombotic therapy: resumption of anticoagulant therapy should be considered as soon as medically appropriate; dabigatran can be restarted 24 hours after administration (§2.4). Paediatric: safety and effectiveness have not been established in paediatric patients (§8.4). NO UK SPC (eMC) POSOLOGY WAS AVAILABLE IN THIS BUNDLE — dose taken from US labelling; clinician to verify against UK product information.

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 (US label §4 states "None")

Side effects

  • Headache (most frequent reaction in healthy volunteers, ≥5%)
  • Constipation (patients, ≥5%)
  • Nausea (patients, ≥5%)
  • Thromboembolic events — reversing dabigatran exposes patients to the thrombotic risk of their underlying disease
  • Hypersensitivity reactions (discontinue administration and evaluate); risk of serious adverse reactions in patients with hereditary fructose intolerance due to the sorbitol excipient

Clinical monograph

How it works

It binds dabigatran and its active metabolites with very high affinity, neutralising their anticoagulant effect and rapidly reversing dabigatran-mediated thrombin inhibition.

Prescribing in practice

  • It reverses dabigatran only and has no effect on other anticoagulants, so it must not be used for bleeding due to factor Xa inhibitors, warfarin, or heparins.
  • Reversing anticoagulation removes thromboprophylaxis and restores the patient's underlying thrombotic risk, so anticoagulation should be reconsidered as soon as clinically appropriate.
  • Given intravenously; recurrence of dabigatran effect can occasionally occur and a further dose may be considered. Refer to the SPC.

Monitoring

Monitor clinical bleeding and coagulation parameters where available, and watch for re-elevation of dabigatran activity and for thrombotic events after reversal.

Counselling the patient

  • This medicine rapidly reverses the blood-thinning effect of dabigatran in an emergency.
  • Because your clot risk returns, the team will discuss restarting anticoagulation when it is safe.
  • Tell future treating clinicians that you have received a dabigatran reversal agent.

Evidence & guidelines

Idarucizumab is licensed for dabigatran reversal on the basis of the RE-VERSE AD study, which demonstrated rapid and near-complete reversal of dabigatran anticoagulant activity.

Reference: NICE NG196; RE-VERSE AD trial; Praxbind SPC; 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).

Related

Curated clinical cross-links plus same-class fallbacks.

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📚 MRCEM Revision

Featured in these MRCEM clinical pathways

Idarucizumab (Praxbind) is a core drug in the following exam-focused workups on our sister siteReviseMRCEM.

MRCEM Primary / Intermediate / OSCE candidates: each pathway includes exam-style questions, RCEM/NICE citations, and FAQ summaries.