PRAXBIND 50 mg/ml
Idarucizumab
What it does
Idarucizumab is a medication used to reverse the effects of certain blood thinners, specifically dabigatran, in case of emergency situations.
Commonly used for: reversal of dabigatran effects, emergency bleeding situations
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Sourcing - Kenya onlyRegistration & product details
Source: South African Health Products Regulatory Authority · fetched 2026-04-15 21:18:06 · updated 2026-10-25 04:00:56
About this medicine
Idarucizumab is a medication used to reverse the effects of certain blood thinners, specifically dabigatran, in case of emergency situations.
What it treats
- reversal of dabigatran effects
- emergency bleeding situations
How it works
It binds to dabigatran, neutralizing its blood-thinning effects quickly.
Who it's for
It is for patients who are taking dabigatran and need urgent reversal of its effects, for example, before surgery or in case of severe bleeding.
AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.
Clinical monograph: Idarucizumab
BNF-referencedIdarucizumab is a humanized monoclonal antibody fragment specifically designed to reverse the anticoagulant effects of dabigatran, a direct thrombin inhibitor. It is primarily indicated in situations requiring rapid reversal of dabigatran due to life-threatening or uncontrolled bleeding, or prior to emergency surgical procedures.
Indications
- Rapid reversal of dabigatran for emergency procedures
- Life-threatening or uncontrolled bleeding
Dosage
Children: null
Adults: 5 g administered by intravenous injection or infusion, followed by an additional 5 g if necessary.
Mechanism of action
Idarucizumab binds specifically to dabigatran and its active metabolites, neutralizing their anticoagulant effect. This binding occurs through high-affinity interactions that prevent dabigatran from inhibiting thrombin, thereby restoring normal hemostasis.
Pharmacodynamics
The pharmacodynamic effect of idarucizumab is the rapid reversal of the anticoagulant effects of dabigatran. Following administration, it leads to a significant increase in thrombin generation and platelet aggregation, which are crucial for normal blood clotting. The onset of action is immediate, making it suitable for urgent clinical scenarios.
Pharmacokinetics
Idarucizumab is administered via intravenous injection or infusion. It has a distribution volume consistent with that of a large protein, and its elimination is primarily through renal pathways. The half-life of idarucizumab is approximately 20-30 hours, allowing for sustained action after a single dose. Following administration, idarucizumab is quickly cleared from the bloodstream as it binds to dabigatran, effectively reducing its plasma concentration.
Adverse effects
- thromboembolism
- hypersensitivity reactions
- headache
- nausea
- vomiting
- hypotension
Interactions
- dabigatran
- anticoagulants
- antiplatelet agents
Precautions
- monitor for thrombosis after reversal
- consider re-starting anticoagulant therapy as soon as medically appropriate
- use with caution in patients with severe renal impairment
Pregnancy
Manufacturer advises use only if potential benefit outweighs risk; no information available.
Breast-feeding
Manufacturer advises caution; consult healthcare provider.
Storage
Store in a refrigerator at 2–8°C.
Formulations
- 500 mg powder for solution for infusion vials
AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.
This drug in other countries
The same active ingredient registered across other registries we cover - including different brands.