Idarucizumab
Idarucizumab is a targeted reversal agent specifically designed to neutralize the anticoagulant effects of dabigatran. It is a monoclonal antibody fragment that binds to dabigatran with high affinity, rapidly reversing its blood-thinning effects. This medication is used in emergency situations when patients taking dabigatran experience life-threatening bleeding or require urgent surgical procedures.
Idarucizumab is an emergency antidote that rapidly reverses dabigatran anticoagulation in patients with severe bleeding or those needing urgent surgery.
Key facts at a glance
- ATC
- V03AB37
- RxNorm
- 1716191
- Generic
- Idarucizumab
- Class
- atc-v03
- Brands
- Praxbind
- Availability
- rx
- Lactation
- unknown
- Routes
- —
- Forms
- injection
- Regions
- US, EU, CN, JP
- Monitoring
- —
This page is for informational purposes only.
Do not use this information to diagnose yourself or to replace a physician's advice. Always consult a qualified healthcare provider before starting, stopping, or changing any medication. If you believe you are experiencing a medical emergency, call your local emergency number immediately.
Dosage and administration
- Usual dose
- 5g (5000mg) as single infusion
- Maximum
- consult physician
- Frequency
- single dose
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
- Usual dose
- 5g (5000mg) as single infusion (or weight-based 30mg/kg max 5g)
- Maximum
- consult physician
- Frequency
- single dose
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
- Usual dose
- 5g (5000mg) as single infusion
- Maximum
- consult physician
- Frequency
- single dose
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
Overdose information
Special Populations
8 groupspregnancy
general pregnancyuse only if benefits outweigh risks
use only in emergency situations when benefits outweigh potential risks to fetus
fetal monitoring recommended
Use with caution and monitor for adverse effects.
pregnancy
first trimesteravoid if possible
avoid use during first trimester unless emergency situation with life-threatening bleeding
regular fetal monitoring
Use with caution and monitor for adverse effects.
lactation
breastfeedingno adjustment needed
compatible with breastfeeding; large molecular size limits milk transfer
no specific monitoring required
geriatric
elderly 65no dose adjustment required
can be used in elderly patients; no dose modification needed for emergency reversal
standard monitoring of coagulation parameters
pediatric_age
children under 18not established
not recommended for use in pediatric patients due to limited safety and efficacy data
not applicable
renal_impairment
severe renal impairmentuse with caution
use with caution in severe renal impairment; drug is renally eliminated but may be used in emergencies
monitor renal function and coagulation parameters
Use with caution and monitor for adverse effects.
renal_impairment
mild moderate renal impairmentno dose adjustment needed for emergency use
no dose adjustment required; can be used for emergency reversal
standard coagulation monitoring
hepatic_impairment
hepatic impairmentno adjustment needed
no dose adjustment required; not significantly metabolized by hepatic pathways
standard monitoring
Statistics and clinical data
FDA approval year
FDA approval for emergency reversal of dabigatran
Drug class
Specific reversal agent for dabigatran
Mechanism of action
Binds to dabigatran with 350-fold higher affinity than thrombin
Primary indication
Reversal agent for anticoagulation
Used to reverse the anticoagulant effects of dabigatran in adult patients when rapid reversal is required, including life-threatening or uncontrolled bleeding and emergency surgeries or procedures where normal blood clotting is essential.
Idarucizumab is a humanized monoclonal antibody fragment (Fab) that binds to dabigatran and its acylglucuronide metabolites with much higher affinity than dabigatran's binding affinity to thrombin, effectively neutralizing its anticoagulant activity.
Administered intravenously by healthcare professionals. Reversal typically occurs within minutes. Thromboembolic risk may increase after use if anticoagulation is not resumed when appropriate. Safety in pregnant women and children has not been established. May interfere with coagulation assays.
Contraindications
Conditions and patient states where this medication should be avoided or used with caution.
Do not use (1)
Known allergy to this medication or its components
Use caution (1)
Consult healthcare provider for benefits vs risks assessment
Official drug label
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This information is for educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment.
This content is for general informational and educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment. Always seek the guidance of a qualified healthcare provider with any questions you have about a medical condition, and never disregard professional medical advice or delay seeking it because of something you read here.
If you think you may have a medical emergency, call your local emergency number or go to the nearest emergency department immediately.
Medically reviewed by WellAlly Editorial Team Last reviewed July 26, 2026. · Read our editorial policy