Emicizumab
Emicizumab is a bispecific monoclonal antibody medication used for routine prophylaxis to prevent or reduce bleeding episodes in patients with hemophilia A, including those who have developed factor VIII inhibitors. It mimics the function of activated factor VIII to help restore normal blood clotting.
Emicizumab is a prophylactic treatment for hemophilia A that works by mimicking factor VIII to restore blood clotting, suitable for patients with or without factor VIII inhibitors.
This medication carries a boxed (black box) warning — the strongest type of FDA warning. Review the full prescribing information before use.
Key facts at a glance
- ATC
- B02BX06
- RxNorm
- 1989794
- Generic
- Emicizumab
- Class
- atc-b02
- Brands
- Hemlibra
- 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
- 500mg twice daily
- Maximum
- consult physician
- Frequency
- every 12 hours
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
- Usual dose
- 250mg twice daily
- Maximum
- consult physician
- Frequency
- every 12 hours
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
- Usual dose
- 400mg daily
- Maximum
- consult physician
- Frequency
- once daily
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
Overdose information
Special Populations
7 groupspregnancy
first trimesteravoid if possible
use only if benefits outweigh potential risks to fetus
regular prenatal monitoring and fetal ultrasound assessments
Use with caution and monitor for adverse effects.
pregnancy
second third trimestercontinue if already receiving
continuation may be considered if already established on therapy and benefits outweigh risks
routine prenatal care
Use with caution and monitor for adverse effects.
lactation
breastfeedingno adjustment needed
decision to continue or discontinue breastfeeding should consider benefit to infant and benefit to mother
monitor infant for any adverse effects
pediatric_age
all agesno adjustment needed
approved for use in pediatric patients of all ages including newborns; dosing based on body weight
regular monitoring for adverse reactions and efficacy
geriatric
65 years and olderno adjustment needed
no specific dose adjustment required; monitor renal function
standard clinical monitoring
renal_impairment
mild to moderateno adjustment needed
no dose adjustment required for mild to moderate renal impairment
routine clinical monitoring
hepatic_impairment
mild to moderateuse with caution
use only if benefits outweigh potential risks; limited clinical data available
monitor liver function tests and clinical status
Use with caution and monitor for adverse effects.
Statistics and clinical data
FDA approval year
Initial FDA approval date for Hemlibra
Drug class
Therapeutic classification of Emicizumab
Common uses
Primary therapeutic indications
Route of administration
Method of drug delivery
Prevention and reduction of bleeding episodes in hemophilia A, including patients with acquired factor VIII inhibitors (neutralizing antibodies). May be used in both patients with and without factor VIII inhibitors as routine prophylactic therapy.
Emicizumab is a bispecific monoclonal antibody that binds to both activated factor IX and factor X, bridging them to mimic the function of missing activated factor VIII and restore the coagulation cascade for effective hemostasis.
Administered by subcutaneous injection, typically once weekly. Requires monitoring for thrombotic events and thrombotic microangiopathy when used with bypassing agents. Not indicated for on-demand treatment of acute bleeding episodes. Patients should not discontinue without medical consultation.
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