Factor VIII
Factor VIII is a recombinant or plasma-derived clotting factor replacement therapy used to treat and prevent bleeding episodes in patients with Hemophilia A, a genetic disorder characterized by deficiency of this essential blood clotting factor. It is administered via intravenous injection and provides the missing factor to restore normal blood clotting cascade function.
Factor VIII replacement therapy treats Hemophilia A by supplying the missing clotting factor needed for proper blood coagulation.
Key facts at a glance
- ATC
- B02BD02
- RxNorm
- 4257
- Generic
- Factor Viii
- Class
- atc-b02
- Brands
- Alphanate, Obizur, Novoeight, Koate, Monoclate, Nuwiq, Adynovate, Kovaltry, Afstyla, Helixate, Esperoct, Hemofil, Humate-P, Advate, Recombinate
- Availability
- rx
- Lactation
- unknown
- Routes
- —
- Forms
- injection, prefilled syringe
- 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
10 groupspregnancy
first trimesterindividualize based on clinical need
use only if clearly needed, benefits must outweigh potential risks to fetus
regular fetal monitoring and maternal coagulation parameters
Use with caution and monitor for adverse effects.
pregnancy
second trimesterindividualize based on clinical need
use for treatment or prevention of acute bleeding episodes
monitor factor VIII levels and fetal development
Use with caution and monitor for adverse effects.
pregnancy
third trimestermay require increased dosing during labor
adequate factor VIII levels essential for safe delivery
close monitoring of factor VIII levels and fetal status
Use with caution and monitor for adverse effects.
lactation
n/ano specific adjustment needed
use only if needed for bleeding events, generally considered compatible with breastfeeding
monitor infant for unusual bleeding
Use with caution and monitor for adverse effects.
pediatric_age
neonatesweight-based dosing typically 25-50 IU/kg
use for prevention or treatment of bleeding in neonates with hemophilia A
monitor factor VIII levels, inhibitors, and for signs of bleeding
Use with caution and monitor for adverse effects.
pediatric_age
children 1 month to 5 yearsweight-based dosing typically 25-40 IU/kg for prophylaxis
standard use for prophylaxis and treatment of bleeding episodes
regular monitoring of factor VIII levels and inhibitor development
pediatric_age
children 6 to 12 yearsstandard adult dosing may apply
used for prophylaxis and on-demand treatment
monitor for inhibitor development and joint health
geriatric
n/ano specific adjustment needed but consider comorbidities
use standard dosing for hemophilia A patients
monitor cardiovascular status and renal function
Use with caution and monitor for adverse effects.
renal_impairment
mild to moderateno dose adjustment typically required
standard dosing for hemophilia A treatment
monitor renal function and bleeding status
hepatic_impairment
mild to moderatemay require adjustment based on clinical response
use with caution as liver produces clotting factors
monitor liver function tests and coagulation parameters
Use with caution and monitor for adverse effects.
Statistics and clinical data
Commonly prescribed since
General prescribing information for Factor VIII products
Drug class
Classification of Factor VIII concentrates
Common uses
Primary therapeutic indications
Mechanism of action
Pharmacological mechanism of action
Factor VIII is primarily used for the treatment and prevention of bleeding in patients with Hemophilia A (congenital Factor VIII deficiency). It is indicated for on-demand treatment of acute bleeding episodes, routine prophylaxis to prevent bleeding, and perioperative management in patients undergoing surgery or dental procedures.
Factor VIII is a crucial component of the intrinsic pathway of the blood coagulation cascade. In the presence of Factor IXa and calcium ions, Factor VIII acts as a cofactor that dramatically increases the activation rate of Factor X. This leads to the conversion of prothrombin to thrombin, which ultimately results in fibrin clot formation to stop bleeding.
Factor VIII products may be derived from human plasma or produced recombinantly. Patients should be monitored for the development of Factor VIII inhibitors (antibodies) which can reduce treatment effectiveness. Viral inactivation processes are used for plasma-derived products. Storage requirements vary by product formulation, and reconstitution must follow manufacturer instructions carefully before intravenous administration.
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 August 20, 2026. · Read our editorial policy