Factor Ix
Factor IX is a recombinant coagulation factor replacement therapy used for the treatment and prevention of bleeding episodes in patients with hemophilia B. The medication works by temporarily replacing the missing Factor IX in the blood, which is essential for effective blood clotting. This is a PEGylated form of Factor IX, where the factor is conjugated to a 40-kDa polyethylene glycol molecule to extend its half-life.
A long-acting replacement therapy for hemophilia B that provides missing coagulation Factor IX to help prevent and treat bleeding.
Key facts at a glance
- ATC
- B02BD04
- RxNorm
- 4249
- Generic
- Factor Ix
- Class
- atc-b02
- Brands
- Rixubis, Kcentra, Ixinity, IDELVION, Rebinyn, Alphanine SD, Balfaxar, BeneFIX
- 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
- 40-50 IU/kg
- Maximum
- consult physician
- Frequency
- as needed for bleeding episodes
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
- Usual dose
- 40-50 IU/kg
- Maximum
- consult physician
- Frequency
- as needed for bleeding episodes or prophylaxis 2-3 times weekly
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
- Usual dose
- 30-40 IU/kg
- Maximum
- consult physician
- Frequency
- as needed for bleeding episodes
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
Overdose information
Special Populations
8 groupspregnancy
first trimesteruse lowest effective dose
use only if clearly needed for hemophilia B treatment; considerConsultation with hematologist and obstetrician
regular fetal monitoring and maternal factor IX levels
Use with caution and monitor for adverse effects.
pregnancy
third trimesteruse lowest effective dose
use during delivery only if absolutely necessary; avoid if possible
close monitoring during labor and delivery; fetal monitoring
Use with caution and monitor for adverse effects.
lactation
breastfeedingno specific adjustment
limited data on excretion in breast milk; use with caution
monitor infant for any unusual bleeding
pediatric_age
neonates infantsweight-based dosing required
dosing based on body weight and individual pharmacokinetics; prophylaxis commonly used
regular factor IX levels monitoring and inhibitor screening
pediatric_age
children adolescentsweight-based dosing with adjustments as needed
standard prophylaxis regimens; individualize dosing
regular monitoring of factor IX levels, inhibitor testing, joint assessments
geriatric
elderlyindividualize based on clinical response
use with caution due to increased cardiovascular risk and comorbidities
monitor for thrombotic events, cardiovascular status, and renal function
Use with caution and monitor for adverse effects.
renal_impairment
mild moderateno specific adjustment typically required
use standard dosing; monitor for enhanced response
monitor factor IX levels and renal function
hepatic_impairment
mild moderatemay require dose adjustment based on clinical response
use with caution; impaired hemostasis may increase bleeding risk
monitor liver function tests and factor IX levels
Use with caution and monitor for adverse effects.
Statistics and clinical data
Commonly prescribed since
First recombinant Factor IX (BeneFIX) approved in 1997
Drug class
ATC code B02BD04 - Recombinant coagulation factor IX products
Common uses
Treatment and prevention of bleeding episodes in patients with hemophilia B
Treatment and prophylaxis of bleeding in patients with hemophilia B (congenital Factor IX deficiency). Used for routine prophylaxis to prevent bleeding episodes, on-demand treatment of bleeding, and surgical bleeding management.
Provides exogenous Factor IX that temporarily replaces the deficient endogenous Factor IX in hemophilia B patients. The PEGylation (conjugation to polyethylene glycol) extends the circulating half-life of the factor, allowing for less frequent dosing while maintaining effective Factor IX levels for hemostasis.
Administered via intravenous injection. Patients should be monitored for signs of allergic reactions, thromboembolic events, and development of inhibitors (neutralizing antibodies). Factor IX activity levels should be monitored periodically to ensure adequate treatment response. Not for use in patients with known hypersensitivity to the product components.
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