Overview
Alprolix is a recombinant coagulation Factor IX concentrate used intravenously to treat and prevent bleeding in individuals with hemophilia B, a genetic clotting disorder. It can be used to control bleeding episodes, manage bleeding during surgery, and for routine prophylaxis to reduce bleeding frequency.
What is it used for?
Alprolix is indicated for use in adults and children with hemophilia B (congenital Factor IX deficiency) for:
- On-demand treatment and control of bleeding episodes.
- Perioperative management of bleeding (during surgery).
- Routine prophylaxis to reduce the frequency of bleeding episodes.
Limitation: It is not indicated for inducing immune tolerance in patients with hemophilia B.
Active ingredients
Coagulation Factor IX (Recombinant), Fc Fusion Protein
How it works
Alprolix provides a recombinant form of coagulation Factor IX that helps replace the deficient or dysfunctional Factor IX in the blood of patients with hemophilia B. This replacement supports the blood clotting process to control and prevent bleeding.
Dosage and administration
General Administration
Alprolix is provided as a lyophilized powder that must be reconstituted with the provided diluent and administered intravenously. Use aseptic technique during preparation and inspect the solution for particles or discoloration before use. Administer by intravenous bolus infusion no faster than 10 mL per minute.
On-demand Treatment of Bleeding
The dose depends on the severity of bleeding:
| Type of Bleeding | Target Factor IX Level (IU/dL or % of normal) | Dosing Interval |
|---|---|---|
| Minor and moderate (e.g., uncomplicated joint or superficial muscle bleeding) | 30–60 | Repeat every 48 hours as needed |
| Major bleeding (e.g., deep muscle with neurovascular injury, CNS bleeding) | 80–100 | Repeat dose after 6–10 hours, then every 24 hours for 3 days, then every 48 hours until healing |
Perioperative Management
| Type of Surgery | Target Factor IX Level (IU/dL or % of normal) | Dosing Interval |
|---|---|---|
| Minor surgery (including dental extraction) | 50–80 | Single infusion may suffice; repeat as needed every 24–48 hours until healed |
| Major surgery | 60–100 initially | Repeat dose after 6–10 hours, then every 24 hours for 3 days, then every 48 hours until bleeding stops and healing achieved |
Routine Prophylaxis
- Adults and adolescents ≥12 years: 50 IU/kg once weekly or 100 IU/kg once every 10 days.
- Children <12 years: start at 60 IU/kg once weekly; younger children (<6 years) may need higher or more frequent doses.
Dosing Considerations
One IU/kg of Alprolix raises circulating Factor IX by about 1% in adults and children ≥6 years and by 0.6% in children under 6 years. Individual pharmacokinetics and clinical response should guide dosing. In vivo recovery testing before major surgery is recommended.
Contraindications
Alprolix is contraindicated in patients with known hypersensitivity, including anaphylaxis, to Alprolix or any of its excipients such as sucrose, mannitol, sodium chloride, L-histidine, or polysorbate 20.
Warnings and precautions
- Hypersensitivity reactions: Serious allergic reactions including anaphylaxis may occur. Stop treatment and provide emergency care if symptoms like rash, chest tightness, angioedema, wheezing, or hypotension occur.
- Inhibitor development: Neutralizing antibodies against Factor IX can form, reducing effectiveness. Monitor by clinical response and assay if recovery is inadequate.
- Thromboembolism risk: Factor IX product use is associated with thromboembolic events, especially with continuous infusion. Alprolix should be administered as a bolus infusion.
- Nephrotic syndrome: Reported rarely after immune tolerance induction with Factor IX products in patients with inhibitors and allergic history.
- Laboratory monitoring: Factor IX activity measurement may vary depending on assay reagent; kaolin-based aPTT reagents can underestimate levels. Use validated one-stage clotting assays.
Side effects
- Hypersensitivity and allergic reactions including rash, angioedema, nausea, vomiting, restlessness, wheezing, and anaphylaxis.
- Development of Factor IX inhibitors which may reduce treatment efficacy.
- Potential thromboembolic complications, although rare.
Drug interactions
No direct drug interactions are detailed in the label. However, co-administration with other intravenous medications in the same tubing or container is not recommended.
Storage
Store Alprolix as a lyophilized powder in single-dose vials at room temperature prior to reconstitution. After reconstitution, use the solution promptly, preferably immediately, and not later than 3 hours. Protect from direct sunlight. Do not refrigerate after reconstitution.
Manufacturer(s)
Medical references
- U.S. National Library of Medicine – DailyMed
- Official prescribing information
- Other authoritative medical references, where applicable
References are used to support the medical information presented on this page.
Medical information disclaimer
The information on WikiDrug is provided for educational and informational purposes only. It is not intended to replace professional medical advice, diagnosis, or treatment. Always consult a qualified healthcare professional before making decisions about medication use.
Last updated November 3, 2026