Eftrenonacog alfa is a long-acting recombinant human coagulation Factor IX Fc-fusion protein used in the treatment and prevention of bleeding in patients with Hemophilia B (congenital Factor IX deficiency). It is produced using recombinant DNA technology in a human embryonic kidney (HEK) cell line.
Eftrenonacog alfa consists of human coagulation Factor IX covalently linked to the Fc domain of human immunoglobulin G1 (IgG1). The protein contains 867 amino acids and has an approximate molecular weight of 98 kDa.
ALPROLIX is supplied as a lyophilized white to off-white powder or cake with a separate clear, colorless diluent for reconstitution. It is supplied in single-use vials with nominal strengths of 250 IU, 500 IU, 1000 IU, 2000 IU, 3000 IU and 4000 IU in the current U.S. labeling.
The formulation contains eftrenonacog alfa along with excipients including sucrose, histidine, mannitol and polysorbate 20. The supplied diluent contains sodium chloride and water for injection.
Factor IX potency is determined using a one-stage clotting assay, with product-specific analytical controls. The reported specific activity is approximately 55–84 IU/mg protein.
Eftrenonacog alfa is used for:
Treatment should be administered under the supervision of a healthcare professional experienced in hemophilia management.
Unopened ALPROLIX should generally be stored at 2°C–8°C, protected from light and should not be frozen. Depending on the applicable product labeling, it may be stored at room temperature up to 30°C for a defined period. Follow the applicable approved product label for the market concerned.
| Parameter | Specification |
|---|---|
| Appearance | White to off-white lyophilized powder or cake |
| Identification | Conforms to product-specific identity testing for eftrenonacog alfa |
| pH (1% Solution) | 6.5 – 7.5 after reconstitution |
| Individual Impurity | Product-specific impurity profile; complies with approved specifications |
| Water Content | Product-specific lyophilized-product specification |
| Solubility | Reconstitutes with supplied diluent to a clear to slightly opalescent, colorless solution |