Factor IX (Recombinant), albumin fusion protein

Class: Hemostatics
VA Class: BL500
Chemical Name: Human coagulation factor IX (EC 3.4.21.22, Christmas factor, plasma thromboplastin component) 148-threonine variant fusion protein with prolyl(human coagulation factor IX 148-threonine variant-(137-153)-peptide) fusion protein with human serum albumin, produced in CHO cells (alfa glycoform)
Molecular Formula: C₅₀₇₇H₇₈₄₆N₁₃₆₇O₁₅₈₈PS₆₇
CAS Number: 1357448-54-4
Brands: Idelvion

Medically reviewed by Drugs.com on Jan 25, 2022. Written by ASHP.

Introduction

Biosynthetic (recombinant DNA origin) preparation of blood coagulation factor IX (rIX-FP) genetically fused to recombinant albumin via a short, cleavable peptide derived from the activation peptide of native factor IX.

Uses for Factor IX (Recombinant), albumin fusion protein

Hemophilia B

On-demand control and prevention of bleeding episodes in patients with hemophilia B (congenital factor IX deficiency; Christmas Disease).

Maintenance of hemostasis in patients with hemophilia B undergoing surgery (i.e., perioperative management).

Designated an orphan drug by FDA for treatment of patients with hemophilia B.

Routine prophylaxis (i.e., administration at regular intervals) to prevent or reduce frequency of hemorrhagic events. Such prophylactic therapy considered the current standard of care for patients with hemophilia B. Decreases frequency of spontaneous musculoskeletal hemorrhage, preserves joint function, and improves quality of life.

Circulating half-life of factor IX (recombinant), albumin fusion protein longer than that of unmodified recombinant or plasma-derived factor IX preparations; may allow for less frequent dosing and improved patient compliance with prophylactic regimens.

Several factor IX concentrates are currently available in the US, including a variety of recombinant and plasma-derived preparations; the Medical and Scientific Advisory Council (MASAC) of the National Hemophilia Foundation recommends preferential use of recombinant factor IX preparations because of their potentially superior safety profile with respect to pathogen transmission. Other experts (e.g., World Federation of Hemophilia) state that choice of preparation should be determined by local criteria. When selecting an appropriate factor IX product, consider characteristics of each clotting factor concentrate, individual patient variables, patient/provider preference, and emerging data.

Manufacturer states that factor IX (recombinant), Fc fusion protein not indicated for induction of immune tolerance in patients with hemophilia B.

Factor IX (Recombinant), albumin fusion protein Dosage and Administration

General

• Individualize dosage and duration of therapy based on severity of factor IX deficiency, location and extent of bleeding, and patient’s clinical condition, age, and recovery of factor IX.

• Monitor factor IX activity (with one-stage clotting assay) to individualize dosage and assess response to therapy. Ensure that adequate levels are atta...