Antihemophilic Factor (recombinant), Fc Fusion Protein
Name: Antihemophilic Factor (recombinant), Fc Fusion Protein
- Antihemophilic Factor recombinant, Fc Fusion Protein drug
- Antihemophilic Factor recombinant, Fc Fusion Protein injection
- Antihemophilic Factor recombinant, Fc Fusion Protein names
Uses for Antihemophilic Factor (recombinant), Fc Fusion Protein
Hemophilia A
On-demand treatment and control of bleeding episodes in patients with hemophilia A (congenital factor VIII deficiency; classic hemophilia).1 4
Maintenance of hemostasis in patients with hemophilia A undergoing surgery (i.e., perioperative management of bleeding).1 4
Routine prophylaxis (i.e., administration at regular intervals) to reduce frequency of bleeding events.1 4 Such prophylaxis considered the current standard of care for patients with hemophilia A.17 215 218 Decreases frequency of spontaneous musculoskeletal bleeding, preserves joint function, and improves quality of life.215 224 231
Designated an orphan drug by FDA for treatment of hemophilia A.3
Half-life of antihemophilic factor (recombinant), Fc fusion protein is longer than that of conventional preparations of recombinant antihemophilic factor; may allow for less frequent dosing and possibly improve patient compliance with prophylactic regimens.1 4 5 8 10 16 17
Several antihemophilic factor 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 antihemophilic factor preparations because of their potentially superior safety profile with respect to pathogen transmission.218 246 247 Other experts (e.g., World Federation of Hemophilia) state that choice of preparation should be determined by local criteria.215 When selecting an appropriate antihemophilic factor preparation, consider characteristics of each clotting factor concentrate, individual patient variables, patient/provider preference, and emerging data.215 243 246 247
Not indicated for the treatment of von Willebrand disease.1
Antihemophilic Factor (recombinant), Fc Fusion Protein Pharmacokinetics
Absorption
Plasma Concentrations
In adults, mean recovery of factor VIII is approximately 2.26 units/dL for each 1 unit/kg of antihemophilic factor (recombinant), Fc fusion protein administered.1 Mean incremental recoveries in pediatric patients 1–5, 6–11, and 12–17 years of age are 1.92, 2.44, and 1.85 units/dL, respectively.1
Duration
Compared with conventional preparations of recombinant antihemophilic factor, exhibits increased time after dosing to 1% factor VIII activity suggesting potentially longer therapeutic duration.5
Distribution
Extent
Not known whether antihemophilic factor (recombinant), Fc fusion protein is distributed into milk.1
Elimination
Half-life
Following administration of a single 50-unit/kg dose given as a 10-minute IV injection in adults, terminal half-life was approximately 19.7 hours and time to reach 1% factor VIII activity was 5.1 days.1
Compared with adults, pediatric patients appear to have a shorter half-life; in one study, half-life was approximately 12.7, 14.9, or 16.4 hours in pediatric patients 1–5, 6–11, or 12–17 years of age, respectively.1
In pediatric patients 1–5 years of age, clearance is substantially increased compared with older pediatric patients and adults.1 256
Compared with conventional preparations of recombinant antihemophilic factor, half-life of antihemophilic factor (recombinant), Fc fusion protein is prolonged and clearance reduced.5 8
Stability
Storage
Parenteral
Powder for Injection2–8°C in original package; do not freeze or expose to direct sunlight.1 Freezing may damage prefilled diluent syringe.1
May store at room temperature (≤30°C) for a single period of up to 6 months or until expiration date on label.1 Do not place back into refrigerator after storage at room temperature.1
Reconstituted SolutionMay store at room temperature (≤30°C); protect from direct sunlight.1 Use solution within 3 hours of reconstitution.1
Preparations
Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.
Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer |
---|---|---|---|---|
Parenteral | For injection, for IV use only | number of units indicated on label (nominally 250, 500, 750, 1000, 1500, 2000, or 3000 units) | Eloctate (with prefilled diluent syringe; available with vial adapter) | Biogen |