Xyntha Description

White to off-white cake. Upon reconstitution, XYNTHA appears as a clear to slightly opalescent, colorless solution.
XYNTHA 250 IU powder and solvent for solution for injection: Antihemophilic Factor (Recombinant) freeze-dried is supplied in kits that include single-use vials that contain nominally 250 IU moroctocog alfa per vial.
XYNTHA 500 IU powder and solvent for solution for injection: Antihemophilic Factor (Recombinant) freeze-dried is supplied in kits that include single-use vials that contain nominally 500 IU moroctocog alfa per vial.
XYNTHA 1,000 IU powder and solvent for solution for injection: Antihemophilic Factor (Recombinant) freeze-dried is supplied in kits that include single-use vials that contain nominally 1,000 IU moroctocog alfa per vial.
Actual factor VIII activity in IU is stated on the label of each XYNTHA Antihemophilic Factor (Recombinant) vial.
In addition, each XYNTHA Antihemophilic Factor (Recombinant) kit contains one pre-filled diluent syringe containing 4 mL 0.9% Sodium Chloride with plunger rod for assembly, one vial adapter, one sterile infusion set, two alcohol swabs, one bandage, one gauze, and package insert.
Excipients/Inactive Ingredients: Powder: Polysorbate 80, Sucrose, L-Histidine, Calcium Chloride Dihydrate, Sodium Chloride (after reconstitution with diluent).
Solvent: Sodium chloride, Water for injections.