Factor VIII polypeptide formulations

摘要

The present invention provides a formulation of a Factor VIII polypeptide, e.g., FVIII-Fc, and methods of using the same. The FVIII polypeptide can be a recombinant FVIII protein, a short-acting FVIII protein, or a long-acting FVIII protein. The pharmaceutical formulation comprising a FVIII polypeptide can be used for individual prophylaxis, weekly prophylaxis, episodic (on-demand) treatment, or perioperative management of hemophilia.

主权项

1. A pharmaceutical composition comprising:
a) about 50 IU/ml to about 2500 IU/ml of a long-acting FVIII polypeptide; b) about 10 mg/ml to about 25 mg/ml of a stabilizing agents selected from the group consisting of sucrose, trehalose, raffinose, arginine, and any mixture thereof; c) about 8.8 mg/ml to about 14.6 mg/ml sodium chloride (NaCl); d) about 0.75 mg/ml to about 2.25 mg/ml L-histidine; e) about 0.75 mg/ml to about 1.5 mg/ml calcium chloride dihydrate; and f) about 0.08 mg/ml to about 0.25 mg/ml polysorbate 20 or polysorbate 80.