NovoSeven^Ò is recombinant human coagulation Factor VIIa (rFVIIa), intended for promoting hemostasis by activating the extrinsic pathway of the coagulation cascade.¹ NovoSeven is a vitamin K-dependent glycoprotein consisting of 406 amino acid residues (MW 50 K Dalton). NovoSeven is structurally similar to human plasma-derived Factor VIIa.

The gene for human Factor VII is cloned and expressed in baby hamster kidney cells (BHK cells). Recombinant FVII is secreted into the culture media (containing newborn calf serum) in its single-chain form and then proteolytically converted by autocatalysis to the active two-chain form, rFVIIa, during a chromatographic purification process. The purification process has been demonstrated to remove exogenous viruses (MuLV, SV40, Pox virus, Reovirus, BEV, IBR virus). No human serum or other proteins are used in the production or formulation of NovoSeven.

NovoSeven is supplied as a sterile, white lyophilized powder of rFVIIa in single-use vials.

Each vial of lyophilized drug contains the following:

* per mg of rFVIIa: 0.44 mEq sodium, 0.06 mEq calcium

After reconstitution with the appropriate volume of Sterile Water for Injection, USP (not supplied), each vial contains approximately 0.6 mg/mL NovoSeven (corresponding to 600 mg/mL). The reconstituted vials have a pH of approximately 5.5 in sodium chloride (3 mg/mL), calcium chloride dihydrate (1.5 mg/mL), glycylglycine (1.3 mg/mL), polysorbate 80 (0.1 mg/mL), and mannitol (30 mg/mL). The reconstituted product is a clear colorless solution which contains no preservatives. NovoSeven contains trace amounts of proteins derived from the manufacturing and purification processes such as mouse IgG (maximum of 1.2 ng/mg), bovine IgG (maximum of 30 ng/mg), and protein from BHK-cells and media (maximum of 19 ng/mg).

REFERENCES

1. Roberts, H.R.: Thoughts on the mechanism of action of FVIIa, 2 ^nd Symposium on New Aspects of Hemophilia Treatment, Copenhagen, Denmark, 1991, pgs. 153-156.

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