Effect of X-ray radiation exposure on lyophilized recombinant activated factor VII (formulated for storage at room temperature).

Objective: To investigate effects of air transport and X-ray radiation exposure through airport security of a new room temperature-stable rFVIIa formulation (NovoSeven/NovoSeven RT, Novo Nordisk A/S, Bagsvaerd, Denmark) lyophilized using in vitro study methodology, thus evaluating possible effects of exposure through airport security and airplane travel.

Research Design And Methods: The effect of X-ray radiation exposure of rFVIIa and the solvent histidine at two different doses (400 microSv and 2000 microSv) was examined immediately after exposure, and post-exposure after storage at 30 degrees C for 1 month. References samples, not exposed to X-ray radiation, were used for comparison.

In vitro stability of lyophilized and reconstituted recombinant activated factor VII formulated for storage at room temperature.

Background: Recombinant activated factor VII (rFVIIa) is indicated to treat bleeding episodes or prevent bleeding related to surgery in patients with hemophilia A or B who have antibodies to coagulation factors VIII or IX. The first-generation rFVIIa formulation is stable when stored under refrigeration. A new formulation has been developed for storage at room temperature, which may improve patients' access to treatment during bleeding episodes.

In vitro stability of two formulations of recombinant activated factor VIIa reconstituted in inappropriate solvents or at inappropriate volumes.

Background: Recombinant activated factor VIIa (rFVIIa) is indicated for on-demand treatment of bleeding and the prevention and treatment of surgical bleeding in patients with hemophilia A or B who have antibodies to coagulation factors VIII or IX. The currently approved single-use formulation of rFVIIa is freeze dried and is stable for up to 3 years when stored at 2 degrees C to 8 degrees C (36 degrees F-46 degrees F). A new formulation has been developed that is stable for up to 2 years when stored at temperatures up to 25 degrees C (77 degrees F).