New Non-Refrigerated Coagulation Product (July 2008)
Pharmacy
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Description
FDA has approved a new formulation of the genetically engineered version of Factor VIIa that does not need to be refrigerated. Factor VIIa is a plasma protein essential for blood clotting that can be used to treat and prevent bleeding in people with certain bleeding disorders, including hemophilia. The new product, called NovoSeven RT, can be stored at room temperature for up to two years. NovoSeven RT is a re-formulated version of NovoSeven Coagulation Factor VIIa Recombinant. The original formula could be stored for up to three years, but required refrigeration. The new formulation contains sucrose and L-methionine, which allows the product to be stored at room temperature. The re-formulation could be helpful to facilities with limited refrigeration space, and it could give health care providers and patients greater flexibility in the management of certain blood disorders.
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