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ANX-514 (docetaxel lyophilized emulsion for injection) ANX-514 is a novel emulsion formulation of the chemotherapy drug docetaxel. TaxotereŽ, a branded formulation of docetaxel, is approved to treat breast, non-small cell lung, prostate, gastric and head and neck cancers. In the U.S., aspects of Taxotere are covered by patents through November 2013. According to Taxotere's label, patients should be observed closely for hypersensitivity, or allergic, reactions, which may occur within a few minutes following initiation of Taxotere administration. These reactions generally are believed to be associated with polysorbate 80, which is present in Taxotere, and range from mild, including flushing, rash, breathing difficulty and drop in blood pressure, to severe, including generalized rash/erythema, hypotension and, in rare cases, fatal anaphylaxis. Taxotere's label recommends that all patients should be premedicated with oral corticosteroids for three days starting one day prior to Taxotere administration to reduce the severity of hypersensitivity reactions, among other reasons. Even following premedication, hypersensitivity reactions have been observed, including, in rare cases, fatal anaphylaxis. ANX-514 is formulated without polysorbate 80 or other detergents and is designed to reduce the incidence and severity of side effects associated with detergents, such as hypersensitivity reactions. |
