Docefrez

DRUG DESCRIPTION

Docetaxel is an antineoplastic agent belonging to the taxoid family. It is prepared by semisynthesis beginning with a precursor extracted from the renewable needle biomass of yew plants. The chemical name for docetaxel (anhydrous) is (2R,3S)-N-carboxy-3-phenylisoserine,N-tert-butyl ester, 13-ester with 5?-20epoxy-1,2?,4,7?,10?,13?-hexahydroxytax-11-en-9-one 4-acetate 2-benzoate. Docetaxel (anhydrous) has the following structural formula:

DOCEFREZ (docetaxel)  Structural Formula Illustration

Docetaxel (anhydrous) is a white to almost-white powder with an empirical formula of C43H53NO14, and a molecular weight of 807.88. It is highly lipophilic and practically insoluble in water.

DOCEFREZ (Lyophilized Powder for Injection and Diluent)

DOCEFREZ (docetaxel) for injection is a sterile, lyophilized, non-pyrogenic, white powder and is available in single use vials containing 20 mg or 80 mg of docetaxel (anhydrous).

DOCEFREZ (docetaxel) for injection requires reconstitution with Diluent prior to use. For each 20 mg or 80 mg vial, a sterile, non-pyrogenic, single dose Diluent vial is co-packaged. The Diluent for DOCEFREZ (docetaxel) for injection contains 35.4 % w/w ethanol in polysorbate 80.



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