DESCRIPTION
ABRAXANE for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension) is an albumin-bound form of paclitaxel with a mean particle size of approximately 130 nanometers. ABRAXANE is supplied as a white to yellow, sterile, lyophilized powder for reconstitution with 20 mL of 0.9% Sodium Chloride Injection, USP prior to intravenous infusion. Each single-use vial contains 100 mg of paclitaxel and approximately 900 mg of human albumin. Each milliliter (mL) of reconstituted suspension contains 5 mg paclitaxel. ABRAXANE is free of solvents.The active agent in ABRAXANE is paclitaxel, a natural product with antitumor activity. Paclitaxel is obtained from . The chemical name for paclitaxel is 5,20-Epoxy-1,2±,4,7,10,13±-hexahydroxytax-11-en-9-one 4,10-diacetate 2-benzoate 13-ester with (2,3)--benzoyl-3-phenylisoserine.Paclitaxel has the following structural formula:Paclitaxel is a white to off-white crystalline powder with the empirical formula CHNO and a molecular weight of 853.91. It is highly lipophilic, insoluble in water, and melts at approximately 216°C to 217°C.