SPL Set ID: 5e755c40-6e73-4572-b474-4d8a131693d1

KIMYRSA (oritavancin) for injection contains oritavancin diphosphate, a semisynthetic lipoglycopeptide antibacterial drug for intravenous infusion. The chemical name for oritavancin is [4"R]-22- O -(3-amino-2,3,6-trideoxy-3- C -methyl-α-L- arabino -hexopyranosyl)- N 3''-[(4'-chloro[1,1'-biphenyl]-4-yl)methyl] vancomycin phosphate [1:2] [salt]. The empirical formula of oritavancin diphosphate is C 86 H 97 N 10 O 26 Cl 3 •2H 3 PO 4 and the molecular weight is 1989.09. The chemical structure is represented below: ∙2H 3 PO 4 KIMYRSA for injection is supplied as a sterile white to off-white or pink lyophilized powder in a single-dose clear glass vial that contains 1,200 mg of oritavancin (equivalent to 1331.16 mg oritavancin diphosphate) and the following inactive ingredients: hydroxypropyl-β-cyclodextrin (HPβCD) (2400 mg), mannitol (800 mg) and phosphoric acid or sodium hydroxide (to adjust pH 4.0 to 6.0). The vial is reconstituted with sterile water for injection and further diluted with 0.9% sodium chloride injection or 5% dextrose in sterile water (D5W) for intravenous infusion. Both the reconstituted solution and the diluted solution for infusion should be a clear, colorless to pink solution, free of visible particles [see Dosage and Administration (2.3) ] . Chemical Structure