SPL Set ID: 75c0c785-38e0-4049-a6fb-b77581f5b35c
1 drug(s) with this SPL Set ID
FETROJA is a cephalosporin antibacterial drug product consisting of cefiderocol sulfate tosylate for intravenous infusion. Cefiderocol functions as a siderophore [see Microbiology (12.4) ] . The chemical name of cefiderocol sulfate tosylate is Tris[(6 R ,7 R )-7-[(2 Z )-2-(2-amino-1,3-thiazol-4-yl)-2-{[(2-carboxypropan-2-yl)oxy]imino}acetamido]-3-({1-[2-(2-chloro-3,4-dihydroxybenzamido)ethyl]pyrrolidin-1-ium-1-yl}methyl)-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate] tetrakis(4-methylbenzenesulfonate) monosulfate hydrate, and the molecular weight is 3043.50 (anhydrous). The molecular formula is 3C 30 H 34 ClN 7 O 10 S 2 ∙4C 7 H 8 O 3 S∙H 2 SO 4 ∙xH 2 O. Figure 1 Chemical Structure of Cefiderocol Sulfate Tosylate FETROJA for injection is a white to off-white, sterile, lyophilized powder formulated with 1 gram of cefiderocol (equivalent to 1.6 grams of cefiderocol sulfate tosylate), sucrose (900 mg), sodium chloride (216 mg), and sodium hydroxide to adjust pH. The sodium content is approximately 176 mg/vial. The pH of the reconstituted solution of 1 gram cefiderocol (1 vial) dissolved in 10 mL water is 5.2 to 5.8. Figure 1