Peginesatide is an ESA that is a synthetic, pegylated
dimeric peptide comprised of two identical, 21-amino acid chains covalently
bonded to a linker derived from iminodiacetic acid and β-alanine.
Peginesatide is manufactured as an acetate salt. The dimeric peptide (approximate
MW 4,900 daltons) is covalently linked to a single lysine-branched
bis-(methoxypoly(ethylene glycol)) (PEG) chain (approximate MW 40,000 daltons).
The structure is provided in Figure 1; peginesatide has no amino acid sequence
homology to erythropoietin. The empirical formula is C2031H3950N62O958S6 (free
base). The total molecular weight is approximately 45,000 daltons.
Figure 1: Structure of peginesatide acetate
Injection is formulated as a sterile, colorless to slightly yellow
preservative-free solution and a sterile, colorless to slightly yellow
preserved solution for intravenous or subcutaneous administration.
Single use, preservative-free
injectable solutions of OMONTYS in vials and pre-filled syringes are supplied
in multiple strengths. Each 0.5 mL vial or pre-filled syringe contains
peginesatide, 23.5 mg sorbitol, 1.5 mg sodium phosphate monobasic (dihydrate),
0.06 mg sodium phosphate dibasic, 0.02 mg polysorbate 20, and water for
injection, USP. Sodium hydroxide added to adjust pH. The pH is 6.0 ± 0.3.
Multiple use, preserved
injectable solutions of OMONTYS in vials are supplied in two fill volumes: 1 mL
and 2 mL. Each mL contains 10 mg peginesatide, 47 mg sorbitol, 5 mg phenol, 1.5
mg L-methionine, 0.6 mg glacial acetic acid, and water for injection, USP.
Sodium hydroxide added to adjust pH. The pH is 5.4 ± 0.5.
Last reviewed on RxList: 12/19/2012
This monograph has been modified to include the generic and brand name in many instances.