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

OMONTYS (peginesatide) 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.