REDEMPLO Injection for solution Ref.[116088] Active ingredients: Plozasiran

REDEMPLO contains plozasiran (present as plozasiran sodium), a small interfering RNA (siRNA) that degrades apolipoprotein C-III (apoC-III) mRNA by RNA interference. Plozasiran contains a covalently linked ligand containing three N-acetylgalactosamine (GalNAc) residues to facilitate delivery to hepatocytes. The 2´ positions of the ribose subunits in plozasiran are modified with either fluorine (2´F) or methoxy (2´O-Me) groups. Each strand of plozasiran also includes multiple phosphorothioates.

The molecular formula of plozasiran sodium is C₄₉₃H₆₁₁F₁₁N₁₆₄Na₄₃O₃₁₁P₄₃S₇ and its molecular weight is 16,563.98 Da. Plozasiran sodium is freely soluble in water. Plozasiran has the following structural formula:

Abbreviations: A = 2'-O-methyladenosine; A = 2'-fluoro(2'-deoxy-2'-fluoro)adenosine; C = 2'-O-methylcytidine; C = 2'-fluorocytidine; G = 2'-O-methylguanosine; G = 2'-fluoroguanosine; I = 2'-O-methylinosine; U = 2'-O-methyluridine; U = 2'-fluorouridine; - (single line) = phosphodiester linkage; = (double line) = phosphorothioate linkage; · (middle dot) depicts base pairing between the two strands

REDEMPLO is a sterile, preservative-free, clear, colorless to yellow solution for subcutaneous use in a prefilled syringe. Each syringe contains 0.5 mL of solution containing 25 mg plozasiran (present as 27 mg plozasiran sodium), sodium chloride to adjust tonicity, and water for injection.