DAWNZERA Solution for injection Ref.[116065] Active ingredients: Donidalorsen

Donidalorsen is a prekallikrein-directed antisense oligonucleotide (ASO) covalently linked to a ligand containing three N‑acetyl galactosamine (GalNAc) residues to facilitate delivery of the ASO to hepatocytes.

DAWNZERA contains donidalorsen sodium as the active ingredient. Donidalorsen sodium is a white to yellow solid and it is freely soluble in water and in sodium phosphate buffer. The molecular formula of donidalorsen sodium is C₂₉₆H₄₁₅N₈₃O₁₅₁P₂₀S₁₅Na₂₀and the molecular weight is 9112.27 daltons. The chemical name of donidalorsen is DNA, d([2′-O(2-methoxyethyl)]m ⁵rU-s ^p-[2′O(2-methoxyethyl)]rG-s ^p-[2′ O(2-methoxyethyl)]m ⁵rC-[2′ O(2-methoxyethyl)]rA-[2′O(2-methoxyethyl)]rA-s ^p-G-s^p-T-s^p-m ⁵C-s ^p-T-s ^p-m⁵C-s^p-T-s ^p-T-s ^p-G-s ^p-G-s^p-m⁵C-s ^p-[2′ O(2-methoxyethyl)]rA-[2′O(2-methoxyethyl)]rA-[2′ O(2methoxyethyl)]rA-s^p-[2′O(2-methoxyethyl)]m ⁵rC-s^p-[2′ O-(2-methoxyethyl)]rA), 5′-[26-[[2-(acetylamino)-2-deoxy-β-d-galactopyranosyl]oxy]-14,14-bis[[3-[[6-[[2-(acetylamino)-2-deoxy-β-d-galactopyranosyl]oxy]hexyl]amino]-3-oxopropoxy]methyl]-8,12,19-trioxo-16-oxa-7,13,20-triazahexacos-1-yl hydrogen phosphate], sodium salt (1:20).

The chemical structure of donidalorsen sodium is presented below:

DAWNZERA (donidalorsen) injection is a sterile, preservative‑free solution for subcutaneous injection supplied as a single-dose autoinjector. Each single‑dose autoinjector contains 80 mg of donidalorsen (equivalent to 84 mg donidalorsen sodium) in 0.8 mL of solution. The solution also contains disodium hydrogen phosphate; sodium chloride; sodium dihydrogen phosphate; water for injection; and may include hydrochloric acid and/or sodium hydroxide for pH adjustment between 6.9 to 7.9. Each dose of DAWNZERA injection contains 6 mg of phosphorous and 5 mg of sodium.