RYTELO Solution for injection Ref.[110353] Active ingredients: Imetelstat

RYTELO for injection contains imetelstat, an oligonucleotide telomerase inhibitor for intravenous use. Imetelstat sodium is a white to off-white or slightly yellow, amorphous, solid powder. It is highly soluble in aqueous solutions, including in 0.9% Sodium Chloride Injection, at both refrigerated and room temperatures. Imetelstat sodium is hygroscopic.

The chemical name for the imetelstat sodium drug substance is DNA, d(3'-amino-3'-deoxy-P-thio) (T-AG-G-G-T-T-A-G-A-C-A-A), 5'[O[2-hydroxy-3-(hexadecanoylamino)propyl] phosphorothioate], sodium salt (1:13). The molecular formula is C₁₄₈H₁₉₈N₆₈O₅₃P₁₃S₁₃Na₁₃ (as sodium salt), which equates to a formula weight of 4896 g/mol. The molecular formula for the free acid form is C₁₄₈H₂₁₁N₆₈O₅₃P₁₃S₁₃ which equates to a formula weight of 4610 g/mol. The structural formula for imetelstat sodium is:

RYTELO (imetelstat) for injection is a sterile, preservative-free, white to off-white or slightly yellow lyophilized powder for intravenous infusion after reconstitution and dilution. Each single-dose vial provides either 47 mg of imetelstat (equivalent to 50 mg imetelstat sodium) or 188 mg of imetelstat (equivalent to 200 mg imetelstat sodium). The following inactive ingredients may be added during manufacturing: sodium carbonate anhydrous (for the 47 mg preparation)/sodium carbonate monohydrate (for the 188 mg preparation) or hydrochloric acid (to adjust to pH of 7.0 to 8.5).