ABSTRACT
Description: The active ingredient in Vitravene is a 21-base phosphorothioate oligonucleotide of the indicated nucleotide base sequence 5’—GCG TTT GCT CTT CTT CTT GCG-3’. It is a white to off-white hygroscopic, amorphous powder with a molecular formula of C204H243N63O114P20S20Na20 and a molecular weight of 7122 Da. It is the only antisense-based product approved in any world region thus far. The final product is supplied in a preservative-free, single-use vial containing 0.25 ml. In addition to the active ingredient (at a concentration of 26.4 mg/ml), the product contains sodium carbonate, sodium bicarbonate, and sodium chloride formulated in water for injection. The final product pH is adjusted to a pH of 8.7 with NaOH/HCl.
