Defibrotide

5 mL (80 mg/mL) Sodium citrate dihydrate Hydrochloric acid (for pH adjustment) Sodium hydroxide (for pH adjustment) Water for injection DESCRIPTION DEFITELIO™ is an oligonucleotide mixture with profibrinolytic properties. Defibrotide sodium is a polydisperse mixture of predominantly single-stranded (ss) polydeoxyribonucleotide sodium salts derived from porcine intestinal tissue having a mean weighted molecular weight of 13-20 kDa, and a potency of 27-39 and 28-38 biological units per mg as determined by two separate assays measuring the release of a product formed by contact between defibrotide sodium, plasmin and a plasmin substrate.

The chemical name of defibrotide sodium is polydeoxyribonucleotide, sodium salt. DEFITELIO™ (defibrotide sodium) solution is a clear, light yellow to brown, sterile, preservative- free solution in a single-use vial for intravenous infusion.

Each milliliter of the injection contains 80 mg of defibrotide sodium and 10 mg of Sodium Citrate, in Water for Injection. 8. INDICATIONS AND CLINICAL USE DEFITELIO™ (defibrotide sodium) solution for intravenous infusion is indicated for the treatment of adult and pediatric patients with severe hepatic veno-occlusive disease (VOD) also known as sinusoidal obstruction syndrome (SOS), following haematopoietic stem-cell transplantation (HSCT).

1 Therapeutic indication Defitelio is indicated for the treatment of severe hepatic veno-occlusive disease (VOD) also known as sinusoidal obstruction syndrome (SOS) in haematopoietic stem-cell transplantation (HSCT) therapy. It is indicated in adults and in adolescents, children and infants over 1 month of age.