• Defibrotide


Facts of Defibrotide (Defitelio 80 mg/ml) ?

  • Medicine Name: Defibrotide
  • Generic Name: Defibrotide
  • Approval Date: 18 October 2013
  • Company Name: Gentium SpA
  • Indication : Anti Coagulant
  • Available as (Form & Strength): 80 mg/mL concentrate for solution for infusion, Box of 10s

Product Description

What are the indications and usage?

Defibrotide is a CD30-directed anti body-drug conjugate indicated for :

  • The treatment of patients with Hodgkin lymphoma after failure of autologous stem cell transplant (ASCT) or after failure of at least two prior multi-agent chemotherapy regimens in patients who are not ASCT candidates
  • The treatment of patients with systemic anaplastic large cell lymphoma after failure of at least one prior multi-agent chemotherapy regimen

These indications are based on response rate. There are no data available demonstrating improvement in patient reported outcomes or survival with DEFIBROTIDE.

How supplied/storage and handling ?

Keep this medicine out of th e sight and reach of children. Do not use Defitelio after the expiry date which is stated on the carton and label after EXP. The expiry date refers to the last day of that month. Do not freeze. Once diluted for use the infusion storage should not exceed 24 hours at 2-8°C unless dilution has taken place in controlled and vali dated aseptic conditions. Defitelio should not be used if the solu tion is cloudy or contains particles.


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