Defibrotide(Defitelio)
Acetylcysteine Injection, FLUIMUCIL, Acetylcysteine InjectionAcetylcysteine Injection, FLUIMUCIL, Acetylcysteine InjectionAcetylcysteine Injection, FLUIMUCIL, Acetylcysteine Injection
Reference price:
Manufacturer:
Jazz Pharmaceuticals Plc
Formulation:
INJECTION
Validity period:
24 months
Reminder: The outer packaging is for reference only, please purchase and use under the guidance of a pharmacist. For read by medical and pharmaceutical professionals only.

Defitelio is a medication formulated as an intravenous injection containing defibrotide sodium, primarily used for managing hepatic veno-occlusive disease (VOD) in patients undergoing hematopoietic stem-cell transplantation (HSCT). VOD is a serious condition characterized by the obstruction of small veins in the liver, which may lead to hepatic dysfunction and multi-organ failure. This drug is particularly crucial in cases where VOD is accompanied by renal or pulmonary complications.

The mechanism of action of Defitelio is not fully elucidated in the document; however, it is known to exert its therapeutic effects by improving endothelial function and protecting vascular integrity, making it a vital intervention in critically ill post-transplant patients. The treatment protocol typically involves administering a 6.25 mg/kg dose every 6 hours through a 2-hour intravenous infusion for a minimum of 21 days, with continued treatment if symptoms persist.

Generic name

Defibrotide(Defitelio)
English name
Defibrotide
Alternative Names
Defitelio
Drug prices
Indications

DEFITELIO is indicated for the treatment of adult and pediatric patients with hepatic veno-occlusive disease (VOD), also known as sinusoidal obstruction syndrome (SOS), who develop renal or pulmonary dysfunction following hematopoietic stem-cell transplantation (HSCT).

Therapeutic Target
DEFITELIO targets hepatic veno-occlusive disease (VOD)/sinusoidal obstruction syndrome (SOS).
Active Ingredients
Defibrotide sodium.
Dosage form
INJECTION
specifications
200mg/2.5ml
Description

DEFITELIO (defibrotide sodium) injection is a sterile, preservative-free, clear, light yellow to brown solution for intravenous use. It contains 80 mg/mL of defibrotide sodium and 10 mg/mL of Sodium Citrate, USP, in Water for Injection, USP. The pH may be adjusted with Hydrochloric Acid, NF, and/or Sodium Hydroxide, NF, to a range of 6.8-7.8. Defibrotide sodium is an oligonucleotide mixture with profibrinolytic properties, derived from porcine intestinal tissue. It is a polydisperse mixture of predominantly single-stranded (ss) polydeoxyribonucleotide sodium salts with a mean weighted molecular weight of 13-20 kDa.

Dosage and Administration

Recommended Dosage: The recommended dose is 6.25 mg/kg administered every 6 hours as a 2-hour intravenous infusion. The dose should be based on the patient’s baseline body weight (prior to the HSCT preparative regimen).

Duration of Treatment: Treat for a minimum of 21 days. If signs and symptoms of VOD have not resolved after 21 days, continue treatment until resolution or up to a maximum of 60 days.

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