1 / 1

Defibrotide(Defitelio)

Acetylcysteine Injection, FLUIMUCIL, Acetylcysteine InjectionAcetylcysteine Injection, FLUIMUCIL, Acetylcysteine InjectionAcetylcysteine Injection, FLUIMUCIL, Acetylcysteine Injection

Reference price:

Manufacturer:

Formulation:

INJECTION

Validity period:

Not specified in the specification.

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

DEFITELIO is supplied as an injection in a single-patient-use glass vial containing 200 mg of defibrotide sodium in 2.5 mL of solution (80 mg/mL). The solution is clear, light yellow to brown, and sterile.

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.

Administration Instructions:

Must be diluted prior to infusion (to a final concentration of 4 mg/mL to 20 mg/mL in 5% Dextrose Injection, USP or 0.9% Sodium Chloride Injection, USP).

Confirm the patient is not experiencing clinically significant bleeding and is hemodynamically stable on no more than one vasopressor before administration.

Administer via constant intravenous infusion over 2 hours using an infusion set with a 0.2 micron in-line filter.

Flush the intravenous line with 5% Dextrose Injection, USP or 0.9% Sodium Chloride Injection, USP immediately before and after administration.

Do not co-administer with other intravenous drugs concurrently within the same intravenous line.

Preparation:

Determine dose and number of vials based on baseline weight.

Withdraw the calculated volume and add to an infusion bag containing 0.9% Sodium Chloride Injection or 5% Dextrose Injection to achieve the target concentration.

Gently mix. Inspect visually for particulate matter and discoloration. The diluted solution may vary from colorless to light yellow.

Vials are single-patient-use; discard partially used vials. Use diluted solution within 4 hours if stored at room temperature or within 24 hours if refrigerated. Up to four doses may be prepared at one time if refrigerated.

Treatment Modification:

Hypersensitivity Reaction (Severe/Life-threatening): Discontinue DEFITELIO permanently.

Bleeding (Persistent, severe, or potentially life-threatening): Withhold DEFITELIO, treat bleeding, provide supportive care. Consider resuming when bleeding has stopped and patient is hemodynamically stable. If recurrent significant bleeding occurs, discontinue DEFITELIO permanently.

Invasive Procedures: Discontinue DEFITELIO infusion at least 2 hours prior. Resume after the procedure once the risk of procedure-related bleeding is resolved. There is no known reversal agent for its profibrinolytic effects.

CATEGORY NAVIGATION