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DEFITELIO is a brand name for Defibrotide, supplied as a solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AND CLINICAL USE ..............................................................................3 CONTRAINDICATIONS ...................................................................................................4 WARNINGS AND PRECAUTIONS…
Verbatim from this product's HC label. Tap a section to expand.
Dosing Considerations Administer DEFITELIO™ for a minimum of 21 days. If after 21 days signs and symptoms of hepatic VOD have not resolved, continue DEFITELIO until resolution of VOD. Prior to administration of DEFITELIO, confirm that the patient is not experiencing clinically significant bleeding and is haemodynamically stable on no more than one vasopressor.
25 mg/kg every 6 hours given as a 2-hour intravenous infusion. Dosing should be based on patient’s baseline body weight, defined as the patient’s weight prior to the preparative regimen for HSCT. Renal Impairment No dosage adjustment is needed for patients with renal impairment or who are on hemodialysis.
Hepatic Impairment No dosage adjustment is needed for patients with hepatic impairment. Paediatric population No dose adjustments are needed for pediatric patients. Administration DEFITELIO™ must be diluted prior to infusion. DEFITELIO should be administered by constant intravenous infusion over a 2-hour period.
Do not co-administer DEFITELIO and other intravenous drugs concurrently within the same intravenous line. 2 micron in-line filter. 9% Sodium Chloride Injection, immediately before and after administration.
Reconstitution:
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Discard vial if either is present. 9% Sodium Chloride Injection, to a concentration of 4 mg/mL to 20 mg/mL. Administer the diluted solution over 2 hours.
The total dose and volume of infusion should be determined based on the individual patient’s baseline weight (weight prior to the preparative regimen for HSCT). Vials contain no antimicrobial preservatives and are intended for a single use only.
Partially used vials should be discarded. The diluted DEFITELIO solution should be used within 4 hours if stored Defitelio Product Monograph Page 12 of 26 at room temperature or within 24 hours if stored at 2oC to 8oC, unless dilution has taken place in controlled and validated aseptic conditions.
Up to four doses may be prepared at one time.
Preparation Instructions:
Determine the dose (mg) and number of vials of DEFITELIO based on the individual patient’s baseline weight (kg) (weight prior to the preparative regimen for HSCT). Calculate the volume of DEFITELIO needed. 9% Sodium Chloride Injection for each dose to make a final concentration of 4 mg/mL to 20 mg/mL.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Gently mix the solution for infusion. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Only clear solutions without visible particles should be used.
Depending on the type and amount of diluent, the color of the diluted solution may vary from colorless to light yellow. 2 micron in-line filter. Partially used vials should be discarded. Use the diluted DEFITELIO solution within 4 hours if stored at room temperature or within 24 hours if stored under refrigeration.
OVERDOSAGE There is no antidote for DEFITELIO™ and DEFITELIO is not dialyzable. If an overdose occurs, general supportive measures should be instituted. For management of a suspected drug overdose, contact your regional Poison Control Centre.
ACTION AND CLINICAL PHARMACOLOGY Mechanism of Action Defibrotide sodium is an oligonucleotide mixture with demonstrated actions on multiple pathways affecting endothelial homeostasis. Endothelial cell (EC) activation promotes thrombogenesis, fibrinogenesis, leukocyte and platelet adhesion, vasoconstriction, and vascular permeability.
Defibrotide reduces EC activation by mechanisms that are antithrombotic, fibrinolytic, anti- adhesive, and anti-inflammatory, thereby restoring the thrombotic-fibrinolytic balance and preserving endothelial homeostasis. Defibrotide inhibits leukocyte and Defitelio Product Monograph Page 13 of 26 platelet adhesion to EC: by suppressing P-selectin and vascular cell adhesion molecule-1 (VCAM)-1 interfering with lymphocyte function-associated antigen 1-intercellular adhesion molecule (LFA-1 – ICAM) mediated leukocyte transmigration; and increasing nitric oxide (NO), Prostaglandin I2 (PGI2) and Prostaglandin E2 (PGE2).
Defibrotide sodium protects ECs from damage and promotes tissue homeostasis by decreasing fludarabine-mediated apoptosis of EC while maintaining its anti-leukemic effect and inhibiting the expression of heparanase. 4 times the maximum recommended dose, DEFITELIO does not prolong the QTc interval to any clinically relevant extent.
PAI-1 Inhibition Plasma concentrations of PAI-1 were assessed on an exploratory basis as a potential pharmacodynamic marker for efficacy in a clinical study. PAI-1 is an inhibitor of t-PA and therefore of fibrinolysis. Mean PAI-1 levels on Days 7 and 14 were lower than those at baseline in patients with complete response (CR) and in those who were alive at Day+100, but this trend did not reach statistical significance.
There were no […]