Defitelio Details

1. All information is from publicly available website of Jazz Pharmaceuticals. All copyrights belong to that company. This
detailing deck is for illustrative purposes only.
The drug for management of hepatic Veno Occlusive Disease (VOD) in
post hematopoietic stem-cell transplantation (HSCT)

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

3. Dosage and Administration
• Administer DEFITELIO 6.25 mg/kg every 6 hours given as a 2-hour
intravenous infusion.
• Treat for a minimum of 21 days. If after 21 days signs and symptoms
of VOD have not resolved, continue treatment until resolution.
Dosage Form
• Injection: 200 mg/2.5 mL (80 mg/mL) in a single-patient-use vial

4. Contraindications
1. Concomitant administration with
systemic anticoagulant or fibrinolytic
therapy.
2. Known hypersensitivity to DEFITELIO
or to any of its excipients
1. Hemorrhage: Monitor patients for
bleeding.
2. Hypersensitivity Reactions
Adverse Reactions
1. The most common adverse
reactions (incidence ≥10% and
independent of causality) with
DEFITELIO treatment were
hypotension, diarrhea, vomiting,
nausea and epistaxis.
Warnings Drug Interactions
1. DEFITELIO may enhance the activity
of antithrombotic/fibrinolytic drugs.

5. Use in specific populations
Pregnancy
No human data
Animal data - Treatment with defibrotide sodium resulted in a decreased number of
implantations and viable fetuses.
Lactation
No human data
In general, advised against breastfeeding during treatment with Defitelio
Pediatric
The safety and effectiveness of DEFITELIO have been established in pediatric patients.
Geriatric No data available

6. Clinical Trials Data
WASHI
NGTON
TEXAS
OKLAH
OMA
KANSA
S
NEBRA
SKA
SOUTH
DAKOTA
NORTH
DAKOTA MINN
ESOT
A
IOWA
MISS
OURI
ARKA
NSAS
LOU
ISIA
NA
WISC
ONSI
N
ILLI
NO
IS
MIC
HIG
AN
O
H
I
O
ALASK
A
HAWAI
I

7. Key highlights of the drug
On March 30, 2016,
the U. S. Food and
Drug Administration
approved Defitelio
(defibrotide sodium,
Jazz Pharmaceuticals,
Inc.)
The approval was
based on survival at
Day +100 after HSCT.
The Day +100 survival
rates for 3 studies
across 528 patients
Defibrotide sodium
protected ECs from
damage caused
by chemotherapy,
tumor necrosis
factor-α (TNF-α),
serum starvation,
and perfusion

8. INCREASES DECREASES
1. Endothelial Cell
Mediated Fibrinolysis
2. Tissue Plasminogen
Activator
3. Thrombomodulin
Expression
1. Endothelial Cell
Activation
2. Expression Of Von
Willebrand Factor
3. Plasminogen Activator
Inhibitor In
Endothelial Cells
How does the drug alter body functions

9. All copyrights
© 2020 Jazz Pharmaceuticals, Inc.