DEFITELIO defibrotide 200 mg/2.5 mL concentrated solution for infusion vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

defibrotide, Quantity: 200 mg

Available from:

Jazz Pharmaceuticals ANZ Pty Ltd

Pharmaceutical form:

Injection, concentrated

Composition:

Excipient Ingredients: hydrochloric acid; sodium citrate dihydrate; sodium hydroxide; water for injections

Administration route:

Intravenous

Units in package:

10 vials

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Defitelio is indicated for the treatment of severe hepatic veno-occlusive disease (VOD) also known as sinusoidal obstruction syndrome (SOS) in haematopoietic stem-cell transplantation (HSCT) therapy.,It is indicated in adults and in adolescents, children and infants of 1 month of age and above.

Product summary:

Visual Identification: Clear light yellow to brown solution.; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2020-07-23

Patient Information leaflet

DEFITELIO CMI – V2
1
This medicine is subject to additional monitoring. This will allow
quick identification of new safety
information. You can help by reporting any side effects you may get.
You can report side effects to your doctor,
or directly at https://www.tga.gov.au/reporting-problems.
DEFITELIO
®
_defibrotide _
________________________________________________________________________________________________________________
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
DEFITELIO. It does not contain
all the available information. It
does not take the place of talking
to your doctor.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you using
DEFITELIO against the benefits
they expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
USING THIS MEDICINE, ASK YOUR
DOCTOR.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT DEFITELIO IS
USED FOR
DEFITELIO is a medicine that
contains the active substance
defibrotide.
DEFITELIO is used to treat a
condition called hepatic veno-
occlusive disease (or VOD), in
which the blood vessels in the
liver become damaged and
obstructed by blood clots. This
can be caused by medicines that
are given prior to a stem cell
transplantation.
DEFITELIO works by protecting
the cells of the blood vessels and
preventing or breaking down the
blood clots.
This medicine can be used in
adults, and in adolescents,
children and infants over one
month of age.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS
MEDICINE HAS BEEN PRESCRIBED
FOR YOU.
This medicine is available only
with a doctor's prescription.
This medicine is not expected to
affect your ability to drive a car or
operate machinery.
BEFORE YOU ARE GIVEN
DEFITELIO
_WHEN YOU MUST NOT BE _
_GIVEN THIS MEDICINE _
You must not be given
DEFITELIO if you:
•
are allergic to defibrotide or
any of the other ingredients
listed in this leaflet
•
are using other medicines to
break down blood clots such
as tissue plasminogen
activators (e.g. a

Summary of Product characteristics

Page 1 of 16
Defitelio Product Information V4
This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse events
at www.tga.gov.au/reporting-problems.
AUSTRALIAN PRODUCT INFORMATION – DEFITELIO®
(DEFIBROTIDE) CONCENTRATED SOLUTION FOR INFUSION
1.
NAME OF THE MEDICINE
Defibrotide
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One mL of concentrate contains defibrotide* 80 mg corresponding to a
quantity of 200 mg in 2.5 mL
in a vial before dilution. The final concentration of the solution
should be in the range of 4 mg/mL to
20 mg/mL after dilution.
* produced from porcine intestinal mucosa.
For the full list of excipients, see section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Concentrated solution for infusion (sterile concentrate).
The solution is clear light yellow to brown, free from particulate
matter or turbidity.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Defitelio is indicated for the treatment of severe hepatic
veno-occlusive disease (VOD) also known as
sinusoidal obstruction syndrome (SOS) in haematopoietic stem-cell
transplantation (HSCT) therapy.
It is indicated in adults and in adolescents, children and infants of
1 month of age and above.
4.2
DOSE AND METHOD OF ADMINISTRATION
Defitelio must be prescribed and administered to patients by
specialised physicians experienced in
the diagnosis and treatment of complications of HSCT.
Dosage
The recommended dose is 6.25 mg/kg body weight every 6 hours (25
mg/kg/day).
There is limited efficacy and safety data on doses above this level
and consequently it is not
recommended to increase the dose above 25 mg/kg/day.
The treatment should be administered for a minimum of 21 days and
continued until the symptoms
and signs of severe VOD resolve.
Page 2 of 16
Defitelio Product Information V4
Dose adjustment
_Renal impairment _
Dose adjustment is not required for patients with renal impairment or
who are on intermittent
haemodi