ONIVYDE irinotecan (as sucrosofate) 43 mg/10 mL nanoliposomal concentrated injection for infusion

Land: Australien

Språk: engelska

Källa: Department of Health (Therapeutic Goods Administration)

Aktiva substanser:

irinotecan hydrochloride trihydrate, Quantity: 5 mg/mL

Tillgänglig från:

Servier Laboratories (Aust) Pty Ltd

INN (International namn):

irinotecan hydrochloride trihydrate,sucrosofate

Läkemedelsform:

Injection, concentrated

Sammansättning:

Excipient Ingredients: distearoylphosphatidylcholine; cholesterol; sodium methoxy PEG-40-carbonyl-distearoylphosphatidylethanolamine; hepes; sodium chloride; water for injections; sucrosofate

Administreringssätt:

Intravenous

Enheter i paketet:

1 x vial

Receptbelagda typ:

(S4) Prescription Only Medicine

Terapeutiska indikationer:

ONIVYDE is indicated:,? in combination with oxaliplatin and 5 fluorouracil (5 FU) and leucovorin (LV) for the first-line treatment of metastatic pancreatic adenocarcinoma.,? in combination with 5-FU and LV for the treatment of metastatic pancreatic adenocarcinoma after disease progression following gemcitabine-based therapy.

Produktsammanfattning:

Visual Identification: Sterile, white to slightly yellow opaque isotonic liposomal dispersion; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 3 Years; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Bemyndigande status:

Licence status A

Tillstånd datum:

2016-12-19

Bipacksedel

ONIVYDE
_Nanoliposomal irinotecan - Irinotecan 4.3 mg/mL concentrate for
solution for infusion_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about ONIVYDE.
It does not contain all of the available
information. All medicines have risks
and benefits. Your doctor has
weighed the risks of using your
medicine against the benefit that it
will have for you.
It does not take the place of talking to
your doctor or pharmacist.
IF YOU HAVE ANY CONCERNS ABOUT
HAVING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
PLEASE READ THIS LEAFLET CAREFULLY
AND KEEP IT FOR FUTURE REFERENCE.
Please also note that this leaflet is
subjected to change, therefore, ask
your doctor whether this is the latest
information regarding this medicine.
WHAT IS ONIVYDE
ONIVYDE is a nanoliposomal
formulation of irinotecan which
means that the active substance
irinotecan is contained in tiny lipid
(fatty) particles called
nanoliposomes.
Irinotecan is an anticancer medicine
that belongs to the group of
'topoisomerase inhibitors'. It blocks
an enzyme called topoisomerase I,
which is involved in the division of
cell DNA. When the enzyme is
blocked, the DNA strands break.
This prevents the cancer cells from
multiplying and growing, and they
eventually die.
The nanoliposomes are expected to
accumulate within the tumour and
release the medicine slowly over
time, thereby decreasing the rate at
which the irinotecan is removed from
the body and allowing it to act for
longer duration.
WHAT ONIVYDE IS
USED FOR
This medicine is used to treat
Pancreatic Cancer.
This medicine belongs to a group of
medicines called antineoplastic or
cytotoxic medicines. You may also
hear of these being called
chemotherapy medicines.
ONIVYDE works by killing cancer
cells and stopping them from
multiplying. It will be given in
combination with other anticancer
medicines.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
There is no eviden

Produktens egenskaper

AUSTRALIAN PRODUCT INFORMATION
ONIVYDE® (NANOLIPOSOMAL IRINOTECAN AS SUCROSOFATE)
Version: 7
1/21
AUSTRALIAN PRODUCT INFORMATION
ONIVYDE
® (NANOLIPOSOMAL IRINOTECAN AS SUCROSOFATE)
DO NOT SUBSTITUTE ONIVYDE FOR OR WITH OTHER MEDICINE PRODUCTS
CONTAINING IRINOTECAN. ONIVYDE
IS NOT EQUIVALENT TO NON-LIPOSOMAL IRINOTECAN FORMULATIONS AND SHOULD
NOT BE INTERCHANGED.
1
NAME OF THE MEDICINE
Nanoliposomal irinotecan as sucrosofate.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
ONIVYDE is formulated with irinotecan hydrochloride trihydrate, a
topoisomerase inhibitor, into a
liposomal dispersion for intravenous use. The liposome is a small
unilamellar lipid bilayer vesicle,
approximately 110 nm in diameter, which encapsulates an aqueous space
containing irinotecan in a gelated
or precipitated state, as the sucrosofate (sucrose octasulfate) salt.
Each 10 mL vial contains 43 mg irinotecan (4.3 mg/mL) equivalent to 50
mg irinotecan hydrochloride
trihydrate (5.0 mg/mL).
The liposome carriers are composed of 68.1 mg
distearoylphosphatidylcholine (6.81 mg/mL); 22.2 mg
cholesterol (2.22 mg/mL) and 1.2 mg Sodium methoxy PEG-40-carbonyl-
distearoylphosphatidylethanolamine (0.12 mg/mL). The solution is
buffered at pH 7.25.
For the full list of excipients, see _section 6.1 - List of
excipients_.
3
PHARMACEUTICAL FORM
The concentrated injection is supplied as a sterile, white to slightly
yellow opaque isotonic liposomal
dispersion for intravenous use.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Treatment of metastatic adenocarcinoma of the pancreas, in combination
with 5-fluorouracil and folinic
acid (leucovorin) in adult patients who have been previously treated
with gemcitabine-based therapy.
4.2
D
OSE AND METHOD OF ADMINISTRATION
ONIVYDE must only be prescribed and administered to patients by
healthcare professionals experienced in
the use of anti-cancer therapies.
ONIVYDE is not equivalent to non-liposomal irinotecan formulations and
should not be interchanged.
Dilute ONIVYDE prior to administration.
ONIVYDE treatment shou