Onivyde pegylated liposomal (previously known as Onivyde)

Country: Եվրոպական Միություն

language: անգլերեն

source: EMA (European Medicines Agency)

active_ingredient:

irinotecan anhydrous free-base

MAH:

Les Laboratoires Servier

ATC_code:

L01CE02

INN:

irinotecan hydrochloride trihydrate

therapeutic_group:

Antineoplastic agents

therapeutic_area:

Pancreatic Neoplasms

therapeutic_indication:

Treatment of metastatic adenocarcinoma of the pancreas, in combination with 5 fluorouracil (5 FU) and leucovorin (LV), in adult patients who have progressed following gemcitabine based therapy.

leaflet_short:

Revision: 11

authorization_status:

Authorised

authorization_date:

2016-10-14

PIL

30
B. PACKAGE LEAFLET
31
PACKAGE LEAFLET: INFORMATION FOR THE USER
ONIVYDE PEGYLATED LIPOSOMAL 4.3 MG/ML CONCENTRATE FOR DISPERSION
FOR INFUSION
irinotecan
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or nurse.
-
If you get any side effects, talk to your doctor or nurse. This
includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What ONIVYDE pegylated liposomal is and what it is used for
2.
What you need to know before you use ONIVYDE pegylated liposomal
3.
How ONIVYDE pegylated liposomal is used
4.
Possible side effects
5.
How to store ONIVYDE pegylated liposomal
6.
Contents of the pack and other information
1.
WHAT ONIVYDE PEGYLATED LIPOSOMAL IS AND WHAT IT IS USED FOR
WHAT ONIVYDE PEGYLATED LIPOSOMAL IS AND HOW IT WORKS
ONIVYDE pegylated liposomal is a cancer medicine that contains the
active substance irinotecan.
This active substance is held in tiny lipid (fatty) particles called
liposomes.
Irinotecan belongs to a group of cancer medicines called
‘topoisomerase inhibitors’. It blocks an
enzyme called topoisomerase I, which is involved in the division of
cell DNA. This prevents the
cancer cells from multiplying and growing, and they eventually die.
The liposomes are expected to accumulate within the tumour and release
the medicine slowly over
time, thereby allowing it to act for longer.
WHAT ONIVYDE PEGYLATED LIPOSOMAL IS USED FOR
ONIVYDE pegylated liposomal is used to treat adult patients with
metastatic pancreatic cancer
(cancer of the pancreas that has already spread elsewhere in the body)
whose previously cancer
treatment included a medicine called gemcitabine. ONIVYDE pegylated
liposomal is used in
combination with other cancer medicines, called 5-fluorouracil and
leucovorin.
If you have any questions about how ONIVYDE pegylated liposomal works
or why this medicine has
b

SPC

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
ONIVYDE pegylated liposomal 4.3 mg/ml concentrate for dispersion for
infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One 10 ml vial of concentrate contains 43 mg irinotecan anhydrous free
base (as irinotecan
sucrosofate salt in a pegylated liposomal formulation).
One ml of concentrate contains 4.3 mg irinotecan anhydrous free base
(as irinotecan sucrosofate salt in
a pegylated liposomal formulation).
Excipient with known effect
One ml of concentrate contains 0.144 mmol (3.31 mg) sodium.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Concentrate for dispersion for infusion.
White to slightly yellow opaque isotonic liposomal dispersion.
The concentrate has a pH of 7.2 and an osmolality of 295 mOsm/kg.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of metastatic adenocarcinoma of the pancreas, in combination
with 5-fluorouracil (5-FU)
and leucovorin (LV), in adult patients who have progressed following
gemcitabine based therapy.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
ONIVYDE pegylated liposomal must only be prescribed and administered
to patients by healthcare
professionals experienced in the use of anti-cancer therapies.
ONIVYDE pegylated liposomal is not equivalent to non-liposomal
irinotecan formulations and should
not be interchanged.
Posology
ONIVYDE pegylated liposomal, leucovorin and 5-fluorouracil should be
administered sequentially.
The recommended dose and regimen of ONIVYDE pegylated liposomal is 70
mg/m
2
intravenously
over 90 minutes, followed by LV 400 mg/m
2
intravenously over 30 minutes, followed
by 5-FU 2,400 mg/m
2
intravenously over 46 hours, administered every 2 weeks. ONIVYDE
pegylated
liposomal should not be administered as a single agent.
A reduced starting dose of ONIVYDE pegylated liposomal of 50 mg/m
2
should be considered for
patients known to be homozygous for the UGT1A1*28 allele (see sections
4.8 and 5.1). A dose
increase of ONIVYDE pegylated liposomal to 70 m