IRINOTECAN KABI irinotecan hydrochloride trihydrate 300mg/15mL concentrated injection vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

irinotecan hydrochloride trihydrate, Quantity: 300 mg

Available from:

Fresenius Kabi Australia Pty Ltd

INN (International Name):

irinotecan hydrochloride trihydrate

Pharmaceutical form:

Injection, concentrated

Composition:

Excipient Ingredients: sorbitol; lactic acid; sodium hydroxide; water for injections

Administration route:

Intravenous Infusion

Units in package:

carton of 1's

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Irinotecan injection is indicated for patients with metastatic carcinoma of the colon or rectum whose disease has recurred or progressed following initial therapy.

Product summary:

Visual Identification: Pale yellow, clear, aqueous solution; Container Type: Vial; Container Material: Glass; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2014-01-24

Patient Information leaflet

CMI for Irinotecan Kabi
Aug, 2012
Filename: IriCMI240114-clean
Page 1 of 4
IRINOTECAN KABI
Irinotecan Hydrochloride Concentrated Injection
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions
about
Irinotecan
hydrochloride
concentrated
injection.
It does not contain all the available
information.
It does not take the place of talking
to your doctor or pharmacist.
All
medicines
have
risks
and
benefits
.
Your doctor has weighed
the risks of you taking Irinotecan
hydrochloride
concentrated
injection against the benefits they
expect it will have for you.
ASK YOUR DOCTOR IF YOU HAVE ANY
CONCERNS
ABOUT
BEING
TREATED
WITH THIS MEDICINE.
KEEP
THIS
LEAFLET
WITH
THE
MEDICINE.
You may need to read it again.
WHAT IRINOTECAN
HYDROCHLORIDE
CONCENTRATED INJECTION
IS USED FOR
Irinotecan
hydrochloride
concentrated
injection
is
used
to
treat
bowel
cancer
which
has
spread to other parts of the body.
Cancer which has spread cannot
be treated by surgery alone and
one of the options in this situation is
treatment
with
an
anticancer
medicine, known as chemotherapy.
Alternatively,
Irinotecan
hydrochloride
concentrated
injection is used alone when the
cancer has not responded or has
returned after initial treatment.
Irinotecan
hydrochloride
concentrated injection is specially
developed
to
target
cancer
cells
rather than normal, healthy cells.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY IRINOTECAN
HYDROCHLORIDE
CONCENTRATED
INJECTION HAS BEEN PRESCRIBED FOR
YOU.
Your
doctor
may
have
prescribed Irinotecan hydrochloride
concentrated injection for another
purpose.
Irinotecan
hydrochloride
concentrated
injection
is
not
addictive.
This medicine is available only with
a doctor’s prescription.
_Use in children _
It
is
not
known
if
Irinotecan
hydrochloride
concentrated
injection is safe and effective in the
treatment of children.
BEFORE BEING TREATED
WITH IRINOTECAN
HYDROCHLORIDE
CONCENTRATED INJECTION
_WHEN _
_IRINOTECAN _
_HYDROCHLORIDE _
_CONCENTRATED INJECTION MUST NOT _
_BE GIVEN IT _
Iri

Summary of Product characteristics

Filename: IriPI240114-clean
Page 1 of 26
PRODUCT INFORMATION
NAME OF THE MEDICINE
Irinotecan Kabi Concentrated Injection
Non-proprietary name: Irinotecan hydrochloride concentrated injection
Chemical name: (4_S_)-4,
11-diethyl-4-hydroxy-9-[(4-piperidinopiperidino)
carbonyloxy]-1_H_-pyrano[3', 4':6, 7]indolizino[1, 2-_b_]quinoline-3,
14(4_H_, 12_H_)
dione hydrochloride trihydrate
CAS Number: CAS-136572-09-3
Irinotecan hydrochloride is a pale yellow to yellow crystalline
powder, with the
empirical formula C
33
H
38
N
4
O
6
•HCl•3H
2
O and a molecular weight of 677.19.
Irinotecan hydrochloride is slightly soluble in water and organic
solvents.
DESCRIPTION
Irinotecan hydrochloride is an antineoplastic agent of the
topoisomerase I
inhibitor class.
Irinotecan hydrochloride is a semisynthetic derivative of
camptothecin, an
alkaloid extract from plants such as _Camptotheca acuminata. _
Irinotecan hydrochloride concentrated injection is supplied as a
sterile, pale
yellow, clear, aqueous solution of pH 3.5. It is intended for dilution
with 5%
Glucose Injection (_preferred_) or 0.9% Sodium Chloride Injection
prior to
infusion.
In addition to irinotecan hydrochloride, the ingredients are sorbitol,
lactic acid,
sodium hydroxide and water for injections.
PHARMACOLOGY
Irinotecan
hydrochloride
is
a
derivative
of
camptothecin.
Camptothecins
interact specifically with the enzyme topoisomerase I which relieves
torsional
Filename: IriPI240114-clean
Page 2 of 26
strain
in
DNA
by
inducing
reversible
single-strand
breaks.
Irinotecan
hydrochloride and its active metabolite SN-38 bind to the
topoisomerase I -
DNA complex and prevent religation of these single-strand breaks.
Current
research suggests that the cytotoxicity of irinotecan hydrochloride is
due to
double-strand DNA damage produced during DNA synthesis when
replication
enzymes interact with the ternary complex formed by topoisomerase I,
DNA,
and
either
irinotecan
hydrochloride
or
SN-38.
Mammalian
cells
cannot
efficiently repair these double-strand breaks.
Irinotecan hydroch