Irinotecan Ebewe

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Irinotecan hydrochloride trihydrate 20 mg/mL;  

Available from:

Novartis New Zealand Ltd

INN (International Name):

Irinotecan hydrochloride trihydrate 20 mg/mL

Dosage:

20 mg/mL

Pharmaceutical form:

Solution for injection

Composition:

Active: Irinotecan hydrochloride trihydrate 20 mg/mL   Excipient: Lactic acid Sodium hydroxide Sorbitol Water for injection

Units in package:

Vial, glass, 500mg/25mL in a 50mL amber Type 1 glass vial with bromobutyl rubber stopper, 1 dose unit

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Dr Reddy's Laboratories Limited

Therapeutic indications:

Irinotecan Ebewe is indicated for the first line treatment of patients with metastatic carcinoma of the colon or rectum, in combination with 5FU/leucovorin. Irinotecan Ebewe is also indicated for patients with metastatic carcinoma of the colon or rectum whose disease has recurred or progressed following initial therapy.

Product summary:

Package - Contents - Shelf Life: Vial, glass, 40mg/2mL in a 2 mL amber Type 1 glass vial, bromobutyl rubber stopper - 2 mL - 24 months from date of manufacture stored at or below 25°C protect from light - Vial, glass, 150mg/7.5mL in a 10mL amber Type 1 glass vial, bromobutyl rubber stopper - 5 dose units - 24 months from date of manufacture stored at or below 25°C protect from light - Vial, glass, 100mg/5mL in a 5 mL amber Type 1 glass vial, bromobutyl rubber stopper - 5 dose units - 24 months from date of manufacture stored at or below 25°C protect from light - Vial, glass, 40mg/2mL in a 2 mL amber Type 1 glass vial, bromobutyl rubber stopper - 5 dose units - 24 months from date of manufacture stored at or below 25°C protect from light - Vial, glass, 100mg/5mL in a 5 mL amber Type 1 glass vial, bromobutyl rubber stopper - 5 mL - 24 months from date of manufacture stored at or below 25°C protect from light - Vial, glass, 150mg/7.5mL in a 10mL amber Type 1 glass vial, bromobutyl rubber stopper - 7.5 mL - 24 months from date of manufacture stored at or below 25°C protect from light - Vial, glass, 300mg/15mL in a 20mL amber Type 1 glass vial with bromobutyl rubber stopper - 15 mL - 24 months from date of manufacture stored at or below 25°C protect from light - Vial, glass, 500mg/25mL in a 50mL amber Type 1 glass vial with bromobutyl rubber stopper - 25 mL - 24 months from date of manufacture stored at or below 25°C protect from light

Authorization date:

2008-08-25

Patient Information leaflet

Irinotecan Ebewe
Irinotecan Ebewe_CMI_v1_24Sept09
Page 1 of 5
IRINOTECAN EBEWE
irinotecan hydrochlori
de
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
Irinotecan Ebewe.
It does not contain all the
available information. It does
not take the place of talking to
your doctor or pharmacist.
All medicines have benefits
and risks. Your doctor has
weighed the risks of you taking
Irinotecan against the benefits
this medicine is expected to
have for you.
IF YOU HAVE ANY CONCERNS
ABOUT TAKING THIS MEDICINE,
ASK YOUR DOCTOR OR
PHARMACIST.
KEEP THIS LEAFLET
YOU MAY NEED TO READ IT
AGAIN.
It is important to remember
that Irinotecan Ebewe is a
PRESCRIPTION ONLY
MEDICINE.
Irinotecan Ebewe will only be
given to you by specially
trained personnel in a hospital
environment.
WHAT IRINOTECAN
EBEWE IS USED FOR
Irinotecan Ebewe belongs to
the group of medicines called
antineoplastics or cytotoxic
medicines.
Irinotecan Ebewe 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.
Irinotecan Ebewe may be used
once spread of cancer beyond
the bowel is first diagnosed. At
this time Irinotecan Ebewe will
be given in combination with
other anticancer medicines.
Alternatively, Irinotecan
Ebewe is used alone when the
cancer has not responded or
has returned after initial
treatment.
ASK YOUR DOCTOR IF YOU HAVE
ANY QUESTIONS ABOUT WHY
IRINOTECAN EBEWE HAS BEEN
PRESCRIBED FOR YOU.
Your doctor may have
prescribed it for another
purpose.
BEFORE YOU ARE GIVEN
IRINOTECAN EBEWE
_WHEN YOU MUST NOT BE GIVEN _
_THIS MEDICINE: _
YOU MUST NOT BE GIVEN THIS
MEDICINE IF YOU HAVE HAD AN
ALLERGIC REACTION TO IRINOTECAN
EBEWE OR TO ANY OF THE
INGREDIENTS LISTED AT THE END
OF THIS LEAFLET
(
SEE PRODUCT
DESCRIPTION
).
Symptoms of an allergic
reaction may include:
•
shortness of breath,
wheezing, difficulty
breathing or a ti

Summary of Product characteristics

DataSheet_23 May 2014_v4.0
Page 1 of 37
DATASHEET
IRINOTECAN EBEWE
_ _
_IRINOTECAN HYDROCHLORIDE INJECTION 20 MG/ML _
NAME OF THE MEDICINE
Non-proprietary name: Irinotecan hydrochloride
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
DESCRIPTION
Irinotecan Ebewe (irinotecan hydrochloride injection) 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 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. It is slightly soluble in water and
organic solvents. Its
structural formula is as follows:
Irinotecan Ebewe is supplied as a sterile, light yellow, aqueous
solution with pH 3.0-3.8.
It is intended for dilution with 5% Glucose Injection or 0.9% Sodium
Chloride Injection
DataSheet_23 May 2014_v4.0
Page 2 of 37
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
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 hydrochloride serves as a w