IRINOTECAN ACCORD irinotecan hydrochloride trihydrate 100 mg/5 mL concentrated injection vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

irinotecan hydrochloride trihydrate, Quantity: 100 mg

Available from:

Accord Healthcare Pty Ltd

INN (International Name):

irinotecan hydrochloride trihydrate

Pharmaceutical form:

Injection, concentrated

Composition:

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

Administration route:

Intravenous Infusion

Units in package:

1 vial

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Irinotecan hydrochloride is indicated as a component of first-line therapy for patients with metastatic carcinoma of the colon or rectum. Irinotecan hydrochloride is also indicated for patients with metastatic carcinoma of the colon or rectum whose disease has recurred or progressed following initial therapy.

Product summary:

Visual Identification: A pale yellow clear solution; Container Type: Vial; Container Material: Glass Type I Coloured; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Licence status A

Authorization date:

2014-06-12

Patient Information leaflet

Version 4.0
Page 1 of 5
IRINOTECAN ACCORD
_Irinotecan Hydrochloride Concentrated Injection 40 mg/2mL, 100 mg/5
mL, 300 mg/15 mL and _
_500 mg/25 mL _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Irinotecan Accord. 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 Accord 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.
You may need to read it again.
WHAT IRINOTECAN
ACCORD IS USED FOR
Irinotecan Accord 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 Accord may be used once
spread of cancer beyond the bowel is
first diagnosed. At this time Irinotecan
Accord will be given in combination
with other anticancer medicines.
Alternatively, Irinotecan Accord 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
Accord has been prescribed for you.
Your doctor may have prescribed it
for another purpose.
_USE IN CHILDREN _
It is not known if Irinotecan Accord is
safe and effective in the treatment of
children.
BEFORE YOU ARE GIVEN
IRINOTECAN ACCORD
_WHEN IRINOTECAN ACCORD _
_MUST NOT BE GIVEN _
Irinotecan Accord must not be given if
you:
•
are allergic to irinotecan
hydrochloride
•
or any of the ingredients listed at
the end of this leaflet
•
Some of the symptoms of an allergic
reaction may include:
•
shortness of breath
•
wheezing or difficulty breathing
•
swelling of the face, lips, tongue
or other parts of the body
•
rash, itching or hives on the skin
•
add any other specific reactions

Summary of Product characteristics

Page 1 of 25
AUSTRALIAN PRODUCT INFORMATION
IRINOTECAN ACCORD (IRINOTECAN HYDROCHLORIDE TRIHYDRATE)
CONCENTRATED INJECTION
1
NAME OF THE MEDICINE
Irinotecan hydrochloride trihydrate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Irinotecan
Accord
(Irinotecan
hydrochloride
trihydrate)
concentrated
injection
is
available
in
40 mg/2 mL, 100 mg/5 mL, 300 mg/15 mL and 500 mg/25 mL single dose
vials.
For the full list of excipients, see
SECTION 6.1 LIST OF EXCIPIENTS
.
3
PHARMACEUTICAL FORM
Irinotecan hydrochloride concentrated injection is supplied as a
sterile, pale yellow, clear, aqueous
solution with pH 3.0 – 3.8. It is intended for dilution with 5%
Glucose Injection or 0.9% Sodium Chloride
Injection prior to infusion.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Irinotecan hydrochloride is indicated as a component of first-line
therapy for patients with metastatic
carcinoma of the colon or rectum. Irinotecan hydrochloride is also
indicated for patients with metastatic
carcinoma of the colon or rectum whose disease has recurred or
progressed following initial therapy.
4.2
D
OSE AND METHOD OF ADMINISTRATION
It is recommended that patients receive premedication with antiemetic
agents. Prophylactic or therapeutic
administration of atropine should be considered in patients
experiencing cholinergic symptoms (see
SECTION 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
).
COMBINATION AGENT THERAPY
_DOSAGE REGIMENS _
_IRINOTECAN HYDROCHLORIDE IN COMBINATION WITH FLUOROURACIL (5-FU) AND
LEUCOVORIN (LV). _
Irinotecan hydrochloride should be administered as an intravenous
infusion over 90 minutes (see
Preparation of Infusion solution). For all regimens, the dose of LV
should be administered immediately
after irinotecan hydrochloride, with the administration of 5-FU to
follow immediately after the
administration of LV. The recommended regimens are shown in Table 1.
TABLE 1:
COMBINATION AGENT DOSAGE REGIMENS & DOSE MODIFICATIONS
A
REGIMEN 1
6 week cycle
Treatment
resumes Day
43
Irinotecan
hydrochloride
LV
5-FU
125 mg/m
2
IV o