Irinotecan 20 mg/ml Concentrate for solution for infusion

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Irinotecan hydrochloride trihydrate

Available from:

Fresenius Kabi Oncology Plc

ATC code:

L01XX; L01XX09

INN (International Name):

Irinotecan hydrochloride trihydrate

Dosage:

20 milligram(s)/millilitre

Pharmaceutical form:

Concentrate for solution for infusion

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Other antineoplastic agents; miltefosine

Authorization status:

Not marketed

Authorization date:

2008-05-02

Patient Information leaflet

Ver 005, September 2018
PACKAGE LEAFLET: INFORMATION FOR THE USER
IRINOTECAN 20 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION
irinotecan hydrochloride trihydrate
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
x
Keep this leaflet. You may need to read it again.
x
If you have any further questions, ask your doctor, pharmacist or
nurse.
x
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Irinotecan is and what it is used for
2.
What you need to know before you use Irinotecan
3.
How to use Irinotecan
4.
Possible side effects
5.
How to store Irinotecan
6.
Contents of the pack and other information
1.
WHAT IRINOTECAN IS AND WHAT IT IS USED FOR
Irinotecan is an anticancer medicine containing the active substance
irinotecan hydrochloride,
trihydrate.
Irinotecan hydrochloride trihydrate interferes with the growth and
spread of cancer cells in the body.
Irinotecan is indicated in combination with other medicines for the
treatment of patients with
advanced or metastatic cancer of the colon or rectum.
Irinotecan may be used alone in patients with metastatic cancer of the
colon or rectum whose disease
has recurred or progressed following initial fluorouracil-based
therapy.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE IRINOTECAN
DO NOT USE IRINOTECAN
x
if you have chronic inflammatory bowel disease and/or bowel
obstruction
x
if you are allergic to irinotecan hydrochloride trihydrate or any of
the other ingredients of this
medicine (listed in section 6 “What Irinotecan contains”)
x
if you are a breast-feeding woman (see section 2)
x
if your bilirubin level is higher than 3 times the upper limit of the
normal range
x
if you have severe bone marrow failure
x
if you are in poor general condition (WHO performance status higher
than 2)
x
if you are taking or have recently taken St John´s Wort (a herbal
extract containing Hyper

Summary of Product characteristics

Health Products Regulatory Authority
28 January 2019
CRN008QH2
Page 1 of 31
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Irinotecan 20 mg/ml Concentrate for solution for infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains 20 mg Irinotecan hydrochloride trihydrate, equivalent
to 17.33 mg
Irinotecan.
Each vial with 2 ml contains 40 mg Irinotecan hydrochloride
trihydrate.
Each vial with 5 ml contains 100 mg Irinotecan hydrochloride
trihydrate.
Each vial with 15 ml contains 300 mg Irinotecan hydrochloride
trihydrate.
Each vial with 25 ml contains 500 mg Irinotecan hydrochloride
trihydrate.
Excipient(s) with known effect:
Each ml contains 45 mg sorbitol.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Concentrate for solution for infusion.
Light yellow coloured solution.
pH: 3.0 – 3.7
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Irinotecan is indicated for the treatment of patients with advanced
colorectal cancer:

in combination with 5-fluorouracil and folinic acid in patients
without prior
chemotherapy for advanced disease,

as a single agent in patients who have failed an established
5-fluorouracil
containing treatment regimen.
Irinotecan in combination with cetuximab is indicated for the
treatment of patients
with epidermal growth factor receptor (EGFR)–expressing RAS
wild-type metastatic
colorectal cancer, who had not received prior treatment for metastatic
disease or
after failure of irinotecan-including cytotoxic therapy (see section
5.1).
Health Products Regulatory Authority
28 January 2019
CRN008QH2
Page 2 of 31
Irinotecan in combination with 5-fluorouracil, folinic acid and
bevacizumab is
indicated for first-line treatment of patients with metastatic
carcinoma of the colon
or rectum.
Irinotecan in combination with capecitabine with or without
bevacizumab is indicated
for first-line treatment of patients with metastatic colorectal
carcinoma.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
For adults only. Irinotecan solution for