Irinotecan Hydrochloride 20mg/ml concentrate for solution for infusion (500mg/25ml)

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

IRINOTECAN HYDROCHLORIDE TRIHYDRATE

Available from:

Hospira UK Limited

ATC code:

L01XX19

INN (International Name):

IRINOTECAN HYDROCHLORIDE TRIHYDRATE

Pharmaceutical form:

CONCENTRATE FOR SOLUTION FOR INFUSION

Composition:

IRINOTECAN HYDROCHLORIDE TRIHYDRATE 20 mg

Prescription type:

POM

Therapeutic area:

ANTINEOPLASTIC AGENTS

Authorization status:

Authorised

Authorization date:

2009-12-11

Patient Information leaflet

Page 1 of 9
PACKAGE LEAFLET: INFORMATION FOR THE USER
IRINOTECAN HYDROCHLORIDE 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.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor, or pharmacist or
nurse
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm
them, even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor, or 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 Hydrochloride is and what it is used for
2.
What you need to know before you use Irinotecan Hydrochloride
3.
How to use Irinotecan Hydrochloride
4.
Possible side effects
5
How to store Irinotecan Hydrochloride
6.
Contents of the pack and other information
1.
WHAT IRINOTECAN HYDROCHLORIDE IS AND WHAT IT IS USED FOR
Irinotecan
Hydrochloride
belongs
to
a
group
of
medicines
called
cytostatics
(anti-cancer
medicines).
Irinotecan Hydrochloride is used for the treatment of advanced cancer
of colon and rectum in adults
and where the disease is at an advanced stage in the large intestine,
either in combination with other
medicines (combination therapy) or alone (monotherapy).
Your doctor may use a combination of irinotecan with
5-fluorouracil/folinic acid (5-FU/FA) and
bevacizumab to treat your cancer of the colon and rectum.
Your doctor may use a combination of irinotecan with capecitabine with
or without bevacizumab to
treat your cancer of the colon and rectum.
Your doctor may use a combination of irinotecan with cetuximab to
treat cancer of the large
intestine (KRAS wild-type) that is of a certain type known to display
cell markers referred to as
epidermal growth factor receptors (EGFR) which are blocked by the
monoclonal antibody.
If you need any further information

Summary of Product characteristics

Page 1 of 24
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Irinotecan Hydrochloride 20mg/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 25 ml contains 500 mg Irinotecan hydrochloride
trihydrate.
Excipients with known effect:
Sorbitol (E420): 45.0 mg/ml
Each 40 mg/2ml vial contains 0.069 mg/ml of sodium (0.14 mg).
Each 100mg/5 ml vial contains 0.071 mg/ml sodium (0.35 mg)
Each 500 mg/25 ml vial contains 0.071 mg/ml of sodium (1.77 mg).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Concentrate for solution for infusion
A clear, colourless to pale yellow solution.
pH: 3.0 – 3.8
Osmolarity: 276 mOsm/kg.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Irinotecan is indicated for the treatment of patients with advanced
colorectal cancer:

In combination with 5-fluorouracil (5-FU) and folinic acid (FA) in
patients without
prior chemotherapy for advanced disease.

As a single agent in patients who have failed an established 5-FU
containing treatment
regimen
Page 2 of 24
Irinotecan in combination with Cetuximab is indicated for the
treatment of patients with
epidermal growth factor receptor (EGFR)-expressing, KRAS 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).
Irinotecan in combination with 5-FU, FA 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
For adults only. Diluted Irinotecan