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IRINOTECAN HYDROCHLORIDE 20MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION

Active substance(s): IRINOTECAN HYDROCHLORIDE TRIHYDRATE

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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 on
your condition, please ask your doctor.

2. What you need to know before
you use Irinotecan Hydrochloride
Do not use Irinotecan Hydrochloride:
• if you are hypersensitive (allergic) to
irinotecan hydrochloride trihydrate or
any of the other ingredients of this
medicine (listed in section 6).
• if you have any other bowel disease
or a history of bowel obstruction
• if you have increased levels of
bilirubin in the blood (more than
3 times the upper limit of the
normal range)
• if you have an imbalance of
your blood cells (severe bone
marrow failure)
• if you are in a poor general health
(evaluated by an international
standard)
• if you are using the natural
remedy St John’s wort
(Hypericum perforatum)
• if you are pregnant or breast-feeding
or if you think you might be pregnant
For additional contraindications
of cetuximab or bevacizumab or
capecitabine, which may be used in
combination with irinotecan, please
refer to the product information for
these medicinal products.

Warnings and precautions:
This medicine is intended for adults
only. Check with your doctor if this
medicine has been prescribed for use
in a child.
Special care is also needed in
elderly patients.
As Irinotecan Hydrochloride is
an anti-cancer medicine it will be
administered to you in a special unit
and under supervision of a doctor
qualified in the use of anti-cancer
medicines. The units’ personnel will
explain to you what you need to take
special care of during and after the
treatment. This leaflet may help you to
remember that.
If you receive irinotecan in combination
with cetuximab or bevacizumab or
capecitabine, please make sure that
you also read the package leaflet for
these medicinal products.

Before you use this medicine tell
your doctor if any of the following
apply to you:
If you have heart problems.
If you smoke, have high blood pressure
or high cholesterol as these can
increase the risk of heart problems
during treatment with this medicine.
If you have had or are due to have
any vaccinations.
During administration of
irinotecan (30-90 minutes) and up
to 24 hours after administration
you may experience some of the
following symptoms:
• diarrhoea
• sweating
• abdominal pain
• watering eyes
• visual disturbance
• excessive mouth watering
The medical term for these symptoms
is “acute cholinergic syndrome”
which can be treated (with atropine).
If you have any of these symptoms,
immediately tell your doctor who will
give you any treatment necessary.
From the day after treatment with
irinotecan until next treatment you
may experience various symptoms,
which may be serious and require
immediate treatment and close
supervision.
These can be:
Diarrhoea
If your diarrhoea starts more than
24 hours after administration of

irinotecan (“delayed diarrhoea”) it may
be serious. It is often seen about 5 days
after administration. The diarrhoea
should be treated immediately
and kept under close supervision.
Immediately after the first liquid stools
do the following:
1. Take any antidiarrhoeal treatment
that the doctor has given you,
exactly as he/she has told you.
The treatment must not be changed
without consulting the doctor.
Recommended antidiarrhoeal
treatment is loperamide (4 mg for
the first intake and then 2 mg every
2 hours, also during the night).
This should be continued for at
least 12 hours after the last liquid
stools. The recommended dosage
of loperamide must not be taken for
more than 48 hours.
2. Drink large amounts of water and
rehydration fluids, immediately
(i.e. water, soda water, fizzy drinks,
soup or oral rehydration therapy).
3. Immediately inform your doctor who
is supervising the treatment, and
tell him/her about the diarrhoea. If
you are not able to reach the doctor,
contact the hospital unit supervising
the irinotecan treatment. It is very
important that they are aware of
the diarrhoea.
Hospitalisation is recommended for the
management of the diarrhoea, in the
following cases:
• you have diarrhoea as well as fever
(over 38°C)
• you have severe diarrhoea (and
vomiting) with excessive loss of
water requiring intravenous hydration
• you still have diarrhoea 48 hours
after starting the diarrhoea treatment
Note! Do not take any treatment for
diarrhoea other than that given to you
by your doctor and the fluids described
above. Follow the doctor’s instructions.
The antidiarrhoeal treatment should not
be used preventive, even though you
have experienced delayed diarrhoea at
previous cycles.
Fever
If the body temperature increases over
38°C it may be a sign of infection,
especially if you also have diarrhoea.
If you have any fever (over 38°C)
contact your doctor or the hospital unit
immediately so that they can give you
any treatment necessary.
Nausea (feeling sick) and vomiting
If you have nausea and/or vomiting
contact your doctor or the hospital
unit immediately.
Neutropenia
Irinotecan may cause a decrease in
the number of some of your white
blood cells, which play an important
role in fighting infections. This is called
neutropenia. Neutropenia is often
seen during treatment with irinotecan
and is reversible. Your doctor should
arrange for you to have regular blood
tests to monitor these white blood
cells. Neutropenia is serious and
should be treated immediately and
carefully monitored.
Breathing difficulties
If you have any breathing difficulties
contact your doctor immediately.
Impaired liver function
Before treatment with irinotecan is
started and before every following
treatment cycle your doctor will monitor
your liver function (by blood tests).
Impaired kidney function
As this medicine has not been tested in
patients with kidney problems, please
check with your doctor if you have any
kidney problems.
If you have one or more of the
symptoms mentioned above,
after you have returned home
from the hospital, you should
immediately contact the doctor or
the hospital unit supervising your
irinotecan treatment.

Other medicines and Irinotecan
Hydrochloride
Please tell your doctor or hospital
pharmacist if you are taking or have
recently taken, any other medicines,
including medicines obtained without
a prescription. This is also valid for
herbal medicines.
The following medications can alter the
effects of irinotecan:
• carbamazepine, phenobarbital
or phenytoin (drugs used in the
management of epilepsy)
• ketoconazole (used for the treatment
of fungal infections)
• rifampicin (used for the treatment
of tuberculosis)
• the herbal medicine St John’s wort
(Hypericum perforatum) must not be
used during treatment with irinotecan
and not between treatments,
as it may decrease the effect
of irinotecan.
• Atazanavir (used to treat HIV)
• Anticoagulants (used to thin
the blood)
• Vaccines. Tell your doctor if you
have had or are due to have
any vaccinations
• Ciclosporin or tacromilus (used
to dampen down your body’s
immune system)
If you require an operation, please tell
your doctor or anaesthetist that you
are using this medicine, as it may alter
the effect of some medicines used
during surgery.

Pregnancy and breast-feeding:
You must not be given irinotecan if you
are pregnant.
If you or your partner is being treated
with irinotecan you must avoid
becoming pregnant during treatment.
Men and women should use adequate
contraception while being treated and
for at least:
• three months after cessation of
therapy
Still, if you become pregnant, during
this period you must immediately inform
your doctor.
You must not breast-feed while you are
being treated with irinotecan.

Driving and using machines
In some cases Irinotecan Hydrochloride
may cause side effects which affect
your ability to drive and use tools and
machines. Contact your doctor or
pharmacist if you are unsure.
During the first 24 hours after
administration of Irinotecan
Hydrochloride you may feel dizzy
or have visual disturbances. If this
happens to you do not drive or
operate machinery.
Irinotecan Hydrochloride contains
sorbitol. If you have been told by your
doctor that you have an intolerance to
some sugars (e.g. fructose intolerance),
contact your doctor before you take this
medicinal product.
This medicinal product also contains
less than 1 mmol sodium (23 mg) per
dose, i.e. essentially ‘sodium-free’.

The following information is intended for healthcare professionals only

INSTRUCTIONS FOR USE, HANDLING AND DISPOSAL
As with other potentially toxic compounds, caution should be exercised when handling
and preparing irinotecan solutions.

Instructions for use/handling
As with other antineoplastic agents, irinotecan must be prepared and handled with
caution. The use of goggles, mask and gloves is required. Pregnant women should
not handle cytotoxics. If irinotecan concentrate or infusion solutions should come into
contact with the skin, it must be washed off immediately and thoroughly with soap and
water. If irinotecan concentrate or infusion solutions should come into contact with the
mucous membranes, it must be washed off immediately with water.
Q710113

Component Specification

Requester

Item number:

Q710113

Request number:

AS5468

Country:

UK

OI template:
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Mulgrave version:

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Dimensions:
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Supplier:
Stock:
Folded dimensions:
Printed both sides:
Perforated:

118 x 570 mm
(20 panels)
Vial
EU Packing Centre
40 gsm
28.5 x 118 mm
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colours, registration numbers and scientific
equations, the name and address and
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related items.
This artwork is in conformance with the
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Previous Item Number: Q73939

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Signed:
Date:
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Technician: NR
Date: 22/Jan/16

Version 2
Technician: JE
Date: 16/Feb/16

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Date: 18/Feb/16

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3. How to use Irinotecan Hydrochloride
Always use this medicine exactly as
your doctor or pharmacist has told you.
Check with your doctor or pharmacist if
you are not sure.
For adults only.
Irinotecan will be given as an infusion
into your veins over a period of
30-90 minutes.
The amount of infusion you are given
will depend on your age, height, weight
and general medical condition. Your
doctor will calculate your body surface
area in square metres (m2) from your
height and weight. The dosage will also
depend on any other treatment you may
have received for your cancer.
• if you have previously been treated
with 5-fluorouracil you will normally
be treated with irinotecan alone
starting with a dose of 350 mg/m2
every 3 weeks.
• if you have not had previous
chemotherapy you will normally
receive 180 mg/m2 irinotecan every
two weeks. This will be followed by
folinic acid and 5-fluorouracil.
If you receive irinotecan in combination
with cetuximab, irinotecan must not be
administered earlier than one hour after
the end of the cetuximab infusion.
Please follow the advice of your doctor
regarding your current treatment.
These dosages may be adjusted
by your doctor depending on your
condition and any side effects you
may have.

If you use more Irinotecan
Hydrochloride than you should
receive:
In case you were given a higher dosage
of irinotecan than required the occurring
side effects may be more severe. You
will get maximum supportive care to
prevent dehydration due to diarrhoea
and to treat any infectious complication.
If you think you have been administered
an overdose please contact your doctor.
If you have any further questions on the
use of this medicine, ask your doctor or
pharmacist or nurse.

4. Possible side effects
Like all medicines, this medicine
can cause side effects, although not
everybody gets them. Your doctor will
discuss these side effects with you
and explain the risks and benefits of
your treatment.

Some of these side effects must be
treated immediately. These are:
• diarrhoea
• a decrease in the number of
neutrophil granulocytes, a type of
white blood cell, which plays an
important role in fighting infections.
• fever
• nausea and vomiting
• breathing difficulties (possible
symptom of severe allergic reactions)
Please read instructions described
in section “Take special care with
irinotecan” carefully and follow them
if you have any of the side effects
listed above.

Other side effects include:
Very common side effects (more than
1 in 10 patients)
• blood disorders including
abnormally low number of neutrophil
granulocytes, a type of white blood
cell (neutropenia) and reduction
of the quantity of haemoglobin in
blood (anaemia)
• in combination therapy,
thrombocytopenia (reduction in the
number of blood platelets) causing
bruises, tendency to bleed and
abnormal bleeding
• in monotherapy, fever
• in monotherapy, infections
• delayed severe diarrhoea
• in monotherapy, severe nausea
(feeling sick) and vomiting
(being sick)
• hair loss (the hair grows again after
end of treatment)
• in combination therapy, transient
and mild to moderate increase in
serum levels of some liver enzymes
(SGPT, SGOT, alkaline phosphatase)
or bilirubin
Common side effects (less than 1 in
10 patients but more than 1 in 100)
• severe transient acute cholinergic
syndrome: the main symptoms
are defined as early diarrhoea and
various other symptoms such as
abdominal pain; red, sore, itching
or weeping eyes (conjunctivitis);
running nose (rhinitis); low blood
pressure; flushing due to widening
of the blood vessels (vasodilation);
sweating; chills; a feeling of
general discomfort and illness;
dizziness; visual disturbances; pupil
contraction; watering eyes and
increased salivation, occurring during
or within the first 24 hours after the
infusion of Irinotecan Hydrochloride
• in monotherapy, thrombocytopenia
(reduction in the number of blood
platelets) causing bruises, tendency
to bleed and abnormal bleeding
• in combination therapy, fever
• in combination therapy, infections
• infections associated with a severe
decrease in the number of some
white blood cells (neutropenia)
resulting in death in 3 cases
• fever associated with a severe
decrease in the number of some
white blood cells (febrile neutropenia)
• in combination therapy, severe
nausea (feeling sick) and vomiting
(being sick)
• loss of water (dehydration),
commonly associated with diarrhoea
and/or vomiting
• constipation
• feeling weak (asthenia)
• in monotherapy, transient and mild to
moderate increase in serum levels of
some liver enzymes (transaminases,
alkaline phosphatase) or bilirubin
• transient and mild to moderate
increase of levels of creatinine in
the blood
• in combination therapy, transient
pronounced (grade 3) increase in
serum levels of bilirubin
Uncommon side effects (less than 1 in
100 patients but more than 1 in 1,000)
• mild allergic reaction (skin rash
including red itchy skin, urticaria,
conjunctivitis, rhinitis)
• mild skin reactions
• mild reactions at the infusion site
• lung disease presenting as shortness
of breath, dry cough, and inspiratory
crackles (interstitial pulmonary
disease); early effects such as
breathing difficulties
• partial or complete blockage of the
bowel (intestinal obstruction, ileus),
stomach and intestines bleeding
• bowel inflammation causing
abdominal pain and/or
diarrhoea (a condition known as
pseudo-membraneous colitis)

• renal insufficiency, low blood
pressure or cardio-circulatory
failure in patients who experienced
episodes of dehydration associated
with diarrhoea and/or vomiting or
sepsis
Rare side effects (less than 1 in
1,000 patients but more than 1 in 10,000)
• severe allergic reactions
(anaphylatic/anaphylactoid
reaction), including swelling of
the hands, feet, ankles, face, lips,
mouth or throat which may cause
difficulty in swallowing or extreme
difficulty breathing
• muscular contraction or cramps and
numbness (paraesthesia)
• inflammation of the large
bowel causing abdominal pain
(colitis including typhlitis, ischemic
and ulcerative colitis)
• intestinal perforation
• loss of appetite
• abdominal pain
• inflammation of the mucous
membranes
• decreased levels of potassium and
sodium in the blood, mostly related
to diarrhoea and vomiting
• symptomatic and asymptomatic
inflammation of the pancreas
(mainly abdominal pain)
• increased blood pressure during and
following administration
Very rare effects (less than 1 in
10,000 patients)
• transient speech disorders
• increase in levels of some digestive
enzymes which break down sugars
(amylase) and fats (lipase)
• one case of low platelet count
in the blood due to antibodies
against platelets
If you receive irinotecan in combination
with cetuximab, some of the side
effects you may experience can also
be related to this combination. Such
side effects may include an acne-like
rash. Therefore, please make sure
that you also read the package leaflet
for cetuximab.
If you receive irinotecan in combination
with capecitabine, some of the side
effects you may experience can also
be related to this combination. Such
side effects may include: very common
blood clots, common allergic reactions,
heart attack and fever in patients with
a low white blood cell count. Therefore,
please make sure that you also read
the package leaflet for capecitabine.
If you receive irinotecan in combination
with capecitabine and bevacizumab,
some of the side effects you may
experience can also be related to this
combination. Such side effects include:
low white blood cell count, blood
clots, high blood pressure and heart
attack. Therefore, please make sure
that you also read the package leaflet
for capecitabine.

Reporting of side effects
If you get any side effects, talk to your
doctor or pharmacist. This includes any
possible side effects not listed in this
leaflet. You can also report side effects
directly via UK Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
By reporting side effects you can help
provide more information on the safety
of this medicine.

5. How to store Irinotecan
Hydrochloride
• Keep this medicine out of the sight
and reach of children.
• Do not use this medicine after the
expiry date which is stated on the
label and carton. The expiry date
refers to the last day of that month.
• Concentrate: Keep vials in the
outer carton in order to protect
from light. Do not freeze. Once
opened vials should be used
immediately as they contain no
antimicrobial preservatives.
• Diluted concentrate: For single
use only. Unused solution should
be discarded
• Following dilution: Chemical and
physical in-use stability has been
demonstrated in glucose 50 mg/ml
(5%) and sodium chloride 9 mg/ml
(0.9%) for 72 hours at 2-8°C. From
a microbiological point of view, the
product should be used immediately.
If not used immediately, in-use
storage times and conditions prior to
use are the responsibility of the user
and would normally not be longer
than 24 hours at 2 to 8°C, unless
dilution has taken place in controlled
and validated aseptic conditions.
Do not use this medicine if you notice
particles visible in the concentrate or
infusion solution.
Do not throw away any medicines
via wastewater or household waste.
Ask your pharmacist how to throw
away medicines you no longer use.
These measures will help protect
the environment.

6. Contents of the pack and other
information
What Irinotecan Hydrochloride
contains
• The active substance is irinotecan
hydrochloride trihydrate. Each
millilitre (ml) of solution contains
20 milligrams (mg) of irinotecan
hydrochloride trihydrate, equivalent
to 17.33 mg irinotecan.
• The other ingredients are sorbitol
(E420), lactic acid, Water for
Injections, and sodium hydroxide and
hydrochloric acid (used to adjust pH).

What Irinotecan Hydrochloride looks
like and contents of the pack
Irinotecan Hydrochloride is in the form
of a concentrate for solution for infusion
(a concentrated solution which is diluted
to make a solution which is given as a
slow infusion via a drip).
The medicine comes in glass
containers called vials, containing
2 ml, 5 ml and 25 ml of irinotecan
hydrochloride trihydrate.
The vials are wrapped in a protective
plastic to reduce the risk of spillage if
the vials break - these are referred to
as ONCO-TAIN™ vials.
The vials are available in single packs.
Not all presentations may be marketed.

Marketing Authorisation Holder and
Manufacturer
Hospira UK Limited
Queensway
Royal Leamington Spa
Warwickshire CV31 3RW
United Kingdom
This leaflet was last revised in
October 2015.

Preparation of the intravenous infusion
As with any other infusions, irinotecan infusion must be prepared using
aseptic technique.
If any precipitate is observed in the vials or in the infusion solution, the product must
be discarded according to standard procedures for discarding cytotoxic agents.
Aseptically withdraw the required amount of irinotecan concentrate from the vial with
a calibrated syringe and inject into a 250 ml infusion bag or bottle containing either
9 mg/ml (0.9%) sodium chloride solution or 50 mg/ml (5%) glucose solution only.
The infusion should then be thoroughly mixed by manual rotation.

Disposal
All materials used for dilution and administration should be disposed of according to
local procedures applicable to the discarding of cytotoxic agents.
Q710113

Component Specification

Requester

Item number:

Q710113

Request number:

AS5468

Country:

UK

OI template:
Amalia version:
Mulgrave version:

SVI007
1
N/A

Dimensions:
Container(s):
Supplier:
Stock:
Folded dimensions:
Printed both sides:
Perforated:

118 x 570 mm
(20 panels)
Vial
EU Packing Centre
40 gsm
28.5 x 118 mm
Yes
No

I have checked this artwork against the
registered text including spelling, layout, size,
colours, registration numbers and scientific
equations, the name and address and
trademarks. Also for any possible changes to
related items.
This artwork is in conformance with the
Marketing Authorisation and can now proceed
to the printing stage.
Previous Item Number: Q73939

Pharma code:
Pharma code length:
Supplier Code:

N/A
N/A
N/A

Colours
Black:

Signed:
Date:
Version 1
Technician: NR
Date: 22/Jan/16

Version 2
Technician: JE
Date: 16/Feb/16

Version 3
Technician: JW
Date: 18/Feb/16

Version 4
Technician: XX
Date: dd/mmm/yy

Version 5
Technician: XX
Date: dd/mmm/yy

Version 6
Technician: XX
Date: dd/mmm/yy

Version 7
Technician: XX
Date: dd/mmm/yy

Version 8
Technician: XX
Date: dd/mmm/yy

Version 9
Technician: XX
Date: dd/mmm/yy

Version 10
Technician: XX
Date: dd/mmm/yy

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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