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IRINOTECAN 20MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION

Active substance(s): IRINOTECAN HYDROCHLORIDE TRIHYDRATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

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Irinotecan 20 mg/ml Concentrate for
Solution for Infusion

Irinotecan hydrochloride trihydrate

Read all of this leaflet carefully before you start using this medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm
them, even if their symptoms are the same as yours.
• If any of the side effects gets serious, or if you notice any side effects not listed in
this leaflet, please tell your doctor.

In this leaflet:
1. What Irinotecan is and what it is used
for
2. Before you use Irinotecan
3. How to use Irinotecan
4. Possible side effects
5. How to store Irinotecan
6. Further information

1

What Irinotecan is and what
it is used for

Irinotecan belongs to a group of medicines
called cytostatics (anti-cancer medicines).
Irinotecan is used for the treatment of
advanced cancer of the colon and rectum in
adults, either in a combination with other
medicines (i.e. 5-fluorouracil/folinic acid,
bevacizumab, cetuximab, capecitabine) or
alone.

2

Before you use Irinotecan

Do not use Irinotecan
• if you are allergic (hypersensitive) to
irinotecan hydrochloride trihydrate or any
of the other ingredients of Irinotecan
• if you have any other bowel disease or a
history of bowel obstruction
• if you are pregnant or breast-feeding
• if you have increased levels of bilirubin in
the blood (more than 3 times the upper
limit of normal)
• if you have 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.
Johnsʼ Wort (Hypericum perforatum)
About additional contraindications of
cetuximab, bevacizumab or capecitabine
please read the product information of
these medicines.

Take special care with Irinotecan
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 is an anti-cancer medicine it
will be administered to you in a special unit
and under the supervision of a doctor
qualified in the use of anti-cancer
medicines. The unitʼs 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.
1)

The first 24 hours after
administration of Irinotecan

During administration of Irinotecan
(30-90 min.) and shortly 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.
2)

From the day after treatment with
Irinotecan until next treatment

During this period you may experience
various symptoms, which may be serious
and require immediate treatment and close
supervision.

- 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.

2.
3.

Take any anti-diarrhoeal treatment
that the doctor has given you,
exactly as he/she has told you. The
treatment may not be changed
without consulting the doctor.
Recommended anti-diarrhoeal
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 may not be taken for
more than 48 hours.
Drink large amounts of water and
rehydration fluids, immediately (i.e.
water, soda water, fizzy drinks, soup
or oral rehydration therapy).
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 unit at the hospital
supervising the Irinotecan
treatment. It is very important that
they are aware of the diarrhoea.

You must immediately tell the doctor, or
the unit supervising the treatment, if
• you have nausea and vomiting as well
as diarrhoea
• you have any fever as well as the
diarrhoea
• 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 doctorʼs instructions. The
anti-diarrhoeal treatment should not be
used to prevent a further episode of
diarrhoea, even though you have
experienced delayed diarrhoea at previous
cycles.

The following information is intended for
medical or healthcare professionals
only:

- 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 unit immediately so that they
can give you any treatment necessary.
- Nausea and vomiting
If you have nausea and/or vomiting contact
your doctor or the 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 immediateley 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
the liver function should be monitored (by
blood tests).
If you have one or more of the symptoms
mentioned, after you have returned home
from the hospital, you should immediately
contact the doctor or the unit supervising
the Irinotecan treatment.

- 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.

Using other medicines
Please tell your doctor if you are taking or
have recently taken any other medicines,
including medicines obtained without a
prescription. This is also valid for herbal
medicines, strong vitamins and minerals.
Some medicines may alter the effects of
Irinotecan e.g. ketoconazole (for the
treatment of fungal infections), rifampicin
(for the treatment of tuberculosis) and some
medicines for the treatment of epilepsy
(carbamazepine, phenobarbital and
phenytoin).
The herbal medicine St Johnʼs Wort
(Hypericum perforatum) may not be used
concurrent with Irinotecan and not between
treatments, as it may decrease the effect of
irinotecan.
If you require an operation, please tell your
doctor or anaesthetist that you are using
this medicine, as it may alter the affect of
some medicines used during surgery.

If you receive Irinotecan in combination with
a medicinal product containing cetuximab,
bevacizumab or capecitabine, please make
sure that you also read the package inserts
for those products.
Pregnancy
You must not receive Irinotecan if you are
pregnant.
Women of child-bearing age should avoid
becoming pregnant. Contraceptive
measures must be taken by both male and
female patients during and for at least three
months after cessation of therapy. Still, if
you become pregnant, think you could be
pregnant, or could become pregnant during
this period you must immediately inform
your doctor.
Breast-feeding
It is not known whether Irinotecan is
excreted in human milk. Consequently, you
must not breast-feed while you are treated
with Irinotecan.
Driving and using machines
In some cases Irinotecan may cause side
effects which affect the 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 you may feel
dizzy or have visual disturbances. If this
happens to you do not drive or use any
tools or machines.

Important information about some of the
ingredients of Irinotecan
Irinotecan contains sorbitol. If you suffer
from intolerance to some sugars, tell your
doctor before you are given this medicinal
product.
This medicinal product contains less than
1 mmol sodium (23 mg) per dose, i.e.
essentially ʻsodium- freeʼ.

3

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, size and general
medical condition. It will also depend on
any other treatment you may have received
for your cancer. Your doctor will calculate
your body surface area in square meters
(m2).

• 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.

Continued on the next page >>

2.

Instruction for use

Cytotoxic
Handling of Irinotecan
As with all antineoplastic agents, caution
should be exercised when handling
Irinotecan. Dilution should be carried out
under aseptic conditions by trained
personnel in a designated area.
Precautions should be taken to avoid
contact with the skin and mucous
membranes.
Protection instructions for preparation of
Irinotecan solution for infusion
1. Protective chamber should be used
and protective gloves as well as
protective gown should be worn. If
there is no protective chamber
available mouth cover and goggles
should be used.

How to use Irinotecan

3.

Opened containers, like injection vials
and infusion bottles and used
cannulae, syringes, catheters, tubes,
and residuals of cytostatics should be
considered as hazardous waste and
undergo disposal according to local
guidelines for the handling of
HAZARDOUS WASTE.
Follow the instructions below in case of
spillage:
- protective clothing should be worn
- broken glass should be collected
and placed in the container for
HAZARDOUS WASTE
- contaminated surfaces should be
flushed properly with copious
amounts of cold water
- the flushed surfaces should then be
wiped thoroughly and the materials
used for wiping should be disposed
as HAZARDOUS WASTE

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Continued on the next page >>

• 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 are treated with Irinotecan in
combination with cetuximab you will
normally receive the same dose of
irinotecan as administered in the last
cycles of the prior irinotecan containing
regimen.

Irinotecan must not be administered earlier
than 1 hour after the end of the cetuximab
infusion.

If you receive Irinotecan in combination with
cetuximab, please consult the cetuximab
leaflet.
If you receive Irinotecan in combination with
bevacizumab, please consult the
bevacizumab leaflet.
If you receive Irinotecan in combination with
capecitabine, please consult the
capecitabine leaflet.
These dosages may be adjusted by your
doctor depending on your condition and
any side-effects you may have.

4

Possible side effects

Like all medicines, Irinotecan 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,
see also information in section “Take
special care with Irinotecan”.

Very common side effects (affects more
than 1 user in 10):
• Neutropenia (decreased number of
some white blood cells), which increases
the risk of infections.
• Anaemia (decreased number of red
blood cells), which can make the skin
pale and cause weakness and
breathlessness.
• In combination therapy,
thrombocytopenia (decreased number of
blood platelets) causing bruises,
tendency to bleed and abnormal
bleeding.
• In monotherapy, fever and infection.
• Delayed severe diarrhoea.
• In monotherapy, severe nausea, and
vomiting.
• In monotherapy, fever in the absence of
infection and without concomitant severe
decrease in the number of some white
blood cells (neutropenia).
• Hair loss (the hair grows again after end
of treatment).
• In combination therapy, transient and
mild to moderate increase in serum
levels of some enzymes (SGPT, SGOT,
alkaline phosphatase) or bilirubin.
• In combination therapy with capecitabine
all grade adverse drug reactions:
thrombosis/embolism.

Common side effects (affects 1 to 10
users in 100):
• 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;
widening of the blood vessels; 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.
• In monotherapy, thrombocytopenia
(decreased number of blood platelets)
causing bruises, tendency to bleed and
abnormal bleeding.
• In combination therapy, fever and
infections.
• In combination therapy, fever in the
absence of infection and without
concomitant severe decrease in the
number of some white blood cells
(neutropenia).
• Infections associated with a severe
decrease in the number of some white
blood cells (neutropenia) resulting in
death in 3 cases. 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).
• Loss of water (dehydration), commonly
associated with diarrhoea and/or
vomiting.
• Constipation.
• In combination therapy, severe nausea
and vomiting.
• Feeling weak (asthenia).
• In monotherapy, transient and mild to
moderate increase in serum levels of
liver enzymes (transaminases, alkaline
phosphatase) and bilirubin.
• In combination therapy, transient severe
increase in serum levels of bilirubin.
• Transient and mild to moderate increase
in levels of creatinine in the blood.
• In combination therapy with capecitabine
all grade adverse drug reactions:
hypersensitivity reaction, cardiac
ischemia/infarction and grade 3 and
grade 4 adverse drug reactions: febrile
neutropenia, thrombosis/embolism,
hypertension, and cardiac
ischemia/infarction.
• In combination with capecitabine and
bevacizumab: grade 3 and grade 4
adverse drug reactions: neutropenia,
thrombosis/embolism, hypertension, and
cardiac ischemia/infarction.
Uncommon side effects (affects 1 to 10
users in 1,000):
• Mild allergic reactions including red itchy
skin, urticaria, conjunctivitis, rhinitis.
• Mild skin reactions; mild reactions at the
infusion site.
• Early effects such as breathing
difficulties (dyspnoea).
• Lung disease presenting as shortness of
breath, dry cough and inspiratory
crackles (interstitial pulmonary disease).
• Partial or complete blockage of the
bowel (intestinal obstruction, ileus).
• Gastrointestinal bleeding.
• Bowel inflammation, causing abdominal
pain and/or diarrhoea (a condition known
as pseudomembraneous 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 (affects 1 to 10 users in
10,000):
• Severe allergic reactions including
swelling of the of the hands, feet, ankles,
face, lips, mouth or throat which may
cause difficulty in swallowing or extreme
difficulty breathing
(anaphylactic/anaphylactoid reactions). If
this happens you should tell your doctor
immediately.
• Early effects such as muscular
contraction or cramps and numbness
(paraesthesia).
• Inflammation of the large bowel causing
abdominal pain (colitis including the
appendix, ischemic and ulcerative
colitis).
• Intestinal perforation; loss of appetite
(anorexia); abdominal pain; inflammation
of the mucous membranes.
• Symptomatic or asymptomatic
inflammation of the pancreas.
• Increased blood pressure during and
following administration.
• Decreased levels of potassium and
sodium in the blood, mostly related to
diarrhoea and vomiting.
Very rare side effects (affects less than 1
user in 10,000):
• Transient speech disorders.
• Increase in levels of some digestive
enzymes which break down sugars and
fats.
• One case of peripheral
thrombocytopenia with antiplatelet
antibodies was reported.

If you receive Irinotecan in combination with
a medicine containing cetuximab,
bevacizumab or capecitabine, some of the
side effects you may experience can also
be related to these combination. Such side
effects may include an acne-like rash.
Therefore, please make sure that you also
read the package leaflet for cetuximab,
bevacizumab or capecitabine.
If any of the side effects gets serious, or if
you notice any side effects not listed in this
leaflet, please tell your doctor or
pharmacist.

5

How to store Irinotecan

Keep out of the reach and sight of children.
For single use only.
Before opening
Keep the vial in the outer carton in order to
protect from light.
Do not use this medicinal product after the
expiry date which is stated on the carton
after EXP. The expiry date refers to the last
day of that month.
After opening
The product should be diluted and used
immediately after opening.

After dilution
From a microbiological point of view, the
product should be used immediately after
dilution. If not used immediately, in-use
storage times and conditions prior to use
are the responsibility of the user and would
normally be not longer than 24 hours at
2-8°C, unless dilution has taken place in
controlled and validated aseptic conditions.
Chemical and physical in-use stability have
been demonstrated for 28 days at 2-8°C as
well as at room temperature (20-25°C) with
light protection and for 48 hours without
light protection.
Do not use Irinotecan if you notice particles
in the solution.
Medicines should not be disposed of via
wastewater or household waste. Ask your
pharmacist how to dispose medicines no
longer required. These measures will help
to protect the environment.

6

Further information

What Irinotecan contains
• The active substance is irinotecan
hydrochloride trihydrate.
• One ml of concentrate contains 20 mg
irinotecan hydrochloride trihydrate
equivalent to 17.33 mg of irinotecan.
• One 2ml vial contains 40 mg irinotecan
hydrochloride trihydrate.
• One 5ml vial contains 100 mg irinotecan
hydrochloride trihydrate.
• One 7.5ml vial contains 150 mg
irinotecan hydrochloride trihydrate.
• One 15ml vial contains 300 mg
irinotecan hydrochloride trihydrate.
• One 25ml vial contains 500 mg
irinotecan hydrochloride trihydrate.
• The other ingredients are sorbitol E420,
lactic acid, sodium hydroxide and water
for injections

What Irinotecan looks like and contents
of the pack
Amber class I glass vial with rubber stopper
(fluoropolymer coated bromobutyl rubber
stopper), with or without a protective plastic
overwrap (Onco-Safe). “Onco-Safe” does
not come into contact with the medicinal
product and provides additional transport
protection, which increases the safety for
the medical and pharmaceutical personnel.
The vials are sealed with aluminium crimp
caps.
Clear, colourless to slightly yellow solution.
Pack sizes:
40 mg/2 ml: 1 vial, 5 vials, 10 vials
100 mg/5 ml: 1 vial, 5 vials, 10 vials
150 mg/7.5 ml: 1 vial, 5 vials, 10 vials
300 mg/15 ml: 1 vial
500 mg/25 ml: 1 vial
Not all pack sizes may be marketed.

Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Holder:
Sandoz Ltd.,
Frimley Business Park, Frimley,
Camberley, Surrey, GU16 7SR, UK.

Manufacturer:
EBEWE Pharma Ges.m.b.H. Nfg. KG,
Mondseestraße 11,
A-4866 Unterach,
Austria.

This leaflet was last approved in 11/2011
(to be amended after approval).

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In the event of Irinotecan contact with
the skin, the area should be rinsed
with plenty of running water and then
washed with soap and water. In case
contact with mucous membranes,
wash the contacted area thoroughly
with water. If you have any discomfort,
contact a doctor.
In case of contact of Irinotecan with
eyes, wash them thoroughly with
plenty of water. Contact an
ophthalmologist immediately.

Preparation of infusion solution
Irinotecan concentrate for solution for
infusion is intended for intravenous infusion
only after diluting prior to administration in
the recommended diluents, either 0.9 %
Sodium chloride solution for infusion or 5%
glucose solution for infusion. Aseptically
withdraw the required amount of Irinotecan
concentrate for solution from the vial with a
calibrated syringe and inject into a 250 ml
infusion bag or bottle. The infusion should
be thoroughly mixed by manual rotation.

If any precipitate is observed in the vials or
after reconstitution, the product should be
discarded according to standard
procedures for cytotoxic agents.

Read the package leaflet for the shelf life of
the diluted product.
Irinotecan should not be delivered as an
intravenous bolus or an intravenous
infusion shorter than 30 minutes or longer
than 90 minutes.
Disposal
All items used for preparation,
administration or otherwise coming into
contact with irinotecan should undergo
disposal according to local guidelines for
the handling of cytotoxic compounds.

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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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