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IRINOTECAN HYDROCHLOIDE 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 20mg/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
- If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not listed in this leaflet. See section 4.
The name of your medicine is Irinotecan hydrochloride 20mg/ml
concentrate for solution for infusion, which will be called Irinotecan
throughout this leaflet.
What is in this leaflet:
1. What Irinotecan is and what it is used for
2. What you need to know before you take 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 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 either in combination with other medicines or
alone.
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 take Irinotecan
Do not use irinotecan if:
- you are allergic (hypersensitive) to irinotecan or any of the other
ingredients of this medicine (listed in section 6)
- you have any other bowel disease or a history of bowel obstruction
- you are pregnant or breast feeding
- you have increased levels of bilirubin in the blood (more than 3 times
the upper limit of the normal range)
- you have severe bone marrow failure (imbalance of your blood
cells)
- you are taking the natural remedy St. John’s Wort (Hypericum
perforatum - used for depression)
- you are in poor general health (this will be decided by your doctor
using an international standard)

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.
b) Drink large amounts of water and rehydration fluids, immediately
(i.e. water, soda water, fizzy drinks, soup or oral rehydration therapy).
c) 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, if
- you have severe diarrhoea (and vomiting) with excessive loss of the
water requiring intravenous hydration
- you have fever as well as the diarrhea
- 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 to prevent
a further episode of diarrhoea, 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.
Heart disease
If you have a heart disease or known risk factors, your doctor will
monitor you closely.

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.

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.

Special care is also needed in elderly patients.

Other medicines and Irinotecan
Tell your doctor or pharmacist if you are taking or have recently taken,
any other medicines, including medicines obtained without a
prescription.

As Irinotecan 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 unit’s 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.
Talk to your doctor or pharmacist before taking Irinotecan.
- 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
1) The first 24 hours after administration of irinotecan
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.
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.
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:
a) Take any antidiarrhoeal treatment that the doctor has given you,

The following medications can alter the effects of irinotecan:
- Suxamethonium (muscle relaxant)
- 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 natural remedy St. John’s Wort (a treatment for depression)
- Atazanavir (used to treat HIV)
- 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
If you are pregnant or breast-feeding, think you may be pregnant or are
planning to have a baby, ask your doctor or pharmacist for advice before
taking this medicines.
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 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
Irinotecan may make you feel dizzy or cause visual disturbances within
24 hours after administration of the product. If this happens to you do
not drive or use any tools or machines.
Irinotecan contains sorbitol. If you have been told by your doctor that
you have intolerance to some sugars (e.g. fructose intolerance), contact
your doctor before you are given this medicinal product.

3. How to use Irinotecan
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.
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The following information is intended for medical or healthcare
professionals only:
Instruction for use - Cytotoxic
Handling of Irinotecan
As with all neoplastic agents, caution should be exercised when
handling irinotecan.
Dilution should be carried out under asceptic conditions by trained
personnel in a designated area. Precautions should be taken to avoid
contact with skin and mucouds membranes.
Protection instruction forpreparation 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.

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

Irinotecan
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Irinotecan
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2. 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.

3. 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 copius
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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Perforation

The amount of irintotecan you are given will depend on your age, height,
weight and general medical condition. Your doctor will calculate your
body surface area in square meters (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.

- Inflammation of the large bowel causing abdominal pain (colitis)
- Intestinal perforation causing severe abdominal pain, nausea and
vomiting
- 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
- Inflammation of the pancreas causing upper abdominal pain
- Increased blood pressure during and following administration
Very rare effects (may affect up to 1 in 10,000 people)
- Short-term speech disorders
- increase in levels of some digestive enzymes which break down
sugars (amylase) and fats (lipase)
- Bruising or bleeding easily due to your body destroying its own
blood platelets (one case)

These dosages may be adjusted by your doctor depending on your
condition and any side-effects you may have.

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 use more Irinotecan than you should
Irinotecan will be given to you by a doctor or nurse who is familliar
with this type of treatment so the chances is very small to be given an
overdose. If you were given a higher dosage of irinotecan than required
or an overdose, the side effects could be severe. If you think you have
been administered an overdose please contact your doctor.

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 have any further questions on the use of this medicine, ask your
doctor or pharmacist or nurse.

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.

Please follow the advice of your doctor regarding your current treatment.

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. 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 “Warnings and
precautions” carefully and follow them if you have any of the side
effects listed above.
Other side effects include:
Very common side effects (may affect more than 1 in 10 people)
- Blood disorders including abnormally low number of neutrophil
granulocytes, a type of white blood cell (neutropenia) which may
make you more susceptible to infections and reduction of the quantity
of red blood cells which can make you feel tired, weak and look pale
(anaemia)
- In combination therapy (when irinotecan is used with other medicines
to treat your cancer), thrombocytopenia (reduction in the number of
blood platelets) causing bruises, tendency to bleed and abnormal
bleeding, short term increases in levels of liver enzymes (SGPT,
SGOT, alkaline phosphatase) or bilirubin.
- In monotherapy (when irinotecan is used alone to treat your cancer),
fever, infections, severe nausea (feeling sick) and vomiting (being
sick).
- Delayed severe diarrhoea
- Hair loss (the hair grows again after end of treatment)
Common side effects (may affect up to 1 in 10 people)
- Severe short term acute cholinergic syndrome: the main symptoms
are 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
- In monotherapy, decreased number of blood platelets
(thrombocytopenia) which increases the risk of bruising and bleeding,
increased levels of some liver enzymes (transaminases, alkaline
phosphatase) or bilirubin
- In combination therapy, fever, infections, severe nausea (feeling sick)
and vomiting (being sick), transient pronounced (grade 3) increase in
serum levels of bilirubin.
- 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
- Feeling weak (asthenia)
- Increase of creatinine in the blood
Uncommon side effects (may affect up to 1 in 100 people)
- Mild allergic reaction (skin rash , sore and itchy eyes, runny nose)
- Pain or redness at or close to the injection sits during the infusion
- Early effects such as breathing difficulties
- Lung disease causing shortness of breath, dry cough and crackly
breathing (interstitial pulmonary disease)
- Partial or complete blockage of the bowel
- Bleeding in the stomach and bowel which may cause you to vomit
blood or pass dark tarry stools
- Bowel inflammation causing abdominal pain and/or diarrhoea (a
condition known as pseudo-membraneous colitis)
- Dehydration, often associated with diarrhoea and vomiting, which can
lead to kidney problems, low blood pressure or collapse
- Sepsis (a severe, whole body response to infection), which can lead to
kidney problems, low blood pressure or collapse.
Rare side effects (may affect up to 1 in 1,000 people)
- 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. If this happens you should tell your doctor immediately
- Muscular contraction or cramps and numbness (paraesthesia)

Preparation of infusion solution
As with any other injectable drugs, the irinotecan concentrate solution
for infusion must be prepared aseptically.
If any precipitate is observed in the vials or after reconstitution, the
product should be discarded according to standard procedures for
cytotoxic agents.
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 containing either 0.9% (w/v) sodium chloride or
5% (w/v) glucose solution.
The infusion should then be thoroughly mixed by manual rotation.

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This
includes any possible side effects not listed in this leaflet. You can also
report side effects directly via the Yellow Card Scheme at:
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
- Keep this medicine out of the sight and reach of children.
- Do not use irinotecan after the expiry date which is stated on the vial
and carton after EXP. The expiry date refers to the last day of that
month.
o
- Keep the vial below 25 C and protect from light.
- After dilution the solution should be used immediately. If this is not
possible, the diluted solution should not be kept longer than 24
o
hours at 2-8 C
- Do not use irinotecan if you notice any particles or cloudyness in the
solution or if there are any other visible signs of deterioration.
- 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 contains
The active substance is irinotecan (as hydrochloride trihydrate).
Each vial filled with 2ml Irinotecan hydrochloride trihydrate 20mg/ml
contains 40 mg irinotecan hydrochloride trihydrate to 34.66 mg
irinotecan.
Each vial filled with 5ml Irinotecan hydrochloride trihydrate 20mg/ml
contains 100 mg irinotecan hydrochloride trihydrate to 86.65 mg
irinotecan.
Each vial filled with 15 ml Irinotecan hydrochloride trihydrate 20mg/ml
contains 300 mg irinotecan hydrochloride trihydrate to 259.95 mg
irinotecan.
Each vial filled with 25 ml Irinotecan hydrochloride trihydrate 20mg/ml
contains 500 mg irinotecan hydrochloride trihydrate to 433.25 mg
irinotecan.
The other ingredients are sorbitol (E420), lactic acid, sodium hydroxide
or hydrochloric acid and water for injection.
What irinotecan looks like and contents of the pack
Irinotecan Concentrate for solution for infusion is a clear, colourless
pale yellow solution packaged in 5 ml ,15 ml and 25 ml Type I amber
coloured glass vials with rubber stopper and aluminium flip-off tear-off
seal.
Pack size:
2 ml fill volume
5 ml fill volume
15 ml fill volume
25 ml fill volume
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Cipla (EU) Limited,
Hillbrow House, Hillbrow Road, Esher, Surrey
KT10 9NW
United Kingdom
Manufacturer:
Cipla (EU) Limited, 20 Balderton Street,
London W1K 6TL,
United Kingdom
Cipla Europe NV
Uitbreidingstraat 80, 2600 Antwerp,
Belgium
This leaflet was last revised in 10/2015
21044600

Irinotecan concentrate solution for infusion should be infused into a
peripheral or central vein.
Irinotecan should not be delivered as an intravenous bolus or an
intravenous infusion shorter than 30 minutes or longer than 90 minutes.
Disposal
All materials used for dilution and administration should be disposed of
according to hospital standard procedures applicable to cytotoxic agents.

It is recommended, that in order to reduce microbiological hazard, the
infusion solutions should be prepared immediately prior to use and
infusion commenced as soon as practicable after preparation. 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 reconstitution / dilution (etc) has taken place in
controlled and validated aseptic conditions.

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Perforation

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Product Name: Irinotecan

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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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