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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

Irinotecan 20 mg/ml

Concentrate for solution for infusion
irinotecan hydrochloride, trihydrate
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).
Nausea (feeling sick) and vomiting
If you have nausea and/or vomiting contact your doc tor or the hospital unit
immediately.
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.
Cardiac disorders
If you have heart problems or additional risk factors such as smoking, high blood
pressure or high cholesterol your doctor will monitor your condition.
Increase susceptibility to infections
1. What Irinotecan is and what it is used for
Chemotherapeutic agents may damper down your body’s immune systems. Special
This medicinal product belongs to a group of medicines called antineoplastic
care should be taken with the administration of live or live-atenuated vaccines.
cytostatics (anti-cancer medicines).
Vaccination with a live vaccine should be avoided.
Irinotecan is indicated for the treatment of adult patients with advanced colorectal
Alterations in the composition of your blood
cancer, either combined with other medicines or as a single agent.
Due the the risk of alterations in the composition of your blood, your doctor will
monitor your blood at weekly intervals.”
2. What you need to know before you take Irinotecan
Dehydration
Do not take Irinotecan:
Infrequent cases of renal insufficiency, hypotension or circulatory failure have been
• if you are allergic to irinotecan hydrochloride trihydrate or any of the other
observed in patients who experienced episodes of dehydration associated with
ingredients of this medicine (listed in section 6).
diarrhoea and/or vomiting, or sepsis.
• if you suffer from chronic inflammatory bowel disease and/or bowel obstruction
Other medicines and Irinotecan:
• if you are breast feeding
Please inform your doctor or pharmacist if you are taking, have recently taken or
• if you have liver problems with increased bilirubin values in your blood (more
might take any other medicines.
than 3 times higher than the upper limit of the normal range)
• if you have an imbalance of your blood cells (severe bone marrow failure)
The following medicines may change Irinotecan effects, and therefore should not
• if you are in a poor general health (WHO performance status greater than 2)
be administered concomitantly:
• if you are taking any prescription medicines or herbal extract containing St
• Carbamazepine, phenobarbital or phenytoin (drugs used in the management of
John’s Wort (medicine against depression).
epilepsy);
If you receive Irinotecan in combination with 5-fluorouracil, capecitabine, • Ketoconazole (used for the treatment of fungal infections);
• Rifampicin (used for the treatment of tubercolosis);
cetuximab or bevacizumab, please make sure that you also read the
• Warfarin (an anticoagulant used to thin the blood);
package inserts of these medicinal products.
• Atazanavir (used to treat HIV);
Warnings and precautions
• Vaccines (response to killed or inactivated vaccines may be diminished);
Talk to you doctor or pharmacist before taking Irinotecan.
• Ciclosporin or Tacromilus (used to dampen down your body’s immune system).
Irinotecan will be given to you only in units specialised in the administration of anti- Natural medicines based on St John’s Wort (Hypericum perforatum) must not be
cancer medicines (antineoplastic cytotoxic chemotherapy), under the supervision
co-administered with this medicine, not even between treatments, since it can
of a physician qualified in the use of these medicines. The unit’s personnel will
affect Irinotecan efficacy. If you are taking any preparations containing St John’s
explain to you what you need to take special care of during and after the treatment. Wort, please suspend it immediately and inform your doctor.
This leaflet may help you to remember that.
The following medicines may be influenced by Irinotecan:
This medicine is intended for adults only.
• Muscle relaxants used during surgery (e.g. suxamethonium, non-depolarising
drugs), as Irinotecan may prolong or block their effects. If you require an
Check with your doctor if this medicine has been prescribed for use in a child.
operation, please tell your doctor or anaesthetist that you are using this medicine.
Special care is also needed in elderly patients.
Irinotecan
with food and drink - Not applicable.
During administration of Irinotecan (30-90 min.) and up to 24 hours after
administration you may experience some of the following symptoms: diarrhoea,
Pregnancy and breast-feeding
sweating, abdominal pain, visual disturbance, excessive mouth watering. The
If you are pregnant or breast-feeding, think you may be pregnant or are planning to
medical term for these symptoms is “acute cholinergic syndrome” which can be
have a baby, ask your doctor for advice before taking this medicine
treated (with atropine).
Pregnancy
If you have any of these symptoms immediately tell your doctor who will give you
You must not receive this medicine if you are pregnant unless clearly indicated.
any treatment necessary.
If you are in child-bearing age and receiving Irinotecan treatment, you should be
From the day after treatment with Irinotecan until next treatment you may
advised to avoid becoming pregnant. Contraceptive measures must be taken by
experience various symptoms, which may be serious and require immediate
both male and female patients during treatment and until 3 months after the end
treatment and close supervision.
of treatment.
Diarrhoea
Still, if you become pregnant during this period you must immediately inform your
If your diarrhoea starts more than 24 hours after administration of This medicine
doctor.
(“delayed diarrhoea”) it may be serious. It is often seen about 5 days after
Breast-feeding
administration. The diarrhoea should be treated immediately and kept under close
It is not known whether Irinotecan is excreted in human milk. Consequently, you
supervision. Immediately after the first liquid stools do the following:
must not breast-feed while you are treated with this product.
• Take any anti-diarrhoeal treatment that the doctor has given you, exactly as he/
Driving and using machines
she has told you. The treatment may not be changed without consulting the
Due to the potential for dizziness or visual disturbances, which may occur within
doctor. Recommended anti-diarrhoeal treatment is loperamide (4 mg for the
24 hours following administration of Irinotecan, you should not drive or operate
first intake and then 2 mg every 2 hours, also during the night). This should be
machinery if these symptoms occur.
continued for at least 12 hours after the last liquid stools. The recommended
Contact your doctor or pharmacist in case of any doubt.
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 Irinotecan contains sorbitol.
water, fizzy drinks, soup or oral rehydration therapy).
This medicine contains 45 mg sorbitol in each millilitre of solution.
• Immediately inform your doctor who is supervising the treatment, and tell him/
Sorbitol is a source of fructose. If you (or your child) have hereditary fructose
her about the diarrhoea. If you are not able to reach the doctor, contact the unit
intolerance (HFI), a rare genetic disorder, you (or your child) must not receive this
at the hospital supervising the Irinotecan treatment. It is very important that they medicine. Patients with HFI cannot break down fructose, which may cause serious
are aware of the diarrhoea.
side effects.
You must tell your doctor before receiving this medicine if you (or your child) have
Hospitalisation is recommended for the management of the diarrhoea, in the
HFI or if your child can no longer take sweet foods or drinks because they feel sick,
following cases:
vomit or get unpleasant effects such as bloating, stomach cramps or diarrhoea.
• you have diarrhoea as well as fever (over 38°C)
• you have severe diarrhoea (and vomiting) with excessive loss of water requiring
This medicine contains less than 1 mmol sodium (23 mg) per mL of solution, that
intravenous hydration
is to say essentially ‘sodium-free’
• you still have diarrhoea 48 hours after starting the diarrhoea treatment
• you still have diarrhoea 48 hours after starting the diarrhoea treatment
3. How to take Irinotecan
Note! Do not take any treatment for diarrhoea other than that given to you by
This medicinal product will be administered as an intravenous infusion over a 30
your doctor and the fluids described above. Follow the doctors instructions. The
to 90 minute period. Dosage will depend on your age, size and general clinical
anti-diarrhoeal treatment should not be used preventive, even though you have
condition. It will also depend on any other treatment you may have received for
experienced dealyed diarrhoea at previous cycles.
your cancer. Your doctor will calculate your body surface in square meters (m2).
• If you have previously been treated with 5-fluorouracil you normally be treated
Blood monitoring
Irinotecan may cause a decrease in the number of some of your white blood cells,
with Irinotecan alone, starting with a dose of 350mg/m2 every 3 weeks.
• If you have not had previous chemotherapy you will normally receive 180mg/m2
which play an important role in fighting infections. This is called neutropenia.
Neutropenia is often seen during treatment with irinotecan and is reversible.
of Irinotecan every 2 weeks. This will be followed by folinic acid and 5-fluorouracil
Your doctor should arrange for you to have regular blood tests to monitor these
administration.
white blood cells. Neutropenia is serious and should be treated immediately and
If you receive Irinotecan in combination with cetuximab, please consult the
carefully monitored.
cetuximab leaflet. Irinotecan must not be administered earlier than 1 hour after the
Fever
end of the cetuximab infusion. Please follow the advice of your doctor regarding
If you have any fever over 38°C contact your doctor or the unit immediately so that your current treatment.
they can give you any treatment necessary.
Read all of this leaflet carefully before you start taking 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.
• 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. 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 take Irinotecan
3. How to take Irinotecan
4. Possible side effects
5. How to store Irinotecan
6. Contents of the pack and other information

&

The following information is intended for healthcare professionals only

Irinotecan 20 mg/ml

Concentrate for solution for infusion
irinotecan hydrochloride, trihydrate

Handling:
As with other antineoplastic/cytotoxic agents, Irinotecan must be prepared and
handled with caution. The use of goggles, mask and gloves is mandatory.
In case of skin contact with the concentrate or diluted solution, wash immediately
and thoroughly with soap and water. If Irinotecan solution or infusion solution
should came into contact with the mucous membranes, wash immediately
with water.

Instructions for dilution:
As with any other injectable drugs, Irinotecan solution must be prepared aseptically.
If any precipitate is observed in the original vials or after reconstitution, the product
should be discarded according to standard procedures for cytotoxic agents.
Aseptically withdraw the required amount of Irinotecan solution from the vial with a
calibrated syringe and inject into a 250 ml infusion bag or bottle containing either
0.9 % sodium chloride solution or 5% glucose solution.
The infusion should then be thoroughly mixed by manual rotation.
Instructions for protection for dilution:
The preparation should be performed in a defined area for manipulation of the drug
(preferably under system of vertical laminar air flow). The working area should be

If you receive Irinotecan in combination with bevacizumab, please consult the
bevacizumab leaflet. 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 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, 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.
Very common side effects (more than 1out of 10 patients):
IN MONOTHERAPY:
• Neutropenia (reduced white cell count) which increases the risk of infections
• Anaemia (reduction in the number of red blood cells) which can make the skin
pale and causes weakness and breathlessness
• Decreased appetite
• Cholinergic syndrome: the main symptoms were 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 (hypotension),
widening of the blood vessels (vasodilatation), sweating, chills, a feeling of general
discomfort and illness (malaise), dizziness, visual disturbances, pupil contraction
(myosis), watering eyes (lachrymation) and increased salivation occurring during
or within the first 24 hours after the infusion of Irinotecan. These symptoms
disappear after atropine administration
• Diarrhoea
• Vomiting
• Nausea
• Abdominal pain
• Hair loss (hair will grow again after treatment is finished).
• Mucosal inflammation
• Fever
• Asthenia (lack or loss of strength).
IN COMBINATION THERAPY
• Thrombocytopenia (reduction in the number of blood platelets) causing bruises,
tendency to bleed and abnormal bleeding
• Neutropenia
• Anaemia
• Decreased appetite
• Cholinergic syndrome: the main symptoms were 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 (hypotension),
widening of the blood vessels (vasodilatation), sweating, chills, a feeling of general
discomfort and illness (malaise), dizziness, visual disturbances, pupil contraction
(myosis), watering eyes (lacrimation) and increased salivation occurring during or
within the first 24 hours after the infusion of Irinotecan. These symptoms disappear
after atropine administration.
• Diarrhoea
• Vomiting
• Nausea
• Hair loss (hair will grow again after treatment is finished).
• Mucosal inflammation
• Asthenia (lack or loss of strength
• 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 out of 10 patients, but more than 1 out
of 100):
IN MONOTHERAPY
• Infection
• Thrombocytopenia (reduction in the number of blood platelets) causing bruises,
tendency to bleed and abnormal bleeding
• Fever associated with a severe decrease in the number of some white blood cells
(febrile neutropenia)
• Constipation
• Transient and mild to moderate increase of serum levels of creatinine
• Transient and mild to moderate increase in serum levels of some liver enzymes
(transaminases, alkaline phosphatase) or bilirubin.
IN COMBINATION THERAPY
• Infection
• Fever associated with a severe decrease in the number of some white blood cells
(febrile neutropenia)
• Abdominal pain
• Constipation
• Fever.
Rare side effects (less than 1 out of 1,000 patients, but more than 1 out
of 10,000):
IN COMBINATION THERAPY:
• Hypokalemia and hyponatremia mostly related with diarrhea and vomiting.
Frequency not known (cannot be estimated from available data)
• Bowel inflammation causing abdominal pain and/or diarrhoea (a condition known
as pseudomembranous colitis)
• Sepsis (life-threatening condition that arises when the body’s response to infection
causes injury to its own tissues and organs)
• Peripheral thrombocytopenia with antiplatelet antibodies
• Loss of water (dehydration), commonly associated with diarrhoea and/or vomiting
• Hypovolaemia (decrease in volume of blood plasma)
• Hypersensitivity (Allergic) reactions
• Severe allergic reactions (anaphylactic/anaphylactoid reactions) including swelling
of the hands, feet, ankles, face, lips, mouth or throat which may cause difficulty in
swallowing or breathing. Please contact your doctor immediately if you experience
any of these side-effects
• Anaphylactic reactions
• Transient speech disorders, in some cases, the event was attributed to the
cholinergic syndrome observed during or shortly after infusion of irinotecan
• Early effects such as muscular contraction or cramps and numbness (paresthesia)
• Increased blood pressure (hypertension) during or following the infusion
• Kidney problems (renal insufficiency), low blood pressure (hypotension) or collapse
(cardio-circulatory failure) in patients who experienced episodes of dehydration
associated with diarrhoea and/or vomiting or sepsis
• Lung disease (interstitial pulmonary disease) presenting as shortness of breath,
dry cough, and inspiratory crackles
• Breathing difficulties
• Hiccups (involuntary contraction of the diaphragm that may repeat several times
per minute)
• Partial or complete blockage of the bowel (intestinal obstruction, ileus)
• Gastrointestinal bleeding or haemorrhage
protected by coating with disposable absorbent paper and plastic. Protective
clothing should be used: protective goggles, hair cap, gown and gloves and
disposable masks.
Open containers such as bottles of the injection and infusion bottles and tubes,
syringes, catheters and tubes used, as well as cytotoxic waste, should be
considered hazardous waste and be disposed of in accordance with local guidelines
for handling of HAZARDOUS waste.
In case of spillage, protective clothing should be used. Broken glass should be
collected and placed in hazardous waste containers. The contaminated surfaces
should be properly rinsed with abundant amounts of cold water and thoroughly
cleaned. The materials used for cleaning should be disposed of as hazardous waste.

Inflammation of the large bowel causing abdominal pain (colitis including typhlitis,
ischemic and ulcerative colitis)
• Abnormal dilation of the colon (Megacolon)
• Symptomatic or asymptomatic elevated pancreatic enzymes
• Intestinal perforation
• Skin reactions
• Infusion site reactions
• Increase in levels of some digestive enzymes which break down sugars (amylase)
or fats (lipase)
• Hypokalaemia
• Hyponatremia mostly related with diarrhoea and vomiting
• Increase in serum levels of some liver enzymes (transaminases, i.e. AST and ALT)
in the absence of progressive liver metastasis have been very rarely reported
• Muscular contraction or cramps.
If you receive Irinotecan in combination with cetuximab, some of the side effects you
may experience can also be related to these combinations. 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 and bevacizumab.
It is necessary to tell your doctor if you experience:
• “early” diarrhoea with associated symptoms referred to as “the acute cholinergic
syndrome” (see Section 2)
• “delayed” diarrhoea
• diarrhoea persisting for 48 hours after treatment initiation
• fever
• nausea, vomiting
• respiratory disorders, non-productive cough, symptoms of crepitations in the lungs.
Patient’s hospitalisation is indicated in the following situations:
• diarrhoea and coexisting fever (over 38°C)
• severe diarrhoea (and vomiting) with clinical features of excessive dehydration
(intravenous fluid replacement is necessary)
• diarrhoea not subsiding within 48 hours of treatment initiation.
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 the Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for
MHRA Yellow Card in the Google Play or Apple App Store. 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.
Store below 25°C. Store in the original package in order to protect from light.
For single use only.
After dilution with 5% glucose, physical and chemical stability was demonstrated for
24 hours, when stored between 2-8ºC and for 12 hours when stored at 25 ±2ºC,
protected from light.
After dilution with 0.9% sodium chloride, physical and chemical stability was
demonstrated for 12 hours when stored at 25 ±2ºC, protected from light.
Irinotecan should be diluted and used immediately after opening.
From a microbiologic point of view, unless the method of dilution precludes the risk
of microbial contamination, the product should be used immediately.
If not used immediately, in-use storage times and conditions are the responsibility
of user.
Do not use this medicine after the expiry date which is stated on the label and
carton after EXP. The expiry date refers to the last day of that month.
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 to protect the environment

6. Contents of the pack and other information
What Irinotecan contains
The active substance of Irinotecan is irinotecan hydrochloride, trihydrate.
1 ml of concentrate contains 20mg of irinotecan hydrochloride, trihydrate
(equivalent to 17.33mg/ml of irinotecan).
One vial of 2ml contains 40mg of irinotecan hydrochloride, trihydrate.
One vial of 5ml contains 100mg of irinotecan hydrochloride, trihydrate.
One vial of 15ml contains 300mg of irinotecan hydrochloride, trihydrate.
One vial of 25ml contains 500mg of irinotecan hydrochloride, trihydrate.
The other ingredients are sorbitol (E420), lactic acid, sodium hydroxide and/or
hydrochloric acid (for pH adjustment to 3.5) and water for injection.
Irinotecan is a yellow clear solution.
pH: 3.0 – 4.0
Osmolality: 265-350 mosmol/kg
What Irinotecan looks like and contents of the pack
Amber glass vial, with FluroTec rubber stopper or equivalent and aluminium
flip-off cap.
Package size:
Pack with 1 vial of 2 ml – Pack with 1 vial of 5 ml – Pack with 1 vial of 15 ml – Pack
with 1 vial of 25 ml
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Hikma Farmacêutica (Portugal), S.A.
Estrada do Rio da Mó, nº 8, 8A – 8B Fervença 2705 – 906 Terrugem SNT
Portugal
Manufacturer
Thymoorgan Pharmazie GmbH
Schiffgraben 23, D-38690 Goslar, Germany
Distributor:
Consilient Health (UK) Ltd.
No. 1 Church Road, Richmond upon Thames, Surrey. TW9 2QE
This leaflet was last revised in 03/2018.

P0698

In case Irinotecan comes into contact with the skin, the area should be rinsed
profusely with running water and then washed with soap and water. In case of
contact with mucous membranes, wash thoroughly the affected area contacted
with water. If you feel some unease, contact a doctor.
In case of eye contact with Irinotecan, wash them thoroughly with plenty of water.
Contact an ophthalmologist immediately.
Disposal:
All materials used for dilution and administration should be disposed of according
to hospital standard procedures applicable to cytotoxic agents.

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