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IRINOTECAN 20 MG/ ML CONCENTRATE FOR SOLUTION FOR INFUSION

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Irinotecan 20 mg/ml concentrate for solution for infusion
Irinotecan hydrochloride trihydrate

The name of the product is Irinotecan 20 mg/ml concentrate for solution
for infusion and will be referred to as Irinotecan Solution throughout this
document.
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 Solution is and what it is used for
2.
Before you are given Irinotecan Solution
3.
How Irinotecan Solution will be given to you
4.
Possible side effects
5.
How to store Irinotecan Solution
6.
Further information

1.

WHAT IRINOTECAN SOLUTION IS AND WHAT IT IS USED FOR

Irinotecan Solution belongs to a group of medicines called cytostatics (anti-cancer
medicines). It is used for the treatment of advanced cancer of the colon and rectum in adults,
either alone or in combination with other medicines.

2.

BEFORE YOU ARE GIVEN IRINOTECAN SOLUTION

You should not be given Irinotecan Solution if you:








are allergic (hypersensitive) to irinotecan hydrochloride trihydrate or to any of the
ingredients in Irinotecan Solution (see list of ingredients in section 6 Further
Information)
have any other bowel disease or a history of bowel obstruction
are pregnant or breast-feeding
have increased levels of bilirubin in the blood (more than 3 times the upper limit of
normal)
have severe bone marrow failure
are in poor general health (evaluated by an international standard)
are using the natural remedy St John’s Wort (Hypericum perforatum).

Take special care with Irinotecan Solution
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 for elderly patients.
As Irinotecan Solution 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
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.
1.
The first 24 hours after administration of Irinotecan Solution
During administration of Irinotecan Solution (30 – 90 min) and within 24 hours after
administration you may experience some of the following symptoms: diarrhoea, 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 disturbance, pupil contraction, watering eyes and excessive mouthwatering. 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 Solution until the 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 Solution
(“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 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.

2.

Drink large amounts of water and rehydration fluids immediately (such as 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 unit at the
hospital supervising the Irinotecan Solution 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, vomiting or any fever as well as 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 doctor’s instructions. The anti-diarrhoeal treatment
should not be used to prevent a further episode of diarrhoea, even if you have experienced
delayed diarrhoea at previous cycles.

Fever
If the body temperature increases over 38ºC it may be a sign of infection, especially if you
also have diarrhoea. If you have any fever (over 38ºC) 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 Solution 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 Solution 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
Solution 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.
Taking other medicines
Please tell your doctor or 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, strong vitamins and minerals.
Some medicines may alter the effects of Irinotecan Solution, for example, 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 John’s Wort (Hypericum perforatum) may not be used at the same
time as Irinotecan Solution 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 effects of some medicines used during surgery.
Pregnancy and Breast-feeding
Irinotecan Solution must not be used during pregnancy. 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. If you become
pregnant during this period you must immediately inform your doctor.

Breast-feeding must be discontinued for the duration of Irinotecan Solution therapy.
Driving and using machines
In some cases Irinotecan Solution 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 Solution 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 the ingredients of Irinotecan Solution
Irinotecan Solution contains sorbitol. If you suffer from an intolerance to some sugars, tell
your doctor before you are given Irinotecan Solution.
This medicinal product contains less than 1 mmol sodium per dose, therefore it can be
considered to be essentially “sodium-free”.

3.

HOW IRINOTECAN SOLUTION WILL BE GIVEN TO YOU

Irinotecan Solution will be given as an infusion into your vein over a period of 30 to 90
minutes.
The amount of Irinotecan Solution you will be given depends on your age, height, weight and
general medical condition. It will also depend on any other treatment you may have received
for your cancer. Your doctor will decide what is the right amount to use (the dose).



If you have previously been treated with 5-fluorouracil, you will normally be treated
with Irinotecan Solution 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 Solution every 2 weeks. This will be followed by folinic acid and
5-fluorouracil.

These dosages may be adjusted by your doctor depending on your condition and any side
effects you may have.
If you receive more Irinotecan Solution than you should
Tell your doctor or care provider if you think that you have been given too much Irinotecan
Solution. Acute overdosing worsens side effects like diarrhoea or neutropenia (a decrease in
the number of white blood cells in the blood). Should this happen you will receive treatment
to prevent dehydration. Your blood cell count will be monitored and any infections treated
accordingly.

4.

POSSIBLE SIDE EFFECTS

Like all medicines Irinotecan Solution 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
medicine.

Serious side effects: if you notice any of the following, tell your doctor immediately as you
may need urgent medical attention. See also the information in section 2, “Take special care
with Irinotecan Solution”.

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 blood vessels,
sweating, chills, a feeling of general discomfort and illness, dizziness, visual
disturbances, pupil contraction, watering eyes and excessive mouth-watering occurring
during or within the first 24 hours after the infusion of Irinotecan Solution.

“Delayed diarrhoea” which may occur more than 24 hours after administration of
Irinotecan Solution and often occurs about 5 days after administration. Please read and
follow the instructions in section 2.

Fever above 38ºC.

Breathing difficulties.
If any of the above symptoms occur, you should inform your doctor who will give you any
necessary treatment.
Very common side effects (more than 1 in 10 patients):
Blood disorders: Neutropenia (decreased number of some white blood cells which may
make you more susceptible to infections)

Feeling tired and weak and looking pale (caused by anaemia, a reduction in your red
blood cells)

In combination therapy (when Irinotecan Solution is used with other medicines to treat
your cancer), bruising or bleeding easily (caused by thrombocytopenia, a reduction in
your blood platelets)

In monotherapy (when Irinotecan Solution is used alone to treat your cancer), fever and
infections

In monotherapy, fever when there is no infection and no severe reduction in some of
your white blood cells

Delayed severe diarrhoea

In monotherapy, severe nausea, and vomiting

Temporary hair loss

In combination therapy short-term increase in levels of liver enzymes (SGPT,SGOT,
alkaline phosphatase) or bilirubin


Common side effects (less than 1 in 10 patients):
Severe transient acute cholinergic syndrome: the main symptoms are defined in this
section under ‘serious side effects’

In monotherapy, bruising or bleeding easily (caused by thrombocytopenia, a reduction
in your blood platelets)

Infections associated with a severe decrease in the number of some white blood cells
(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, fever when there is no infection and no severe reduction in
some of your white blood cells

Loss of water (dehydration), commonly associated with diarrhoea and/or vomiting

Constipation

In combination therapy, severe nausea and vomiting

Severe weakness (asthenia)

Short-term increase in levels of liver enzymes (transaminases, alkaline phosphatase) or
bilirubin (which may be severe in combination therapy), short-term increase in levels
of creatinine


Uncommon side effects (less than 1 in 100 patients):

Mild skin reactions and allergic reactions (skin rash, sore and itchy eyes, runny nose)

Pain or redness close to or at the injection site during the infusion

Early effects such as breathing difficulties

Scarring of the lungs, which causes shortness of breath, dry cough and crackly
breathing (interstitial pulmonary disease)

Partial or complete bowel obstruction

Bowel inflammation which causes abdominal pain and/or diarrhoea (a condition known
as pseudomembraneous colitis)

Bleeding in the stomach or bowel, which may cause you to vomit blood or pass dark
tarry stools

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 (less than 1 in 1,000 patients):
Severe allergic reactions (anaphylactic/anaphylactoid reactions), causing skin rash
including red itchy skin, swelling of the hands, feet, ankles, face, lips, mouth or throat
(which may cause difficulty in swallowing or breathing). 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 (colitis) causing abdominal pain

Intestinal perforation causing severe abdominal pain, nausea and vomiting

Loss of appetite (anorexia), abdominal pain, inflammation of the mucous membranes

Inflammation of the pancreas causing upper abdominal pain
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 (less than 1 in 10,000 patients):
Bruising or bleeding easily due to your body destroying its own blood platelets (one
case)

Short- term speech disorders

Increase in levels of some digestive enzymes which break down sugars and fats (lipase,
amylase)


If any of the side effects get serious, or if you notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist.

5.

HOW TO STORE IRINOTECAN SOLUTION

Keep out of the reach and sight of children.
Do not use Irinotecan Solution after the expiry date which is stated on the vial label and outer
carton.
Keep the vial in the outer carton in order to protect from light.
For single use only.
Do not store above 25°C. Do not freeze.
After reconstitution and dilution under strict aseptic conditions, Irinotecan Solution must be
used (infusion completed) immediately or within 24 hours if stored in a refrigerator (2°C8°C).

If any cloudiness (precipitate) is observed in the vials or after reconstitution, the product
should be disposed of.
Your doctor must use the Irinotecan Solution as soon as it has been made.
Vials that have already been used must be disposed of by your healthcare professional
according to hospital standard procedures applicable to cytotoxic medicines.

6.

FURTHER INFORMATION

What Irinotecan Solution contains

The active substance is irinotecan hydrochloride trihydrate 20 mg/ml.

The other ingredients are sorbitol E420, lactic acid, sodium hydroxide, hydrochloric
acid and water for injections.
What Irinotecan Solution looks like and contents of the pack
Irinotecan 20 mg/ml concentrate for solution for infusion is a clear, yellow solution. It must
be diluted before infusion into the patient.
It comes in two sizes:

1 x 40 mg of irinotecan hydrochloride trihydrate in a 2 ml amber glass, rubber
stoppered vial

1 x 100 mg of irinotecan hydrochloride trihydrate in a 5 ml amber glass, rubber
stoppered vial.
Marketing Authorisation Holder and Manufacturer
The Marketing Authorisation Holder is:
Flynn Pharma Ltd
Alton House
4 Herbert Street
Dublin 2
Republic of Ireland
The Manufacturer is:
Thymoorgan Pharmazie GmbH
Schiffgraben 23
38690 Vienenburg
GERMANY
This medicinal product is authorised in the Member States of the EEA under the
following names:

<{Name of the Member State}> <{Name of the medicinal product}>

Call 01462 458474 for a leaflet in an alternative format.

This leaflet was last approved in 07/2009.

------------------------------------------------------------------------------------------------------INFORMATION FOR HEALTHCARE PROFESSIONALS

Irinotecan 20 mg/ml concentrate for solution for infusion
Irinotecan hydrochloride trihydrate
The following information is intended for medical or healthcare professionals only:
Instructions for use – cytotoxic
Handling of Irinotecan
As with all other 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.
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 copious amounts of cold
water
the flushed surfaces should then be wiped thoroughly and the materials used for
wiping should be disposed of as HAZARDOUS WASTE.
4.
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 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.
Preparation of the infusion solution
Irinotecan 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 dilution, the product should be discarded
according to standard procedures for cytotoxic agents.
This medicinal product must not be mixed with other medicinal products except those
mentioned above.
Irinotecan 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.

After dilution: the solution should be used immediately as it contains no antibacterial
preservative. If reconstitution and dilution are performed under strict aseptic conditions (e.g.
on Laminar Air Flow bench) the solution should be used (infusion completed) immediately or
within 24 hours if stored at 2°-8°C after the first opening.
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.
PL 13621/0037

Expand Transcript

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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