IRINOTECAN HYDROCHLORIDE 20 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION

Active substance: IRINOTECAN HYDROCHLORIDE TRIHYDRATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

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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.
• 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.

In this leaflet:
1. What Irinotecan Hydrochloride is and what it is
used for
2. What you need to know before you use Irinote
can Hydrochloride
3. How to use Irinotecan Hydrochloride
4. Possible side effects
5. How to store Irinotecan Hydrochloride
6. Contents of the pack and other information

1.

What Irinotecan Hydrochloride is
and what it is used for

Irinotecan Hydrochloride belongs to a group of
medicines called cytostatics (anti-cancer medicines).
Irinotecan Hydrochloride is used for the treatment
of advanced cancer of 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.

What you need to know before you
use Irinotecan Hydrochloride

Do not use Irinotecan Hydrochloride:
• if you are allergic (hypersensitive) to irinotecan
hydrochloride trihydrate or any of the other
ingredients of Irinotecan Hydrochloride
• 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. Johnʼs
Wort (Hypericum perforatum
About additional contraindications of cetuximab,
bevacizumab or capecitabine please read the
product information of these medicines.

Warnings and precautions
Take special care with Irinotecan Hydrochloride:
This medicine is intended for adults only. Check
with your doctor if this medicine has been
prescribed for use in a child.
Special care is also needed in elderly patients.
As Irinotecan Hydrochloride is an anti-cancer
medicine it will be administered to you in a special
unit and under 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 Hydrochloride

During administration of Irinotecan Hydrochloride
(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.

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.

- 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 Hydrochloride 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
Hydrochloride 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 Hydrochloride 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
Hydrochloride 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.

- Heart problems
Heart attacks have been observed following
treatment with Irinotecan Hydrochloride. If you
have any heart disease, known risk factors for
heart disease, or previous cytotoxic
chemotherapywill monitor you closely. Action
should be taken to try to minimize all modifiable
risk factors for heart problems (e.g. smoking, high
blood pressure,fat).
- Infections
You might get serious infections or face reduced
response to vaccinations during therapy with
Irinotecan Hydrochloride. Your doctor will try to
avoid vaccinations during therapy with Irinotecan
Hydrochloride.

Other medicines and Irinotecan Hydrochloride
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
Hydrochloride e.g. ketoconazole (for the treatment
of fungal infections), rifampicin (for the treatment of
tuberculosis), atazanavir sulphate (for the
treatment of HIV-1) 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 Hydrochloride 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.
You should not get yellow fever vaccine during
during therapy with Irinotecan Hydrochloride. Tell
your doctor that you are using this medicine if you
require any other vaccine, as this might result in
side effects.

2) From the day after treatment with Irinotecan If you receive Irinotecan Hydrochloride in
Hydrochloride until next treatment
combination with a medicinal product containing
cetuximab, bevacizumab, cyclosporine, tacrolimus
During this period you may experience various
or capecitabine, please make sure that you also
symptoms, which may be serious and require
read the package inserts for those products.
immediate treatment and close supervision.
- Diarrhoea
If your diarrhoea starts more than 24 hours after
administration of Irinotecan Hydrochloride
(“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 (i.e. water, soda water, fizzy
drinks, soup or oral rehydration therapy).
3. Immediately inform your doctor who is
supervising the treatment, and tell him/her
about the diarrhoea. If you are not able to
reach the doctor, contact the unit at the
hospital supervising the Irinotecan
Hydrochloride 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

THE FOLLOWING INFORMATION IS INTENDED
FOR MEDICAL OR HEALTHCARE
PROFESSIONALS ONLY
Instruction for use

Cytotoxic
Handling of Irinotecan Hydrochloride
As with all antineoplastic agents, caution should be
exercised when handling Irinotecan Hydrochloride.
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
Hydrochloride 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.

Pregnancy:
You must not receive Irinotecan Hydrochloride
during pregnancy, especially during the first
trimester, unless clearly necessaryif 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 Hydrochloride is
excreted in human milk. Consequently, you must
not breast-feed while you are treated with
Irinotecan Hydrochloride.
Driving and using machines
In some cases Irinotecan Hydrochloride 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 Hydrochloride 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 Hydrochloride
Irinotecan Hydrochloride 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
“sodium- free”.

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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 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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3.

How to use Irinotecan
Hydrochloride

(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.

Irinotecan Hydrochloride will be given as an
infusion into your veins over a period of 30-90
minutes. Theamount 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 Rare side effects (affects 1 to 10 users in 10,000):
• Severe allergic reactions including swelling of
square meters (m2).
the of the hands, feet, ankles, face, lips, mouth
or throat which may cause difficulty in
• If you have previously been treated with
swallowing or extreme difficulty breathing
5-fluorouracil you will normally be treated with
(anaphylactic/anaphylactoid reactions). If this
Irinotecan Hydrochloride alone starting with a
happens you should tell your doctor immediately.
dose of 350 mg/m2 every 3 weeks.
• If you have not had previous chemotherapy you • Early effects such as muscular contraction or
cramps and numbness (paraesthesia).
will normally receive 180 mg/m2 Irinotecan
Hydrochloride every two weeks. This will be
• Inflammation of the large bowel causing
abdominal pain (colitis including the appendix,
followed by folinic acid and 5-fluorouracil.
• If you are treated with Irinotecan Hydrochloride
ischemic and ulcerative colitis).
in combination with cetuximab you will normally • Intestinal perforation; loss of appetite (anorexia);
receive the same dose of irinotecan as
abdominal pain; inflammation of the mucous
administered in the last cycles of the prior
membranes.
• Symptomatic or asymptomatic inflammation of
irinotecan containing regimen.
the pancreas.
Irinotecan Hydrochloride must not be administered • Increased blood pressure during and following
earlier than 1 hour after the end of the cetuximab
administration.
infusion.
• Decreased levels of potassium and sodium in the
blood, mostly related to diarrhoea and vomiting.
If you receive Irinotecan Hydrochloride in
combination with cetuximab, please consult the
cetuximab leaflet.
If you receive Irinotecan Hydrochloride in
combination with bevacizumab, please consult the
bevacizumab leaflet.
If you receive Irinotecan Hydrochloride 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

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 Hydrochloride 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
Like all medicines, Irinotecan Hydrochloride can
notice any side effects not listed in this leaflet,
cause side effects, although not everybody gets
them. Your doctor will discuss these side effects
please tell your doctor or pharmacist.
with you and explain the risks and benefits of your
treatment. Some of these side effects must be
How to store Irinotecan
treated immediately, see also information in section
Hydrochloride
“Take special care with Irinotecan Hydrochloride”.
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.

5.

Keep out of the sight and reach 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 2-8ºC, 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
Common side effects (affects 1 to 10 users in 100): use Irinotecan Hydrochloride if you notice particles
• Acute cholinergic syndrome: the main symptoms in the solution.
are defined as early diarrhoea and various other
Medicines should not be disposed of via wastewater
symptoms such as abdominal pain; red, sore,
itching or weeping eyes (conjunctivitis); running or household waste. Ask your pharmacist how to
dispose of medicines no longer required. These
nose (rhinitis); low blood pressure; widening of
measures will help protect the environment.
the blood vessels; sweating, chills; a feeling of
general discomfort and illness; dizziness; visual
disturbances, pupil contraction; watering eyes
Contents of the pack and other
and increased salivation, occurring during or
information
within the first 24 hours after the infusion of
Irinotecan Hydrochloride.
What Irinotecan Hydrochloride contains
• In monotherapy, thrombocytopenia (decreased
• The active substance is irinotecan hydrochloride
number of blood platelets) causing bruises,
trihydrate.
tendency to bleed and abnormal bleeding.
• One ml of concentrate contains 20 mg irinotecan
• In combination therapy, fever and infections.
hydrochloride trihydrate equivalent to 17.33 mg
• In combination therapy, fever in the absence of
of irinotecan.
infection and without concomitant severe
• One 2 ml vial contains 40 mg irinotecan
decrease in the number of some white blood
hydrochloride trihydrate.
cells (neutropenia).
• Infections associated with a severe decrease in • One 5 ml vial contains 100 mg irinotecan
hydrochloride trihydrate.
the number of some white blood cells
• One 7.5 ml vial contains 150 mg irinotecan
(neutropenia) resulting in death in 3 cases.
hydrochloride trihydrate.
Infections associated with a severe decrease in
• One 15 ml vial contains 300 mg irinotecan
the number of some white blood cells
hydrochloride trihydrate.
(neutropenia) resulting in death in 3 cases.
• Fever associated with a severe decrease in the • One 25 ml vial contains 500 mg irinotecan
hydrochloride trihydrate.
number of some white blood cells (febrile
• The other ingredients are sorbitol E420, lactic
neutropenia).
acid, sodium hydroxide and water for injections
• Loss of water (dehydration), commonly
associated with diarrhoea and /or vomiting.
What Irinotecan Hydrochloride looks like and
• Constipation.
contents of the pack
• In combination therapy, severe nausea and
Amber class I glass vial with rubber stopper
vomiting.
(fluoropolymer coated bromobutyl rubber stopper),
• Feeling weak (asthenia).
with or without a protective plastic overwrap
• In monotherapy, transient and mild to moderate
(Onco-Safe). “Onco-Safe” does not come into
increase in serum levels of liver enzymes
contact with the medicinal product and provides
(transaminases, alkaline phosphatase) and
additional transport protection, which increases the
bilirubin.
safety for the medical and pharmaceutical personnel.
• In combination therapy, transient severe
The vials are sealed with aluminium crimp caps.
increase in serum levels of bilirubin.
• Transient and mild to moderate increase in
Clear, colourless to slightly yellow solution.
levels of creatinine in the blood.
Pack sizes:
• In combination therapy with capecitabine all
40 mg/2 ml: 1 vial, 5 vials, 10 vials
grade adverse drug reactions: hypersensitivity
reaction, cardiac ischemia/infarction and grade 3 100 mg/5 ml: 1 vial, 5 vials, 10 vials
150 mg/7.5 ml: 1 vial, 5 vials, 10 vials
and grade 4 adverse drug reactions: febrile
300 mg/15 ml: 1 vial
neutropenia, thrombosis/embolism,
500 mg/25 ml: 1 vial
hypertension, and cardiac ischemia/infarction.
Not all pack sizes may be marketed.
• In combination with capecitabine and

6.

bevacizumab: grade 3 and grade 4 adverse drug Marketing authorisation holder and
reactions: neutropenia, thrombosis/embolism,
manufacturer
hypertension, and cardiac ischemia/infarction.
Sandoz Ltd, Frimley Business Park, Frimley,
Uncommon side effects (affects 1 to 10 users in Camberley, Surrey, GU16 7SR.

Manufacturer
Lek Pharmaceuticals d.d., Verovska 57, SI 1526
Ljubljana, Slovenia or
Salutas Pharma GmbH, Otto-von-Guericke-Allee 1,
39179 Barleben, Germany or
EBEWE Pharma Ges.m.b.H., Nfg. KG
Mondseestraße 11, A-4866 Unterach, Austria.

4. In the event of Irinotecan Hydrochloride
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 Hydrochloride
with eyes, wash them thoroughly with plenty of
water. Contact an ophthalmologist immediately.

SAP: 5135298840
P.h: 1130
C.V: 1 - 2 - 3 - 4 - 20

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

mixed by manual rotation.

Preparation of infusion solution
Irinotecan Hydrochloride 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 Hydrochloride
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

This leaflet was last revised in 05/2013.

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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 Hydrochloride 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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