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IRINOTECAN HYDROCHLORIDE MEDAC 20 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION

Active substance(s): IRINOTECAN HYDROCHLORIDE TRIHYDRATE

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Irinotecan Hydrochloride medac 20 mg/ml · 87300-VBGB · BA · 08.15 · Pharma-Code: 276 (Dummy)
Format: 486 x 252 mm · HKS 44 · Corrective action: KV01_osc_03.03.15 / KV02_osc_04.03.15 / KV03_osc_10.08.15 / KV04_jte_21.08.15

Package leaflet: Information for the user

Irinotecan Hydrochloride medac
20 mg/ml,
concentrate for solution for infusion
Irinotecan hydrochloride trihydrate
Read all of this leaflet carefully before you are
given 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.

Irinotecan
Hydrochloride
20 mg/ml
87300-VBGB
BA

Irinotecan
Hydrochloride
20 mg/ml
87300-VBGB
BA

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

1. What Irinotecan Hydrochloride medac is and
what it is used for
Irinotecan Hydrochloride medac belongs to a group of
medicines called cytostatics (anticancer medicines).
Irinotecan Hydrochloride medac may be used alone or
in combination with a number of other medicines used
to treat cancer. These combinations may be used to
treat cancers of the large intestine (colon or rectum)
where the disease is at an advanced stage.
Your doctor may use a combination of Irinotecan
Hydrochloride medac with 5-fluorouracil/folinic acid
(5-FU/FA) and bevacizumab to treat your cancer of the
large intestine (colon or rectum).
Your doctor may use a combination of Irinotecan
Hydrochloride medac with cetuximab to treat
a particular type of cancer of the large intestine,
which expresses a protein called EGFR.
If you need any further information on your condition,
please ask your doctor.

2. What you need to know before you are given
Irinotecan Hydrochloride medac
You will not be given Irinotecan Hydrochloride medac
• if you are allergic to irinotecan hydrochloride
trihydrate or any of the other ingredients of this
medicine (listed in section 6).

• if you have any other bowel disease or a history of
bowel obstruction.
• if you are breast-feeding.
• if you have increased levels of bilirubin in the blood
(more than 3 times the upper limit of the normal
range).
• if you have an imbalance of your blood cells (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. John’s wort
(Hypericum perforatum).
For additional contraindications of cetuximab or
bevacizumab which may be used in combination with
Irinotecan Hydrochloride medac, please refer to the
product information for these medicines.
Warnings and precautions
Talk to your doctor or pharmacist before you are given
Irinotecan Hydrochloride medac.
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 medac is an anticancer
medicine it will be administered to you in a special unit
and under the supervision of a doctor qualified in the
use of anticancer 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 Hydrochloride medac in
combination with cetuximab or bevacizumab, please
make sure that you also read the package leaflet for
these medicines.
During administration of Irinotecan Hydrochloride
medac (30 – 90 minutes) and up to 24 hours after
administration you may experience some of the
following signs and symptoms:
• Diarrhoea
• Sweating
• Abdominal pain
• 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.
From the day after treatment with Irinotecan
Hydrochloride medac until next treatment 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 Hydrochloride medac
(“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 antidiarrhoeal treatment that the doctor
has given you, 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.
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
hospital unit supervising the Irinotecan Hydrochloride
medac 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:
• You have diarrhoea as well as fever (over 38 °C).
• You have severe diarrhoea (and vomiting) with
excessive loss of water requiring intravenous
hydration.
• 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
preventive, 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 Hydrochloride medac 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 medac 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 medac is
started and before every following treatment cycle your
doctor will monitor your liver function (by blood tests).

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, breast-feeding and fertility

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.
Accidental injection beside the blood vessel (extravasation)
If accidental injection beside the blood vessel occurs,
the infusion site should be monitored for signs of
inflammation. Your doctor will flush the site and may
also treat it with ice.
Heart problems
Myocardial ischaemia (a painful heart condition caused
by lack of blood flow to the heart) has been observed
following treatment with Irinotecan Hydrochloride
medac. If you have any heart disease, known risk
factors for heart disease, or previous treatment with
anti-cancer medicines your doctor will monitor you
closely. Action should be taken to try to minimise all
modifiable risk factors for heart problems (e.g. smoking,
high blood pressure, and high level of fat in the blood).
Infections
You might get serious infections or face reduced
response to vaccinations during therapy with
Irinotecan Hydrochloride medac. Your doctor will try
to avoid vaccinations during therapy with Irinotecan
Hydrochloride medac. Killed or inactivated vaccines
may be administered; however, the response to such
vaccines may be diminished.
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 hospital unit supervising the Irinotecan
Hydrochloride medac treatment.
Other medicines and
Irinotecan Hydrochloride medac
Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other medicines.
This is also valid for herbal medicines.
Medicines known to alter the effects of Irinotecan
Hydrochloride medac or vice versa:
• ketoconazole (for the treatment of fungal infections)
• rifampicin (for the treatment of tuberculosis)
• carbamazepine, phenobarbital and phenytoin
(medicines for the treatment of epilepsy)
• atazanavir (for the treatment of HIV infection)
• anticoagulants (medicines to prevent blood clotting)
• yellow fever vaccine and other live vaccines.
Tell your doctor if you have had or are due to have
any vaccinations.
• cyclosporine and tacrolimus (used to dampen down
your body’s immune system)
• The herbal medicine St. John’s wort (Hypericum
perforatum) must not be used during treatment with
Irinotecan Hydrochloride medac and not between
treatments, as it may decrease the effect of irinotecan.

Pregnancy
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 medicine.
You should not be given Irinotecan Hydrochloride
medac if you are pregnant. If you or your partner is
being treated with Irinotecan Hydrochloride medac,
you must avoid becoming pregnant during treatment
and for at least three months after cessation of therapy.
Still, if you become pregnant during this period you
must immediately inform your doctor.
Breast-feeding
You must discontinue breast-feeding for the duration of
Irinotecan Hydrochloride medac therapy.
Fertility
There are no human data on the effect of irinotecan on
fertility. In treated animals the fertility of offspring was
decreased. If you plan to become pregnant or father
a child, please talk to your doctor.
Driving and using machines
In some cases Irinotecan Hydrochloride medac 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 medac you may feel dizzy or
have visual disturbances. If this happens to you do not
drive or use any tools or machines.
Irinotecan Hydrochloride medac contains sorbitol
Irinotecan Hydrochloride medac contains sorbitol.
If you have been told by your doctor that you have an
intolerance to some sugars (e.g. fructose intolerance),
contact your doctor or pharmacist before you are given
this medicine.

3. How Irinotecan Hydrochloride medac will be given
to you
This medicine is intended for adults only.
Irinotecan Hydrochloride medac will be given as
an infusion into your veins over a period of 30 to
90 minutes.
The amount of Irinotecan Hydrochloride medac you are
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 calculate your body surface area in square
metres (m²) from your height and weight.
• If you have previously been treated with 5-fluorouracil
you will normally be treated with Irinotecan
Hydrochloride medac alone starting with a dose of
350 mg/m² every three weeks.

Irinotecan Hydrochloride medac 20 mg/ml · 87300-VBGB · BA · 08.15 · Pharma-Code: 276 (Dummy)
Format: 486 x 252 mm · HKS 44 · Corrective action: KV01_osc_03.03.15 / KV02_osc_04.03.15 / KV03_osc_10.08.15 / KV04_jte_21.08.15

• If you have not had previous chemotherapy you will
normally receive 180 mg/m² Irinotecan Hydrochloride
medac every two weeks. This will be followed by
folinic acid and 5-fluorouracil.

• Hair loss (the hair grows again after end of treatment)
• In combination therapy, transient and mild to moderate
increase in serum levels of liver enzymes (such as
transaminases, alkaline phosphatase) or bilirubin

If you receive Irinotecan Hydrochloride medac in
combination with cetuximab, Irinotecan Hydrochloride
medac must not be administered earlier than one hour
after the end of the cetuximab infusion. Please follow the
advice of your doctor regarding your current treatment.

Common: may affect up to 1 in 10 people
• Severe transient 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);
runny nose (rhinitis); low blood pressure; flushing due
to widening of 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 Hydrochloride medac.
• In monotherapy, thrombocytopenia (reduction in the
number of blood platelets) causing bruises, tendency
to bleed and abnormal bleeding
• In combination therapy, fever
• In combination therapy, infections
• Infections associated with a severe decrease in the
number of some white blood cells (neutropenia)
resulting in death in three cases
• In combination therapy, severe nausea (feeling sick)
and vomiting (being sick)
• 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)
• Transient and mild to moderate increase of levels of
creatinine in the blood
• In monotherapy, transient and mild to moderate
increase in serum levels of liver enzymes (such as
transaminases, alkaline phosphatase) or bilirubin
• In combination therapy, transient pronounced
(grade 3) increase in serum levels of bilirubin

These dosages may be adjusted by your doctor depending
on your condition and any side effects you may have.
If you are given more Irinotecan Hydrochloride
medac than you should
In case you were given a higher dosage of Irinotecan
Hydrochloride medac than required the occurring side
effects may be more severe. You will get maximum
supportive care to prevent dehydration due to diarrhoea
and to treat any infectious complication. If you think you
have been administered an overdose please contact
your doctor.
If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.

4. Possible side effects
Like all medicines, Irinotecan Hydrochloride medac 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: may affect more than 1 in 10 people
• Blood disorders including abnormally low number
of neutrophil granulocytes, a type of white blood
cell (neutropenia) and reduction of the quantity of
haemoglobin in blood (anaemia)
• In combination therapy, thrombocytopenia (reduction
in the number of blood platelets) causing bruises,
tendency to bleed and abnormal bleeding
• Delayed severe diarrhoea
• In monotherapy, fever
• In monotherapy, infections
• In monotherapy, severe nausea (feeling sick) and
vomiting (being sick)

Uncommon: may affect up to 1 in 100 people
• Mild allergic reactions – skin rash including red itchy
skin, urticaria, conjunctivitis, rhinitis
• Mild skin reactions
• Mild reactions at the infusion site
• Lung disease presenting as shortness of breath, dry
cough and inspiratory crackles (interstitial pulmonary
disease), early effects such as breathing difficulties
• Partial or complete blockage of the bowel (intestinal
obstruction, ileus), stomach and intestines bleeding
• Bowel inflammation which causes abdominal pain
and/or diarrhoea (a condition known as pseudomembraneous colitis)
• Kidney failure, low blood pressure or cardiocirculatory failure as a consequence of dehydration
associated with diarrhoea and/or vomiting, or in
patients who experienced sepsis
Rare: may affect up to 1 in 1,000 people
• Severe allergic reactions (anaphylactic/anaphylactoid
reaction), including swelling of the hands, feet, ankles,
face, lips, mouth or throat which may cause difficulty
in swallowing or extreme difficulty breathing.

• Muscular contraction or cramps and numbness
(paraesthesia)
• Inflammation of the large bowel causing abdominal
pain (colitis including typhlitis, ischemic and ulcerative
colitis)
• Intestinal perforation; loss of appetite; abdominal
pain; inflammation of the mucous membranes
• Inflammation of the pancreas without or with
symptoms (mainly abdominal pain)
• High blood pressure during and following
administration
• Low levels of potassium and sodium in the blood,
mostly related to diarrhoea and vomiting
Very rare: may affect up to 1 in 10,000 people
• Transient speech disorders
• Increase in levels of some digestive enzymes which
break down sugars (amylase) and fats (lipase)
• One case of low platelet count in the blood due to
antibodies against platelets
If you receive Irinotecan Hydrochloride medac 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.

6. Contents of the pack and other information
What Irinotecan Hydrochloride medac contains
• The active substance is irinotecan hydrochloride
trihydrate. Each millilitre of the concentrate for
solution for infusion contains 20 mg irinotecan
hydrochloride trihydrate, equivalent to 17.33 mg
irinotecan.
Each vial of 2 ml contains 40 mg of irinotecan
hydrochloride trihydrate (40 mg/2 ml).
Each vial of 5 ml contains 100 mg of irinotecan
hydrochloride trihydrate (100 mg/5 ml).
Each vial of 15 ml contains 300 mg of irinotecan
hydrochloride trihydrate (300 mg/15 ml).
• The other ingredients are sorbitol (E420), lactic acid,
sodium hydroxide (to adjust to pH 3.5) and water for
injections.
What Irinotecan Hydrochloride medac looks like and
contents of the pack
Irinotecan Hydrochloride medac 20 mg/ml, concentrate
for solution for infusion is a clear yellow solution.
Irinotecan Hydrochloride medac 40 mg: One 2 ml vial.
Irinotecan Hydrochloride medac 100 mg: One 5 ml vial.
Irinotecan Hydrochloride medac 300 mg: One 15 ml vial.
Not all pack sizes may be marketed.

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 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 Hydrochloride medac
Keep this medicine out of the sight and reach of
children.
Do not use this medicine after the expiry date, which
is stated on the vial and on the carton after EXP.
The expiry date refers to the last day of that month.
Do not freeze.
Keep the vial in the outer carton in order to protect
from light.
For single use only.
Once the concentrate has been diluted for infusion the
solution can be kept for 6 hours at room temperature
(15 °C – 25 °C) or for 24 hours in a refrigerator
(2 °C – 8 °C).
Do not use Irinotecan Hydrochloride medac if you
notice any precipitate in the vials or after dilution.
Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to dispose
of medicines no longer required. These measures will
help protect the environment.

Marketing Authorisation Holder and Manufacturer
medac
Gesellschaft für klinische
Spezialpräparate mbH
Theaterstr. 6
22880 Wedel
Germany
This medicinal product is authorised in the Member
States of the EEA under the following names:
Czech Republic Irinotecan medac 20 mg/ml,
koncentrát pro přípravu infuzního
roztoku
Finland
Irinotecan medac 20 mg/ml,
Infuusiokonsentraatti, liuosta varten
France
IRINOTECAN MEDAC 20 mg/ml,
solution à diluer pour perfusion
Germany
Irinomedac® 20 mg/ml Konzentrat zur
Herstellung einer Infusionslösung
Ireland
Irinotecan medac 20 mg/ml,
concentrate for solution for infusion
Poland
Irinotecan medac
Portugal
Irinotecano medac 20 mg/ml,
Concentrado para solução para
perfusão
Slovak Republic Irinotecan medac 20 mg/ml
infúzny koncentrát
United Kingdom Irinotecan Hydrochloride medac
20 mg/ml, concentrate for solution for
infusion
This leaflet was last revised in 08/2015.

---------------------------------------------------------------

The following information is intended for medical or
healthcare professionals only:
Instructions for use/handling, preparation and disposal
guide for use with Irinotecan Hydrochloride medac
concentrate for solution for infusion
Use/handling
As with other antineoplastic agents, Irinotecan
Hydrochloride medac must be prepared and handled
with caution.
The use of glasses, mask and gloves is required.
If Irinotecan Hydrochloride medac concentrate for
solution for infusion or the prepared solution for
infusion should come into contact with the skin, wash
immediately and thoroughly with soap and water.
If Irinotecan Hydrochloride medac concentrate for
solution for infusion or the prepared solution for infusion
should come into contact with the mucous membranes,
wash immediately with water.
Preparation of the intravenous solution
As with any other injectable drugs, the Irinotecan
Hydrochloride medac solution for infusion must be
prepared aseptically.
If any precipitate is observed in the vials or after dilution,
the product should be discarded according to standard
procedures for cytotoxic agents.
Aseptically withdraw the required amount of Irinotecan
Hydrochloride medac concentrate for solution for
infusion 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 % dextrose
solution. The solution for infusion should then be
thoroughly mixed by manual rotation.
Irinotecan solution for infusion should be infused into
a peripheral or central vein.
Irinotecan Hydrochloride medac should not be delivered
as an intravenous bolus or an intravenous infusion
shorter than 30 minutes or longer than 90 minutes.
After dilution in 0.9 % sodium chloride solution or
5 % dextrose solution, chemical and physical in-use
stability has been demonstrated for up to 6 hours at
room temperature (approximately 25 °C) and ambient
lighting or 48 hours if stored at refrigerated temperatures
(approximately 2 °C – 8 °C).
From a microbiological point of view, the solution
for infusion should be used immediately. 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 6 hours at room
temperature or 24 hours if stored at 2 °C – 8 °C unless
dilution has taken place in controlled and validated
aseptic conditions.
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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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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