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IRINOTECAN MEDAC 20MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION

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Irinotecan medac 20 mg/ml · 87300-VPGB · BA · 04.14 · Pharma-Code: 790
Format: 592 x 112 mm · HKS 44 · Corrective action: KV01_jem_10.04.14

PACKAGE LEAFLET: INFORMATION FOR THE USER

Irinotecan medac 20 mg/ml,

concentrate for solution for infusion
Irinotecan hydrochloride trihydrate
Read all of this leaflet carefully before you are given this
medicine.
• 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. 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 or
pharmacist.
In this leaflet:
1. What Irinotecan medac is and what it is used for
2. Before you are given Irinotecan medac
3. How to use Irinotecan medac
4. Possible side effects
5. How to store Irinotecan medac
6. Further information
1. WHAT IRINOTECAN MEDAC IS AND WHAT IT IS USED FOR
Irinotecan medac belongs to a group of medicines called
cytostatics (anticancer medicines).
Irinotecan medac is used for the treatment of advanced cancer
of the colon and rectum in adults, either in a combination with
other medicines or alone.
If you need any further information on your condition, please
ask your doctor.

2. BEFORE YOU ARE GIVEN IRINOTECAN MEDAC
You will not be given Irinotecan medac
• if you are allergic (hypersensitive) to irinotecan hydrochloride
trihydrate or any of the other ingredients of Irinotecan
medac.
• if you have any other bowel disease or a history of bowel
obstruction.
• if you are pregnant or breast-feeding or if you think you
might be pregnant.
• 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 medac,
please refer to the product information for these medicinal
products.
Take special care with Irinotecan 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 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 medac in combination with cetuximab
or bevacizumab, please make sure that you also read the
package leaflet for these medicinal products.
During administration of Irinotecan medac (30 – 90 minutes)
and up to 24 hours after administration you may experience
some of the following symptoms:
• Diarrhoea
• Sweating
• Abdominal pain
• Watering eyes
• Visual disturbance
• Excessive mouth watering
The medical term for these symptoms is “acute cholinergic
syndrome” which can be treated (with atropine). If you have
any of these symptoms, immediately tell your doctor who will
give you any treatment necessary.
From the day after treatment with Irinotecan 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 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 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 as preventive, even though you have
experienced delayed diarrhoea at previous cycles.
Fever
If your 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 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 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 medac is started and before
every following treatment cycle your doctor will monitor your
liver function (by blood tests).
Impaired kidney function
As this medicine has not been tested in patients with kidney
problems, please check with your doctor if you have any kidney
problems.
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 medac treatment.
Taking other medicines
Please tell your doctor or hospital 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.

Medicines known to alter the effects of Irinotecan medac:
• ketoconazole (for the treatment of fungal infections)
• rifampicin (for the treatment of tuberculosis)
• carbamazepine, phenobarbital and phenytoin (medicines for
the treatment of epilepsy)
• The herbal medicine St. John’s wort (Hypericum perforatum)
must not be used during treatment with Irinotecan medac or
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 effect of some medicines used during surgery.
Pregnancy and breast-feeding
You must not be given Irinotecan medac if you are pregnant. If
you or your partner is being treated with Irinotecan medac, you
must avoid becoming pregnant during and for at least three
months after cessation of therapy. Still, if you become pregnant
during this period you must immediately inform your doctor.
You must discontinue breast-feeding for the duration of
Irinotecan medac therapy.
Driving and using machines
In some cases Irinotecan medac may cause side effects which
affect the ability to drive and operate tools and machinery.
Contact your doctor or pharmacist if you are unsure.
During the first 24 hours after administration of Irinotecan
medac 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 medac
Irinotecan 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 medicinal product.

3. HOW TO USE IRINOTECAN MEDAC
This medicine is intended for adults only.
Irinotecan medac will be given as an infusion into your veins
over a period of 30 to 90 minutes.
The amount of Irinotecan 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 medac alone starting
with a dose of 350 mg/m² every three weeks.
• If you have not had previous chemotherapy you will normally
receive 180 mg/m² Irinotecan medac every two weeks. This
will be followed by folinic acid and 5-fluorouracil.
If you receive Irinotecan medac in combination with cetuximab,
Irinotecan 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.
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 medac than you should
In case you were given a higher dosage of Irinotecan 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 product, ask
your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Irinotecan 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 “Take special
care with Irinotecan medac” carefully and follow them if you
have any of the side effects listed above.
Other side effects include:
Very common side effects (more than 1 in 10 patients)
• 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)

Irinotecan medac 20 mg/ml · 87300-VPGB · BA · 04.14 · Pharma-Code: 790
Format: 592 x 112 mm · HKS 44 · Corrective action: KV01_jem_10.04.14

• 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
Common side effects(less than 1 in 10 patients but more than
1 in 100)
• 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 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
Uncommon side effects (less than 1 in 100 patients but more
than 1 in 1,000)
• 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 pseudo-membraneous
colitis)
• Kidney failure, low blood pressure or cardio-circulatory
failure as a consequence of dehydration associated with
diarrhoea and/or vomiting, or in patients who experienced
sepsis
Rare side effects (less than 1 in 1,000 patients but more than
1 in 10,000)
• 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 side effects (less than 1 in 10,000 patients)
• 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 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.
If any of the side effects gets serious, or if you notice any
side effects not listed in this leaflet, please tell your doctor
or pharmacist.
5. HOW TO STORE IRINOTECAN MEDAC
Keep out of the reach and sight of children.
Do not use Irinotecan medac 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 medac if you notice any precipitate in the
vials or after dilution.
Medicines should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose of
medicines no longer required. These measures will help to
protect the environment.
6. FURTHER INFORMATION
What Irinotecan 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 medac looks like and contents of the pack
Irinotecan medac 20 mg/ml, concentrate for solution for infusion
is a clear yellow solution.

Irinotecan medac 40 mg: One 2 ml vial.
Irinotecan medac 100 mg: One 5 ml vial.
Irinotecan medac 300 mg: One 15 ml vial.
Not all pack sizes may be marketed.
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:
Austria
Irinotecan medac 20 mg/ml
Konzentrat zur Herstellung einer Infusionslösung
Belgium
Irinotecan medac 20 mg/ml,
Concentraat voor oplossing voor infusie
Bulgaria
Irinotecan medac 20 mg/ml,
Концентрат за инфузионен разтвор
Czech Republic Irinotecan medac 20 mg/ml,
Koncentrát pro přípravu infuzního roztoku
Denmark
Irinotecan medac 20 mg/ml,
Koncentrat till infusionsvaeske, opløsning
Estonia
Irinotecan medac
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
Greece
Irinotecan medac 20 mg/ml,
Πυκνό διάλυμα για παρασκευή διαλύματος προς
έγχυση

Hungary

Irinotecan medac 20 mg/ml,
Koncentrátum oldatos infúzióhoz
Ireland
Irinotecan medac 20 mg/ml,
Concentrate for solution for infusion
Latvia
Irinotecan medac
Lithuania
Irinotecan medac
Netherlands
Irinotecan medac 20 mg/ml,
Concentraat voor oplossing voor infusie
Norway
Irinotecan medac 20 mg/ml,
Konsentrat til infusjonsvæske
Poland
Irinotecan medac
Portugal
Irinotecan medac 20 mg/ml,
Concentrado para solução para perfusão
Romania
Irinotecan medac 20 mg/ml,
Concentrat pentru soluţie perfuzabilă
Spain
Irinotecan medac 20 mg/ml,
Concentrado para solución para perfusión
Sweden
Irinotecan medac 20 mg/ml,
Koncentrat till infusionsvätska, lösning
Slovak Republic Irinotecan medac 20 mg/ml,
Infúzny koncentrát
Slovenia
Irinotekanijev klorid medac 20 mg/ml koncentrat
za raztopino za infundiranje
United Kingdom Irinotecan medac 20 mg/ml,
concentrate for solution for infusion
This leaflet was last approved in 04/2014.
The following information is intended for medical or healthcare
professionals only:
Instructions for use/handling, preparation and disposal guide for
use with Irinotecan medac concentrate for solution for infusion

Use/handling
As with other antineoplastic agents, Irinotecan medac must be
prepared and handled with caution.
The use of glasses, mask and gloves is required.
If Irinotecan 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 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 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 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 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.

87300-VPGB
BA

+ 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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