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
Irinotecan hydrochloride 20 mg/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.
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Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist or nurse.
If you get any of the side effects, talk to your doctor or pharmacist or nurse. This includes any
side effects not listed in this leaflet, please tell your doctor or pharmacist.See section 4.

What is in this leaflet:
1.
What Irinotecan hydrochloride 20 mg/ml concentrate for solution for infusion is and what it is
used for
2.
What you need to know before Irinotecan hydrochloride 20 mg/ml concentrate for solution for
infusion is administered to you
3.
How Irinotecan hydrochloride 20 mg/ml concentrate for solution for infusion is administered to
you
4.
Possible side effects
5.
How to store Irinotecan hydrochloride 20 mg/ml concentrate for solution for infusion
6.
Contents of the pack and other information
1.

What Irinotecan hydrochloride 20 mg/ml concentrate for solution for infusion is and what it is
used for

Irinotecan hydrochloride 20 mg/ml concentrate for solution for infusion belongs to a group of
medicines called cytostatics (anti-cancer medicines).
Irinotecan hydrochloride 20 mg/ml 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.
Irinotecan hydrochloride may also be authorized to treat other conditions which are not mentioned in
this leaflet. Please ask your doctor or pharmacist if you have further questions.
2.

What you need to know before you use Irinotecan hydrochloride 20 mg/ml concentrate for
solution for infusion

Do not use Irinotecan hydrochloride 20 mg/ml concentrate:
If you are allergic to irinotecan hydrochloride or any of the other ingredients in this medicine
(see section 6)
If you have or had chronic inflammatory 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
normal)
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 taking St John’s Wort (a herbal medicine).
For additional contraindications of cetuximab, bevacizumab or capecitabine which may be used in
combination with Irinotecan hydrochloride 20 mg/ml, please refer to the product information for this
medicinal product.

Warnings and Precautions
Take special care with Irinotecan hydrochloride 20 mg/ml concentrate for solution for infusion
As Irinotecan hydrochloride 20 mg/ml 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.
Talk to your doctor before using Irinotecan hydrochloride 20 mg/ml concentrate for solution
for infusion if any of the following apply to you:
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You have liver problems or jaundice
You have kidney problems
You have asthma
You have ever received radiation therapy
You experienced severe diarrhoea or fever after being treated with Irinotecan hydrochloride
before
You have heart problems
You smoke, have high blood pressure or high cholesterol as these can increase the risk of heart
problems during treatment with Irinotecan hydrochloride

During administration of Irinotecan hydrochloride 20 mg/ml (30-90 min.) and up to 24 hours
after administration: You may have severe allergic reaction (anaphylactic/anaphylactoid reaction):
swelling of the hands, feet, ankles, face, lips, mouth or throat which may cause difficulty in
swallowing or extreme difficulty breathing and you may feel you are going to faint. If this happens
you should tell your doctor immediately. 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 hydrochloride 20 mg/ml until next treatment you
may experience various symptoms, which may be serious and require immediate treatment and close
supervision.
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Diarrhoea
If your diarrhoea starts more than 24 hours after administration of Irinotecan hydrochloride 20
mg/ml (“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 20 mg/ml 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 doctors instructions. The anti-diarrhoeal treatment
should not be used preventive, even though you have experienced delayed diarrhoea at previous
cycles.
infrequent cases of renal insufficiency, hypotension or circulator failure have been
observed in patients who experienced episodes of dehydration associated with diarrhoea and/or
vomiting, or sepsis.
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Fever
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 vomitng contact your doctor or the unit immediately
Neutropenia
Irinotecan 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 shoul darrange 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 20 mg/ml is started and before every following
treatment cycle your doctor will monitor your liver function (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.

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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 problem.
Vaccinations
Before treatment with Irinotecan hydrochloride, tell your doctor, if you have had or are due to
have any vaccinations.
Heart problems
If you have any heart problems contact your doctor immediately.

Other medicines and Irinotecan hydrochloride
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.
If you receive Irinotecan hydrochloride 20 mg/ml concentrate for solution for infusion in combination
with cetuximab, bevacizumab or capecitabine please make sure that you also read the package insert
for cetuximab, bevacizumab or capecitabine.
Medicines known to alter the effects of Irinotecan hydrochloride 20 mg/ml:
ketoconazole (for the treatment of fungal infections),
rifampicin (for the treatment of tuberculosis),
carbamazepine, phenobarbital and phenytoin (medicines for the treatment of epilepsy).
Warfarin, acenocoumarol (an anticoagulant used to thin the blood)

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Atazanavir (used to treat HIV)
Ciclosporin or Tacrolimus (used to dampen down your body’s immune system)
The herbal medicine St John’s Wort (Hypericum perforatum) may not be used concurrent with
Irinotecan hydrochloride 20 mg/ml and not between treatments, as it may decrease the effect of
irinotecan.

If you go into hospital to have an operation, tell the anaesthetist and the medical staff that you are
being treated with Irinotecan hydrochloride and any other medicines you are taking.
Pregnancy breast-feeding and fertility
Irinotecan hydrochloride 20 mg/ml must be avoided during pregnancy during the first trimester. Your
doctor will discuss with you the potential risk of taking Irinotecan hydrochloride during pregnancy.

You should also avoid becoming pregnant while you are being treated with Irinotecan
hydrochloride.
Women of childbearing potential and men have to use effective contraception while being treated
with Irinotecan hydrochloride and for at least three months (by males) and one month (by females)
after cessation of therapy..
If you do become pregnant while being treated with Irinotecan hydrochloride you must inform your
doctor IMMEDIATELY.
Breast-feeding must be discontinued for the duration of Irinotecan hydrochloride 20 mg/ml therapy.
Ask your doctor for advice before taking any medicine
Driving and using machines
In some cases Irinotecan hydrochloride 20 mg/ml 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 20 mg/ml you may feel
dizzy or have visual distrubances. If this happens to you do not drive or use any tools or machines.
Irinotecan hydrochloride 20 mg/ml concentrate for solution for infusion contains sorbitol, which
is unsuitable for people who cannot tolerate fructose.
If you have been told by your doctor that you have an intolerance to some sugars (i.e. fructose
intolerance), tell your doctor or hospital pharmacist before you are given Irinotecan hydrochloride 20
mg/ml concentrate for solution for infusion.
This medicinal product contains less than 1 mmol sodium (23 mg) per dose, therefore it can be
considered to essentially ‘sodium- free’.
3.

How to use Irinotecan hydrochloride 20 mg/ml concentrate for solution for infusion

Irinotecan hydrochloride 20 mg/ml will be given as an infusion into your veins over a period of 30 to
90 minutes.
The amount of Irinotecan hydrochloride 20 mg/ml 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 square metres (m2).
If you have previously been treated with 5-fluorouracil you will normally be treated with
Irinotecan hydrochloride 20 mg/ml 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
hydrochloride 20 mg/ml every two weeks. This will be followed by folinic acid and 5fluorouracil.
These dosages may be adjusted by your doctor depending on your condition and any side-effects you
may have.

Duration of treatment:
The number of infusions that you receive will depend on how you are responding to treatment. Your
doctor will discuss this with you.
Blood Monitoring
Whilst you are taking Irinotecan hydrochloride and/or other similar medicines you will have regular
blood tests to monitor your treatment and to ensure that there are no untoward adverse effects.
If you have any further question on the use of this medicine, ask your doctor or pharmacist or nurse.
4.

Possible side effects

Like all medicines, Irinotecan hydrochloride 20 mg/ml 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
See also information in section “Take special care with Irinotecan hydrochloride”
The following side effects have been reported at the approximate frequencies shown. Within each
frequency grouping, undesirable effects are presented in order of decreasing seriousness
Very common (may affect more than 1 in 10 people):
Delayed diarrhoea
Blood disorders including abnormally low number of neutrophil granulocytes, a type of white
blood cell (Neutropenia), reduction of the quantity of haemoglobin in blood (anaemia) and the
presence of relatively few platelets in blood.(trombocytopenia)
Nausea and vomiting
Hair loss (the hair grows again after the end of treatment)
Increase in levels of liver enzymes, such as transaminases and alkaline phosphatase or bilirubin
Common (may affect up to 1 in 10 people):
Fever associated with a severe decrease in the number of some white blood cells (febrile
neutropenia)
Fever, infections (including sepsis)
Acute cholinergic syndrome: the main symptoms are early diarrhoea and various other
symptoms such as abdominal cramps, watering eyes, visual disturbance, low blood pressure,
sweating, chills, dizziness, feeling unwell, and excessive mouth watering, red, sore, itching or
weeping eyes (conjunctivitis), runny nose (rhinitis); flushing due to widening of blood vessels
(vasodilation) occurring during or within 24 hours after the infusion of Irinotecan hydrochloride
20 mg/ml concentrate for solution for infusion
Dehydration (associated with diarrhoea and/or vomiting)
Constipation relative to Irinotecan hydrochloride and/or loperamide
Fatigue
Transient and mild to moderate increases of liver enzymes and creatinine in the blood.
Uncommon (may affect up to 1 in 100 people):
Allergic reactions – skin rash including red itchy skin, urticaria, conjunctivitis, rhinitis
Mild skin reactions: mild reactions at the infusion site
Early effects such as breathing difficulties
Lung disease (interstitial pulmonary disease)
Abdominal pain and inflammation, causing diarrhoea (a condition known as
pseudomembraneous colitis)
Infrequent cases of renal insufficiency, low blood pressure or cardio-circulatory failure have
been observed in patients who experienced episodes of dehydration associated with diarrhoea
and/or vomiting, or in patients who experienced sepsis
Intestinal blockage, gastrointestinal bleeding

Rare (may affect up to 1 in 10,000 people)
Severe allergic reaction (including swelling of the hands, feet, ankles, face, lips, mouth or
throat which may cause difficulty in swallowing or extreme difficulty breathing and you may
feel you are going to faint (anaphylactic/anaphylactoid reaction). If this happens you should tell
your doctor immediately.
High blood pressure during or following the infusion.
Gastrointestinal bleeding and inflammation of the colon including the appendix
loss of appetite, abdominal pain, inflammation of the mucous membranes
Inflammation of the pancreas
Low levels of potassium and sodium, mostly related to diarrhoea and vomiting
Muscular contraction or cramps, numbness (paraesthesia)
Intestinal perforation
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 peripheral thrombocytopenia with antiplatelet antibodies
Unknown
Muscle cramps, muscle tension or twitch
Pins and needles
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
Please read instructions, described in section 2 “What you need to know before Irinotecan
hydrochloride 20 mg/ml concentrate for solution for infusion is administered to you” carefully and
follow them if you have any of the side-effects listed above.
If you receive Irinotecan hydrochloride 20 mg/ml in combination with capecitabine, some of the side
effects you may experience can also be related to this combination. Such side effects may include:
very common blood clots, common allergic reactions, heart attack and fever in patients with a low
white blood cell count. Therefore, please make sure that you also read the package leaflet for
capecitabine.
If you receive Irinotecan hydrochloride 20 mg/ml in combination with capecitabine and bevacizumab,
some of the side effects you may experience can also be related to this combination. Such side effects
include: low white blood cell count, blood clots, high blood pressure and heart attack. Therefore,
please make sure that you also read the package leaflet for capecitabine and bevacizumab.
If you get any side effects talk to your doctor or nurse. This includes any side effects not listed in this
leaflet.
Reporting of side effects
If you get 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 Irinotecn hydrochloride 20 mg/ml concentrate for solution for infusion

Keep out of the sight and reach of children.
Do not use Irinotecan hydrochloride 20 mg/ml concentrate after the expiry date which is stated on the
carton and the vials. The expiry date refers to the last day of that month.
Concentrate: Keep the vials in the outer carton in order to protect from light
Diluted concentrate:
For single use only.
Unused solution should be discarded.
Once the concentrate has been diluted for infusion with 5% Dextrose, the solution can be kept
for 48 hours in a refrigerator (2 to 8°C), or after dilution with 0.9% Sodium chloride or 5%
Dextrose solution, it can be stored for 24 hours at room temperature.
Do not throw away any medicines should not be disposed of via wastewater or household waste. Ask
your pharmacist how to throw away medicines you no longer use. These measures will help protect
the environment.
6.

Contents of the pack and further information

What Irinotecan hydrochloride 20 mg/ml concentrate for solution for infusion contains
The active ingredient is irinotecan hydrochloride trihydrate
Each ml contains 20 mg irinotecan hydrochloride trihydrate, equivalent to 17.33 mg irinotecan.
The inactive ingredients are sorbitol, lactic acid, sodium hydroxide, hydrochloric acid and
water for injections.
What Irinotecan hydrochloride 20 mg/ml concentrate for solution for infusion looks like and
contents of the pack
Irinotecan hydrochloride 20 mg/ml is clear, from colourless to pale yellow solution.
This medicine is supplied to the hospital as glass vials containing 20 mg/ml Irinotecan hydrochloride,
trihydrate (equivalent to 17.33 mg/ml irinotecan) in carton boxes. It is available as a concentrate,
which should be diluted before infusion and comes in four sizes:
Each 2 ml vial contains 40 mg irinotecan hydrochloride as trihydrate.
Each 5 ml vial contains 100 mg irinotecan hydrochloride as trihydrate
Each 15 ml vial contains 300 mg irinotecan hydrochloride as trihydrate
Each 25 ml vial contains 500 mg irinotecan hydrochloride as trihydrate
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
TEVA UK Limited, Eastbourne, BN22 9AG
Manufacturer:
Teva Czech Industries s.r.o., Ostravská 29, c.p. 305, 747 70 Opava-Komárov, Czech Republic
This leaflet was last revised in September 2014
PL 00289/1018
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The following information is intended for medical or healthcare professionals only
Irinotecan hydrochloride 20 mg/ml Concentrate for Solution for Infusion
irinotecan hydrochloride trihydrate
Use / Handling
As with other neoplastic agents, Irinotecan hydrochloride 20 mg/ml concentrate for solution for
infusion must be prepared and handled with caution. Pregnant women should not manipulate
cytotoxics.
The use of glasses, masks and gloves is required. If Irinotecan hydrochloride 20 mg/ml concentrate or
infusion solution should come in contact with the skin, wash immediately and thoroughly with soap
and water. If Irinotecan hydrochloride 20 mg/ml concentrate or infusion solution should come into
contact with the mucous membranes, wash immediately with water.
Preparation for the intravenous solution
As with any other injectable drugs, Irinotecan hydrochloride 20 mg/ml concentrate for solution for
infusion must be prepared aseptically.
If any precipitate is observed in the vials or after reconstitution, the product should be discarded
according to standard procedures for cytotoxic agents.
Aseptically withdraw the required amount of Irinotecan hydrochloride 20 mg/ml 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 or 5% dextrose solution. The infusion should then be
thoroughly mixed by manual rotation.
Irinotecan hydrochloride 20 mg/ml concentrate for solution for infusion should be infused into a
peripheral or central vein.
Irinotecan hydrochloride 20 mg/ml concentrate for solution for infusion should not be delivered as an
intravenous bolus or an intravenous infusion shorter than 30 minutes or longer than 90 minutes.
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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