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CAMPTO 20MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION

Active substance(s): IRINOTECAN HYDROCHLORIDE TRIHYDRATE

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Campto

®

20mg/ml

PACKAGE LEAFLET: INFORMATION FOR THE USER

Campto

®

Concentrate for solution for infusion
irinotecan hydrochloride

20mg/ml

Concentrate for solution for infusion
irinotecan hydrochloride

HEALTHCARE PROFESSIONAL
INFORMATION:

The following information
is intended for medical or
healthcare professionals only:
Instructions for use/handling,
preparation and disposal
guide for use with Campto
Concentrate for Solution for
Infusion.
Use/handling

As with other neoplastic agents, Campto
must be prepared and handled with
caution.
The use of glasses, masks and gloves is
required. If Campto solution or infusion
solution should come in contact with the
skin, wash IMMEDIATELY and thoroughly
with soap and water. If Campto solution
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, the
Campto solution 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 Campto solution 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%
glucose solution. The infusion should
then be thoroughly mixed by manual
rotation.

Read all of this leaflet carefully
before you start taking this medicine.

Following dilution: Campto is physically
and chemically stable with infusion
solutions (0.9% (w/v) sodium chloride
and 5% (w/v) glucose solution) for up
to 28 days when stored in LDPE or
PVC containers at 5°C or at 30°C and
protected from light. When exposed to
light, physicochemical stability has been
demonstrated for up to 3 days.
It is recommended, that in order to
reduce microbiological hazard, the
infusion solutions should be prepared
immediately prior to use and infusion
commenced as soon as practicable after
preparation. If not used immediately,
in-use storage times and conditions prior
to use are the responsibility of the user
and should not be longer than 24 hours
at 2 to 8°C, unless dilution has taken
place in controlled and validated aseptic
conditions.
Campto infusion should be infused into a
peripheral or central vein.
Campto 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.

• 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 Campto is and what it is used for
2. Before you are given Campto
3. How you will be given Campto
4. Possible side effects
5. How to store Campto
6. Further information

1. What Campto is and what it
is used for
Your medicine is called Campto. Campto
belongs to a group of medicines called
cytostatics (anti-cancer medicines).

Campto 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 Campto
with 5-fluorouracil/folinic acid (5FU/FA) and
bevacizumab to treat your cancer of the large
intestine (colon or rectum).
Your doctor may use a combination of
Campto with capecitabine with or without
bevacizumab to treat your cancer of the
colon and rectum.
Your doctor may use a combination of Campto
with cetuximab to treat a particular type of
cancer of the large intestine (KRAS wildtype) which expresses a protein called EGFR.

2. Before you are given
Campto

You should not be given Campto if any of
the following apply to you:
• If you are allergic to irinotecan
hydrochloride or any of the other
ingredients of Campto
• If you have or have had chronic
inflammatory bowel disease or bowel
obstruction
• If you are pregnant or breast-feeding or if
you think you might be pregnant
• If you have severe liver disease
• If you have severe bone marrow failure
• If your general health status does not allow
you to carry out general activities of daily
living
• If you are taking St Johns’ Wort (a herbal
supplement)

Take special care with Campto

Before treatment with Campto tell your doctor if
any of the following apply to you:
• 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 Campto 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
Campto
• You have had or are due to have any
vaccinations.
• You are taking any other medicines. Please
see the section below “Taking other
medicines”
As with all anti-cancer medicines the use
of Campto is associated with a number of
side-effects which may be serious. These
side-effects require special management to
minimise the risk of complications.
You will be treated by a specialist team
experienced in using these kinds of treatments
and managing their side effects, which are

usually temporary. However, it is essential
that you read the section “POSSIBLE SIDE
EFFECTS” and follow the instructions carefully
if you get any of the symptoms described.

Taking other medicines:

Please tell your doctor if you are taking or
have recently taken any other medicines,
including medicines obtained without a
prescription.
If you receive Campto in combination
with either capecitabine, cetuximab or
bevacizumab, please make sure that you
also read the patient information leaflet for
each medicine.
Some medicines, when taken at the same
time as Campto, may affect the way Campto
works or Campto may affect the way they
work. Tell your doctor if you are taking any of
the following medicines:
• St John’s Wort (a herbal supplement)
• Ketoconazole (an antibiotic)
• Rifampicin (an antibiotic)
• Carbamazepine (used to treat seizures)
• Phenobarbital (used to treat seizures)
• Phenytoin (used to treat epilepsy)
• Warfarin (an anticoagulant used to thin
the blood)
• Atazanavir (used to treat HIV)
• Ciclosporin or Tacromilus (used to
dampen down your body’s immune
system)
If you go into hospital to have an operation,
tell the anaesthetist and the medical staff
that you are being treated with Campto and
any other medicines you are taking.

Pregnancy and breast-feeding

You must not use Campto if you are
pregnant as it may harm your unborn baby.
You should also avoid becoming pregnant
while you are being treated with Campto.
Men and Women should use adequate
contraception while being treated with Campto
and for:
• up to 1 month after you receive your last
dose of Campto if you are female
• up to 3 months after your last dose of
Campto if you are male.
If you do become pregnant while being treated
with Campto you must inform your doctor
IMMEDIATELY.
Because Campto may be harmful to nursing
infants, women must not breast-feed while
being treated with Campto.

Driving and Using Machines

Campto may make you feel dizzy or cause
visual disturbances. If this happens to you do
not drive or operate machinery until this
resolves.

Important Information about some
of the ingredients of Campto

Warning:
This medicine contains sorbitol, a type of
sugar. If you have been told by your doctor
that you have an intolerance to some
sugars tell your doctor or nurse before you
are given Campto.

3. How you will be given
Campto

If you are prescribed Campto it will only be
given to you by doctors or nurses experienced
in giving chemotherapy.
Method of administration: Campto will be
given as an infusion into your veins over a
period of 30 to 90 minutes.
If you receive Campto in combination with
cetuximab, Campto must not be administered
earlier than 1 hour after the end of the
cetuximab infusion.

Dosage and frequency of
administration:

The amount of Campto 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 Campto 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 Campto every two weeks.
This will be followed by folinic acid and
5-fluorouracil.
These dosages may be adjusted by your
doctor depending on your condition and any
side-effects you may have.

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 Campto 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.

4. Possible side effects

Medicines like Campto will cause unwanted
side-effects.
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.
Please read the following instructions
carefully and follow them if you have any
of the side-effects listed.

Diarrhoea

Campto may cause you to have diarrhoea.
There are two types of diarrhoea, which can
be distinguished by when they start. “Early”
diarrhoea starts less than 24 hours after the
infusion and “delayed” diarrhoea starts more
than 24 hours after the infusion. If you have
ANY DIARRHOEA it is IMPORTANT that you
follow these instructions carefully.

Early diarrhoea

• if your diarrhoea starts less than 24 hours
after the infusion (“early diarrhoea”)
you should contact your doctor or nurse
IMMEDIATELY and they will give you a
suitable treatment.
This “early diarrhoea” may be accompanied
by other symptoms such as
• sweating
• chills
• abdominal cramps
• watering eyes
• stuffy nose
• visual disturbance
• dizziness
• low blood pressure
• feeling unwell
• feeling weak
• excessive mouth watering
• pupils of the eye get smaller
Tell your doctor or nurse about all your
symptoms.
Do not use any anti-diarrhoeal treatment
that your doctor has given you for “delayed
diarrhoea”.

Delayed Diarrhoea

• if your diarrhoea starts more than
24 hours after the infusion (“delayed
diarrhoea”) you should IMMEDIATELY
take any anti-diarrhoeal treatment that
the doctor has given you EXACTLY as he
has told you. If you are unsure of what
this is, ask your doctor or nurse.
Drink large amounts of rehydration fluids,
IMMEDIATELY (i.e. water, soda water, fizzy
drinks, soup or oral rehydration therapy).

You must tell your doctor 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
Do not take any treatment for diarrhoea
other than that given to you by your
doctor or nurse and only drink the fluids
described above.

Decrease in white blood cells

Campto 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.
Your doctor will probably arrange for you to
have regular blood tests to monitor these
white blood cells.
If you have any fever this may be an indication
of infection associated with this neutropenia
and requires immediate treatment.
If you have any fever, and particularly if you
also have diarrhoea, contact your doctor or
nurse IMMEDIATELY so that they can give
you necessary treatment.

Nausea and vomiting

If you have nausea and/or vomiting contact
your doctor or nurse IMMEDIATELY.

Breathing difficulties

If you have breathing difficulties contact your
doctor or nurse IMMEDIATELY.

Other side effects

All medicines can cause allergic reactions.
If you experience any of the following
conditions please report it to a doctor or nurse
IMMEDIATELY:
• wheeziness
• difficulty in breathing
• swelling
• rash or itching (especially affecting the
whole body)














dehydration
kidney problems
low blood pressure
heart problems
blockage or perforation (a ‘hole’) in the
bowel
bleeding from the bowel
inflammation in the bowel
inflammation of the pancreas
severe stomach pain
passing black or blood stained stools
vomiting blood
changes in laboratory tests

If you receive Campto 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 you receive Campto 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 Campto 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.
Other side effects which may occur when you
are treated with Campto are:
• hair loss
• fatigue
• loss of appetite
• mild allergic skin reactions
• mild stomach pains
• muscular cramps and twitches
• pins and needles
• constipation
• inflammation at the injection site
• mouth ulcers
• temporary speech disorders
• high blood pressure

5. How to store Campto

Keep out of the reach and sight of children.
Store below 25ºC. Do not use Campto after the
expiry date which is stated on the vial and on
the box after “EXP”. The expiry date refers to
the last day of that month.
Store in the original package in order to protect
from light.
Once the concentrate has been diluted for
infusion the solution can be kept for 24 hours in
a refrigerator (at 2 to 8°C).

6. Further information
What Campto contains

The active substance is irinotecan
hydrochloride.
The other ingredients are Sorbitol, lactic acid,
sodium hydroxide, hydrochloric acid and water
for injections.

What Campto looks like and contents
of the pack
Campto is a liquid in a vial with a rubber
stopper. Each 2ml vial contains 40mg of
Campto, each 5ml vial contains 100mg of
Campto and each 15ml vial contains 300mg of
Campto.

Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Holder:
Pfizer Limited
Ramsgate Road
Sandwich
Kent
CT13 9NJ
UK

Manufacturer

Pfizer Service Company BVBA
Hoge Wei 10
1930, Zaventem
Belgium
This leaflet was last revised in 11/2011
CF 13_1

If any of the side effects get serious, or if
you notice any side effects not listed in
this leaflet, please tell your doctor or nurse
immediately.
PAM627PG

PAM627PG

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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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