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IRINOTECAN HYDROCHLORIDE 20MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION

Active substance(s): 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.
ee t is lea et ou ma need to
read it again
ou a e an urt er uestions,
as our doctor, or armacist
or nurse
is medicine as been rescribed
or ou onl
o not ass it on to
ot ers t ma arm t em, e en i
t eir signs o illness are t e same
as ours
ou get an side e ects, tal
to our doctor, or armacist or
nurse
is includes an ossible
side e ects not listed in t is lea et
ee section
What is in this leaflet
at rinotecan droc loride is and
at it is used or
at ou need to no be ore ou
use rinotecan droc loride
o to use rinotecan droc loride
ossible side e ects
5 o to store rinotecan droc loride
ontents o t e ac and ot er
in ormation

1. What Irinotecan Hydrochloride
is and what it is used for
rinotecan droc loride belongs to a
grou o medicines called c tostatics
anti cancer medicines
rinotecan droc loride is used or t e
treatment o ad anced cancer o colon
and rectum in adults and
ere t e
disease is at an ad anced stage in t e
large intestine, eit er in combination
it ot er medicines combination
t era
or alone monot era
our doctor ma use a combination o
irinotecan it
uorouracil olinic acid
and be aci umab to treat
our cancer o t e colon and rectum
our doctor ma use a combination
o irinotecan it ca ecitabine it
or it out be aci umab to treat our
cancer o t e colon and rectum
our doctor ma use a combination
o irinotecan it cetu imab to
treat cancer o t e large intestine
ild t e t at is o a certain
t e no n to dis la cell mar ers
re erred to as e idermal gro t actor
rece tors
ic are bloc ed b
t e monoclonal antibod
ou need an urt er in ormation on
our condition, lease as our doctor

2. What you need to know before
you use Irinotecan Hydrochloride
Do not use Irinotecan Hydrochloride:
i ou are
ersensiti e allergic to
irinotecan droc loride tri drate or
an o t e ot er ingredients o t is
medicine listed in section
i ou a e an ot er bo el disease
or a istor o bo el obstruction
i ou a e increased le els o
bilirubin in t e blood more t an
times t e u er limit o t e
normal range
i ou a e an imbalance o
our blood cells se ere bone
marro ailure
i ou are in a oor general ealt
e aluated b an international
standard
i ou are using t e natural
remed t o n s ort
(Hypericum perforatum
i ou are regnant or breast eeding
or i ou t in ou mig t be regnant
or additional contraindications
o cetu imab or be aci umab or
ca ecitabine,
ic ma be used in
combination it irinotecan, lease
re er to t e roduct in ormation or
t ese medicinal roducts

Warnings and precautions:
is medicine is intended or adults
onl
ec it our doctor i t is
medicine as been rescribed or use
in a c ild
ecial care is also needed in
elderl atients
s rinotecan droc loride is
an anti cancer medicine it ill be
administered to ou in a s ecial unit
and under su er ision o a doctor
ualified in t e use o anti cancer
medicines
e units ersonnel ill
e lain to ou
at ou need to ta e
s ecial care o during and a ter t e
treatment
is lea et ma el ou to
remember t at
ou recei e irinotecan in combination
it cetu imab or be aci umab or
ca ecitabine, lease ma e sure t at
ou also read t e ac age lea et or
t ese medicinal roducts

Before you use this medicine tell
your doctor if any of the following
apply to you:
ou a e eart roblems
ou smo e, a e ig blood ressure
or ig c olesterol as t ese can
increase t e ris o eart roblems
during treatment it t is medicine
ou a e ad or are due to a e
an accinations
During administration of
irinotecan (30-90 minutes) and up
to 24 hours after administration
ou ma e erience some o t e
ollo ing s m toms
diarr oea
s eating
abdominal ain
atering e es
isual disturbance
e cessi e mout
atering
e medical term or t ese s m toms
is “acute cholinergic syndrome”
ic can be treated it atro ine
ou a e an o t ese s m toms,
immediately tell your doctor
o ill
gi e ou an treatment necessar
From the day after treatment with
irinotecan until next treatment ou
ma e erience arious s m toms,
ic ma be serious and re uire
immediate treatment and close
su er ision
ese can be
Diarrhoea
our diarr oea starts more t an
ours a ter administration o

irinotecan dela ed diarr oea it ma
be serious t is o ten seen about da s
a ter administration
e diarr oea
s ould be treated immediatel
and e t under close su er ision
mmediatel a ter t e first li uid stools
do t e ollo ing
a e an antidiarr oeal treatment
t at t e doctor as gi en ou,
e actl as e s e as told ou
e treatment must not be c anged
it out consulting t e doctor
ecommended antidiarr oeal
treatment is lo eramide mg or
t e first inta e and t en mg e er
ours, also during t e nig t
is s ould be continued or at
least
ours a ter t e last li uid
stools
e recommended dosage
o lo eramide must not be ta en or
more t an
ours
rin large amounts o ater and
re dration uids, immediatel
i e ater, soda ater, fi
drin s,
sou or oral re dration t era
mmediatel in orm our doctor
o
is su er ising t e treatment, and
tell im er about t e diarr oea
ou are not able to reac t e doctor,
contact t e os ital unit su er ising
t e irinotecan treatment t is er
im ortant t at t e are a are o
t e diarr oea
os italisation is recommended or t e
management o t e diarr oea, in t e
ollo ing cases
ou a e diarr oea as ell as e er
o er
ou a e se ere diarr oea and
omiting it e cessi e loss o
ater re uiring intra enous dration
ou still a e diarr oea
ours
a ter starting t e diarr oea treatment
N ot e! o not ta e an treatment or
diarr oea ot er t an t at gi en to ou
b our doctor and t e uids described
abo e ollo t e doctor s instructions
e antidiarr oeal treatment s ould not
be used re enti e, e en t oug ou
a e e erienced dela ed diarr oea at
re ious c cles
Fever
t e bod tem erature increases o er
it ma be a sign o in ection,
es eciall i ou also a e diarr oea
ou a e an e er o er
contact our doctor or t e os ital unit
immediatel so t at t e can gi e ou
an treatment necessar
Nausea (feeling sick) and vomiting
ou a e nausea and or omiting
contact our doctor or t e os ital
unit immediatel
Neutropenia
rinotecan ma cause a decrease in
t e number o some o our
ite
blood cells,
ic la an im ortant
role in fig ting in ections
is is called
neutro enia eutro enia is o ten
seen during treatment it irinotecan
and is re ersible our doctor s ould
arrange or ou to a e regular blood
tests to monitor t ese
ite blood
cells eutro enia is serious and
s ould be treated immediatel and
care ull monitored
Breathing difficulties
ou a e an breat ing di ficulties
contact our doctor immediatel
Impaired liver function
e ore treatment it irinotecan is
started and be ore e er ollo ing
treatment c cle our doctor ill monitor
our li er unction b blood tests
Impaired kidney function
s t is medicine as not been tested in
atients it idne roblems, lease
c ec
it our doctor i ou a e an
idne roblems
If you have one or more of the
symptoms mentioned above,
after you have returned home
from the hospital, you should
immediately contact the doctor or
the hospital unit supervising your
irinotecan treatment.

Other medicines and Irinotecan
Hydrochloride
lease tell our doctor or os ital
armacist i ou are ta ing or a e
recentl ta en, an ot er medicines,
including medicines obtained it out
a rescri tion
is is also alid or
erbal medicines
e ollo ing medications can alter t e
e ects o irinotecan
carbama e ine, enobarbital
or en toin drugs used in t e
management o e ile s
etocona ole used or t e treatment
o ungal in ections
ri am icin used or t e treatment
o tuberculosis
t e erbal medicine t o n s ort
(Hypericum perforatum must not be
used during treatment it irinotecan
and not bet een treatments,
as it ma decrease t e e ect
o irinotecan
ta ana ir used to treat
nticoagulants used to t in
t e blood
accines ell our doctor i ou
a e ad or are due to a e
an accinations
iclos orin or tacromilus used
to dam en do n our bod s
immune s stem
ou re uire an o eration, lease tell
our doctor or anaest etist t at ou
are using t is medicine, as it ma alter
t e e ect o some medicines used
during surger

Pregnancy and breast-feeding:
ou must not be gi en irinotecan i ou
are regnant
ou or our artner is being treated
it irinotecan ou must a oid
becoming regnant during treatment
en and omen s ould use ade uate
contrace tion
ile being treated and
or at least
t ree mont s a ter cessation o
t era
till, i ou become regnant, during
t is eriod ou must immediatel in orm
our doctor
ou must not breast eed
ile ou are
being treated it irinotecan

Driving and using machines
n some cases rinotecan
droc loride
ma cause side e ects
ic a ect
our abilit to dri e and use tools and
mac ines ontact our doctor or
armacist i ou are unsure
uring t e first
ours a ter
administration o rinotecan
droc loride ou ma eel di
or a e isual disturbances t is
a ens to ou do not dri e or
o erate mac iner
Irinotecan Hydrochloride contains
sorbitol
ou a e been told b our
doctor t at ou a e an intolerance to
some sugars e g ructose intolerance ,
contact our doctor be ore ou ta e t is
medicinal roduct
is medicinal roduct also contains
less t an mmol sodium
mg er
dose, i e essentiall sodium ree

e ollo ing in ormation is intended or ealt care ro essionals onl

INSTRUCTIONS FOR USE, HANDLING AND DISPOSAL
s it ot er otentiall to ic com ounds, caution s ould be e ercised
and re aring irinotecan solutions

en andling

Instructions for use/handling
s it ot er antineo lastic agents, irinotecan must be re ared and andled it
caution
e use o goggles, mas and glo es is re uired regnant omen s ould
not andle c toto ics irinotecan concentrate or in usion solutions s ould come into
contact it t e s in, it must be as ed o immediatel and t oroug l
it soa and
ater irinotecan concentrate or in usion solutions s ould come into contact it t e
mucous membranes, it must be as ed o immediatel
it
ater
H03990

Component Specification

Requester

Item number:

H03990

Request number:

N/A

Country:

UK

OI template:
Amalia version:
Mulgrave version:

SVI007
1
N/A

Dimensions:
Container(s):
Supplier:
Stock:
Folded dimensions:
Printed both sides:
Perforated:

118 x 570 mm
(20 panels)
Vial
EU Packing Centre
40 gsm
28.5 x 118 mm
Yes
No

I have checked this artwork against the
registered text including spelling, layout, size,
colours, registration numbers and scientific
equations, the name and address and
trademarks. Also for any possible changes to
related items.
This artwork is in conformance with the
Marketing Authorisation and can now proceed
to the printing stage.
Previous Item Number: Q710113

Pharma code:
Pharma code length:
Supplier Code:

N/A
N/A
N/A

Colours
Black:

Signed:
Date:
Version 1
Technician:
Date:

LH
04/Apr/16

Version 2
Technician:
Date:

LH
17/May/16

Version 3
Technician:
Date:

XX
dd/mmm/yy

Version 4
Technician:
Date:

XX
dd/mmm/yy

Version 5
Technician:
Date:

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dd/mmm/yy

Version 6
Technician:
Date:

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dd/mmm/yy

Version 7
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Date:

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dd/mmm/yy

Version 8
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Date:

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dd/mmm/yy

Version 9
Technician:
Date:

XX
dd/mmm/yy

Version 10
Technician:
Date:

XX
dd/mmm/yy

3. How to use Irinotecan Hydrochloride
l a s use t is medicine e actl as
our doctor or armacist as told ou
ec it our doctor or armacist i
ou are not sure
For adults only.
rinotecan ill be gi en as an in usion
into our eins o er a eriod o
minutes
e amount o in usion ou are gi en
ill de end on our age, eig t, eig t
and general medical condition our
doctor ill calculate our bod sur ace
area in s uare metres m2 rom our
eig t and eig t
e dosage ill also
de end on an ot er treatment ou ma
a e recei ed or our cancer
i

ou a e re iousl been treated
it
uorouracil ou ill normall
be treated it irinotecan alone
starting it a dose o
mg m2
e er
ee s
i ou a e not ad re ious
c emot era
ou ill normall
recei e
mg m2 irinotecan e er
t o ee s
is ill be ollo ed b
olinic acid and
uorouracil
ou recei e irinotecan in combination
it cetu imab, irinotecan must not be
administered earlier t an one our a ter
t e end o t e cetu imab in usion
lease ollo t e ad ice o our doctor
regarding our current treatment
ese dosages ma be ad usted
b our doctor de ending on our
condition and an side e ects ou
ma a e

If you use more Irinotecan
Hydrochloride than you should
receive:
n case ou ere gi en a ig er dosage
o irinotecan t an re uired t e occurring
side e ects ma be more se ere ou
ill get ma imum su orti e care to
re ent de dration due to diarr oea
and to treat an in ectious com lication
ou t in ou a e been administered
an o erdose lease contact our doctor
ou a e an urt er uestions on t e
use o t is medicine, as our doctor or
armacist or nurse

4. Possible side effects
i e all medicines, t is medicine
can cause side e ects, alt oug not
e er bod gets t em our doctor ill
discuss t ese side e ects it ou
and e lain t e ris s and benefits o
our treatment

Some of these side effects must be
treated immediately. These are:
diarr oea
a decrease in t e number o
neutro il granuloc tes, a t e o
ite blood cell,
ic la s an
im ortant role in fig ting in ections
e er
nausea and omiting
breat ing di ficulties ossible
s m tom o se ere allergic reactions
lease read instructions described
in section “Take special care with
irinotecan” care ull and ollo t em
i ou a e an o t e side e ects
listed abo e

Other side effects include:
Very common side effects (more than
1 in 10 patients)
blood disorders including
abnormall lo number o neutro il
granuloc tes, a t e o
ite blood
cell neutro enia and reduction
o t e uantit o aemoglobin in
blood anaemia
in combination t era ,
t romboc to enia reduction in t e
number o blood latelets causing
bruises, tendenc to bleed and
abnormal bleeding
in monot era , e er
in monot era , in ections
dela ed se ere diarr oea
in monot era , se ere nausea
eeling sic and omiting
being sic
air loss t e air gro s again a ter
end o treatment
in combination t era , transient
and mild to moderate increase in
serum le els o some li er en mes
,
, al aline os atase
or bilirubin
Common side effects (less than 1 in
10 patients but more than 1 in 100)
se ere transient acute c olinergic
s ndrome t e main s m toms
are defined as earl diarr oea and
arious ot er s m toms suc as
abdominal ain red, sore, itc ing
or ee ing e es con uncti itis
running nose r initis lo blood
ressure us ing due to idening
o t e blood essels asodilation
s eating c ills a eeling o
general discom ort and illness
di iness isual disturbances u il
contraction atering e es and
increased sali ation, occurring during
or it in t e first
ours a ter t e
in usion o rinotecan droc loride
in monot era , t romboc to enia
reduction in t e number o blood
latelets causing bruises, tendenc
to bleed and abnormal bleeding
in combination t era , e er
in combination t era , in ections
in ections associated it a se ere
decrease in t e number o some
ite blood cells neutro enia
resulting in deat in cases
e er associated it a se ere
decrease in t e number o some
ite blood cells ebrile neutro enia
in combination t era , se ere
nausea eeling sic and omiting
being sic
loss o ater de dration ,
commonl associated it diarr oea
and or omiting
consti ation
eeling ea ast enia
in monot era , transient and mild to
moderate increase in serum le els o
some li er en mes transaminases,
al aline os atase or bilirubin
transient and mild to moderate
increase o le els o creatinine in
t e blood
in combination t era , transient
ronounced grade increase in
serum le els o bilirubin
Uncommon side effects (less than 1 in
100 patients but more than 1 in 1,000)
mild allergic reaction s in ras
including red itc s in, urticaria,
con uncti itis, r initis
mild s in reactions
mild reactions at t e in usion site
lung disease resenting as s ortness
o breat , dr coug , and ins irator
crac les interstitial ulmonar
disease earl e ects suc as
breat ing di ficulties
artial or com lete bloc age o t e
bo el intestinal obstruction, ileus ,
stomac and intestines bleeding
bo el in ammation causing
abdominal ain and or
diarr oea a condition no n as
seudo membraneous colitis

renal insu ficienc , lo blood
ressure or cardio circulator
ailure in atients
o e erienced
e isodes o de dration associated
it diarr oea and or omiting or
sepsis
Rare side effects (less than 1 in
1,000 patients but more than 1 in 10,000)
• se ere allergic reactions
lactoid
ana
latic ana
reaction , including s elling o
t e ands, eet, an les, ace, li s,
mout or t roat
ic ma cause
di ficult in s allo ing or e treme
di ficult breat ing
muscular contraction or cram s and
numbness araest esia
in ammation o t e large
bo el causing abdominal ain
colitis including t
litis, isc emic
and ulcerati e colitis
intestinal er oration
loss o a etite
abdominal ain
in ammation o t e mucous
membranes
decreased le els o otassium and
sodium in t e blood, mostl related
to diarr oea and omiting
s m tomatic and as m tomatic
in ammation o t e ancreas
mainl abdominal ain
increased blood ressure during and
ollo ing administration
Very rare effects (less than 1 in
10,000 patients)
transient s eec disorders
increase in le els o some digesti e
en mes
ic brea do n sugars
am lase and ats li ase
one case o lo
latelet count
in t e blood due to antibodies
against latelets
ou recei e irinotecan in combination
it cetu imab, some o t e side
e ects ou ma e erience can also
be related to t is combination uc
side e ects ma include an acne li e
ras
ere ore, lease ma e sure
t at ou also read t e ac age lea et
or cetu imab
ou recei e irinotecan in combination
it ca ecitabine, some o t e side
e ects ou ma e erience can also
be related to t is combination uc
side e ects ma include er common
blood clots, common allergic reactions,
eart attac and e er in atients it
a lo
ite blood cell count
ere ore,
lease ma e sure t at ou also read
t e ac age lea et or ca ecitabine
ou recei e irinotecan in combination
it ca ecitabine and be aci umab,
some o t e side e ects ou ma
e erience can also be related to t is
combination uc side e ects include
lo
ite blood cell count, blood
clots, ig blood ressure and eart
attac
ere ore, lease ma e sure
t at ou also read t e ac age lea et
or ca ecitabine

Reporting of side effects
ou get an side e ects, tal to our
doctor or armacist
is includes an
ossible side e ects not listed in t is
lea et ou can also re ort side e ects
directl ia
ello
ard c eme
ebsite
m ra go u ello card
re orting side e ects ou can el
ro ide more in ormation on t e sa et
o t is medicine.

5. How to store Irinotecan
Hydrochloride
ee t is medicine out o t e sig t
and reac o c ildren
o not use t is medicine a ter t e
e ir date
ic is stated on t e
label and carton
e e ir date
re ers to t e last da o t at mont
oncentrate ee ials in t e
outer carton in order to rotect
rom lig t o not ree e nce
o ened ials s ould be used
immediatel as t e contain no
antimicrobial reser ati es
iluted concentrate or single
use onl
nused solution s ould
be discarded
ollo ing dilution
emical and
sical in use stabilit as been
demonstrated in glucose
mg ml
and sodium c loride mg ml
or
ours at
rom
a microbiological oint o ie , t e
roduct s ould be used immediatel
not used immediatel , in use
storage times and conditions rior to
use are t e res onsibilit o t e user
and ould normall not be longer
t an
ours at to
, unless
dilution as ta en lace in controlled
and alidated ase tic conditions
o not use t is medicine i ou notice
articles isible in t e concentrate or
in usion solution
o not t ro a a an medicines
ia aste ater or ouse old aste
s our armacist o to t ro
a a medicines ou no longer use
ese measures ill el rotect
t e en ironment

6. Contents of the pack and other
information
What Irinotecan Hydrochloride
contains
e acti e substance is irinotecan
droc loride tri drate ac
millilitre ml o solution contains
milligrams mg o irinotecan
droc loride tri drate, e ui alent
to
mg irinotecan
e ot er ingredients are sorbitol
, lactic acid, ater or
n ections, and sodium dro ide and
droc loric acid used to ad ust

What Irinotecan Hydrochloride looks
like and contents of the pack
rinotecan
droc loride is in t e orm
o a concentrate or solution or in usion
a concentrated solution
ic is diluted
to ma e a solution
ic is gi en as a
slo in usion ia a dri
e medicine comes in glass
containers called ials, containing
ml, ml and
ml o irinotecan
droc loride tri drate
e ials are ra ed in a rotecti e
lastic to reduce t e ris o s illage i
t e ials brea t ese are re erred to

ials
as
e ials are a ailable in single ac s
ot all resentations ma be mar eted

Marketing Authorisation Holder and
Manufacturer
os ira
imited
ori on
one ane
urle
aiden ead
nited ingdom
This leaflet was last revised in
May 2016

Preparation of the intravenous infusion
s it an ot er in usions, irinotecan in usion must be re ared using
ase tic tec ni ue
an reci itate is obser ed in t e ials or in t e in usion solution, t e roduct must
be discarded according to standard rocedures or discarding c toto ic agents
se ticall it dra t e re uired amount o irinotecan concentrate rom t e ial it
a calibrated s ringe and in ect into a
ml in usion bag or bottle containing eit er
mg ml
sodium c loride solution or
mg ml
glucose solution only
e in usion s ould t en be t oroug l mi ed b manual rotation

Disposal
ll materials used or dilution and administration s ould be dis osed o according to
local rocedures a licable to t e discarding o c toto ic agents
H03990

Component Specification

Requester

Item number:

H03990

Request number:

N/A

Country:

UK

OI template:
Amalia version:
Mulgrave version:

SVI007
1
N/A

Dimensions:
Container(s):
Supplier:
Stock:
Folded dimensions:
Printed both sides:
Perforated:

118 x 570 mm
(20 panels)
Vial
EU Packing Centre
40 gsm
28.5 x 118 mm
Yes
No

I have checked this artwork against the
registered text including spelling, layout, size,
colours, registration numbers and scientific
equations, the name and address and
trademarks. Also for any possible changes to
related items.
This artwork is in conformance with the
Marketing Authorisation and can now proceed
to the printing stage.
Previous Item Number: Q710113

Pharma code:
Pharma code length:
Supplier Code:

N/A
N/A
N/A

Colours
Black:

Signed:
Date:
Version 1
Technician:
Date:

LH
04/Apr/16

Version 2
Technician:
Date:

LH
17/May/16

Version 3
Technician:
Date:

XX
dd/mmm/yy

Version 4
Technician:
Date:

XX
dd/mmm/yy

Version 5
Technician:
Date:

XX
dd/mmm/yy

Version 6
Technician:
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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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