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ETOPOSIDE 20MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION

Active substance(s): ETOPOSIDE

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Etoposide 20mg/ml Concentrate
for Solution for Infusion
Read all of this leaflet carefully
before you start using 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
nurse.
• If you get any side effects, talk
to your doctor. This includes any
possible side effects not listed in
this leaflet. See section 4.

What is in this leaflet
1 What Etoposide is and what
it is used for
2 What you need to know
before you use Etoposide
3 How to use Etoposide
4 Possible side effects
5 How to store Etoposide
6 Contents of the pack and
other information
Etoposide Concentrate
for Solution for Infusion is
given only by healthcare
personnel, who can reply to
any questions, which you
may have after reading this
package leaflet.
1  What Etoposide is and what

it is used for

The name of this medicine is
Etoposide 20mg/ml Concentrate
for Solution for Infusion. It
contains the active ingredient
etoposide. Etoposide belongs to
a group of medicines known as
podophyllotoxin derivatives and it
slows or stops the growth of cancer
cells.
Etoposide is used to treat certain
types of cancers in combination
with other chemotherapeutic
agents.
This medicine is used for the
treatment of testicular cancer, lung
cancer and certain cases of leukemia
(blood cancer).

2  What you need to know

before you use Etoposide
Do not receive Etoposide:

• if you are allergic to etoposide,
podophyllotoxins or
podophyllotoxin-derivatives or
any of the other ingredients of this
medicine (listed in section 6)
• if you need to have a vaccine for
‘yellow fever’ or other live vaccines.
This medicine should only be given
to you as an infusion into a vein.

Warnings and precautions

Talk to your doctor or nurse:
• if you experience any symptoms
that might indicate allergic
reactions, such as fever, difficulty
breathing, chills, rapid heart beat
and low blood pressure.
• if you notice any reactions at the
injection site. Inform your doctor
or nurse right away, as the infusion
might need to be stopped.
• if you are receiving, or did receive
in the past, radiation therapy.
• if you are suffering from infections.
• if you have problems with your
liver.
• if you have severe kidney
problems.
Tell your doctor about any other
treatment you receive for your
illness.
Your doctor will need to do regular
blood tests during treatment with
Etoposide in order to monitor your
blood composition.

Children and adolescents

Safety and effectiveness in children
and adolescents have not been
established. Therefore etoposide is
not recommended for use in this
age group.
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AAAI0316

Other medicines and Etoposide

Tell your doctor if you are taking,
have recently taken or might take
any other medicines. In particular
you should tell your doctor if you are
taking any of the following:
• anti-coagulants such as warfarin
which are used to thin the blood
• the analgesic (pain killing)
and fever lowering medicines
phenylbutazone, aspirin and
aspirin related medicines (sodium
salicylate or salicylic acid)
• the immunosuppressant
ciclosporin (often given after an
organ transplant)
• cisplatin (used to treat cancer)
• phenytoin (a medicine for epilepsy)
• vaccines for ‘yellow fever’ or other
live vaccines.
Etoposide can also have effects
on other medicines used to treat
cancer. Your doctor will take these
effects into account when deciding
on your treatment.

Etoposide with food and drink
Etoposide is not affected by food or
drink.

Pregnancy, breast-feeding and
fertility
If you are pregnant or breastfeeding, think you may be pregnant
or are planning to have a baby, ask
your doctor or pharmacist for advice
before you begin to use, or are
administered Etoposide.
Women of child bearing age must
avoid pregnancy and take effective
contraceptive measures during
treatment and until at the earliest 6
months after therapy with etopside.

Fathering children whilst
taking Etoposide

Men should not father a child whilst
being treated with Etoposide and
until 6 months after treatment has
finished.
It is adviced for men to consider
sperm collection (for cryoconservation) before treatment with
etoposide, because infertility after
treatment can occur.

Driving and using machines

This medication can cause tiredness
and sleepiness. Precaution is advised
in undertaking actions which
require extra alertness, such as the
use of machines and driving.

Etoposide contains ethanol

19.5% ethanol (alcohol) i.e. up
to 0.79g per vial. This may be
dangerous for patients suffering
from alcoholism and for patients in
high-risk groups such as those with
liver problems or epilepsy (fits). The
amount of alcohol in this product
may alter the effects of other
medicines.

3 How to use Etoposide
Etoposide Concentrate for Solution
for Infusion will always be given to
you by a healthcare professional.
This medicine will be diluted with
0.9% sodium chloride or 5% glucose
and will be given to you as an
infusion (a “drip”) into a vein.

Dosage and method of
administration

• The dose of Etoposide will be
individually determined by your
doctor. The dose you are given
depends on your size, i.e. it varies
with your surface area. Technically,
this is measured in square metres,
and is worked out from your height
and weight.
• The recommended dose of
etoposide is 60-120mg/m2 daily for
3-5 days.
• You will receive a treatment cycle
consisting of one dose a day
during 3-5 days, followed by a
10-20 days rest.
• The administration will take at least
30 to 60 minutes.
•U
 sually three or four treatment
cycles are given, but the duration
of the treatment and the number
of treatment is determined by
the doctor and may vary for each
patient.

Continued over page

!

Etoposide 20mg/ml Concentrate for Solution for Infusion
The following information is intended for healthcare professionals only:
For single use only.
Refer to local cytotoxic guidelines.
Like with all anti-neoplastic products
caution is needed with the processing
of etoposide. Dilution should take
place under aseptic conditions in a
safety box, by trained personnel in an
area specifically intended for this, and
protective coats and gloves should be
used. If no safety box is available, the
equipment should be supplemented
with a mask and protective glasses.
Precautions should be taken to avoid
contact with the skin and mucous
membranes. Accidental contact with
the skin or eyes or mucous membranes
should be treated immediately with
copious amounts of water.
In the event of spillage, operators
should put on gloves and mop up the
spilled material with a sponge kept in
the area for that purpose. Rinse the area
twice with water. Put all solutions and
sponges into a plastic bag and seal it.
Pregnant women must avoid contact
with cytostatic drugs.
Bodily waste matter and vomit should
be disposed with care.
If the solution is cloudy or a deposit that
does not dissolve is noticed, the bottle
should be discarded.
A damaged bottle must be regarded
and treated with the same precautions
as contaminated waste.

Contaminated waste must be stored in
waste containers specifically marked for
this. See section “Disposal”.
Preparation of the intravenous
administration
Dilution
Etoposide 20mg/ml Concentrate for
Solution for Infusion must be diluted
immediately prior to use with either
5% glucose or 0.9% sodium chloride
solution to give a final concentration of
0.2 to 0.4mg/ml, usually not more than
0.25mg/ml. At higher concentrations
precipitation of etoposide may occur.
Etoposide needs to be diluted with
volumes ranging from 250-1,000ml,
based on the individual dosage. Care
should be taken not to exceed the final
concentration of 0.4mg/ml.
Examples of approximate volumes
of diluent needed for different dose
ranges:
Amount of
Amount of
etoposide (mg) solution needed
to prepare the
dilution (ml)
≤100mg
250ml
101mg to 200mg 500ml
>200mg

750-1000ml

Solutions showing any signs of
precipitation should not be used.

Continued top of next column
AAAI0316

Continued over page

Etoposide 20mg/ml Concentrate for Solution for Infusion PIL - UK
item no: AAAI0316

dimensions: 130 x 600

print proof no: 2

pharmacode:

origination date: 16.06.15

min pt size: 9

1. Black
2.
3.
4.
5.
6.

originated by: S.Anson
approved for print/date

colours/plates:

revision date: 17.06.15

Technical Approval

revised by: S.Anson

date sent: 16.06.15

supplier: Actavis Romania (Sindan)

technically app. date: 16.06.15

Non Printing Colours
1.
2.
3.

• E toposide is given in combination
with other medicines.
• Your condition will be closely
monitored during treatment. This
routinely involves blood tests and
controls of your liver function.
• Your dose may be changed
depending on your kidney
function.
If you have any questions about
your treatment schedule ask your
doctor or nurse.

If you receive more Etoposide
than you should

As a doctor or nurse will be giving
you your medicine, it is unlikely that
you will receive an incorrect dose.
Tell your doctor or nurse if you have
any concerns about the amount of
medicine that you receive.

If you forget to take Etoposide
If you have missed a dose of your
treatment, consult your doctor or a
nurse.

4  Possible side effects
Like all medicines, this medicine
can cause side effects, although not
everybody gets them.You should
discuss them with your doctor who
will explain the risks and benefits
of your treatment. Some of the side
effects can be lessened or treated by
other medicines or therapy.

Uncommon (may affect up to 1 in
100 people)
•d
 amage to nerves of the hand and
feet
Rare (may affect up to 1 in 1,000
people)
• c onvulsions (fits)
• t iredness and drowsiness
• r eversible loss of vision
• inflammation of the optic nerve
with complete or partial loss of
vision
• inflammation of the tissue in the
lungs
• f ormation of scar tissue in the
lungs
•d
 ifficulty in swallowing
• t aste impairment
• a sunburn-like rash that may
occur on skin that has previously
been exposed to radiotherapy
and can be severe (radiation recall
dermatitis)

Reporting of side effects

If you get any side effects, talk to
your doctor or nurse. This includes
any possible side effects not listed
in this leaflet. You can also report
side effects directly via Yellow Card
Scheme Website:
www.mhra.gov.uk/yellowcard

5 How to store Etoposide
Keep this medicine out of the sight
and reach of children.

Some side effects can be
serious and need immediate
medical attention. Tell your
doctor immediately if you
notice any of the following:

Do not use this medicine after the
expiry date which is stated on the
vial and the outer carton after ‘Exp’.
The expiry date refers to the last day
of that month.

Common (may affect up to 1 in 10
people)
• S evere allergic reactions such
as fever, reddening of the face
and neck, often with a sudden,
subjective feeling of heat
(flushing), rapid heartbeat,
abnormal contraction of your
lungs which can cause a cough and
wheezing, abnormally low blood
pressure and difficulty breathing.
• Chest pain or sensation of chest
tightness (chest pain may radiate
to one or both arms, shoulders,
jaw, neck and upper abdomen),
shortness of breath, sweating, light
headedness and nausea. These
may be symptoms of heart attack
(myocardial infarction).

Do not store above 25°C. Do not
refrigerate or freeze.

Rare (may affect up to 1 in 1,000
people)
• A potentially life-threatening skin
disorder accompanied by severe
skin blisters and often sores in the
membrains of the mouth, nose,
eyes and the anal and gential areas
(Stevens-Johnson syndrome, toxic
epidermal necrolysis).

Other side effects:
Very common (may affect more
than 1 in 10 people)
•b
 one marrow suppression which
results in changes in the number of
white and red blood cells (anaemia,
leukopenia, neutropenia) and
platelets (thrombocytopenia). This
will be monitored by your doctor
during your treatment with regular
blood tests
• liver damage. Your doctor will
monitor your liver function with
blood tests during your treatment
• a bdominal pain
• c onstipation
•n
 ausea
• v omiting
• loss of appetite
• r eversible loss of hair (alopecia)
•d
 arkening of skin (increase in
pigmentation)
• a feeling of weakness or general
discomfort
• f eeling of tiredness due to anaemia
Common (may affect up to 1 in 10
people)
• leukaemia (cancer of the blood)
• irregular heartbeat
•d
 izziness
• r ash, hives, itching
• a bnormally high blood pressure
• low blood pressure causing
dizziness when Etoposide is
administered too quickly
•d
 iarrhoea
• inflammation of the mucous
membrane of the mouth and gullet
• leakage of the medicine into the
surrounding tissues (extravasation)
with symptoms such as pain,
irritation and swelling
• inflammation of a vein

Keep the vial in the outer carton in
order to protect from light.
If the solution is cloudy or a deposit
that does not dissolve is noticed, the
bottle should be discarded.
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.
After dilution:
Chemical and physical in-use
stability has been demonstrated the
diluted solution 0.2mg etoposide/
ml for 96 hours and for the diluted
solution 0.4mg etoposide/ml for
24 hours at 25°C, without any
special protection from light.
From a microbiological point of
view, the product should be used
immediately.

6 Contents of the pack and

other information

What Etoposide contains

• The active substance is etoposide.
1ml of concentrate for solution for
infusion contains 20mg of
etoposide. One vial of 5ml
concentrate for solution for
infusion contains 100mg
etoposide.
• The other ingredients are
macrogol 400, polysorbate 80,
ethanol anhydrous and citric acid,
anhydrous (for pH adjustment).

What Etoposide looks like and
contents of the pack

Etoposide is a clear, pale yellow
concentrate for solution for infusion,
slightly viscous, free from visible
particles in glass injection vials.
Etoposide is contained in 8ml
Type I colourless glass vial with
bromobutyl rubber stop and
sealed with aluminium metallic
cap with flip off. One vial of 5ml of
concentrate for solution for infusion
contains 100mg etoposide.
Pack sizes: 1 or 10 vials per carton
Vial is packed with a protective
plastic overwrap.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Actavis Group PTC ehf.
Reykjavíkurvegi 76-78
220 Hafnarfjörður
Iceland
Manufacturer
S.C. Sindan- Pharma S.R.L
11 Ion Mihalache Blvd
011171 Bucharest
Romania
This leaflet was last revised in
June 2015.

Continued top of next column
AAAI0316

Actavis, Barnstaple, EX32 8NS, UK

!
Administration
The usual dose of etoposide, in
combination with other approved
chemotherapeutic agents, ranges
from 60-120mg/m2/day for 3-5 days.
Chemotherapy courses are repeated
at 2 to 4 week intervals after adequate
recovery from any toxicity.
Overall, a dosage schedule of 100mg/
m²/day on days 1 through 5 or 120mg/
m²/day on days 1, 3, and 5 is used most
frequently.
Generally 3 to 4 chemotherapy cycles
are administered. Dose and amount of
cycles should be adjusted to the level
of bone marrow suppression and the
reaction of the tumour.
In patients with impaired renal function,
the following initial dose modification
should be considered based on
measured creatinine clearance.
Measured
Dose of
creatinine
etoposide
clearance
>50ml/min
100% of dose
15-50ml/min
75% of dose
Subsequent dosing should be based
on patient tolerance and clinical effect.
Data are not available in patients with
creatinine clearance <15ml/min and
further dose reductions should be
considered in these patients.

To prevent the occurrence of
hypotension, the infusion should be
given over a 30 to 60 minute period.
Longer infusion times may be required
based on patient tolerance.
The intravenous solution is suitable
for infusion only in glass and PVC
containers.
Always look at the injection before use.
Only a clear solution, free from particles
should be administered.
Disposal
All materials that have been used for
the preparation and administration,
or which have been in contact with
etoposide in any way, must be
disposed of according to local cytotoxic
guidelines.
Remnants of the medicinal products as
well as all materials that have been used
for dilution and administration must
be destroyed according to hospital
standard procedures applicable to
cytotoxic agents and in accordance
with local requirements related to the
disposal of hazardous waste.

Etoposide is intended for slow
intravenous infusion only. Etoposide
must not be given by rapid
intravenous injection.
Continued top of next column
AAAI0316

Actavis, Barnstaple, EX32 8NS, UK

Etoposide 20mg/ml Concentrate for Solution for Infusion PIL - UK
item no: AAAI0316

dimensions: 130 x 600

print proof no: 2

pharmacode:

origination date: 16.06.15

min pt size: 9

1. Black
2.
3.
4.
5.
6.

originated by: S.Anson
approved for print/date

colours/plates:

revision date: 17.06.15

Technical Approval

revised by: S.Anson

date sent: 16.06.15

supplier: Actavis Romania (Sindan)

technically app. date: 16.06.15

Non Printing Colours
1.
2.
3.

Expand view ⇕

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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