Skip to Content

ETOPOSIDE 20 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION

Active substance(s): ETOPOSIDE

View full screen / Print PDF » Download PDF ⇩
Transcript
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 or nurse. This
includes any possible side effects not listed in this leaflet.
What is in this leaflet:
1. What etoposide is and what it is used for
2. What you need to know before you are given etoposide
3. How etoposide will be given
4. Possible side effects
5. How to store etoposide
6. Contents of the pack and other information
1. What etoposide is and what it is used for
The name of your medicine is ‘Etoposide 20 mg/ml concentrate
for solution for infusion’ but in the rest of the leaflet it will be
called ‘etoposide’. It contains the active ingredient etoposide.
Etoposide belongs to a type of drugs known as podophyllotoxin
derivatives.
Etoposide is used in adults in the treatment of small cell lung
cancer, testicular cancer and cancer of the blood-forming tissues
of bone marrow (acute myelomonocytic and monoblastic
leukaemia). It is often used at the same time as other anti-cancer
medicines.
Etoposide works by interfering with the production of new DNA,
which is needed to make more cells. Therefore, when etoposide is
taken up by the cancer cells, it stops the growth of new cancer cells.
2. What you need to know before you are given etoposide

xxxxxxxx / xxxxxxxxxx
xxx

(Travesh Sharma) D:\Europe\Etoposide\Ireland+UK\Etoposide - Pack Insert - Ireland+UK.indd

Size:

350 x 280 mm

Etoposide 20 mg/ml
TEMP

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 breast-feeding, think you may be pregnant
or are planning to have a baby, ask your doctor for advice before
taking this medicine.

The administration will take at least 30 to 60 minutes.
The duration of the treatment and the number of treatments is
determined by the doctor and may vary for each patient.

Women of childbearing potential must avoid pregnancy and take
effective contraceptive measures during treatment with etoposide
and until at the earliest 6 months after the therapy with etoposide.

Etoposide may be given alone or in combination with other
medicines.

Breast-feeding

Your condition will be closely monitored during treatment. This
routinely involves blood tests and controls of your liver function.

Etoposide is excreted into human breast milk. Women must not
breast-feed during the treatment with etoposide.

Your dose may be changed depending on your kidney function.
Use in children and adolescents:

Fertility

Safety and effectiveness in children have not been established.

Men treated with etoposide are advised not to father a child during,
and up to 6 months after treatment. Advice on conservation
of sperm should be sought prior to treatment because of the
possibility of irreversible infertility.

If you take more etoposide than you should

Driving and using machines
Do not drive or use any tools or machines shortly after treatment
with etoposide as it may make you feel very sleepy or you might
not be able to see for a short time.
Etoposide contains ethanol, benzyl alcohol and polysorbate 80
Ethanol
This medicinal product contains 30.5 % v/v ethanol (alcohol), which
is corresponds to 241.4 mg of ethanol per ml of concentrate i.e

To be taken into account in pregnant or breast-feeding women,
children and high-risk groups such as patients with liver disease,
or epilepsy.

Tell your doctor if you are taking or have recently taken any other
medicines.
- anti-coagulants such as warfarin which are used to thin the
blood
- the immunosuppressant ciclosporine (often given after an
organ transplant)
- other drugs used to treat other forms of cancers such as
cisplatin.
- phenytoin (medicine used in the treatment of epilepsy) may
reduce the effects of etoposide
- phenylbutazone, sodium salicylate and acetylsalicylic acid

Black

Cytotoxic agent

Pregnancy

Warnings and precautions

Other medicines and etoposide

The recommended dose of etoposide is 60-120 mg/m2 daily for
5 days.

For non-haematological indications courses may not be repeated
more frequently than at 21 day intervals.

up to 1.2 g of ethanol per 5 ml vial, equivalent to 24.1 ml of beer,
10.1 ml of wine.

Tell your doctor about any other treatment you receive for your
illness.

The following
information is
intended for healthcare
professionals only:

You will receive a treatment cycle consisting of one dose a day
during 3 - 5 days, followed by a 10 - 20 days rest.

Do not take etoposide
- if you are allergic to etoposide, podophyllotoxines or
podophyllotoxine-derivatives or any other ingredients of this
medicine (listed in section 6).
- If your liver is not working properly
- If your bone marrow is not producing enough blood cells
- If you are breast-feeding
- If you have a weak immune system and you are being
vaccinated against yellow fever at the same time.
Talk to your doctor or nurse before using etoposide.
- if you are suffering from infection.
- if your bone marrow is in low state (myelosuppression).
- If you have problems with your liver
- If you have severe kidney problems

The dose of etoposide will be individually determined by your
doctor. The dose you are given depends on your size: it varies with
your surface area. Technically, this is measured in square meters,
and is worked out from your height and weight.

up to 2.4 g of ethanol per 10 ml vial, equivalent to 48.3´ml of beer,
20.1 ml of wine.
up to 6.0 g of ethanol per 25 ml vial, equivalent to 120.7 ml of
beer, 50.3 ml of wine.
up to 12.1 g of ethanol per 50 ml vial, equivalent to 214.4 ml of
beer, 100.6 ml of wine.
Harmful for those suffering from alcoholism.

Benzyl alcohol
This medicine contains 30 mg/ml of benzyl alcohol. Must not be
given to premature babies or neonates. May cause toxic reactions
and allergic reactions in infants and children up to 3 years old.
Polysorbate 80
Etoposide contains polysorbate 80. A life threatening syndrome,
with liver and kidney failure, decline in respiratory function,
fall in platelet count and swelled abdomen has been reported in
premature infants when administered polysorbate 80 containing
vitamin E injection.
3. How etoposide will be given
Etoposide will always be given to you by a healthcare professional
experience in the use of chemotherapeutic agent. This medicine
will be diluted with 9 mg/ml (0.9 %) sodium chloride or 50 mg/ml
(5 %) dextrose and will be given to you as an infusion (a “drip”)
into a vein.

Times New Roman 9 pts.

Ver. 02

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 have any further questions on the use of this medicine, ask
your doctor or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although
not everybody gets them.
All medicines can cause allergic reactions although serious
allergic reactions are very rare. Any sudden wheeziness, difficulty
in breathing, swelling of the eyelids, face or lips, rash or itching
(especially affecting your whole body), and feeling you are going
to faint (these may be signs of severe allergic reactions or an
anaphylactic shock) should be reported to a doctor immediately.
Very common (may affect more than 1 in 10 people)
• Bone marrow is not producing enough cells
(myelosuppression); Leading to low white blood cells
(leucopenia) /or platelets (thrombocytopenia) or Low counts
of red blood cells (anaemia). This usually resolves 3 weeks
after the last dose.
• Feeling like vomiting (nausea) and vomiting
• Loss of appetite (anorexia)
• Abdominal pain
• Constipation
• Hair loss resulting in total baldness (alopecia, grows back
after end of therapy)
• Liver damage (problems with your liver including increase
in liver blood test values (bilirubin. SGOT and alkaline
phosphatase)
• Pigmentation (discoloration of the skin and mucous membrane)
• Feeling of weakness (Asthenia)
• Generally feeling unwell
Common (may affect up to 1 in 10 people)
• Acute leukaemia (cancer of blood)
• Inflammation of the lining of stomach and the gullet
(oesophagus) (stomatitis and esophagitis)
• Diarrhoea
• Heart attacks and rhythm disturbances (myocardial infarction,
arrhythmia)
• Serious allergic reaction which causes difficulty in breathing
or dizziness

19 March 2014 9:31 AM

Instructions on how to
dilute, store and dispose
of etoposide
Dilution
Etoposide 20 mg/ml
concentrate for solution for
infusion must be diluted
immediately prior to use
with either 50 mg/ ml
(5%) dextrose in water, or
9 mg/ ml (0.9%) sodium
chloride solution to give
a final concentration of
0.2 mg/ml to 0.4 mg/ml.
At higher concentrations
precipitation of etoposide
may occur.
Etoposide is administered
by slow intravenous
infusion. Etoposide
SHOULD NOT BE
GIVEN BY RAPID
INTRAVENOUS
INJECTION.
Storage of the prepared
solution
After dilution
Chemical and physical inuse stability of the solution
diluted to a concentration
of 0.2 mg/ml or
0.4 mg/ml has been
demonstrated up to
24 hours at 15°C to 25°C.
From a microbiological
point of view, the diluted
product should be used
immediately. If not
used immediately, inuse storage times and
conditions prior to use are
the responsibility of the
user and would normally
not be longer than 12 hours
at 15°C to 25°C, unless
dilution has taken place in
controlled and validated
aseptic conditions.
Handling and disposal
The normal procedures
for proper handling and
disposal of anti-cancer
medicinal products should
be adopted:
• Staff should be trained
to reconstitute the
medicinal product.
• Pregnant staff should
be excluded from
working with this
medicinal product.

V001

Etoposide 20 mg/ml
concentrate for solution for infusion

(medicines used to treat inflammation, mild to moderate pain,
and fever )

xxxxxxxxxx

Package leaflet: Information for the user

Circulation No. 1

xxxxxx

Etoposide - Pack Insert - Ireland+UK

Etoposide - Pack Insert - Ireland+UK
• Staff handling this
medicinal product
during dilution should
wear protective
clothing including
mask, goggles and
gloves.
• All items for
administration or
cleaning, including
gloves, should be
placed in high-risk,
waste disposal bags
for high-temperature
incineration.
• Accidental contact
with the skin or eyes
should be treated
immediately with
copious amounts of
water.
Disposal
Any unused product or
waste material should be
disposed of in accordance
with local requirements.

• Fatigue and drowsiness, dizziness
• Low blood pressure (hypotension) may occur if the infusion is
administered too rapidly
• Rash and itching (urticarial, pruritus)
• Leakage of the infusion solution into the surrounding tissue
with swelling, pain phlebitis
• Hypertension (high blood pressure)
Uncommon (may affect up to 1 in 100 people)
• Damage to nerves of the hand and feet (loss of sensation)
Rare (may affect up to 1 in 1,000 people)
• Seizure
• Inflammation of an optic (vision) nerve (Optic neuritis)
• Temporary loss of vision (cortical blindness transient),
neurotoxicities (such as excessive sleepiness (somnolence),
tiredness
• Inflammation of lungs tissue
• Formation of scar tissue in the lungs
• Taste alteration (dysgeusia)
• Severe skin reactions due to an allergic reaction (StevensJohnson syndrome; toxic epidermal necrolysis), symptoms
include fever, general ill feeling, itching of the skin, joint
aches, multiple skin lesions or blisters, which may involve the
face or lips.
• Inflammation of skin (Radiation recall dermatitis)
• Dysphagia (difficulty in swallowing)
Tumour lysis syndrome (sometimes fatal) has been reported when
etoposide was used with other anticancer drugs.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible side effects not listed in this leaflet.
For UK - You can also report side effects directly via the Yellow
Card Scheme at: www.mhra.gov.uk/yellowcard

Circulation No. 1
and would normally not be longer than 12 hours at 15°C to 25°C,
unless dilution has taken place in controlled and validated aseptic
conditions.
Do not throw away any medicines 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 other information
What etoposide contains
- The active substance is Etoposide. Each 1 ml concentrate for
solution for infusion contains 20 mg of etoposide.
Each 5 ml vial contains 100 mg of etoposide.
Each 10 ml vial contains 200 mg of etoposide.
Each 25 ml vial contains 500 mg of etoposide.
Each 50 ml vial contains 1000 mg of etoposide.

- The other ingredients are: macrogol 300, polysorbate

80 (E433), benzyl alcohol (E1519), ethanol and anhydrous
citric acid (E 330).

What etoposide looks like and contents of the pack
Etoposide is a clear, light yellow to pale yellow solution packaged
in type-I, clear, moulded glass vials of 5 ml, 10 ml, 30 ml and
50 ml, closed with 20 mm bromobutyl rubber closure and sealed
with 20 mm flip-off Aluminium overseals (Green, Blue, Red and
Yellow respectively).
Pack sizes: Etoposide is available in packs containing 1 vial of
5 ml, 10 ml, 25 ml and 50 ml.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Fresenius Kabi Oncology Plc.
Lion Court, Farnham Road, Bordon
Hampshire, GU35 0NF
United Kingdom

IMB Pharmacovigilance
Earlsfort Terrace
IRL-Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6762517
Website: www.imb.ie (http://www.imb.ie)
e-mail: imbpharmacovigilance@imb.ie

Austria

Etoposid Kabi 20 mg/ml Konzentrat zur
Herstellung einer Infusionslösung
Belgium
Etoposide Fresenius Kabi 20 mg/ml concentraat
voor oplossing voor infusie
Czech
Etoposide Kabi 20 mg/ml, koncentrát pro infuzní
Republic
roztok
Denmark
Etoposid Fresenius Kabi
Estonia
Etoposide Kabi 20 mg/ml
Spain
Etopósido Kabi 20mg/ml concentrado para
solución para perfusión
Finland
Etoposid Fresenius Kabi 20 mg/ml
infuusiokonsentraatti, liuosta varten
France
Etoposide Kabi 20 mg/ml solution à diluer pour
perfusion
Hungary
Etoposide Kabi 20 mg/ml koncentrátum oldatos
infúzióhoz
Ireland
Etoposide 20 mg/ml concentrate for solution for
infusion
Italy
Etoposide Kabi
Latvia
Etoposide Kabi 20 mg/ml koncentrāts infūziju
šķīduma pagatavošanai
Lithuania
Etoposide Kabi 20 mg/ml koncentratas
infuziniam tirpalui
Malta
Etoposide 20 mg/ml concentrate for solution for
infusion
The
Etoposide Fresenius Kabi 20 mg/ml concentraat
Netherlands voor oplossing voor infusie
Norway
Etoposid Fresenius Kabi
Poland
Etoposide Kabi
Portugal
Etoposido Kabi
Romania
Etopozida Kabi 20 mg/ml concentrat pentru
soluţie perfuzabilă
Sweden
Etoposid Fresenius Kabi 20 mg/ ml koncentrat
till infusionsvätska, lösning
Slovenia
Etopozid Kabi 20 mg/ml koncentrat za raztopino
za infundiranje
Slovak
Etoposide Kabi 20 mg/ml, infúzny koncentrát
Republic
United
Etoposide 20 mg/ml concentrate for solution for
Kingdom
infusion

This leaflet was last revised in 03/2014

By reporting side effects you can help provide more information
on the safety of this medicine.
5. How to store etoposide
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on
the vial and carton after EXP. The expiry date refers to the last
day of that month.
This medicinal product does not require any special temperature
storage conditions. Do not freeze. Store in the original package, in
order to protect from light.

V001

Do not store the diluted product in a refrigerator (2°C to 8°C)
as this might cause precipitation. Solutions showing any sign of
precipitation should not be used.
After dilution

xxxxxxxxxx

Chemical and physical in-use stability of the solution diluted to a
concentration of 0.2 mg/ml or 0.4 mg/ml has been demonstrated
up to 24 hours at 15°C to 25°C.
From a microbiological point of view, the diluted product should
be used immediately. If not used immediately, in-use storage
times and conditions prior to use are the responsibility of the user
Black

xxxxxx

(Travesh Sharma) D:\Europe\Etoposide\Ireland+UK\Etoposide - Pack Insert - Ireland+UK.indd

Size:

350 x 280 mm

For Ireland - Reports may be made by following the links to the
online reporting option accessible from the IMB homepage, or by
completing the downloadable report form also accessible from the
IMB website, which may be completed manually and submitted to
the IMB via freepost, to the following address:

This medicinal product is authorised in the Member States of
the EEA under the following names:

Times New Roman 9 pts.

Ver. 02

19 March 2014 9:31 AM

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.

Hide