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ETOPOSIDE 20 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION

Active substance(s): ETOPOSIDE / ETOPOSIDE / ETOPOSIDE

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Etoposide - Pack Insert - Ireland+UK

Breast-feeding
Etoposide is excreted into human breast milk. Women
must not breast-feed during the treatment with etoposide.
Fertility
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.
Driving and using machines
Do not drive or use any tools or machines shortly after

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 experienced in the use of chemotherapeutic
agents. 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.
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.
The recommended dose of etoposide is 60-120 mg/m2 daily
for 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.

Use in children and adolescents:
Safety and effectiveness in children have not been established.
If you take 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 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)

Black

For Ireland - Reports may be made by completing the
downloadable report from the HPRA website and sending
it to:
HPRA Pharmacovigilance
Kevin O’Malley House, Earlsfort Centre
Earlsfort Terrace
IRL-Dublin
Tel: +35316764971
Fax: +35316762517
www.hpra.ie
medsafety@hpra.ie
By reporting side effects you can help provide more
information on the safety of this medicine.

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

6. Contents of the pack and other information

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.
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
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 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.
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.

Dimension: 592 x 300 mm
Folding Size: 60 x 33 mm

(Outline of folding size for indication purpose only, it
should be removed before final printing.)

Form No.: SOP/PDD/014-02 Rev. 00
(Travesh Sharma) \\fre-kp-fp01\PDD-Artworks\EU\Etoposide\Ireland+UK\18 Jan 2017\Etoposide - Pack Insert - Ireland+UK.indd

V002

Pregnancy
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.
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.

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.

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.

Pregnancy, breast-feeding and fertility

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
up to 1.2 g of ethanol per 5 ml vial, equivalent to 24.1 ml of
beer, 10.1 ml of wine.
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.
To be taken into account in pregnant or breast-feeding
women, children and high-risk groups such as patients with
liver disease, or epilepsy.

• 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
• 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
(Stevens-Johnson
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.

LFT00290

2. What you need to know before you are given
etoposide

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

Etoposide contains ethanol, benzyl alcohol and
polysorbate 80

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

Disposal
Any unused product or waste material
should be disposed of in accordance
with local requirements.

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 bloodforming 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.

Instructions on how to dilute, store
and dispose of etoposide

LFT00290 / IRL/GBR

The following information
is intended for healthcare
professionals only:
Cytotoxic agent

Etoposide 20 mg/ml

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

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

treatment with etoposide as it may make you feel very
sleepy or you might not be able to see for a short time.

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.
• 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.

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.

After dilution
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 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.

Etoposide 20 mg/ml
concentrate for solution for infusion

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

Storage of the prepared solution

Package leaflet: Information for the user

Font Size: 10 Pt Times New Roman
Date: 24 April 2017 12:27 PM Version: 03
Final Packaging Site: Bordon
Mfg. Site: Baddi-2

LFT00290 / IRL/GBR

Etoposide 20 mg/ml

Etoposide - Pack Insert - Ireland+UK

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

This medicinal product is authorised in the Member
States of the EEA under the following names:
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
Republic
infuzní 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
Netherlands concentraat 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
Republic
koncentrát
United
Etoposide 20 mg/ml concentrate for
Kingdom
solution for infusion
This leaflet was last revised in 03/2014

V002

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

LFT00290

- The other ingredients are: macrogol 300, polysorbate

Black

Dimension: 592 x 300 mm
Folding Size: 60 x 33 mm

(Outline of folding size for indication purpose only, it
should be removed before final printing.)

Form No.: SOP/PDD/014-02 Rev. 00
(Travesh Sharma) \\fre-kp-fp01\PDD-Artworks\EU\Etoposide\Ireland+UK\18 Jan 2017\Etoposide - Pack Insert - Ireland+UK.indd

Font Size: 10 Pt Times New Roman
Date: 24 April 2017 12:27 PM Version: 03
Final Packaging Site: Bordon
Mfg. Site: Baddi-2

Expand Transcript

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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