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ETOPOSIDE FOR INJECTION CONCENTRATE 20MG/ML

Active substance(s): ETOPOSIDE

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ZINC Ref:

EAS1421a LEA ETOPOSIDE 20MG/ML INF TEVAH Dim’s Changed?:
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No
315 mm
300 mm
N/A
N/A

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3 How you will be given Etoposide
Etoposide will be given to you by a doctor or nurse. It will
be given as a slow infusion into a vein. This may take
between 30 to 60 minutes.
The dose you receive will be specific to you, which the
doctor will calculate. The usual dose, based on etoposide, is
50 to 100 mg/m2 body surface area, daily for 5 days in a
row or 100 to 120 mg/m2 body surface area on days 1, 3
and 5. This course of treatment may then be repeated,
depending on the results of blood tests, but this will not be
for at least 21 days after the first course of treatment.
For children being treated for cancer of the blood or
lymphatic system the dose used is 75 to 150 mg/m2 body
surface area daily for 2 to 5 days.
The doctor may sometimes prescribe a different dose
particularly if you are receiving, or have received, other
treatments for your cancer or if you have kidney problems.
If you are given more Etoposide than you should
As Etoposide is given to you by a doctor or nurse, overdose
is unlikely. However, if this does occur your doctor will treat
any symptoms that follow.
If you have any further questions on the use of this
medicine, ask your doctor, pharmacist or nurse.

4

Possible side effects

Like all medicines, this medicine can cause side effects,
although not everybody gets them.
Tell your doctor or nurse immediately if you get any of the
following symptoms: swelling of your tongue or throat,
breathing difficulties, fast heartbeat, flushing of the skin or
a rash. These may be signs of a severe allergic reaction.

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Uncommon side effects (affecting between 1 in 100 and 1
in 1000 people)
- tingling or numbness in hands and feet
- bleeding
Rare side effects (affecting between 1 in 1,000 and 1 in
10,000 people)
- acid reflux
- flushing
- difficulty swallowing
- a change in the way things taste
- severe allergic reactions
- convulsions (seizure)
- fever
- sleepiness or tiredness
- breathing problems
- temporary blindness
- serious reactions of the skin and/or mucous membranes
which may include painful blisters and fever, including
extensive detachment of the skin (Stevens-Johnson
syndrome and toxic epidermal necrolysis)
- a sunburn-like rash that may occur on skin that has
previously been exposed to radiotherapy and can be
severe (radiation recall dermatitis)
- redness and swelling of the palms of your hands or soles
of your feet which may cause your skin to peel (hand foot
syndrome)
Not known (frequency cannot be estimated from the
available data)
- tumour lysis syndrome (complications of substances
released from treated cancer cells entering the blood)
- face and tongue swelling
- infertility
- difficulty breathing

Reporting of side effects
If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects not listed
Severe liver, kidney or heart damage from a condition called
in this leaflet. You can also report side effects directly via
tumour lysis syndrome, caused by harmful amounts of
the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard
substances from the cancer cells getting into the blood
By reporting side effects you can help provide more
stream, has been seen sometimes when Etoposide is taken
information on the safety of this medicine.
along with other drugs used to treat cancer.
Possible side effects experienced with Etoposide that are;
Very common side effects (affecting (may affect more than
1 in 10 people)
- blood disorders (this is why you will be having blood tests
between courses of treatment)
- temporary hair loss
- nausea and vomiting
- abdominal pain
- loss of appetite
- changes in skin colour (pigmentation)
- constipation
- feeling weak (asthenia)
- generally feeling unwell (malaise)
- damage to the liver (hepatotoxicity)
- increased liver enzymes
- jaundice (increased bilirubin)
Common side effects (affecting between 1 in 10 and 1 in
100 people)
- acute leukaemia
- irregular heart beat (arrhythmia), or a heart attack
(myocardial infarction)
- dizziness
- diarrhoea
- reactions at the site of infusion
- severe allergic reactions
- high blood pressure
- low blood pressure
- sore lips, mouth or throat ulcers
- skin problems such as itching or rash
- inflammation of a vein
- infection

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 carton and vial after EXP. The expiry date
refers to the last day of that month.
Do not store above 25 °C. Store in the original package.
The diluted solution should be discarded within 8 hours of
preparation.

6 Contents of the pack and other information
What Etoposide concentrate for solution for infusion
contains
- The active substance is 20 mg of etoposide per ml of
concentrate for solution for infusion.
- The other ingredients are citric acid, polysorbate 80,
ethanol, macrogol 300.
What Etoposide looks like and contents of the pack
- Etoposide concentrate for solution for infusion is a clear,
yellow, slightly viscous solution in clear, colourless glass
vials.
- Etoposide concentrate for solution for infusion is available
in vials of 5 ml, 10 ml, 20 ml, 25 ml and 50 ml.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation holder: TEVA UK Limited,
Eastbourne, BN22 9AG. Company responsible for
manufacture: Pharmachemie BV, Haarlem, The Netherlands.
This leaflet was last revised: December 2017
EAS1421a
93.130.385-L

ZINC Ref:

Version:

EAS1421a LEA ETOPOSIDE 20MG/ML INF TEVAH Dim’s Changed?:
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Width:
Depth:
Foil Width:

Package leaflet: Information for the patient

Etoposide Concentrate for Solution for
Infusion 20 mg/ml
etoposide
Read all of this leaflet carefully before you are given this
medicine because it contains important information for
you.

No
315 mm
300 mm
N/A
N/A

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93.130.385-L

PL 00289/0473

In order to prevent this, your doctor will need to do regular
blood tests to monitor the level of these substances during
treatment with this medicine.

The following information is intended for healthcare professionals
only:

This medicine can cause a reduction in the level of some
blood cells, which could cause you to suffer from infections,
or may mean that your blood doesn’t clot as well as it
should if you cut yourself. Blood tests will be taken at the
start of your treatment, and before each dose you take, to
make sure that this isn’t happening.
If you have reduced liver or kidney function, your doctor
may also want you to take regular blood tests to monitor
these levels.

1.What Etoposide is and what it is used for
2.What you need to know before you are given Etoposide
3.How you will be given Etoposide
4.Possible side effects
5.How to store Etoposide
6.Contents of the pack and other information

This is especially important

Etoposide belongs to the group of medicines called
cytostatics which are used in the treatment of cancer.
Etoposide is used in the treatment of certain types of
cancers in adults:
-

testicular cancer
small cell lung cancer
cancer of the blood (acute myeloid leukaemia)
tumour in the lymphatic system (Hodgkin’s lymphoma,
non-Hodgkin’s lymphoma)
- reproductive system cancers (gestational trophoblastic
neoplasia and ovarian cancer)
Etoposide is used in the treatment of certain types of
cancers in children:
- cancer of the blood (acute myeloid leukaemia)
- tumour in the lymphatic system (Hodgkin’s lymphoma,
non-Hodgkin’s lymphoma)
The exact reason why you have been prescribed Etoposide
is best discussed with your doctor.

2 What you need to know before you are given
Etoposide

Do not use Etoposide
- If you are allergic to etoposide or any of the other
ingredients of this medicine (listed in section 6).
- If you have recently been given a live vaccine, including
yellow fever vaccine.
- If you are breast-feeding or planning to breast-feed.
If any of the above affects you, or if you are unsure if they
do, tell your doctor who will be able to advise you.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before receiving
Etoposide
- if you have any infections.
- if you have had radiotherapy or chemotherapy recently.
- if you have low levels of a protein called albumin in your
blood.
- if you have liver or kidney problems.
Effective anti-cancer treatment can destroy cancer cells
rapidly in large numbers. On very rare occasions this may
cause harmful amounts of substances from these cancer
cells to be released into the blood. If this happens it can
cause problems with the liver, kidney, heart or blood, which
may result in death if not treated.

13 December 2017
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- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or
pharmacist.
- If you get any side effects, talk to your doctor or
pharmacist. 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

5

Other medicines and Etoposide
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines.
- if you are taking a medicine called ciclosporin (a drug
used to reduce the activity of the immune system).
- if you are being treated with cisplatin (a medicine used to
treat cancer).
- if you are taking phenytoin or any other medicines used
to treat epilepsy.
- if you are taking warfarin (a medicine used to prevent
blood clots from forming).
- if you have recently been given any live vaccines.
- if you are taking phenylbutazone, sodium salicylate, or
acetylsalicylic acid.
- if you are taking any anthracyclines (a group of medicines
used to treat cancer).
- if you are taking any drugs with a similar mechanism of
action as Etoposide.
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 or
pharmacist for advice before using this medicine.
Etoposide must not be used during pregnancy unless clearly
indicated by your doctor.
You must not breastfeed while you are receiving Etoposide.
Both male patients and female patients of child-bearing age
should use an effective contraceptive method (e.g., the
barrier method or condoms) during treatment and for at
least 6 months after the end of treatment with Etoposide.
Male patients treated with Etoposide are advised not to
father a child during treatment and for up to 6 months after
treatment. In addition, men are advised to seek counselling
on sperm preservation before starting treatment.
Both male and female patients who are considering having
a child after having treatment with Etoposide should discuss
this with their doctor or nurse.
Driving and using machines
No studies on the effects on the ability to drive and use
machines have been performed. However, if you feel tired,
sick to your stomach, dizzy or light-headed you should not
do so until you have discussed it with your doctor.
Important information about some of the ingredients of
Etoposide
A bottle with Etoposide contains 30 vol % ethanol
(alcohol).This can be harmful for those suffering from
alcoholism. This must also be taken into account in
pregnant and breast-feeding women, children and high-risk
groups such as patients with liver disease, diseases of the
brains or epilepsy.
The amount of alcohol in this medicine may alter the effects
of other medicines and may also impair your ability to drive
or use machines.
continued overleaf ...

Etoposide Concentrate for Solution for
Infusion 20 mg/ml
etoposide
Preparation of solution for infusion
Procedures for proper handling and disposal of anti-cancer drugs
should be followed. All steps of preparation must be carried out
under Laminar Air Flow conditions. Solutions should be prepared
under aseptic conditions.
The required dose of etoposide concentrate must be diluted with
either 5% dextrose solution for injection or 0.9% saline solution
for injection to give a final concentration of 0.2 mg/ml of
etoposide.
Etoposide should not be physically mixed with any other drug.
Only use clear solutions. Cloudy or discolored solutions must be
discarded.
Do not autoclave.
Any unused medicinal product or waste material should be
disposed of in accordance with local requirements.
Administration and Dosage
Etoposide is administered by slow intravenous infusion (usually
over a 30 to 60 minute period) since hypotension has been
reported as a possible side effect of rapid intravenous injection.
Etoposide SHOULD NOT BE GIVEN BY RAPID INTRAVENOUS
INJECTION.
The recommended dose of Etoposide is 50 to 100 mg/m2/day on
days 1 to 5 or 100 to 120 mg/m2 on days 1, 3, and 5 every 3 to 4
weeks in combination with other drugs indicated in the disease to
be treated. Dosage should be modified to take into account the
myelosuppressive effects of other drugs in the combination or the
effects of prior radiation therapy or chemotherapy which may
have compromised bone marrow reserve.
Administration Precautions: As with other potentially toxic
compounds, caution should be exercised in handling and
preparing the solution of Etoposide. Skin reactions associated with
accidental exposure to Etoposide may occur. The use of gloves is
recommended. If Etoposide solution contacts the skin or mucosa,
immediately wash the skin with soap and water and flush the
mucosa with water.
Care should be taken to avoid extravasation.
Elderly
No dosage adjustment is necessary in elderly patients (age > 65
years old), other than based on renal function.
Paediatric use
Etoposide in paediatric patients has been used in the range of
75 to 150 mg/m2/day for 2 to 5 days in combination with other
antineoplastic agents. The treatment regimen should be chosen
according to the local standard of care.
Renal Impairment
In patients with impaired renal function, the following initial dose
modification should be considered based on measured creatinine
clearance.

Measured Creatinine Clearance

Dose of Etoposide

>50 mL/min

100% of dose

15-50 mL/min

75% of dose

Subsequent dosing should be based on patient tolerance and
clinical effect. In patients with creatinine clearance less than
15 mL/min and on dialysis further dose reduction should be
considered.

EAS1421a
93.130.385-L

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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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