Etoposide 20 mg/ml – patient leaflet, side effects, dosage

1. What etoposide is and what it is used for

The name of this 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 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 take etoposide

• if you are allergic to etoposide or any of the other

  ingredients of this medicine (listed in section 6).

• If you are breast-feeding or planning to breast-feed

• If you have recently been given a live vaccine, including

  Yellow fever vaccine.

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 you receive

etoposide:

• if you have low levels of a protein called albumin in

  your blood.

• if you have had radiotherapy or chemotherapy recently
• if you have any infections
• 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.

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.

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.

Other medicines and etoposide

Tell your doctor if you are taking, have recently taken or

might take any other medicines.

This is especially important

• if you are taking warfarin (a medicine used to prevent

  blood clots from forming).

• if you are taking a medicine called cyclosporin (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 phenylbutazone, sodium salicylate, or

    aspirin

  • if you have recently been given any live vaccines.

  • 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.

The amount of alcohol in this medicine may alter the effects

of other medicines. Talk to your doctor or pharmacist if

you are taking other medicines.

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.

Pregnancy

Etoposide must not be used during pregnancy unless clearly

indicated by your doctor.

Breast-feeding

You must not breast-feed while you are receiving etoposide.

Fertility

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.

Etoposide contains ethanol, benzyl alcohol and polysorbate 80

Ethanol

This medicine contains 241.4 mg of alcohol (ethanol) in

1 ml which is equivalent to 24.14 % w/v. The amount

in 10.38 ml of dose is equivalent to 62.64 ml of beer or

25.06 ml of wine.

The alcohol in this preparation is likely to affect children.

These effects may include feeling sleepy and changes in

behaviour. It may also affect their ability to concentrate and

take part in physical activities.

The amount of alcohol in this medicine can affect your ability to drive or use machines. This is because it may affect your judgement and how fast you react. If you have epilepsy or liver problems, talk to your doctor or pharmacist before taking this medicine. If you are pregnant or breast-feeding, talk to your doctor or pharmacist before taking this medicine. If you are addicted to alcohol, talk to your doctor or pharmacist before taking this medicine. Because this medicine is usually given slowly over 1 hour, the effects of alcohol may be reduced.

Benzyl alcohol

This medicine contains 30 mg benzyl alcohol per ml. Benzyl alcohol may cause allergic reactions. Ask your doctor for advice if you have liver or kidney disease. This is because large amounts of benzyl alcohol can build-up in your body and may cause side effects (called “metabolic acidosis”). Do not use for more than a week in young children (less than 3 years old), unless advised by your doctor or pharmacist. Benzyl alcohol has been linked with the risk of severe side effects including breathing problems (called “gasping syndrome”) in young children. Do not give to your newborn baby (up to 4 weeks old), unless recommended by your doctor.

Polysorbate 80

This medicine contains 80 mg of polysorbate 80 per ml. Polysorbates may cause allergic reactions. Polysorbates can have an effect on your heart and blood circulation (e.g., irregular or abnormal heartbeat, or low blood pressure). Tell your doctor if you or your child has any known allergies.

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 to100 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 a doctor or nurse will be giving you your medicine, 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 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.

Severe liver, kidney or heart damage from a condition called tumour lysis syndrome, caused by harmful amounts of substances from the cancer cells getting into the blood stream, has been seen sometimes when etoposide is taken along with other drugs used to treat cancer.

Possible side effects experienced with etoposide that are; Very common: 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: may affect up to 1 in 10 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 (including infections seen in patients with a weakened immune system, e.g. a lung infection called pneumocystis jirovecii pneumonia)

Uncommon: may affect up to 1 in 100 people

• tingling or numbness in hands and feet
• bleeding

Rare: may affect up to 1 in 1,000 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)

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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via: For UK - Yellow Card Scheme

Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store

For Ireland - HPRA Pharmacovigilance

Website: www.hpra.ie

By reporting side effects you can help provide more information on the safety of this medicine.

Etoposide 20 mg/ml

xxxxxxxxxx / IRL/GBR

Etoposide 20 mg/ml

xxxxxxxxxx / IRL/GBR

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.

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

For UK:

Fresenius Kabi Limited

Cestrian Court, Eastgate Way, Manor Park, Runcorn, Cheshire, WA7 1NT

United Kingdom

For IE:

Fresenius Kabi Deutschland GmbH Else-Kröner-Straße 1,

61352 Bad Homburg v.d.Höhe Germany

Manufacturer:

Fresenius Kabi Deutschland GmbH Pfingstweide 53

61169 Friedberg

Germany

This medicine is authorised in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

This leaflet was last revised in September 2025.