ETOPOSIDE TEVA 20 mg/ml CONCENTRATE FOR INFUSION SOLUTION

Introduction

Package Leaflet: Information for the Patient

Etoposide Teva 20 mg/ml Concentrate for Solution for Infusion

Etoposide

Read all of this leaflet carefully before you are given 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 pharmacist.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the Package Leaflet

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

1. What is Etoposide Teva and what is it used for

Etoposide belongs to a group of medicines called cytostatics used in the treatment of cancer.

Etoposide is used to treat certain types of cancer in adults:

• testicular cancer
• small cell lung cancer
• blood cancer (acute myeloid leukaemia)
• tumours in the lymphatic system (Hodgkin's lymphoma, non-Hodgkin's lymphoma)
• cancer of the reproductive system (gestational trophoblastic neoplasia and ovarian cancer)

Etoposide is used to treat certain types of cancer in children:

• blood cancer (acute myeloid leukaemia)
• tumours in the lymphatic system (Hodgkin's lymphoma, non-Hodgkin's lymphoma)

You should discuss with your doctor the exact reason why you have been prescribed Etoposide Teva.

2. What you need to know before you are given Etoposide Teva

Do not use Etoposide Teva

• 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 the yellow fever vaccine
• If you are breast-feeding or plan to breast-feed.

If any of the above applies to you, or if you are not sure, tell your doctor who will advise you.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before you start using Etoposide Teva.

• If you have any infection.
• If you have recently received radiotherapy or chemotherapy
• If you have low levels of a protein called albumin in your blood.
• If you have liver or kidney problems.

Effective cancer treatment can quickly destroy large amounts of cancer cells. In very rare cases, this can cause harmful amounts of substances from these cancer cells to be released into the bloodstream. If this happens, it can cause problems with the liver, kidney, heart, or blood, which can be life-threatening if not treated.

To prevent this, your doctor will need to perform regular blood tests to check the levels of these substances during treatment with this medicine.

This medicine can cause a reduction in the level of some blood cells, which could cause infections or mean that your blood does not clot as it should if you suffer any cuts. To check that this does not happen, you will have blood tests at the start of treatment and before each dose you receive.

If you have reduced kidney or liver function, your doctor may also want to perform regular blood tests to check these levels.

Other medicines and Etoposide Teva

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

This is especially important

• If you are taking a medicine called ciclosporin (a medicine 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 medicine used to treat epilepsy.
• If you are taking warfarin (a medicine to prevent blood clot formation).
• If you have recently been given live vaccines.
• If you are taking phenylbutazone, sodium salicylate, or acetylsalicylic acid.
• If you are taking anthracyclines (a group of medicines used to treat cancer).
• If you are taking any medicine with a mechanism of action similar to 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 your doctor has clearly told you to do so.

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

Male and female patients of childbearing potential must use an effective method of contraception (such as the barrier method or condoms) during treatment and for 6 months after finishing treatment with etoposide.

Male patients treated with etoposide are advised not to father a child during and up to 6 months after treatment. In addition, male patients are advised to seek advice on sperm preservation before starting treatment.

Patients, both male and female, who are planning to have children after receiving 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 excited, do not drive or use machines until you have discussed this with your doctor.

Etoposide Teva contains ethanol (alcohol)

A vial of this medicine contains 30% vol of alcohol (ethanol).

This medicine contains 1.2 g of alcohol (ethanol) in each 5 ml vial, 2.4 g of alcohol (ethanol) in each 10 ml vial, 4.8 g of alcohol (ethanol) in each 20 ml vial, 6 g of alcohol (ethanol) in each 25 ml vial, and 12 g of alcohol (ethanol) in each 50 ml vial, which is equivalent to 241 mg/ml of concentrate. The amount in one ml of this medicine is equivalent to 6 ml of beer or 2 ml of wine.

Adults

The amount of alcohol contained in this medicine is unlikely to have any effect on adults.

The amount of alcohol contained in this medicine may alter the effect of other medicines. Talk to your doctor or pharmacist if you are taking other medicines.

If you are pregnant, talk to your doctor or pharmacist before taking this medicine.

If you have an alcohol addiction, talk to your doctor or pharmacist before taking this medicine.

Children and adolescents

The alcohol contained in this medicine may affect children who weigh 17 kg (or less). The effects that may appear are changes in behaviour and drowsiness. It may also affect their ability to concentrate and perform physical activities. If the child suffers from epilepsy or liver problems, talk to your doctor or pharmacist before taking this medicine.

Because this medicine is normally administered slowly over 30-60 minutes, the effects of the alcohol may be reduced.

3. How Etoposide Teva is given

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 and 60 minutes.

The dose you receive will be specific to you, and your doctor will calculate it. The normal dose, based on etoposide, is 50 to 100 mg/m2 body surface area per day for 5 consecutive days or 100 to 120 mg/m2 body surface area on days 1, 3, and 5. This treatment cycle may be repeated, depending on the results of blood tests, but not within 21 days after the first cycle of treatment.

For children receiving treatment for blood or lymphatic system cancer, the dose used is 75 to 150 mg/m2 body surface area per day for 2 to 5 days.

Your doctor may prescribe a different dose, especially if you are receiving or have received other cancer treatments or if you have kidney problems.

If you are given too much Etoposide Teva

An overdose is unlikely because this medicine is given by a doctor or nurse. However, if this happens, your doctor will treat any symptoms that appear.

In case of overdose or accidental ingestion, contact the Toxicology Information Service on 91-562 04 20, stating the medicine and the amount administered.

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 the tongue or throat, difficulty breathing, fast heartbeat, redness of the skin or rash. These may be signs of a severe allergic reaction.

On occasions, severe damage to the liver, kidneys, or heart has been observed due to a disorder called tumour lysis syndrome caused by the release of harmful amounts of substances from cancer cells into the bloodstream when Etoposide Teva is given with other medicines used to treat cancer.

Side effects that may be experienced with etoposide are:

Very common side effects(affect more than 1 in 10 people)

• blood disorders (that's why blood tests will be performed between treatment cycles)
• temporary hair loss
• nausea and vomiting
• abdominal pain
• loss of appetite
• changes in skin colour (pigmentation)
• constipation
• feeling weak (asthenia)
• general malaise
• liver damage (hepatotoxicity)
• increased liver enzymes
• jaundice (increased bilirubin)

Common side effects(affect between 1 in 10 and 1 in 100 people)

• acute leukaemia
• irregular heartbeat (arrhythmia) or heart attack (myocardial infarction)
• dizziness
• diarrhoea
• reactions at the infusion site
• severe allergic reactions
• high blood pressure
• low blood pressure
• sore lips, mouth ulcers, or throat ulcers
• skin problems such as itching or rash
• vein inflammation
• infection (including infections observed in patients with a weakened immune system, e.g. a lung infection called Pneumocystis jirovecii pneumonia)

Uncommon side effects(affect between 1 in 100 and 1 in 1,000 people)

• tingling or numbness in hands and feet
• bleeding

Rare side effects(affect between 1 in 1,000 and 1 in 10,000 people)

• acid reflux
• flushing
• difficulty swallowing
• change in taste
• severe allergic reactions
• seizures
• fever
• drowsiness or fatigue
• breathing problems
• temporary blindness
• severe skin and/or mucous membrane reactions that can include painful blisters and fever, including widespread skin peeling (Stevens-Johnson syndrome and toxic epidermal necrolysis)
• a skin rash similar to sunburn that can appear on previously irradiated skin and can be severe (radiation recall dermatitis)
• redness and swelling of the palms of your hands or soles of your feet that can cause your skin to peel (palmar-plantar erythrodysesthesia syndrome)

Not known(cannot be estimated from the available data)

• tumour lysis syndrome (complications of substances released from treated cancer cells entering the bloodstream)
• swelling of the face and tongue
• infertility
• difficulty breathing
• acute kidney failure

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet.

You can also report side effects directly via the Spanish Medicines Agency's website: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Etoposide Teva

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 the month shown.

Do not store above 25°C. Store in the original package.

The diluted solution should be discarded 8 hours after preparation.

6. Contents of the pack and other information

What Etoposide Teva contains

• The active ingredient is 20 mg of etoposide per ml of concentrate for solution for infusion.
• The other ingredients are citric acid, polysorbate 80, ethanol, and macrogol 300.

Appearance and packaging

• Etoposide Teva concentrate for solution for infusion is a clear, yellow, slightly viscous solution in clear glass vials
• Etoposide Teva 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

Teva Pharma, S.L.U.

C/ Anabel Segura, 11, Edificio Albatros B, 1ª planta

28108 Alcobendas (Madrid)

Spain

Manufacturer

Pharmachemie B.V.

2031 GA Haarlem

Netherlands

or

TEVA PHARMA B.V

Industrieweg 23, P.O. Box 217 (Michdrecht) - NL-2640 -

Netherlands

This medicine is authorised in the Member States of the European Economic Area under the following names:

Germany: Eto-Gry 20 mg/ml Konzentrat zur Herstellung einer Infusionslösung

Spain: Etopósido Teva 20 mg/ml concentrado para solución para perfusión

Italy: Etoposide TEVA 20 mg/ml, concentrato per soluzione per infusione

Date of last revision of this leaflet:February 2024

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)

This information is intended only for healthcare professionals:

Preparation of the infusion solution

Procedures for the proper handling and disposal of anticancer medicines should be followed. All stages of preparation should be carried out under laminar airflow conditions. Solutions should be prepared under aseptic conditions.

The required dose of etoposide concentrate should be diluted with 5% dextrose solution for injection or 0.9% sodium chloride solution for injection to achieve a final concentration of 0.2 mg/ml of etoposide.

Etoposide should not be mixed physically with any other medicine.

Only use clear solutions. Turbid or discoloured solutions should be discarded.

Do not use an autoclave.

Disposal of unused medicine and all materials that have come into contact with it should be carried out in accordance with local regulations.

Administration and dosage

Etoposide is administered by slow intravenous infusion (usually over a period of 30 to 60 minutes) since hypotension has been described as a possible side effect of rapid intravenous infusion. Etoposide MUST NOT BE ADMINISTERED 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 3-4 weeks in combination with other medicines indicated for the disease being treated. The dose should be modified taking into account the myelosuppressive effects of other medicines in the combination or the effects of previous radiotherapy or chemotherapy that may have compromised bone marrow reserve.

Administration precautions: as with other potentially toxic compounds, caution should be exercised in the handling and preparation of the etoposide solution. Accidental exposure to etoposide may cause adverse reactions. The use of gloves is recommended. If the etoposide solution comes into contact with the skin or mucous membranes, wash the skin immediately with water and soap and the mucous membranes with water.

Caution should be exercised to avoid extravasation.

Elderly patients

In elderly patients (over 65 years), no dose adjustment is necessary other than that based on renal function.

Paediatric use

In paediatric patients, etoposide 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 local standards of care.

Renal impairment

In patients with renal impairment, the following dose modification should be considered based on creatinine clearance.

Subsequent dosing should be based on patient tolerance and clinical effect. In patients with creatinine clearance below 15 ml/min and on dialysis, a further dose reduction should be considered.