Leaflet: information for the patient

Teva Etoposide 20 mg/ml concentrate for solution for infusion

Etoposide

Read this leaflet carefully before this medicine is administered to you, as it contains important information for you

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What isTeva Etoposideand what it is used for

2. What you need to know before starting to useTeva Etoposide

3. How to useTeva Etoposide

4. Possible side effects

5. Storage ofTeva Etoposide

6. Contents of the pack and additional information

Etopósido belongs to a group of medicines called cytostatics that are used in the treatment of cancer.

Etopósidois used for the treatment of certain types of cancer in adults:

-testicular cancer

-small cell lung cancer

-blood cancer (acute myeloid leukemia)

-lymphatic system tumor (Hodgkin's lymphoma, non-Hodgkin's lymphoma)

-reproductive system cancer (gestational trophoblastic neoplasia and ovarian cancer)

Etopósido is used for the treatment of certain types of cancer in children:

-blood cancer (acute myeloid leukemia)

-lymphatic system tumor (Hodgkin's lymphoma, non-Hodgkin's lymphoma)

It is advisable to discuss the exact reason why you have been prescribed Etopósido Teva with your doctor.

No use Etopósido

• If youare allergic to etoposide or any of the other components of this medication(listed in section 6)
• if you have recently received a live vaccine, including the yellow fever vaccine
• if you are breastfeeding or intend to do so.

If any of the above factors affect you, or if you are unsure, inform your doctor for advice.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to use Etoposide Teva.

-if you have any infection.

-if you have recently received radiation or chemotherapy

-if you have low blood levels of a protein called albumin.

-if you have liver or kidney problems.

A successful cancer treatment can rapidly destroy large quantities of cancer cells. In very rare cases, this can cause harmful substances from these cancer cells to be released into the blood. If this occurs, it can cause problems in the liver, kidneys, heart, or blood, which can lead to death if not treated.

To prevent this, your doctor will need to perform regular blood tests to monitor the level of these substances during treatment with this medication.

This medication 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 a cut. To check that this does not occur, you will have blood tests at the start of treatment and before each dose you take.

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

Other medications and Etoposide Teva

Inform your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication.

This is especially important

-if you are taking a medication called ciclosporin (a medication to reduce the activity of the immune system).

-if you are being treated with cisplatino (a medication used to treat cancer).

-if you are taking phenytoin or any other medication used to treat epilepsy.

-if you are taking warfarin (a medication to prevent the formation of blood clots).

-if you have recently received live vaccines.

-if you are taking phenylbutazone, sodium salicylate, or acetylsalicylic acid.

-if you are taking anthracyclines (a group of medications used to treat cancer).

-if you are taking any medication with a similar mechanism of action to etoposide.

Pregnancy, lactation, and fertility

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

Etoposide should not be used during pregnancy unless your doctor clearly indicates otherwise.

You should not breastfeed while receiving etoposide.

Patients, both men and women of childbearing age, should use an effective contraceptive method (such as a barrier method or condoms) during treatment and for 6 months after completing etoposide treatment.

Men treated with etoposide should not father a child during treatment and for 6 months after treatment. Additionally, men should seek advice on sperm preservation before starting treatment.

Patients, both men and women, considering having a child after receiving etoposide treatment should discuss this with their doctor or nurse.

Driving and operating machinery

No studies have been conducted on the effects on the ability to drive and operate machinery. However, if you feel tired, nauseous, dizzy, or irritable, do not drive or operate machinery until you have discussed this with your doctor.

Etoposide Teva contains ethanol (alcohol)

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

This medication 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 medication is equivalent to 6 ml of beer or 2 ml of wine.

Adults

The amount of alcohol contained in this medication is unlikely to have an effect on adults.

The amount of alcohol contained in this medication may affect the action of other medications. Consult your doctor or pharmacist if you are taking other medications.

If you are pregnant, consult your doctor or pharmacist before taking this medication.

If you have a history of alcohol addiction, consult your doctor or pharmacist before taking this medication.

Children and adolescents

The alcohol contained in this medication may affect children weighing 17 kg (or less). The effects that may occur are changes in behavior and drowsiness. It may also affect your ability to concentrate and perform physical activities. If the child has epilepsy or liver problems, consult your doctor or pharmacist before taking this medication.

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

Etopósido Teva will be administered by a doctor or nurse. It will be administered 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 etopósido, is 50 to 100 mg/m² of body surface area, per day for 5 consecutive days or 100 to 120 mg/m² of 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 at least 21 days after the first treatment cycle.

For children receiving treatment for blood or lymphatic system cancer, the dose used is 75 to 150 mg/m² of 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 receive more Etopósido Teva than you should

A overdose is unlikely, as the medication is administered by a doctor or nurse. However, if this occurs, your doctor will treat any symptoms that appear.

In case of overdose or accidental ingestion, contact the Toxicological Information Service at 91- 562 04 20, indicating the medication and the amount administered.

If you have any other questions about the use of this medication, ask your doctor, pharmacist, or nurse.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Inform your doctor or nurse immediately if you experience any of the following symptoms: swelling of the tongue or throat, difficulty breathing, rapid heartbeat, skin redness or rash. These may be signs of a severe allergic reaction.

In some cases, severe damage has been observed in the liver, kidneys, or heart due to a condition called tumor lysis syndrome caused by the entry of harmful amounts of substances from cancer cells into the bloodstream when Etopósido Teva is administered with other medications used to treat cancer.

Possible side effectsexperienced with etoposide are:

Frequent side effects(affect more than 1 in 10 people)

-blood disorders (blood tests will be performed between treatment cycles)

-temporary hair loss

-nausea and vomiting

-abdominal pain

-loss of appetite

-skin color changes (pigmentation)

-constipation

-weakness (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 leukemia

-irregular heartbeat (arrhythmia), or heart attack (myocardial infarction)

-dizziness

-diarrhea

-reactions at the infusion site

-severe allergic reactions

-high blood pressure

-low blood pressure

-painful lips, mouth ulcers, or throat ulcers

-skin problems such as itching or rash

-venous inflammation

-infection (including infections observed in patients with a weakened immune system, such as pneumonia caused by Pneumocystis jirovecii)

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

-tingling or numbness in hands and feet

-bleeding

Very 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

-respiratory problems

-temporary blindness

-severe skin and/or mucous membrane reactions that may include painful blisters and fever, including extensive skin peeling (Stevens-Johnson syndrome and toxic epidermal necrolysis)

-a skin rash similar to sunburn that may appear on previously irradiated skin and may be severe (radiation recall dermatitis)

-redness and swelling of the palms of your hands or soles of your feet that may cause your skin to peel (hand-foot syndrome)

Unknown(cannot be estimated from available data)

-tumor lysis syndrome (complications of substances released from treated cancer cells that enter the bloodstream)

-facial swelling and tongue swelling

-infertility

-difficulty breathing

-acute kidney failure

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet.

You can also report them directly through the Spanish Medicines Vigilance System Website:www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging and on the vial after CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above 25°C. Store in the original packaging.

The diluted solution must be discarded after 8 hours of preparation.

Etoposide Teva Composition

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

Appearance of the product and contents of the package

Only some sizes of packaging may be commercially available

Marketing Authorization Holder

Teva Pharma, S.L.U.

C/ Anabel Segura, 11, Edificio Albatros B, 1st floor

28108 Alcobendas (Madrid)

Spain

Responsible for manufacturing:

Pharmachemie B.V.

2031 GA Haarlem

NETHERLANDS

or

TEVA PHARMA B.V

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

Netherlands

This medicinal product is authorized in the Member States of the European Economic Area with the following names:

Germany: Eto-Gry 20 mg/ml Concentrate for the preparation of an infusion solution

Spain: Etoposide Teva 20 mg/ml concentrate for solution for infusion

Italy: Etoposide TEVA 20 mg/ml, concentrate for solution for infusion

Last review date of thisleaflet:February 2024

The detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/)

This information is intended solely for healthcare professionals:

Preparation of the infusion solution

They must follow the procedures for the proper handling and disposal of cancer medicines. All stages of preparation must be performed under laminar airflow conditions. Solutions must be prepared in aseptic conditions.

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

Etoposide must not be mixed physically with any other medicine.

Use only clear solutions. Turbid or colour-changed solutions must be discarded

Do not use an autoclave.

The disposal of unused medicine and all materials that have come into contact with it will 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) as rapid intravenous infusion has been described as a possible adverse effect. 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/m2on days 1, 3 and 5 every 3-4 weeks in combination with other medicines indicated in the disease being treated. The dose must be adjusted taking into account the myelosuppressive effects of other medicines in the combination or the effects of previous chemotherapy or radiation therapy that may have compromised the bone marrow reserve.

Administration precautions: as with other potentially toxic compounds, caution must be exercised in the handling and preparation of etoposide solution. Adverse reactions associated with accidental exposure to etoposide may occur. The use of gloves is recommended. If 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.

Care must be taken to avoid extravasation.

Geriatric patients

No dose adjustment is necessary in geriatric patients (over 65 years) other than based on renal function

Pediatric use

In pediatric patients, etoposide has been used at a dose of 75 to 150 mg/m2/day for 2 to 5 days in combination with other antineoplastic agents. The treatment regimen must be chosen in accordance with local standards of care.

Renal impairment

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

Subsequent dosing must be based on the patient's tolerance and clinical effect. In patients with creatinine clearance less than 15 ml/min and on dialysis, additional dose reduction must be considered.