Prospecto: information for the patient

Etoposide Sandoz 20 mg/ml concentrate for solution for infusion EFG

Read this prospect carefully before starting to receive this medicine, because it contains important information for you.

• Keep this prospect, as you may have to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only to you. Do not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

Content of the prospect

1. What Etoposide Sandoz is and for what it is used
2. What you need to know before starting to receive Etoposide Sandoz
3. How you will receive Etoposide Sandoz
4. Possible adverse effects
5. Storage of Etoposide Sandoz
6. Contents of the package and additional information

The name of this medication is Etopósido Sandoz. Each vial contains 100 mg or 200 mg of etoposide as the active ingredient.

Etoposide belongs to a group of medications called cytostatics that are used in the treatment of cancer.

Etoposide is used in the treatment of certain types of cancer in adults:

• testicular cancer,
• small cell lung cancer (microcytic),
• blood cancer (acute myeloid leukemia),
• lymphatic system tumors (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 cancer in children:

• blood cancer (acute myeloid leukemia),
• lymphatic system tumors (Hodgkin's lymphoma, non-Hodgkin's lymphoma).

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

Do not take Etopósido Sandoz:

-if you are allergic to etoposide or any of the other ingredients of this medication (listed in section 6),

-if you have recently received a live virus vaccine, including the yellow fever vaccine,

-if you are breastfeeding or plan to do so.

If any of the above applies to you, or if you are unsure, consult your doctor, who may advise you.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to receive Etopósido:

• if you have anyinfection,
• if you have recently receivedradiation therapy or chemotherapy,
• if you have low levels of a protein calledalbuminin your blood.
• if you have liver or kidney problems.

Effective cancer treatment can destroy cancer cells quickly in large quantities. In very rare cases, this can cause the release of harmful amounts of these cancer cells into the blood. In this case, it can cause problems in the liver, kidneys, heart, or blood, which could be fatal if not treated.

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

This medication may cause a reduction in the level of some blood cells that could make you suffer from infections or prevent your blood from clotting as well as it should if you suffer any cuts. 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 you to have regular blood tests to control these levels.

Other medications and Etopósido Sandoz

Inform your doctor if you are using, have used recently or may need to use any other medication.

This is especially important:

-if you are taking a medication called ciclosporin (which is used to reduce the activity of theimmune system),

-if you are receiving treatment with cisplatin (a medication used to treat cancer),

-if you are taking phenytoin or any other medication used for epilepsy,

-if you are taking warfarin (a medication used to prevent blood clots),

-if you have recently received any live virus vaccine,

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

-if you are taking any anthracycline (a group of medications used to treat cancer),

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

Pregnancy, breastfeeding, and fertility

Do not use etoposide during pregnancy unless your doctor advises you clearly.

Do not breastfeed while receiving etoposide.

Both male and female patients of childbearing age should use an effective contraceptive method (e.g., barrier method or condom) during treatment and at least 6 months after completing etoposide treatment.

Male patients treated with etoposide should not conceive any children during treatment and for at least 6 months after treatment. Additionally, men should seek advice on sperm conservation before starting treatment.

Both male and female patients who plan to have a child after 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 are tired, have an upset stomach, or feel dizzy or disoriented, do not do it until you have discussed it with your doctor.

Etopósido Sandoz contains benzyl alcohol and ethanol

Benzyl alcohol

Etopósido Sandoz contains 20 mg of benzyl alcohol per ml. Benzyl alcohol may cause allergic reactions.

Consult your doctor or pharmacist if you are pregnant or breastfeeding. This is because large amounts of benzyl alcohol can accumulate in your body and cause adverse effects (metabolic acidosis).

Consult your doctor or pharmacist if you have liver or kidney disease. This is because large amounts of benzyl alcohol can accumulate in your body and cause adverse effects (metabolic acidosis).

Benzyl alcohol has been associated with a risk of severe adverse effects that include respiratory problems ("breathing difficulty") in children.

Do not administer this medication to your newborn (up to 4 weeks old) unless your doctor recommends it.

This medication should not be used for more than a week in children under 3 years of age unless your doctor or pharmacist advises you.

Ethanol

This medication contains 26% ethanol (alcohol) corresponding to 260.60 mg of ethanol per ml.With a dose of 100 mg/m² of etoposide, a patient with a body surface area of1.6 m²would receive2.1 gof ethanol, which is equivalent to 52 ml of beer or 21.5 ml of wine.

It is unlikely that the amount of alcohol contained in this medication will have any noticeable effect on adults or adolescents. It may have some effects on young children, such as drowsiness.

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

Consult your doctor or pharmacist if you are pregnant or breastfeeding before taking this medication.

Consult your doctor or pharmacist if you have a history of alcohol addiction before taking this medication.

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Etopósido will be administered by a doctor or nurse. It will be given to you as an infusion into a vein. This may take between 30 and 60 minutes.

The dose you will receive will be specific to you and will be calculated by your doctor. The usual dose, based on etopósido, is between 50 and 100 mg/m² of body surface area, given daily for 5 consecutive days, or between 100 and 120 mg/m² of body surface area on days 1, 3, and 5. This treatment cycle may be repeated as needed based on blood test results, but at least 21 days after the first treatment cycle.

In children treated for blood or lymphatic system cancer, the dose used is between 75 and 150 mg/m² of body surface area daily for 2-5 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 Sandoz Than You Should

Since etopósido is administered by a doctor or nurse, an overdose is unlikely. However, if it occurs, your doctor will treat any symptoms that develop.

If you have received more etopósido than you should, consult your doctor, pharmacist, or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount used.

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

Like all medicines, this medicine may 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. They could be signs of a severe allergic reaction.

On occasion, severe damage to the liver, kidneys, or heart has been observed due to a condition called tumour lysis syndrome caused by the entry of harmful amounts of substances from cancer cells into the bloodstream when etoposide is administered with other drugs used to treat cancer.

Possible side effectsexperienced with etoposide are:

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

Frequent side effects(may affect up to 1 in 10 people)

Rare side effects(may affect up to 1 in 100 people)

• Tickling or tingling in the hands and feet
• Bleeding

Very rare side effects(may affect up to 1 in 1,000 people)

Unknown frequency(cannot be estimated from available data)

• Tumour lysis syndrome (complications that occur when substances released by treated cancer cells enter the bloodstream)
• Swelling of the face and tongue,
• Infertility
• Difficulty breathing

Reporting of side effects

If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet.You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es.Reporting side effects can help provide more information about the safety of this medicine.

Do not store at a temperature above 25°C

Store the vial in the outer packaging to protect it from light.

Etoposide solutions with a final concentration of 0.2 or 0.4 mg/ml are stable for 96 or 24 hours, respectively, at a temperature not exceeding 25°C.

Before using Etoposide Sandoz, it must undergo visual inspection for foreign particles and coloration, provided the solution and container permit.

Expiration Date

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

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and unused medicines. This will help protect the environment.

Composition of Etoposide Sandoz

• The active ingredient is etoposide
• The other components are: benzyl alcohol (20 mg/ml), anhydrous citric acid, ethanol 96.7%, macrogol 300, polisorbate 80, and nitrogen.

Appearance of the product and contents of the container

Glass vials packaged in a box.

Etoposide Sandoz is available in:

• Containers with 1 and 10 vials of 5 ml with 100 mg of etoposide with or without plastic protection (e.g. Sleeving, OncoSafe).

• Containers with 1 vial of 10 ml with 200 mg of etoposide with or without plastic protection (e.g. Sleeving, OncoSafe).

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Sandoz Farmacéutica, S.A.
Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Responsible for manufacturing

EBEWE Pharma Ges.m.b.H. Nfg. KG

Mondseestrasse, 11

A-4866 Unterach

Austria

O

Fareva Unterach GmbH

Mondseestrasse, 11

A-4866 Unterach

Austria

Last review date of this leaflet: January 2024.

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

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This information is intended solely for doctors or healthcare professionals:

They must follow the procedures for correct handling and disposal of cytotoxic drugs.

Pregnant women should not handle or administer this medication.

Like all cytostatic drugs, etoposide should be handled with caution. Dilutions should be carried out in aseptic conditions by experienced personnel in a specific area. It is recommended to use protective gloves. Precautions should be taken to avoid any contact with the skin and mucous membranes. In case of contact with the skin or mucous membranes, they should be washed immediately with plenty of water and soap.

Preparation for IV administration

Before administering etoposide, it should be diluted with 5% glucose solution or 0.9% saline solution to obtain a final concentration of 0.2 or 0.4 mg/ml of etoposide.

If the etoposide solution is diluted to a concentration higher than 0.4 mg/ml, it may precipitate.

Etoposide should not be diluted in solutions tamponed with a pH>8, due to the risk of forming precipitates.

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

Incompatibilities

This product cannot be mixed with other medications, except as mentioned above.

It has been observed that acrylic or ABS plastic materials break or become perforated when using undiluted etoposide. This does not occur with diluted etoposide.

Administration and posology

Etoposide Sandoz should be administered exclusively by intravenous route.

Etoposide is administered by slow intravenous infusion, (usually over a period of 30 to 60 minutes). Depending on the patient's tolerance, longer infusion times may be required (see section 4.4 of the SmPC). Etoposide Sandoz MUST NOT BE ADMINISTERED BY RAPID INTRAVENOUS INJECTION. Cases of hypotension have been described after rapid administration of the preparation.

All dosages are expressed in mg/m2of body surface area calculated according to height and weight.

The recommended dose of etoposide injection is between 50 and 100 mg/m2/day, for days 1 to 5 of consecutive cycles, or 100 mg/m2for days 1, 3, and 5 of cycles every 3-4 weeks, when administered in combination with other medications used for the treatment of the disease.

The dosage should be adjusted to take into account the myelosuppressive effects of other drugs in the combination or the effects of previous radiotherapy or chemotherapy that may have compromised the bone marrow reserve.

Precautions for administration: As with other potentially toxic compounds, caution should be exercised when handling and preparing the etoposide solution. Accidental exposure to etoposide may cause skin reactions. It is recommended to use gloves. If the etoposide solution comes into contact with the skin or mucous membranes, wash the skin immediately with water and soap and rinse the mucous membranes with water.

Care should be taken to avoid extravasation.

Etoposide can only be administered by a specialist in cancer treatment or under their supervision.

Before using Etoposide Sandoz, it should be visually inspected for particulate matter and color, provided that the solution and container also permit.

Geriatric patients

No adjustment of the dose is necessary in geriatric patients (age > 65 years), except on the basis of renal function.

Pediatric use

Etoposide in pediatric patients has been used in the range of 75 to 150 mg/m2/day (etoposide equivalent) for 2-5 days in combination with other antineoplastic drugs. Consult current specialized protocols and guidelines to determine the appropriate treatment.

Renal impairment

In patients with renal impairment, the following dose adjustment should be considered based on the measured creatinine clearance:

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

Shelf life

3 years

Special precautions for storage

Do not store at a temperature above 25°C.

Store the vial in the outer packaging to protect it from light.

Once diluted, to a concentration of 0.2 or 0.4 mg/ml as recommended, it is physically and chemically stable for 96 and 24 hours respectively, at a temperature not exceeding 25°C and with normal fluorescent light. However, from a microbiological point of view, the product should be used immediately. If not, the storage times and conditions before use will be the responsibility of the user and should not normally exceed 24 hours at a temperature between 2°C and 8°C, unless the dilution has been carried out in controlled and validated aseptic conditions.