ETOPOSIDE SANDOZ 20 mg/mL concentrate for infusion solution

Introduction

Package Leaflet: Information for the Patient

Etoposide Sandoz 20 mg/ml Concentrate for Solution for Infusion EFG

Read all of this leaflet carefully before you start receiving 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.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

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

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

The name of this medicine is Etoposide Sandoz. Each vial contains 100 mg or 200 mg of etoposide as the active substance.

Etoposide belongs to a group of medicines called cytostatics 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),
• cancers of the reproductive system (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 recommended that you discuss with your doctor the exact reason why etoposide has been prescribed for you.

2. What you need to know before you receive Etoposide Sandoz

Do not receive Etoposide Sandoz:

• if you are allergic to etoposide or any of the other ingredients of this medicine (listed in section 6),
• if you have recently received a live vaccine, including the yellow fever vaccine,
• if you are breastfeeding or planning to breastfeed.

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

Warnings and precautions

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

• if you have any infection,
• if you have recently received radiotherapy or chemotherapy,
• if you have low levels of a protein called albuminin your blood.
• if you have liver or kidney problems.

Effective anticancer treatment can quickly destroy cancer cells in large quantities. In very rare cases, this can lead to the release of harmful amounts of these cancer cells into the bloodstream. In this case, it can cause problems in the liver, kidney, heart, or blood, which could be life-threatening if left untreated.

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

This medicine may cause a reduction in the level of some blood cells, which could make you more likely to get infections or make your blood less able to clot as it should if you cut yourself. To check that this is not happening, you will have blood tests at the start of treatment and before each dose you receive.

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

Other medicines and Etoposide Sandoz

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

This is especially important:

• if you are taking a medicine called cyclosporin (used to reduce the activity of the immune system),
• if you are receiving treatment with cisplatin (a medicine used to treat cancer),
• if you are taking phenytoin or any other medicine used for epilepsy,
• if you are taking warfarin (a medicine used to prevent blood clots),
• if you have recently received a live vaccine,
• if you are taking phenylbutazone, sodium salicylate, or acetylsalicylic acid,
• if you are taking any anthracycline (a group of medicines used to treat cancer),
• if you are taking any medicine with a mechanism of action similar to etoposide.

Pregnancy, breastfeeding, and fertility

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

You should not breastfeed while receiving etoposide.

Patients of both sexes, men and women, of childbearing age must use an effective contraceptive method (e.g., barrier method or condom) during treatment and at least 6 months after completing treatment with etoposide.

Male patients treated with etoposide are advised not to conceive a child during treatment and up to 6 months after treatment. Additionally, male patients are advised to seek counseling on sperm preservation before starting treatment.

Patients of both sexes who plan to have a child after treatment with etoposide should discuss this with their doctor or nurse.

Driving and using machines

No studies have been conducted on the effects on the ability to drive and use machines. However, if you are tired, have an upset stomach, or feel dizzy or disoriented, you should not do so until you have discussed it with your doctor.

Etoposide Sandoz contains benzyl alcohol and ethanol

Benzyl alcohol

Etoposide 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 the risk of serious adverse effects, including respiratory problems ("gasping syndrome") in children.

Do not administer this medicine to your newborn (up to 4 weeks of age) unless your doctor has recommended it.

This medicine should not be used for more than one week in children under 3 years of age unless indicated by your doctor or pharmacist.

Etanol

This medicine contains 26% ethanol (alcohol), which corresponds to an amount of 260.60 mg of ethanol per ml. With a dose of 100 mg/m² of etoposide, a patient with a body surface area of 1.6 m² would receive 2.1 g of ethanol, equivalent to 52 ml of beer or 21.5 ml of wine.

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

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

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

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

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3. How you will be given Etoposide Sandoz

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

The dose you receive will be specific to you and will be calculated by your doctor. The usual dose, based on etoposide, is between 50 and 100 mg/m² of body surface area, 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 later, depending on the results of your blood tests, 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.

On some occasions, 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 Etoposide Sandoz than you should

Since etoposide is administered by a doctor or nurse, overdose is unlikely. However, if it occurs, your doctor will treat the symptoms that occur.

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

If you have any further questions about 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 experience any of the following symptoms: swelling of the tongue or throat, difficulty breathing, rapid heartbeat, flushing of the skin, or rash. These could be signs of a severe allergic reaction.

On occasion, severe liver, kidney, or heart damagehas been observed due to a disorder called tumor lysis syndrome, which is caused by the release of harmful amounts of substances from cancer cells into the bloodstream when etoposide is administered with other medicines used to treat cancer.

Side effectsexperienced with etoposide are:

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

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

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

• tingling or numbness in hands and feet
• bleeding

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

Frequency not known(cannot be estimated from the available data)

• tumor lysis syndrome (complications that occur when substances released by treated cancer cells enter the bloodstream)
• swelling of the face and tongue,
• infertility
• breathing difficulties

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Agency's website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Etoposide Sandoz

Do not store above 25°C

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

Etoposide dilutions 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 should be visually inspected for particulate matter and discoloration, whenever the solution and container permit.

Expiry date

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

Composition of Etoposide Sandoz

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

Appearance and packaging

Glass vials packaged in a box.

Etoposide Sandoz is available in:

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

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

Marketing authorization holder and manufacturer

Marketing authorization holder

Sandoz Farmacéutica, S.A. Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

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

Mondseestrasse, 11

A-4866 Unterach

Austria

Or

Fareva Unterach GmbH

Mondseestrasse, 11

A-4866 Unterach

Austria

Date of last revision of this leaflet: January 2024.

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

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This information is intended only for healthcare professionals:

Procedures for the correct handling and disposal of cytotoxic medicines should be followed.

Pregnant women should not handle or administer this medicine.

As with all cytostatic medicines, etoposide should be handled with caution. Dilutions should be carried out under aseptic conditions by experienced personnel and 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 intravenous administration

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

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

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

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

Incompatibilities

This product should not be mixed with other medicines, except those mentioned above.

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

Administration and Dosage

Etoposide Sandoz should be administered exclusively by the intravenous route.

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

All dosages are expressed in mg/m2 of calculated body surface area according to height and weight.

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

Dosage should be modified to take into account the myelodepressive effects of other combination drugs or the effects of prior radiation or chemotherapy that may have compromised bone marrow reserve.

Administration precautions: As with other potentially toxic compounds, caution should be exercised when handling and preparing the etoposide solution. Skin reactions may occur with accidental exposure to etoposide. 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 rinse the mucous membranes with water.

Attention should be paid to avoiding extravasation.

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

Before using Etoposide Sandoz, it should be subjected to visual inspection for foreign particles and coloration, as long as the solution and packaging allow it.

Elderly patients

No dose adjustment is necessary in elderly patients (age > 65 years), except based on 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. Current specialized protocols and guidelines should be consulted to determine the appropriate treatment.

Renal Impairment

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

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

Shelf life

3 years

Special storage precautions

Do not store at a temperature above 25°C.

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

Once diluted, at 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 lighting. 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 under controlled and validated aseptic conditions.