Prospect: information for the patient

Etoposide Tevagen 20 mg/ml concentrate for infusion solution

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

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

1. What isEtoposide Tevagenand for what it is used

2. What you need to know before starting to useEtoposide Tevagen

3. How to useEtoposide Tevagen

4. Possible adverse effects

5. Storage ofEtoposide Tevagen

6. Contents of the package and additional information

Etopósido belongs to the group of medications 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 (choriocarcinoma 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 speak with your doctor about the exact reason why you have been prescribed Etopósido Tevagen.

No use Etopósido

-If you are allergic to etoposide, or to 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 applies to you, or if you are unsure, consult your doctor.

This product contains benzyl alcohol. It should not be administered to premature babies or neonates.

Warnings and Precautions

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

-If you have any infection.

-If you have recently received radiation therapy 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. This can cause problems in the liver, kidneys, heart, or blood, which can be fatal if not treated.

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

This medication may cause a reduction in the levels of some blood cells, which could lead to infections or mean that your blood does not clot properly if you suffer a cut. To check this does not happen, 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 Tevagen

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 cisplatin (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 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, Breastfeeding, and Fertility

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

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

Do not breastfeed while receiving etoposide.

Both men and women of childbearing age should use an effective contraceptive method (such as barrier methods or condoms) during treatment and for at least 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.

Both men and women who are 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 Tevagen contains etanol (alcohol) and benzyl alcohol

Etanol

Etoposide Tevagen contains 30% vol of alcohol.

This medication contains 1.2 g of alcohol (ethanol) in each 5 ml vial and 6 g of alcohol (ethanol) in each 25 ml vial, equivalent to 243 mg/ml of concentrate. The amount in one ml of this medication is equivalent to 6 ml of beer or 2 ml of wine.

It is unlikely that the amount of alcohol in this medication will have an effect on adults and adolescents, and its effects on children are unlikely to be noticeable. It may have some effects on younger children, such as drowsiness.

The amount of alcohol in this medication may affect the effects of other medications. Talk to your doctor or pharmacist if you are taking other medications.

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

If you are an alcoholic, talk to your doctor or pharmacist before taking this medication.

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

Alcohol bencílico

This medication contains 150 mg of benzyl alcohol in each 5 ml vial and 750 mg of benzyl alcohol in each 25 ml vial, equivalent to 30 mg/ml of concentrate.

Benzyl alcohol can cause allergic reactions.

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

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

Benzyl alcohol has been linked to the risk of severe adverse effects, including respiratory problems ("breathing difficulty") in children.

Etoposide Tevagen will be administered 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 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 Etoposide Tevagen 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 medications,this medicationmay 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 heart rate, skin redness or rash. These may be signs of a severe allergic reaction.

On occasion, severe damage has been observedto theliver, thekidneys, or theheartdue to a condition called tumor lysis syndrome caused by the entry of harmful substances from cancer cells into the bloodstream when Etopósido Tevagen 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 feeling of illness

-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

-mouth sores, ulcers in the mouth or throat

-skin problems such as itching or rash

• -inflammation of a vein (infection), including infections observed in patients with a weakened immune system, such as pneumonia caused byPneumocystis 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)

Unknown(frequency cannot be estimated from available data)

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

-swelling of the face and tongue

-infertility

• dificultad para respirar

- acute renal failure

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Vigilance of Medicinal Products for Human Use Website: www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

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 vial after CAD. The expiration date is the last day of the month indicated.

Store at a temperature below 25°C, protected from light (keep vials in the outer packaging). Do not freeze.

After dilution, it must be used immediately. If this is not possible, the diluted solution can be stored at room temperature (15-25°C) for a maximum of 12 hours. Do not store the diluted product in a refrigerator (2-8°C) as precipitation may occur. Used solution residues should be discarded.

Composition of Etoposide Tevagen

-The active ingredient is 20 mg of etoposide per ml of concentrate for solution for infusion.

-The other components are macrogol 300, polisorbate 80, benzyl alcohol, ethanol, citric acid.

Aspect of the product and content of the package

Etoposide Tevagen is a viscous liquid of yellowish color in a transparent glass vial with a rubber stopper with aluminum cap and plastic snap-cap.

Eachvialwith 5 ml of concentrate for solution for infusion contains 100 mg of etoposide.

Eachvialwith 25 ml of concentrate for solution for infusion contains 500 mg of etoposide.

One package contains 1vialor 10ampoulesof Etoposide Tevagen.

Only some package sizes may be marketed.

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.

P.O. Box 552, 2003 RN

Haarlem

Netherlands

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

NetherlandsEposin, concentrate for solution for infusion 20 mg/ml

SpainEtoposide Tevagen 20 mg/ml, concentrate for solution for infusion

This leaflet was revised in June 2021

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

The required dose of Etoposide Tevagen 20 mg/ml concentrate for solution for infusion must be diluted with dextrose for injection 5% or sodium chloride for injection 0.9% to achieve a final concentration of 0.2 to 0.4 mg/ml. At higher concentrations, etoposide precipitation may occur.

Etoposide Tevagen must not be mixed physically with any other medicinal product.

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

It has been reported that plastic devices made of acrylic or ABS polymers break when used with undiluted Etoposide Tevagen 20 mg/ml concentrate for solution for infusion. This effect has not been reported with etoposide after dilution of the concentrate for solution for infusion according to the instructions.

Disposal of unused medication 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) since hypotension has been described as a possible adverse effect of rapid intravenous infusion. Etoposide Tevagen 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 medicinal products indicated for the disease being treated. The dose must be adjusted taking into account the myelosuppressive effects of other medicinal products in the combination or the effects of previous chemotherapy or radiation therapy that may have compromised the bone marrow reserve.

Precautions for administration: As with other potentially toxic compounds, caution should 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 should be taken to avoid extravasation.

Geriatric patients

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

Pediatric use

In pediatric patients, etoposide has been used in the dose 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 in accordance with local standards of care.

Renal impairment

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

Subsequent dosing should 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 should be considered.