Etopozid Accord

Package Leaflet: Information for the User

Etoposide Accord, 20 mg/ml, Concentrate for Solution for Infusion

Etoposide

Read all of this leaflet carefully before you start taking 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, pharmacist, or nurse.
• 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 get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

• 1. What Etoposide Accord is and what it is used for
• 2. What you need to know before you take Etoposide Accord
• 3. How to take Etoposide Accord
• 4. Possible side effects
• 5. How to store Etoposide Accord
• 6. Contents of the pack and other information

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

This medicine contains the active substance etoposide. It belongs to a group of medicines called cytostatics, which are used to treat cancer.

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

• testicular cancer;
• small cell lung cancer;
• blood cancer (acute myeloid leukaemia);
• lymphoma (Hodgkin's lymphoma, non-Hodgkin's lymphoma);
• cancer of the reproductive system (gestational trophoblastic disease and ovarian cancer).

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

• blood cancer (acute myeloid leukaemia);
• lymphoma (Hodgkin's lymphoma, non-Hodgkin's lymphoma).

The exact reason why you have been prescribed Etoposide Accord should be discussed with your doctor.

2. What you need to know before you take Etoposide Accord

When you should not take Etoposide Accord

• if you are allergic to etoposide or any of the other ingredients of this medicine (listed in section 6);
• if you have recently been vaccinated, including vaccination against yellow fever;
• if you are breastfeeding.

If any of the above applies to you, or if you are not sure, tell your doctor or pharmacist before taking Etoposide Accord.

Warnings and precautions

Before taking Etoposide Accord, talk to your doctor, pharmacist, or nurse if:

• you have low levels of a protein called albumin in your blood;
• you have recently had radiotherapy or chemotherapy;
• you have an infection, as it should be treated before taking Etoposide Accord;
• you have kidney or liver disease.

Effective cancer treatment can quickly destroy a large number of cancer cells. In very rare cases, this can lead to the release of large amounts of substances from the cancer cells into the blood. As a result, disorders of liver, kidney, heart, or blood function may occur, which can be life-threatening 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 medicine.

This medicine can cause a decrease in the number of certain blood cells, which can increase the risk of infection or bleeding. To ensure this does not happen, blood tests will be performed at the start of treatment and before each dose of Etoposide Accord.

If your liver or kidney function is impaired, your doctor may also order regular blood tests to monitor them.

Etoposide Accord with other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take, including:

• other medicines with a similar mechanism of action to Etoposide Accord;
• recent vaccination with a live vaccine;
• phenylbutazone, sodium salicylate, or acetylsalicylic acid (aspirin);
• warfarin (a medicine that prevents blood clots);
• phenytoin or any other medicine for epilepsy;
• anthracyclines (a group of medicines used to treat cancer);
• cisplatin (a medicine used to treat cancer);
• cyclosporin (a medicine used to weaken the immune system).

Pregnancy, breastfeeding, and fertility

If you are pregnant, breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Do not take Etoposide Accord if you are pregnant, unless your doctor advises you to.

Do not breastfeed while taking Etoposide Accord.

Both men and women of childbearing potential should use effective contraception (e.g., barrier methods or condoms) during and for at least 6 months after treatment with Etoposide Accord. Men treated with Etoposide Accord should not father a child during and for up to 6 months after treatment. Additionally, before starting treatment, men should consult their doctor about sperm preservation.

Men and women planning to have children after treatment with Etoposide Accord should discuss this with their doctor or nurse.

Driving and using machines

No studies have been conducted on the effects of Etoposide Accord on the ability to drive or operate machinery.

If you experience fatigue, nausea, dizziness, or other adverse effects, do not drive or operate machinery until you have discussed this with your doctor.

Etoposide Accord contains alcohol

This medicine contains 30.5% alcohol (ethanol), which is equivalent to 240.64 mg of ethanol per ml of concentrate, i.e., up to 1.2 mg of ethanol per 5 ml vial, equivalent to 30 ml of beer or 12.55 ml of wine, and up to 3 mg of ethanol per 12.5 ml vial, equivalent to 75 ml of beer or 31.4 ml of wine. This is harmful to patients with alcoholism, brain damage, pregnant women, breastfeeding women, children, and patients at risk, such as those with liver disease or epilepsy.

The effects of other medicines may be enhanced or diminished.

Etoposide Accord contains benzyl alcohol

This medicine contains benzyl alcohol, which is 30 mg/ml. Administration of benzyl alcohol to neonates has been associated with serious adverse effects, including gasping syndrome. Do not administer to neonates (up to 4 weeks of age) and do not use for more than one week in young children (under 3 years of age) without consulting a doctor.

In case of pregnancy, breastfeeding, liver or kidney disease, consult your doctor or pharmacist before taking this medicine, as high levels of benzyl alcohol may accumulate in their body and cause adverse effects (metabolic acidosis).

Benzyl alcohol may cause allergic reactions.

Etoposide Accord contains polysorbate 80

This medicine contains polysorbate 80, which is 80 mg/ml. In preterm infants, administration of vitamin E containing polysorbate 80 has been associated with life-threatening conditions, including liver and kidney failure, respiratory failure, thrombocytopenia, and abdominal distension.

3. How to take Etoposide Accord

Etoposide Accord should only be administered by a qualified healthcare professional.

The medicine is given by slow infusion into a vein, which may take 30 to 60 minutes.

The dose will be calculated by your doctor for each individual case. The typical dose, expressed in terms of 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 before 21 days have passed since the end of the first cycle.

In children with blood cancer or lymphoma, the dose is 75 to 150 mg/m² body surface area per day for 2 to 5 days.

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

What to do if you take more Etoposide Accord than you should

Since the medicine is administered by a qualified healthcare professional, overdose is unlikely. If it does occur, your doctor will treat any symptoms that may arise.

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, Etoposide Accord can cause side effects, although not everybody gets them.

Stop taking Etoposide Accord and tell your doctor or nurse immediately if you notice any of the following:

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

Serious damage to the liver, kidneys, or heart due to a condition called tumor lysis syndrome, which is caused by the release of toxic substances from cancer cells into the blood, has been reported in some cases when Etoposide Accord was taken with other cancer medicines.

Other side effects that may occur when taking Etoposide Accord include:

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

• blood disorders (which is why blood tests will be performed between treatment cycles);
• nausea and vomiting;
• loss of appetite;
• abdominal pain;
• constipation;
• temporary hair loss;
• liver damage (hepatotoxicity);
• increased liver enzyme activity;
• skin color changes (pigmentation);
• jaundice (elevated bilirubin levels);
• weakness (asthenia);
• general feeling of being unwell.

Common (may affect up to 1 in 10 people):

• acute leukaemia (a serious blood cancer);
• arrhythmia (irregular heartbeat) and heart attack;
• dizziness;
• high blood pressure;
• low blood pressure;
• herpes simplex, oral herpes, or throat ulcers;
• skin redness;
• infection (including infections in people with weakened immune systems, such as pneumocystis jirovecii pneumonia);
• diarrhoea;
• skin irritation, such as itching or rash;
• vein inflammation;
• severe allergic reactions;
• reactions at the injection site.

Uncommon (may affect up to 1 in 100 people):

• peripheral neuropathy (numbness or weakness in the hands and feet);
• bleeding.

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

• seizures (fits);
• feeling tired or sleepy;
• taste disturbances;
• difficulty swallowing;
• severe skin and mucous membrane reactions, including painful blisters and fever, as well as widespread skin peeling (Stevens-Johnson syndrome or toxic epidermal necrolysis);
• skin rash similar to sunburn, sometimes severe, which may occur on skin previously exposed to radiotherapy (radiation recall);
• fever;
• transient blindness;
• breathing difficulties;
• gastroesophageal reflux;
• hot flashes.

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

• tumor lysis syndrome (a complication caused by the release of substances from cancer cells into the blood);
• facial and tongue swelling;
• infertility;
• breathing difficulties.
• acute kidney failure.

Reporting of side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly to the national reporting system via the contact details below.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Etoposide Accord

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 that month.

Store the vials in the original packaging to protect from light.

Do not store in a refrigerator. Do not freeze.

Chemical and physical in-use stability has been demonstrated for 96 hours and 48 hours at concentrations of 0.2 mg/ml and 0.4 mg/ml, respectively, in sodium chloride 0.9% w/v or glucose 5% w/v solutions at 20-25°C.

From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions are the responsibility of the user.

Do not store the diluted solution in a refrigerator (2-8°C) due to the risk of precipitation.

Do not use this medicine if you notice any precipitation or visible particles in the solution.

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

6. Contents of the pack and other information

What Etoposide Accord contains

The active substance is etoposide.

1 ml of solution contains 20 mg of etoposide.

Each 5 ml vial contains 100 mg of etoposide.

Each 10 ml vial contains 200 mg of etoposide.

Each 12.5 ml vial contains 250 mg of etoposide.

Each 20 ml vial contains 400 mg of etoposide.

Each 25 ml vial contains 500 mg of etoposide.

Each 50 ml vial contains 1000 mg of etoposide.

The other ingredients are citric acid anhydrous, benzyl alcohol, polysorbate 80, macrogol 300, and anhydrous ethanol.

What Etoposide Accord looks like and contents of the pack

The medicine is a clear, colorless to pale yellow solution for injection or infusion.

Available pack sizes:

1 vial of 5 ml

1 vial of 10 ml

1 vial of 12.5 ml

1 vial of 20 ml

1 vial of 25 ml

1 vial of 50 ml

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Accord Healthcare Polska Sp. z o.o.

ul. Taśmowa 7

02-677 Warszawa

Tel: + 48 22 577 28 00

Manufacturer

Accord Healthcare Polska Sp.z o.o.

ul. Lutomierska 50

95-200 Pabianice

Poland

Accord Healthcare Single Member S.A.

64th Km National Road Athens, Lamia, 32009

Greece

This medicine is authorised in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Date of last revision of the package leaflet: September 2024

Information for healthcare professionals only:

Administration and dosage

Etoposide Accord is administered by slow intravenous infusion (usually over 30 to 60 minutes); sudden drops in blood pressure have been reported with rapid intravenous injection. Etoposide Accord SHOULD NOT BE ADMINISTERED BY RAPID INTRAVENOUS INJECTION.

Recommended doses of Etoposide Accord are 50 to 100 mg/m²/day (in terms of etoposide) for 5 consecutive days or 100 to 120 mg/m²/day on days 1, 3, and 5, repeated every 3 to 4 weeks, in combination with other anticancer medicines.

Dosage should be modified based on the myelosuppressive effects of other medicines used in combination or the effects of prior radiotherapy or chemotherapy, which may have reduced bone marrow reserves.

Elderly

In elderly patients (> 65 years), no dose adjustment is necessary based on age alone, but only according to renal function.

Pediatric use

Etoposide Accord has been used in pediatric patients in doses ranging from 75 to 150 mg/m²/day (in terms of etoposide) for 2 to 5 days in combination with other anticancer medicines.

To determine the appropriate treatment regimen, consult current specialist protocols and guidelines.

Renal impairment

In patients with impaired renal function, consider the following dose adjustments based on creatinine clearance:

Creatinine clearance (ml/min) Etoposide dose

>50 ml/min 100% of dose

15-50 ml/min 75% of dose

In patients with creatinine clearance below 15 ml/min and those undergoing dialysis, consider further dose reduction. Subsequent doses should be based on patient tolerance and clinical effects.

Since etoposide and its metabolites are not removed by dialysis, the medicine can be administered before or after hemodialysis.

Instructions for administration and preparation

Follow proper handling and disposal procedures for anticancer medicines.

All procedures involving the preparation of Etoposide Accord solutions should be carried out in accordance with the requirements for cytotoxic medicines.

Take precautions to avoid exposure to the medicine.

As with other potentially toxic compounds, handle Etoposide Accord with care, and avoid accidental exposure. Wear protective gloves.

In case of skin contact or mucous membrane exposure, wash the skin with soap and water and rinse the mucous membrane with water.

Avoid extravasation.

If precipitation or visible particles are observed, discard the prepared solution.

Dispose of any unused medicine or waste material in accordance with local regulations.

Shelf-life after dilution:

Chemical and physical in-use stability has been demonstrated for 96 hours and 48 hours at concentrations of 0.2 mg/ml and 0.4 mg/ml, respectively, in sodium chloride 0.9% w/v or glucose 5% w/v solutions at 20-25°C.

From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions are the responsibility of the user.

Do not store the diluted solution in a refrigerator (2-8°C) due to the risk of precipitation.

Storage conditions:

Store the vials in the original packaging to protect from light.

Do not store in a refrigerator. Do not freeze.