Etoposide Kabi

Package Leaflet: Information for the User

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

Etoposide

Read All of This Leaflet Carefully Before You Start Using This Medicine Because It Contains Important Information for You.

• You should keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• If you get 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 Pack

• 1. What Etoposide Kabi is and What It is Used For
• 2. What You Need to Know Before You Use Etoposide Kabi
• 3. How to Use Etoposide Kabi
• 4. Possible Side Effects
• 5. How to Store Etoposide Kabi
• 6. Contents of the Pack and Other Information

1. What Etoposide Kabi is and What It is Used For

The name of your medicine is Etoposide Kabi, but it will be referred to as etoposide throughout this leaflet.
It contains the active substance etoposide, which belongs to a group of medicines called cytostatics used in the treatment of cancer.
Etoposide is used in adults for the treatment of certain types of cancer:

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

Etoposide is used in children and adolescents for the treatment of certain types of cancer:

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

The exact reason why etoposide has been prescribed for you should be discussed with your doctor.

2. What You Need to Know Before You Use Etoposide Kabi

When You Should Not Use Etoposide Kabi:

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

Warnings and Precautions

Before you are given etoposide, tell your doctor, pharmacist or nurse if:

• you have a low level of a protein called albumin in your blood,
• you have recently had radiotherapy or chemotherapy,
• you have any infection,
• you have liver or kidney problems.

Effective anti-cancer treatment can cause the rapid destruction of large numbers of cancer cells.
This can lead to the release of large amounts of substances from the dying cancer cells into the bloodstream.
This may cause disturbances in liver, kidney, heart or blood function, which may be life-threatening if not treated.
To prevent this, your doctor will order regular blood tests to monitor the levels of these substances in your blood during treatment with Etoposide Kabi.
This medicine can cause a decrease in the number of certain types of blood cells, which can cause infections or make it more difficult for your blood to clot.
To make sure this does not happen, blood tests will be carried out before you start treatment and before each dose of Etoposide Kabi is given.
If your liver or kidney function is disturbed, your doctor may also order regular blood tests to monitor them.

Etoposide Kabi and Other Medicines

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those obtained without a prescription.

• if you are taking warfarin (a medicine to prevent blood clotting),
• if you are taking ciclosporin (a medicine to suppress the immune system),
• if you are being treated with cisplatin (a medicine to treat cancer),
• if you are taking phenytoin or other medicines to treat epilepsy,
• if you are taking phenylbutazone, sodium salicylate or acetylsalicylic acid, or have recently been vaccinated with a live vaccine,
• if you are taking any anthracyclines (medicines to treat cancer),
• if you are taking any medicines that work in a similar way to etoposide.

The amount of alcohol in this medicine may affect how other medicines work.

Pregnancy, Breastfeeding and Fertility

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
Pregnancy
Etoposide Kabi should not be used during pregnancy unless strictly necessary.
Breastfeeding
You should not breastfeed while you are being treated with etoposide.
Fertility
Both men and women of child-bearing age should use effective contraception (e.g. barrier methods or condoms) during and for at least 6 months after treatment with Etoposide Kabi.
Men treated with etoposide should not father a child during and for up to 6 months after treatment, and should seek advice on conservation of sperm prior to treatment.
Both men and women who are planning to become parents after treatment with Etoposide Kabi should discuss this with their doctor or nurse.

Driving and Using Machines

No studies on the effects on the ability to drive and use machines have been performed.
However, if you experience fatigue, nausea, dizziness or fainting, you should not drive or operate machinery until you have discussed this with your doctor.

Etoposide Kabi Contains Ethanol, Benzyl Alcohol and Polysorbate 80

Ethanol

This medicine contains 241.4 mg of ethanol (alcohol) in each 1 ml, which is equivalent to 24.14% v/v.
The amount of alcohol in a 10.38 ml dose of this medicine is equivalent to 62.64 ml of beer or 25.06 ml of wine.
The alcohol in this medicine may affect your ability to drive or operate machinery.
It may also affect the performance and concentration of children.

Benzyl Alcohol

This medicine contains 30 mg of benzyl alcohol in each 1 ml.
Benzyl alcohol may cause allergic reactions.
It is not recommended for use in children under 3 years of age, for more than one week, without consulting a doctor or pharmacist.

Polysorbate 80

Etoposide contains polysorbate 80.
In premature babies who have been given a vitamin E injection containing polysorbate 80, serious side effects have been reported, including liver and kidney failure, breathing difficulties, low blood platelet count and swollen abdomen.

3. How to Use Etoposide Kabi

Etoposide Kabi will be given to you by a doctor or nurse.
The medicine will be given by slow infusion into a vein over 30 to 60 minutes.
The dose will be calculated by your doctor for each individual patient.
The usual dose 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 your blood tests, but not before 21 days after the end of the first cycle.
In children being treated for blood cancer or lymphatic system cancer, the dose is 75 to 150 mg/m2 body surface area per day for 2 to 5 days.

What to Do If You Have Been Given Too Much Etoposide Kabi

As this medicine is given by a doctor or nurse, it is unlikely that you will be given too much.
If you think you have been given too much, tell your doctor or nurse immediately.

4. Possible Side Effects

Like all medicines, Etoposide Kabi can cause side effects, although not everybody gets them.

If You Notice Any of the Following, Tell Your Doctor or Nurse Immediately:

Swelling of the tongue or throat, difficulty breathing, fast heartbeat, sudden redness of the skin or rash.
These may be signs of a severe allergic reaction.
Severe liver, kidney or heart damagedue to a complication called tumour lysis syndrome, caused by the release of toxic substances from cancer cells into the bloodstream, has been reported in some cases when etoposide was given with other cancer medicines.
Other Side Effectsthat may occur during treatment with etoposide include:

• Very Common(may affect more than 1 in 10 people):
• blood disorders (for this reason, blood tests will be carried out between treatment cycles),
• temporary hair loss,
• nausea and vomiting,
• abdominal pain,
• loss of appetite,
• skin colour changes (discoloration),
• constipation,
• weakness (asthenia),
• general feeling of being unwell,
• liver damage (hepatotoxicity),
• increased liver enzyme activity,
• jaundice (increased bilirubin levels).

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

• acute leukaemia,
• irregular heartbeat (arrhythmia) or heart attack (myocardial infarction),
• dizziness,
• diarrhoea,
• reactions at the injection site,
• severe allergic reactions,
• high blood pressure,
• low blood pressure,
• herpes simplex, mouth ulcers or throat ulcers,
• skin problems, such as itching or rash,
• vein inflammation,
• infection.

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

• tingling or numbness of hands and feet,
• bleeding.

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

• acid reflux,
• sudden redness of the skin,
• difficulty swallowing,
• change in taste,
• severe allergic reactions,
• seizures (fits),
• fever,
• drowsiness or fatigue,
• breathing difficulties,
• temporary loss of vision,
• severe skin reactions and (or) mucous membranes, including painful blisters and fever, as well as peeling of large areas of skin (Stevens-Johnson syndrome and toxic epidermal necrolysis),
• sunburn-like rash that may appear on skin previously exposed to radiotherapy and may be severe (radiation recall reaction).

Frequency Not Known(frequency cannot be estimated from the available data):

• tumour lysis syndrome (a complication caused by the release of substances from dying cancer cells into the bloodstream),
• swelling of the face and tongue,
• infertility,
• breathing difficulties.

Reporting of Side Effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.
Side effects can also be reported to the regulatory authority in your country.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to Store Etoposide Kabi

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 label after 'EXP'.
The expiry date refers to the last day of that month.
Store in the original package in order to protect from light.
Do not store the diluted solution in the refrigerator (2°C to 8°C), as this may cause precipitation.
A solution showing signs of precipitation should not be used.
After Dilution

The diluted solution of Etoposide Kabi at a concentration of 0.2 mg/ml or 0.4 mg/ml remains physically and chemically stable for 24 hours at a temperature of 15°C to 25°C.
From a microbiological point of view, the diluted solution should be used immediately.
If not used immediately, in-use storage times and conditions are the responsibility of the user and would normally not be longer than 12 hours at 15°C to 25°C, unless dilution has taken place in controlled and validated aseptic conditions.

6. Contents of the Pack and Other Information

What Etoposide Kabi Contains

The active substance is etoposide.
Each 1 ml of concentrate for solution for infusion contains 20 mg of etoposide.
Each 5 ml vial contains 100 mg of etoposide.
Each 10 ml vial contains 200 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 macrogol 300, polysorbate 80, benzyl alcohol (E1519), anhydrous ethanol and anhydrous citric acid.

• macrogol 300
• polysorbate 80
• benzyl alcohol (E1519)
• anhydrous ethanol
• anhydrous citric acid

What Etoposide Kabi Looks Like and Contents of the Pack

Etoposide Kabi is a clear, pale yellow solution in colourless glass vials of type I, with a capacity of 5 ml, 10 ml, 25 ml and 50 ml, closed with a bromobutyl rubber stopper and an aluminium seal and a PP flip-off cap (respectively green, blue, red and yellow).
Pack Size:Etoposide Kabi is available in packs containing 1 vial of 5 ml, 10 ml, 25 ml or 50 ml.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Fresenius Kabi Polska Sp. z o.o.
Al. Jerozolimskie 134
02-305 Warszawa

Manufacturer

Fresenius Kabi Deutschland GmbH
Pfingstweide 53
61169 Friedberg
Germany