ETOPOSIDE

concentrate for solution for infusion 20 mg/ml

PACKAGE LEAFLET: INFORMATION FOR THE USER

ETOPOSIDE CONCENTRATE FOR SOLUTION FOR INFUSION 20 mg/ml

Read all of this leaflet carefully before you are given your medicine.

It provides a summary of information about your medicine.

•    Keep this leaflet. You may need to read it again.

•    If you have any further questions, ask your doctor or nurse.

•    If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or nurse.

IN THIS LEAFLET:

1.    What Etoposide is and what it is used for

2.    What you need to know before you receive Etoposide

3.    How to receive Etoposide

4.    Possible side effects

5.    How to store Etoposide

6.    Further information

1.    WHAT ETOPOSIDE IS AND WHAT IT IS USED FOR

Etoposide is an anti-cancer drug which is used to treat certain types of cancer, in particular small cell lung cancer and testicular cancer.

Etoposide may be given on its own or in combination with other drugs.

2.    WHAT YOU NEED TO KNOW BEFORE YOU RECEIVE ETOPOSIDE

Do NOT receive Etoposide if you:

•    are allergic (hypersensitive) to etoposide or any of the other ingredients of this medicine

•    are allergic (hypersensitive) to podophyllotoxin or podophyllotoxin-derivatives

•    if you have severe suppression of the functioning of the bone marrow, unless when this is caused by your disease

•    will receive yellow fever vaccine or other live vaccins. Live vaccines should not be used in patients in which the immune system is less functional.

•    suffer from severe liver problems.

Take special care with Etoposide

Etoposide is only used under strict supervision of a doctor experienced with the use of cytostatics.

Tell your doctor if you have previously been treated with products against cancer or if you have received radiation therapy.

Etoposide should be only administered in a vein. If you have a stinging or burning sensation at the place where you have been injected with Etoposide, it may be due to leaking of Etoposide out of the vein. If this happens please tell your doctor as they will start treatment from a different vein and will monitor the affected area carefully.

Your doctor will regularly check your blood and the functioning of your liver during the use of Etoposide.

If you have bone marrow depression caused by radiationtherapy or chemotherapy, your doctor will not restart the treatment until your blood tests shows that this is justified.

Also tell your doctor if you think that you have infections.

If you think that you might have an allergic reaction causing flushing, fast heartbeat, difficulty in breathing and a severe reduction in blood pressure (anaphylactic reaction). Tell your doctor immediately of these symptoms, you may need urgent medical attention.

During and for 6 months after the use of Etoposide both men and women must use products to prevent pregnancy. Because Etoposide can cause infertility, men can have their sperm frozen at the sperm bank before the treatment with Etoposide starts.

Consult your doctor if one of the above warnings is applicable to you, or has been in the past. Taking other medicines

Talk to your doctor if you are taking any of the following:

•    phenytoin (a product used in the treatment of epilepsy). The concomitant use of Etoposide and phenytoin can reduce the effect of Etoposide

•    myelosuppressive drugs (these affect the bone marrow) e.g. cyclophosphamide, carmustine, lomustine, 5-fluorouracil, vinblastine

•    yellow fever vaccine or other live vaccines

•    any other anticancer drugs used to kill cancer cells e.g. bleomycin, cisplatin, ifosfamide, methotrexate, vinorelbine, daunorubicin, doxorubicin, epirubicin and idarubicin

•    non-steroidal anti-inflammatory drugs (NSAIDs) such as phenylbutazone, sodium salicylate or aspirin

•    drugs to thin the blood, such as warfarin

•    ciclosporin (a drug that suppresses the body’s defence system)

•    Etoposide and anthracyclines (products against cancer) can negatively affect each other’s action

Please tell your doctor or nurse if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Pregnancy and breast-feeding

•    Etoposide is not recommended if you are pregnant, planning to become pregnant or breastfeeding. However, your doctor may decide that the benefit you will receive from treatment with this medicine outweighs the risks to your unborn child.

•    Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from Etoposide, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

•    Female patients of child bearing age should use an effective method of contraception, e.g. the barrier method or condoms, to avoid getting pregnant during treatment, as the drug may cause serious birth defects.

•    Male patients receiving treatment with Etoposide should also take adequate contraception precautions to ensure that their partner does not become pregnant while they are being treated or

for upto 6 months after treatment and might want consider having their sperm frozen, as this medicine may cause impaired fertility.

•    Both male and female patients who are considering having a child after the treatment should discuss this with their doctor or nurse.

Driving and using machines

•    Etoposide may cause nausea, vomiting, drowsiness, tiredness, low blood pressure resulting in dizziness, and allergic reactions such as difficulty in breathing and a fast heart rate. If affected do not drive or operate machinery.

•    Etoposide contains alcohol. You should take care if you need to drive immediately after having an Etoposide injection.

Important information about some of the ingredients of Etoposide

•    A bottle with Etoposide contains 24% m/v alcohol. This can be harmful for those suffering from alcoholism. This must also be taken into account in pregnant and breast-feeding women, children and high-risk groups such as patients with liver disease, diseases of the brains or epilepsy.

•    The amount of alcohol in this medicine may alter the effects of other medicines and may also impair your ability to drive or use machines.

3. HOW TO RECEIVE ETOPOSIDE

Etoposide will be given to you by a suitably experienced doctor or nurse and you will have regular tests to monitor your condition.

The required dose of Etoposide concentrate for solution for infusion will be diluted with either 5% dextrose solution for injection or 0.9% saline solution to give the correct concentration. Your medicine will then be given to you by slow intravenous infusion (an injection into the vein) usually over a 30 to 60 minute period and not more than 2 hours.

The duration of your treatment will be decided by the doctor. Your doctor may consider it necessary to give you a repeat course of Etoposide.

The dosage for Etoposide is estimated on your body surface area in square metres (m²) calculated from your height and weight. The usual dose is:

•    Adults (including the elderly)

60 - 120 mg/m² daily for five days.

•    Children

Etoposide is not recommended for use in children.

•    Patients with liver or kidney problems

Your dose may be altered by your doctor.

If you receive more Etoposide than you should

As a doctor or nurse will be giving you your medicine, it is unlikely that you will receive an incorrect dose. Tell your doctor or nurse if you have any concerns about the amount of medicine that you receive.

If you have any further questions on the use of this product, ask your doctor or nurse.

4. POSSIBLE SIDE EFFECTS

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

A few people may experience rare but serious side effects when taking this medicine. If you experience any of the following, tell your doctor immediately:

•    difficulty breathing, wheezing, shortness of breath, low blood pressure

•    fever, chills, faster heart beat

•    Stevens-Johnson syndrome (blistering of the skin, mouth, eyes and genitals)

•    toxic epidermal necrolysis (blistering of the skin)

•    tumour lysis syndrome (a side effect of chemotherapy that occurs when cancer cells break down too quickly) usually when etoposide is given with another anticancer drug. The symptoms of this may include a salt imbalance which could cause heart failure, severe muscle weakness, paralysis, kidney failure, spasms of the hands and feet, seizures, mental retardation, memory loss, movement disorders, anxiety, agitation, swelling of the optic disc, or increased levels of uric acid in the blood which may lead to kidney failure.

Etoposide contains polysorbate 80. In premature infants, injection of a vitamin E product containing polysorbate 80 has led to a life threatening syndrome occurring.

The following side effects have been reported at the appropriate frequencies shown. If you experience any of these effects and they get serious or worry you, please tell your doctor or nurse as soon as possible.

Very common (affecting more than one person in ten):

•    myelosuppression (a reduction in the ability of the bone marrow to produce blood cells) resulting in a reduction in the number of white blood cells, clotting cells and red blood cells, causing infections, bleeding or bruising, pale skin, weakness or breathlessness

•    feeling sick, being sick, loss of appetite

•    hair loss (reversible on stopping Etoposide treatment)

•    skin coloring

•    abdominal pain

•    constipation

•    liver problems, abnormal liver enzymes

•    general weakness (asthenia), malaise

Common (affecting more than one person in one hundred but fewer than one person in ten):

•    blood cancer (Secondary leukemia)

•    hypersensitivity (Anaphylactic-like reactions)

•    dizziness

•    irregular heart beat and heart attack

•    drop in blood pressure after an infusion is administered too rapidly (can be prevented by reducing the rate of the infusion).

•    inflammation of the gastric and oesophageal mucous membrane (mucositis, oesophagitis)

•    rash, nettle rash, itchy skin

•    swelling of the face or tongue

•    stomach, throat, tongue and mouth ulcers, cold sores

•    coughing, sweating, difficulty in catching your breath

•    breathlessness, tiredness, sleepiness

•    high or low blood pressure

•    diarrhoea

•    unexplained bleeding in patients with severe myelosuppression (a condition in which bone marrow activity is decreased, resulting in fewer red blood cells, white blood cells, and platelets)

•    leaking of fluid outside the vessel (extravasation)

•    inflammation of a vein (also known as thrombophlebitis) sometimes accompanied by a clot

Uncommon (affecting more than one person in one thousand but fewer than one person in one hundred):

•    discolouration of skin

•    tingling or numbness in the hands and feet, possibly aggravated by taking vincristine and Etoposide at the same time.

Rare (affecting more than one person in ten thousand but fewer than one person in one thousand):

•    insults (seizure, occasionally associated with allergic reactions),

•    lethargy

•    taste impairment

•    problems with eye sight

•    pneumonia,

•    scarring of the lungs which causes shortness of breath

•    difficulty swallowing

•    localised death of the skin creating blisters (toxic epidermal necrolysis)

•    radiation recall phenomenon (redness and itching at the site of previous radiation)

•    redness and swelling of the palms of your hands or soles of your feet which may cause your skin to peel (hand-foot syndrome)

If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or nurse.

5. HOW TO STORE ETOPOSIDE

Keep out of the reach and sight of children.

Etoposide should be stored below 25^oC. It should be kept in the package or container supplied. Do not transfer it to another container.

Do not use Etoposide after the expiry date that is stated on the outer packaging. The expiry date refers to the last day of that month.

The diluted solution should be discarded within 8 hours of preparation.

6. FURTHER INFORMATION

What Etoposide concentrate for solution for infusion contains:

•    The active ingredient is etoposide.

•    The other ingredients are citric acid, polysorbate 80, ethanol, macrogol 300.

What Etoposide concentrate for solution for infusion looks like and contents of the pack:

•    Etoposide concentrate for solution for infusion is a clear, yellow, slightly viscous solution in clear, colourless glass vials.

•    Etoposide concentrate for solution for infusion is available in vials of 5 ml, 10 ml, 20 ml, 25 ml and 50 ml.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

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This leaflet was last revised:

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The following information is intended for medical or healthcare professionals only:

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