ETOPOPHOS®

ETOPOPHOS®

Active ingredient: etoposide phosphate (e-TOE-poe-side fos-FATE)

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Consumer Medicine Information (CMI)

This leaflet answers some common questions about ETOPOPHOS. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using ETOPOPHOS.

Where to find information in this leaflet:

1. Why am I using ETOPOPHOS?
2. What should I know before I use ETOPOPHOS?
3. What if I am taking other medicines?
4. How do I use ETOPOPHOS?
5. What should I know while using ETOPOPHOS?
6. Are there any side effects?
7. Product details

1. Why am I using ETOPOPHOS?

ETOPOPHOS contains the active ingredient etoposide phosphate an anti-cancer medicine. ETOPOPHOS interferes with the development of cells and causes cell death, particularly in cancer cells.

ETOPOPHOS is used to treat lung cancer, leukaemia (blood cancer), cancer of the lymph glands and testicular cancer.

ETOPOPHOS may be used alone or in combination with other medicines to treat cancer.

2. What should I know before I use ETOPOPHOS?

Warnings

Do not use ETOPOPHOS if:

• you are allergic to etoposide phosphate, or any of the ingredients listed at the end of this leaflet.
• always check the ingredients to make sure you can use this medicine.

Check with your doctor if you:

have or have had any medical conditions, especially the following:

• liver or kidney problems
• any condition which reduces your blood cell “counts” such as white cells (leukopenia), neutrophils (neutropenia) or platelets (thrombocytopenia).
• take any medicines for any other condition
• have an infection or high temperature. Your doctor may decide to delay your treatment until the infection has gone. A mild illness, such as a cold is not usually a reason to delay treatment.
• have had recent surgery
• are receiving radiation therapy, which lowers your immune system.

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

Pregnancy and breastfeeding

Tell your doctor and do not take ETOPOPHOS if you are pregnant or intend to become pregnant.

Like most medicines used to treat cancer, ETOPOPHOS is not recommended for use during pregnancy, unless you and your doctor have discussed the risks and benefits involved.

You should use some kind of birth control while you are having ETOPOPHOS treatment and for at least 6 months after you stop using ETOPOPHOS.

ETOPOPHOS may cause birth defects if either the male or female is using ETOPOPHOS at the time of conception.

Tell your doctor and do not take ETOPOPHOS if you are breast-feeding or plan to breastfeed, unless you have discussed it with your doctor.

It is not known whether ETOPOPHOS passes into breast milk. Therefore there is a possibility that the breast-fed baby may be affected.

If you have not told your doctor about any of the above, tell them before you start taking ETOPOPHOS.

If you are not sure whether you should take ETOPOPHOS talk to your doctor.

3. What if I am taking other medicines?

Tell your doctor or pharmacist if you are taking any other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.

Some medicines and ETOPOPHOS may interfere with each other. These include:

• some other medicines or treatments that are used to treat other forms of cancer such as Levamisol (Ergamisol), doxorubicin, epirubicin, daunoribicin, cisplatin, vincristine, radiation therapy and corticosteroids such as prednisone, prednisolone and dexamethasone.
• ciclosporin a medicine used to prevent rejection of transplanted organs
• medicines used to treat epilepsy
• warfarin, a medicine used to reduce blood clotting
• live viral vaccines
• some medicines for pain including phenylbutazone and aspirin

These medicines may be affected by ETOPOPHOS, or affect how well it works. You may need different amounts of your medicine, or you may need to have different medicines. Your doctor will advise you.

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect ETOPOPHOS.

4. How do I use ETOPOPHOS?

How much is given

Your doctor will decide what dose you will receive. Your dose of ETOPOPHOS injection is worked out based on your body weight and height, the type of cancer you have and other medicines you are taking. The dose worked out for you may be different to the dose for another patient.

ETOPOPHOS may be given alone or in combination with other anti-cancer drugs.

Additional treatment may not be repeated until your blood cell numbers return to acceptable levels and any uncontrolled effects have been controlled.

Ask your doctor if you want to know more about the dose of ETOPOPHOS you receive.

How ETOPOPHOS is given

ETOPOPHOS must only be prepared and administered by a doctor or nurse.

ETOPOPHOS injection is given as an infusion (drip) into your veins, over 5 minutes to 3.5 hours.

How long it is given

ETOPOPHOS is usually given each day for 1 to 5 days for lower dose and every other day: days 1,3,5 for higher dose. This is followed by a treatment-free interval of 3-4 weeks. This is called one cycle of chemotherapy. Your doctor will decide how many of these cycles you will need. ETOPOPHOS may be given at the same time as other anti-cancer agents on days 1, 3 and 5 every 3 to 4 weeks.

If you use too much ETOPOPHOS

As your dose of ETOPOPHOS will be determined and administered by a medical specialist the chance of receiving an overdose is most unlikely.

Symptoms of overdose may include collapse, sores and pain in the mouth and throat, fever, chills, weakness, fatigue, headache, confusion, fast heart beat, nausea and vomiting, yellowing of the skin and eyeballs, and lower back or side pain.

If you think you have received more of this medicine than you should, tell your specialist as soon as possible and your specialist will give you the appropriate treatment.

5. What should I know while using ETOPOPHOS?

Things you should do

Be sure to keep all your doctor’s appointments and follow up appointments so your progress can be checked.

It is important to have your follow-up infusions of ETOPOPHOS at the appropriate time to get the best effect from your treatments.

Tell your doctor, dentist or pharmacist straight away that you are taking ETOPOPHOS if you:

• are about to be started on any new medicine
• plan to have surgery that needs a general anaesthetic

ETOPOPHOS can lower the number of white blood cells and platelets in your blood. This means that you have an increased chance of getting an infection or bleeding. The following precautions should be taken to reduce your risk of infection or bleeding:

• avoid people who have infections. Check with your doctor immediately if you think you may be getting an infection, or if you get a fever, chills, cough, hoarse throat, lower back or side pain or find it painful or difficult to urinate.
• be careful when using a toothbrush, toothpick or dental floss. Your doctor, dentist, nurse or pharmacist may recommend other ways to clean your teeth and gums. Check with your doctor before having any dental work.
• be careful not to cut yourself when you are using sharp objects such as a razor or nail cutters.
• avoid contact sports or other situations where you may bruise or get injured.

Things you must not do

Do not drink alcohol while taking ETOPOPHOS.

You may feel flushed or get headaches.

Driving or using machines

Be careful before you drive or use any machines or tools until you know how ETOPOPHOS affects you.

As with other medicines used to treat cancer, ETOPOPHOS may cause dizziness, light-headedness,tiredness, changes of vision, or vomiting in some people. Make sure you know how you react to ETOPOPHOS before you drive a car, operate machinery, or do anything else that could be dangerous if you are dizzy or light-headed. If this occurs do not drive.

Drinking alcohol

If you drink alcohol, any dizziness or lightheadedness caused by ETOPOHOS may be worse.

Looking after your medicine

ETOPOPHOS will be stored at the Clinic where you are being treated.

ETOPOPHOS vials should be stored in the refrigerator (2-8°C) and protected from light.

Follow the instructions in the carton on how to take care of your medicine properly.

Getting rid of any unwanted medicine

Do not use this medicine after the expiry date.

6. Are there any side effects?

Tell your doctor or nurse as soon as possible if you do not feel well while you are having ETOPOPHOS.

Like other medicines that treat cancer, ETOPOPHOS may have unwanted side effects, some of which may be serious. You may need medical treatment if you get some of the side effects.

See the information below and, if you need to, ask your doctor if you have any further questions about side effects.

Less serious side effects

Less serious side effects	What to do
Gut and digestion-related: nausea vomiting diarrhoea stomach pain or discomfort constipation altered taste Skin and hair: unusual hair loss or thinning Other: dizziness, light headedness feeling tired or weak problems swallowing low/high blood pressure hallucinations muscle cramps or spasms Reproduction: infertility	Tell your doctor or nurse if you have any of these less serious side effects and they worry you.

Serious side effects

Serious side effects	What to do
Signs of infections such as: frequent infections fever chills sore throat mouth ulcers Signs of unusual bleeding such as: bleeding or bruising more easily than normal nose bleeds rash of small reddish-purple spots on your skin blood in your stool or urine Signs of an allergic reaction such as: itching of the skin joint aches blisters that look like hives on the upper body, legs, arms, palms, hands, or feet and may involve the face or lips Other: numbness, tingling and pain in hands or feet sore mouth, eye pain, vision problems tiredness, headaches, being short of breath when exercising, dizziness and looking pale heart problems (e.g. fast heartbeat, heart attack) mouth ulcers cold sores Signs of liver problems (jaundice or hepatitis) such as: abdominal pain loss of appetite with yellowing of the skin and eyes Skin and hair: burning, stinging, pain, redness or swelling at the injection site Signs of kidney problems (when high doses are given which is usually reversible) such as: passing little or no urine drowsiness nausea vomiting breathlessness	Tell your doctor or nurse straight away if you notice any of these serious side effects.
Signs of a sudden life-threatening allergic reaction: chills fever fast heartbeat wheezing or coughing difficulty breathing dizziness flushing sweating swelling of the face, tongue or other parts of the body.	Tell your doctor immediately or go straight to the Emergency Department at your nearest hospital if you notice any of these life-threatening side effects.

Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.

Other side effects not listed here may occur in some people.

The benefits and side effects of ETOPOPHOS may take some time to occur. Therefore even after you have finished your ETOPOPHOS treatment you should tell your doctor immediately if you notice any of the side effects listed in the information above.

Reporting side effects

After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.

Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.

7. Product details

This medicine is only available with a doctor’s prescription.

What ETOPOPHOS contains

Active ingredient (main ingredient)	etoposide phosphate
Other ingredients (inactive ingredients)	sodium citrate dihydrate dextran 40
Potential allergens	none

Do not take this medicine if you are allergic to any of these ingredients.

What ETOPOPHOS looks like

ETOPOPHOS is a white to off-white powder in a glass vial, in either 100mg, 500mg, or 1g strengths:

ETOPOPHOS Injection (equivalent to 100mg etoposide) – AUST R 57483

ETOPOPHOS Injection (equivalent to 500mg etoposide) – AUST R 77219

ETOPOPHOS Injection (equivalent to 1g etoposide) – AUST R 77220

Who distributes ETOPOPHOS

Link Medical Products Pty Ltd.
5 Apollo Street,
Warriewood, NSW, 2102
Ph: 1800 181 060
linkhealthcare.com.au

This leaflet was prepared in July 2022.