CABAZITAXEL ACCORD

CABAZITAXEL ACCORD

Active ingredient: cabazitaxel

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Consumer Medicine Information (CMI)

This leaflet provides important information about using Cabazitaxel Accord. 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 Cabazitaxel Accord.

Where to find information in this leaflet:

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

1. Why am I using Cabazitaxel Accord?

Cabazitaxel Accord contains the active ingredient cabazitaxel. Cabazitaxel Accord belongs to a group of medicines called taxanes used to treat cancers. It works by stopping cells from growing and multiplying.

Cabazitaxel Accord is used to treat prostate cancer that has progressed after having other chemotherapy.

2. What should I know before I use Cabazitaxel Accord?

Warnings

Do not use Cabazitaxel Accord if:

• you are allergic to it or any of the ingredients listed at the end of this leaflet
• the number of your white blood cells is too low (neutrophil counts of 1,500 per cubic millimetre, or less. Your doctor will advise you on this),
• you have a liver disease
• you are pregnant or breast-feeding
• you have recently received or are about to receive a vaccine against yellow fever

Check with your doctor if you have or have had:

• a fever (during treatment with Cabazitaxel Accord, it is more likely that your white blood cell count may be reduced). Your doctor will monitor your blood and general condition for signs of infections.
• any allergies
• lung, liver or kidney problems
• any stomach problems past or present (including ulcers)
• severe or long-lasting diarrhoea, nausea or vomiting.
  Any of these events could cause dehydration. Your doctor may need to treat you.
• if you have a feeling of numbness, tingling, burning or decreased sensation in your hands or feet
• if you have any bleeding from the gut that may cause changes in the colour of your stool or stomach pain

Each vial of this medicine contains about 1.2 g ethanol (alcohol), equivalent to about 24 mL of beer or 10 mL of wine. This should be taken into account if you:

• suffer from alcoholism
• have a liver disease
• have epilepsy/seizures

Tell your doctor if you plan to have surgery.

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

Check with your doctor if you are pregnant or intend to become pregnant.

Talk to your doctor if you are breastfeeding or intend to breastfeed.

As with many medicines, Cabazitaxel Accord may harm your developing or breastfeeding baby.

The use of effective contraception in male patients with partners who may become pregnant is recommended during treatment and for 6 months after the final treatment is given.

Cabazitaxel Accord might be present in your semen. Therefore, the use of a condom is always recommended during sexual intercourse.

If your partner becomes pregnant while you are being given this medicine, tell your doctor immediately.

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.

This is because some medicines can affect the way Cabazitaxel Accord works or Cabazitaxel Accord can affect how other medicines work. These include:

• medicines including medicines used to prevent blood clots and oral non-steroidal anti-inflammatories (NSAIDS).
• medicines used to treat bacterial, fungal or viral infections (e.g. clarithromycin, ketoconazole, rifampicin)
• medicines used to treat seizures or epilepsy (e.g. carbamazepine, phenobarbital, phenytoin)
• herbal remedy for depression and other conditions (St John’s Wort (Hypericum perforatum)

Talk to your doctor before getting vaccinations while you are receiving Cabazitaxel Accord.

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

4. How do I use Cabazitaxel Accord?

How much to use

The dose will depend on your height and weight. Your doctor will calculate your body surface area in square metres and will determine the dose you should receive.

The standard dose of Cabazitaxel Accord is 20 mg per square metre. Your doctor may decide on an alternative dose depending on your condition.

As part of your treatment for prostate cancer, you will also take an oral corticosteroid medicine (prednisone or prednisolone) daily.

Half an hour before you receive Cabazitaxel Accord, you will be given the following medications to reduce your chance of developing an allergic reaction or nausea:

• antihistamine (diphenhydramine or equivalent)
• corticosteroid (dexamethasone or equivalent)
• H₂ antagonist (ranitidine or equivalent)
• anti-nausea medication (if required).

Do not stop using Cabazitaxel Accord without checking with your doctor.

If you do not complete the full course prescribed by your doctor, Cabazitaxel Accord may not work as well as it should

When to use Cabazitaxel Accord

Cabazitaxel Accord will be given by infusion into one of your veins (intravenous use).

The infusion will last approximately 1 hour during which time you will be in the hospital.

You should usually receive your infusion once every 3 weeks.

Each 3 week period is called one cycle of chemotherapy. Your doctor will decide how many of these cycles you will need.

If you use too much Cabazitaxel Accord

As Cabazitaxel Accord is given to you under the supervision of your doctor, it is very unlikely that you will receive too much. However, if you experience any unexpected or worrying side effects after being given Cabazitaxel Accord immediately telephone your doctor, or the Poisons Information Centre (Australia 13 11 26) or go to Accident and Emergency at your nearest hospital.

If you receive too much Cabazitaxel Accord, you may experience one or more of the following symptoms: fever, nausea, diarrhoea, vomiting, constipation, abdominal pain, including upper abdominal pain, indigestion, and reflux.

5. What should I know while using Cabazitaxel Accord?

Things you should do

Tell all the doctors, dentists and pharmacists who are treating you that you are being given Cabazitaxel Accord.

If you are about to be started on any new medicine, tell your doctor and pharmacist that you are being given Cabazitaxel Accord.

If you plan to have surgery that needs a general anaesthetic, tell your doctor or dentist that you are being given this medicine.

Driving or using machines

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

Cabazitaxel Accord may cause side effects such as fatigue or dizziness that may affect your ability to drive and use machinery. Make sure you know how you react to Cabazitaxel Accord before you drive a car, operate machinery, or do anything else that could be dangerous if you feel dizzy or fatigued.

If you experience these symptoms, do not drive or use any tools or machines until they have fully resolved.

Looking after your medicine

The hospital will store Cabazitaxel Accord under the correct conditions.

Keep it where young children cannot reach it.

Getting rid of any unwanted medicine

Your doctor or pharmacist will dispose of any Cabazitaxel Accord that may be left over.

Do not use this medicine after the expiry date.

6. Are there any side effects?

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.

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

Very common/common side effects

Common side effects

What to do

feeling tired, weak or lack of energy symptoms of anaemia like tiredness, and inability to perform daily tasks (due to a decrease in the number of red blood cells) increased bleeding (due to a decrease in the number of platelets) loss of appetite (anorexia) alteration in sense of taste shortness of breath cough stomach upsets including nausea, vomiting and diarrhoea, constipation abdominal pain short term hair loss (in most cases normal hair growth should return after treatment has stopped) back pain joint pain blood in the urine urinary tract infection fever and infection (associated with a reduction of white blood cells) feeling of numbness, tingling, burning or decreased sensations in hands and feet dizziness headache decrease or increase in blood pressure uncomfortable feeling in the stomach or belching after eating gastro-oesophageal reflux or heartburn stomach pain haemorrhoids muscle spasm pain when passing urine urinary incontinence sores in the mouth or on the lips high blood sugar low blood potassium rapid or irregular heartbeat kidney disease or problems ringing in the ear trouble with balance blood clot in the leg pain in mouth or throat rectal bleeding redness of skin skin infections skin feeling hot or flushed muscle discomfort, aches or pain swelling of the feet or legs lung infection chills

Speak to your doctor if you have any of these mild side effects and they worry you.

Serious side effects

Serious side effects

What to do

allergic reaction (swelling of the face, lips, mouth or throat, which may cause difficultly in swallowing or breathing, hives, fainting, yellowing of the skin and eyes (jaundice)) fever (high temperature). This is very common (affects more than 1 in 10 patients) severe loss of body fluids (dehydration). This is common (affects less than 1 in 10 patients) This can occur if you have severe diarrhoea (increase of more than 4 or more stools more than usual a day) or long-lasting diarrhoea, or fever, or if you are vomiting

Call your doctor straight away or go straight to the Emergency Department at your nearest hospital if you notice any of these serious side effects.

Inflammation of the bladder may also occur if you have previously received radiation therapy. Tell your doctor, nurse or pharmacist if you have burning sensation when passing urine.

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.

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.

7. Product details

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

What Cabazitaxel Accord contains

Active ingredient (main ingredient)	cabazitaxel
Other ingredients (inactive ingredients)	absolute ethanol polysorbate 80

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

What Cabazitaxel Accord looks like

Cabazitaxel Accord is a clear, colourless to pale yellow or brownish yellow solution in a glass vial. (Aust R 340843).

Who distributes Cabazitaxel Accord

Accord Healthcare Pty Ltd
Level 24, 570 Bourke Street
Melbourne, VIC, 3000
Australia

This leaflet was prepared in August 2021.