The name of your medicine is Jevtana. It belongs to a group of medicines called 'taxanes' used to treat cancers. Jevtana is used to treat prostate cancer that has progressed after having had other chemotherapy. It works by stopping cells from growing and multiplying.
Ask your doctor if you have any questions about why it has been prescribed for you.
This medicine is only available with a doctor's prescription.
There is no evidence that this medicine is addictive.
Do not receive Jevtana if:
Do not receive Jevtana if you are allergic to it or any of the ingredients listed at the end of this leaflet.
Some symptoms of an allergic reaction include skin rash, itching, shortness of breath or swelling of the face, lips or tongue, which may cause difficulty in swallowing or breathing.
Do not receive Jevtana if you are pregnant or intend to become pregnant.
Jevtana may affect your developing baby if you are given Jevtana during pregnancy. If your partner is pregnant or is planning on becoming pregnant, ensure to use a condom.
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. Jevtana might be present in your semen. Therefore, the use of a condom is always recommended during sexual intercourse.
Do not receive Jevtana if you are breastfeeding or planning to breastfeed.
Jevtana could pass into breast milk and there is a possibility your baby may be affected.
Do not give Jevtana to a child or adolescent.
Do not receive Jevtana after the expiry date (EXP) printed on the vial.
If you receive it after the expiry date has passed, it may not work as well.
Do not receive Jevtana if the packaging is damaged or shows signs of tampering.
Tell your doctor if:
Tell your doctor if you are pregnant or intend to become pregnant.
Like most medicines of this kind, Jevtana is not recommended to be used during pregnancy. Your doctor will discuss the risks and benefits of receiving Jevtana if you are pregnant.
Tell your doctor if you are breastfeeding or planning to breastfeed.
It is not known whether Jevtana passes into breast milk. Your doctor will discuss the risks and benefits of receiving Jevtana if you are breastfeeding or planning to breastfeed.
Tell your doctor if you have or have had any medical conditions, especially the following:
This medicine contains 13% w/w ethanol (alcohol), equivalent to 14 ml of beer or 6 ml of wine. To be taken into account if:
Tell your doctor if you plan to have surgery.
If you have not already told your doctor about any of the above, tell them before you are given Jevtana.
Tell your doctor if you are taking any other medicines including herbal supplements and vitamins and those that you buy without a prescription from your pharmacy, supermarket or health food store.
This is because some medicines can affect the way Jevtana works or Jevtana can affect how other medicines work. These include:
Talk to your doctor before getting vaccinations while you are receiving Jevtana.
Your doctor or pharmacist has more information on medicines to be careful with or to avoid while being given Jevtana.
The dose will depend on your height and weight. Your doctor will calculate your body surface area in square meters (m2) and will determine the dose you should receive.
The standard dose of Jevtana is 25mg 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 Jevtana, you will be given the following medications to reduce your chance of developing an allergic reaction or nausea:
Jevtana will be given by infusion into one of your veins (intravenous use). The infusion will last approximately 1 hour during which 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 have any further questions about how you will receive this medicine, ask your doctor, pharmacist or nurse.
As Jevtana 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 Jevtana immediately telephone your doctor, or the Poisons Information Centre (telephone Australia 13 11 26 or go to Accident and Emergency at your nearest hospital.
If you receive too much Jevtana, you may experience one or more of the following symptoms: fever, nausea, diarrhoea, vomiting, constipation, abdominal pain, including upper abdominal pain, indigestion, and reflux.
Use a condom during sex if your partner is or could become pregnant. Jevtana could be present in your semen and may affect the foetus. You are advised not to father a child during and up to 6 months after treatment and to seek advice on conservation of sperm prior to treatment because Jevtana may alter male fertility.
If your partner becomes pregnant while you are being given this medicine, tell your doctor immediately.
Tell all the doctors, dentists and pharmacists who are treating you that you are being given Jevtana.
If you are about to be started on any new medicine, tell your doctor and pharmacist that you are being given Jevtana.
If you plan to have surgery that needs a general anaesthetic, tell your doctor or dentist that you are being given this medicine.
Do not receive more than the recommended dose unless your doctor tells you to.
Do not stop using Jevtana without checking with your doctor.
If you do not complete the full course prescribed by your doctor, Jevtana may not work as well as it's supposed to.
Be careful driving or operating machinery until you know how Jevtana affects you.
Jevtana 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 Jevtana 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.
Jevtana helps most people with prostate cancer, but it may have unwanted side effects in some people.
All medicines have some unwanted side effects. Sometimes they are serious, but most of the time they are not. Your doctor or pharmacist has weighed the risks of using this medicine against the benefits they expect it will have for you.
Tell your doctor, nurse or pharmacist as soon as possible if you do not feel well while you are being given Jevtana.
Do not be alarmed by this list of possible side effects.
You may not experience any of them.
If any of the following happen while you are being given Jevtana in the hospital/clinic, Jevtana should be stopped immediately. Tell your doctor or nurse immediately. If you are outside of the hospital/clinic go to Accident and Emergency at your nearest hospital:
These are very serious side effects. If you have them, you may have had a serious allergic reaction to Jevtana. You may need urgent medical attention or hospitalisation.
These side effects are very rare.
See a doctor immediately if you notice any of the following side effects:
Tell your doctor, nurse or pharmacist if you notice any of the following:
Very common side effects (affects more than 1 in 10 patients):
Common side effects (affects less than 1 in 10 patients):
Tell your doctor, nurse or pharmacist if you notice anything else that is making you feel unwell.
Other side effects not listed above may occur in some patients.
Ask your doctor, nurse or pharmacist to answer any questions you may have if you experience any side effects.
If you have any queries about any aspect of your medicine, or any questions regarding the information in this leaflet, discuss them with your doctor, nurse or pharmacist.
Jevtana is stored in the pharmacy or on the ward. Do not store at home.
One pack of Jevtana consists of:
The active substance is cabazitaxel. One ml of concentrate contains 40mg cabazitaxel. Each vial of concentrate contains 60mg cabazitaxel.
The other ingredients are polysorbate 80 and citric acid in the concentrate and ethanol 96% and water for injections in the diluent.
Jevtana does not contain gluten, sucrose, lactose, tartrazine or any other azo dyes.
Jevtana is made in the UK.
Jevtana is supplied in Australia by:
sanofi-aventis australia pty ltd
12-24 Talavera Road
Macquarie Park NSW 2113
This leaflet was prepared in June 2013.
Australian Register Number(s)
AUST R 175500