Active ingredient
- cabazitaxel
Legal Category
POM: Prescription only medicine
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: EU/1/11/676/001.
Jevtana
Package leaflet: Information for the patient
JEVTANA® 60 mg concentrate and solvent for solution for infusion
cabazitaxel
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
What is in this leaflet:
1. What JEVTANA is and what it is used for
2. What you need to know before you are given JEVTANA
3. How to use JEVTANA
4. Possible side effects
5. How to store JEVTANA
6. Contents of the pack and other information
1. What JEVTANA is and what it is used for
The name of your medicine is JEVTANA. Its common name is "cabazitaxel". 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.
As part of your treatment, you will also take a corticosteroid medicine (prednisone or prednisolone) by mouth every day. Ask your doctor to give you information about this other medicine.
2. What you need to know before you are given JEVTANA
Do not use JEVTANA if:
You should not be given JEVTANA if any of the above apply to you. If you are not sure, talk to your doctor before having JEVTANA.
Warnings and precautions
Before each treatment with JEVTANA, you will have blood tests to check that you have enough blood cells and sufficient liver and kidney functions to receive JEVTANA.
Tell your doctor immediately if:
If any of the above applies to you, tell your doctor immediately. Your doctor may reduce the dose of JEVTANA or stop the treatment.
Other medicines and JEVTANA
Please tell your doctor, pharmacist or nurse if you are taking or have recently taken any other medicines. This includes medicines obtained without a prescription. This is because some medicines can affect the way JEVTANA works or JEVTANA can affect how other medicines work. These medicines include the following:
Talk to your doctor before getting vaccinations while you are receiving JEVTANA.
Pregnancy, breast-feeding and fertility
JEVTANA should not be used in pregnant women or women of childbearing age not using contraception.
JEVTANA should not be used during breast feeding.
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.
Driving and using machines
You may feel tired or dizzy when having this medicine. If this happens, do not drive or use any tools or machines until you feel better.
JEVTANA contains ethanol (alcohol)
This medicine contains 15% v/v ethanol (alcohol), equivalent to 14 ml of beer or 6 ml of wine. This medicine may be harmful for those suffering from alcoholism.
To be taken into account if you are in a high risk group such as patients with liver disease, or epilepsy.
3. How to use JEVTANA
Instructions for use
Anti-allergic medicines will be given to you before you have JEVTANA to reduce the risk of allergic reactions.
How much and how often to have
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. Your doctor will discuss these with you and will explain the potential risks and benefits of your treatment.
See a doctor immediately if you notice any of the following side effects:
If any of the above applies to you, tell your doctor immediately.
Other side-effects include:
Very common (may affect more than 1 in 10 people):
Common (may affect up to 1 in 10 people):
Uncommon (may affect up to 1 in 100 people):
Frequency not known (cannot be estimated from the available data;
Reporting of side effects
If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the contact details listed below. By reporting side effects you can help provide more information on the safety of this medicine.
United Kingdom
Ireland
Malta
5. How to store JEVTANA
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 outer carton and on the label of the vials after EXP. The expiry date refers to the last day of that month.
Do not store above 30°C. Do not refrigerate.
Information about storage and the time to use JEVTANA, once it has been diluted and is ready to use, are described in the section "PRACTICAL INFORMATION FOR MEDICAL OR HEALTHCARE PROFESSIONALS ON PREPARATION, ADMINISTRATION AND HANDLING OF JEVTANA".
Any unused product or waste material should be disposed of in accordance with local requirements. These measures will help to protect the environment.
6. Contents of the pack and other information
What JEVTANA contains
The active substance is cabazitaxel. One ml of concentrate contains 40 mg cabazitaxel. Each vial of concentrate contains 60 mg cabazitaxel.
The other ingredients are polysorbate 80 and citric acid in the concentrate, and ethanol 96% and water for injections in the solvent (see section 2 "JEVTANA contains alcohol").
Note: Both the JEVTANA 60mg/1.5ml concentrate vial (fill volume: 73.2 mg of cabazitaxel/1.83ml) and the solvent vial (fill volume: 5.67ml) contain an overfill to compensate for liquid loss during preparation. This overfill ensures that after dilution with the ENTIRE contents of the accompanying solvent, there is solution containing 10mg/ml cabazitaxel.
What JEVTANA looks like and contents of the pack
JEVTANA is a concentrate and solvent for solution for infusion (sterile concentrate).
The concentrate is a clear yellow to brownish yellow oily solution.
The solvent is a clear and colourless solution.
One pack of JEVTANA contains:
One single use clear glass vial, closed with a grey chlorobutyl rubber closure sealed by an aluminium cap with a light green plastic flip-off cover containing 1.5ml (nominal volume) concentrate.
Marketing Authorisation Holder
Manufacturer
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
This leaflet was last revised March 2017
Other sources of information
Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
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