Patient Leaflet Updated 09-Feb-2023 | Glenmark Pharmaceuticals Europe Ltd
Cabazitaxel 20 mg/ml concentrate for solution for infusion
Package leaflet: Information for the patient
Cabazitaxel 20 mg/ml concentrate 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 Cabazitaxel is and what it is used for
2. What you need to know before you are given Cabazitaxel
3. How to use Cabazitaxel
4. Possible side effects
5. How to store Cabazitaxel
6. Contents of the pack and other information
1. What Cabazitaxel is and what it is used for
The name of your medicine is Cabazitaxel. Its common name is cabazitaxel. It belongs to a group of medicines called “taxanes” used to treat cancers.
Cabazitaxel 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 Cabazitaxel
Do not use Cabazitaxel if:
You should not be given Cabazitaxel if any of the above apply to you. If you are not sure, talk to your doctor before having Cabazitaxel.
Warnings and precautions
Before each treatment with Cabazitaxel, you will have blood tests to check that you have enough blood cells and sufficient liver and kidney functions to receive Cabazitaxel.
Tell your doctor immediately if:
If any of the above applies to you, tell your doctor immediately. Your doctor may reduce the dose of Cabazitaxel or stop the treatment.
Other medicines and Cabazitaxel
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 Cabazitaxel works or Cabazitaxel can affect how other medicines work. These medicines include the following:
Talk to your doctor before getting vaccinations while you are receiving Cabazitaxel.
Pregnancy, breast-feeding and fertility
Cabazitaxel should not be used in pregnant women or women of childbearing age not using contraception.
Cabazitaxel should not be used during breast-feeding.
Use a condom during sex if your partner is or could become pregnant. Cabazitaxel 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 Cabazitaxel 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.
Cabazitaxel contains ethanol (alcohol)
This medicine contains 1185 mg of alcohol (ethanol) in each vial, which is equivalent to 395 mg/ml. The amount in volume of this medicine is equivalent to 30 ml beer or 12 ml wine.
The amount of alcohol in this medicine is not likely to have an effect in adults and adolescents, and its effects in children are not likely to be noticeable. It may have some effects in younger children, for example feeling sleepy.
The alcohol in this medicine may alter the effects of other medicines. Talk to your doctor or pharmacist if you are taking other medicines.
If you are pregnant, talk to your doctor or pharmacist before taking this medicine.
If you are addicted to alcohol, talk to your doctor or pharmacist before taking this medicine.
3. How to use Cabazitaxel
Instructions for use
Anti-allergic medicines will be given to you before you have Cabazitaxel 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme: Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Cabazitaxel
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.
This medicinal product does not require any special storage conditions.
Information about storage and the time to use Cabazitaxel are described in the section “PREPARATION GUIDE FOR USE WITH CABAZITAXEL 20 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION”.
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 Cabazitaxel contains
What Cabazitaxel looks like and contents of the pack
Cabazitaxel is a concentrate for solution for infusion (sterile concentrate).
The concentrate is a clear yellow to brownish-yellow oily solution.
One vial contains 3 ml (nominal volume) concentrate. Pack sizes of one or ten vials are available. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Manufacturer
This leaflet was last revised in June 2022.
Building 2, Croxley Park, Watford, WD18 8YA
+44 (0)1923 202 950
+44 (0)1923 202 950
www.glenmarkpharma.com
+44 (0)1923 251137
0800 458 0383