Patient leaflet - Cabazitaxel Fresenius Kabi 20 mg/ml concentrate for solution for infusion
1. What Cabazitaxel Fresenius Kabi is and what it is used for
The name of your medicine is Cabazitaxel Fresenius
Kabi. Its common name is cabazitaxel. It belongs to
a group of medicines called “taxanes” used to treat
cancers.
Cabazitaxel Fresenius Kabi 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 Fresenius Kabi
Do not use Cabazitaxel Fresenius Kabi if
you are allergic (hypersensitive) to cabazitaxel, to
other taxanes, or polysorbate 80 or any of the other
excipients of this medicine (listed in section 6),
the number of your white blood cells is too low
(neutrophil counts less than or equal to
1,500/mm3),
- you have severe abnormal liver function,
you have recently received or are about to receive a
vaccine against yellow fever.
You should not be given Cabazitaxel Fresenius Kabi if
any of the above apply to you. If you are not sure, talk to
your doctor before having Cabazitaxel Fresenius Kabi.
Warnings and precautions
Before each treatment with Cabazitaxel Fresenius Kabi,
you will have blood tests to check that you have enough
blood cells and sufficient liver and kidney functions to
receive Cabazitaxel Fresenius Kabi.
Tell your doctor immediately if:
you have fever. During treatment with Cabazitaxel
Fresenius Kabi, 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. He/she may give you other medicines
to maintain the number of your blood cells. People
with low blood counts can develop life-threatening
infections. The earliest sign of infection may be fever,
so if you experience fever, tell your doctor right
away.
you have ever had any allergies. Serious allergic
reactions can occur during treatment with
cabazitaxel.
you have severe or long-lasting diarrhoea, you feel
sick (nausea) or you are being sick (vomiting). Any of
these events could cause severe dehydration. Your
doctor may need to treat you.
you have feeling of numbness, tingling, burning or
decreased sensation in your hands or feet.
you have any bleeding problems from the gut or
have changes in the colour of your stool or stomach
pain. If the bleeding or pain is severe, your doctor
will stop your treatment with cabazitaxel. This
is because Cabazitaxel may increase the risk of
bleeding or developing holes in the gut wall.
- you have kidney problems.
you have yellowing of the skin and eyes, darkening
of the urine, severe nausea (feeling sick) or vomiting,
as they could be signs or symptoms of liver
problems.
you experience any significant increase or decrease
in daily urinary volume.
- you have blood in your urine.
If any of the above applies to you, tell your doctor
immediately. Your doctor may reduce the dose of
Cabazitaxel Fresenius Kabi or stop the treatment.
Other medicines and Cabazitaxel
Fresenius Kabi
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 Fresenius Kabi works or Cabazitaxel
Fresenius Kabi can affect how other medicines work.
These medicines include the following:
- ketoconazole, rifampicin (for infections);
carbamazepine, phenobarbital or phenytoin (for
seizures);
St John’s Wort (Hypericum perforatum) (herbal
remedy for depression and other conditions);
statins (such as simvastatin, lovastatin, atorvastatin,
rosuvastatin, or pravastatin) (for reducing the
cholesterol in your blood);
- valsartan (for hypertension);
- repaglinide (for diabetes).
Talk to your doctor before getting vaccinations while
you are receiving Cabazitaxel Fresenius Kabi.
Pregnancy, breast-feeding and fertility
Cabazitaxel Fresenius Kabi is not indicated for use in
women.
Use a condom during sex if your partner is or could
become pregnant. Cabazitaxel Fresenius Kabi could
be present in your semen and may affect the foetus.
You are advised not to father a child during and up
to 4 months after treatment and to seek advice on
conservation of sperm prior to treatment because
Cabazitaxel Fresenius Kabi 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 Fresenius Kabi contains ethanol (alcohol)
This medicine contains 395 mg of alcohol (ethanol) in 1 ml, which is equivalent to 39.5 % w/v. The amount in 2.25 ml of dose is equivalent to 23 mL of beer or 9 ml of wine.
The small amount of alcohol in this medicine will not have any noticeable effects. If you are addicted to alcohol, have liver disease or epilepsy, talk to your doctor or pharmacist before taking this medicine.
Cabazitaxel Fresenius Kabi 20 mg/ml concentrate for solution for infusion contains polysorbate 80
This medicine contains 540mg of Polysorbate 80. Polysorbates may cause allergic reactions. Polysorbates can have an effect on your heart and blood circulation (e.g., irregular or abnormal heartbeat, or low blood pressure).
Tell your doctor if you have any known allergies.
3. How to use Cabazitaxel Fresenius Kabi Instructions for use
Anti-allergic medicines will be given to you before you have Cabazitaxel Fresenius Kabi to reduce the risk of allergic reactions.
Cabazitaxel Fresenius Kabi will be given to you by a
doctor or a nurse.
Cabazitaxel Fresenius Kabi must be prepared
(diluted) before it is given. Practical information for handling and administration of Cabazitaxel Fresenius Kabi for doctors, nurses and pharmacists is provided with this leaflet.
Cabazitaxel Fresenius Kabi will be given by a drip
(infusion) into one of your veins (intravenous use) in hospital for about an hour.
As part of your treatment, you will also take
a corticosteroid medicine (prednisone or prednisolone) by mouth every day.
How much and how often to have
The usual dose depends on your body surface area.
Your doctor will calculate your body surface area in square meters (m²) and will decide the dose you should have.
- You will usually have an infusion once every 3 weeks.
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:
fever (high temperature). This is common (may affect
up to 1 in 10 people).
severe loss of body fluids (dehydration). This is
common (may affect up to 1 in 10 people).
This can occur if you have severe or long-lasting
diarrhoea, or fever, or if you are being sick (vomiting).
severe stomach pain or stomach pain that doesn’t
go away. This can occur if you have a hole in the stomach, food pipe, gut or bowel (gastrointestinal perforation). This can lead to death.
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):
decrease in the number of red (anaemia), or white
blood cells (which are important in fighting infection)
decrease in the number of platelets (which results in
increased risk of bleeding)
- loss of appetite (anorexia)
stomach upsets including feeling sick (nausea), being
sick (vomiting), diarrhoea or constipation
- back pain
- blood in the urine
- feeling tired, weak or lack of energy.
Common (may affect up to 1 in 10 people):
- alteration of taste
shortness of breath
- cough
- abdominal pain
- short term hair loss (in most cases normal hair growth should return)
- joint pain
- urinary tract infection
- lack of white blood cells associated with fever and infection
- 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, heart burn or belching
- stomach pain
- haemorrhoids
- muscle spasm
- painful or frequent urination
- urinary incontinence
- kidney disease or problems
- sore in the mouth or on lips
- infections or risk of infections
- high blood sugar
- insomnia
- mental confusion
- feeling anxious
- abnormal feeling or loss of sensation or pain in hands and feet
- trouble with balance
- rapid or irregular heartbeat
- blood clot in the leg or in the lung
- skin feeling flushed
- pain in mouth or throat
- rectal bleeding
- muscle discomfort, aches, weakness or pain
- swelling of the feet or legs
- chills
- nail disorder (change in the colour of your nails; nails may detach).
Uncommon (may affect up to 1 in 100 people):
- low blood potassium
- ringing in the ear
- skin feeling hot
Cabazitaxel 20 mg/ml
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Cabazitaxel 20 mg/ml
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- redness of the skin
inflammation of the bladder, which can occur when
your bladder has been previously exposed to radiation therapy (cystitis due to radiation recall phenomenon).
Frequency not known (cannot be estimated from the available data):
• interstitial lung disease (inflammation of the lungs
causing coughing and difficulty breathing).
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 (see details below). By reporting side effects you can help provide more information on the safety of this medicine.
UK
Yellow Card Scheme Website:
www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store
IE
HPRA Pharmacovigilance
Website: www.hpra.ie
5. How to store Cabazitaxel Fresenius Kabi
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 vials after EXP. The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions
After opening
Each vial is for single use and should be used immediately after opening. If not used immediately, in- use storage times and conditions are the responsibility of the user.
After final dilution in the infusion bag/bottle
Chemical and physical stability of the infusion solution has been demonstrated for 8 hours at 15-30°C (including the 1-hour infusion time) and for 48 hours at refrigerated conditions (including the 1-hour infusion
time) in PVC free infusion containers.
From a microbiological point of view, the infusion solution should be used immediately. If not used immediately, in-use storage times and conditions are the responsibility of the user and would normally not be longer than 24 hours at 2°C - 8°C, unless dilution has taken place in controlled and validated aseptic conditions.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment..
6. Contents of the pack and other information
What Cabazitaxel Fresenius Kabi contains
The active substance is cabazitaxel. One ml of concentrate contains 20 mg cabazitaxel. Each 3 ml vial of concentrate contains 60 mg cabazitaxel.
The other ingredients are polysorbate 80, ethanol anhydrous and citric acid (see section 2 “Cabazitaxel Fresenius Kabi contains alcohol”).
What Cabazitaxel Fresenius Kabi looks like and contents of the pack
Cabazitaxel Fresenius Kabi is a concentrate for solution for infusion. The concentrate is a clear colourless to pale yellow solution.
It is supplied as a single-use vial with a deliverable volume of 3 ml concentrate in 6 ml clear glass vial.
Pack size:
Each carton contains one single use vial.
Marketing Authorisation Holder
Fresenius Kabi Deutschland GmbH
Else-Kröner-Straβe 1
61352 Bad Homburg v.d.H
Germany
Manufacturer
Fresenius Kabi Deutschland GmbH
Pfingstweide 53
61169 Friedberg
Germany
This medicine is authorised in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:
Name of the
Member State
Name of medicinal product
Austria Cabazitaxel Fresenius Kabi 20 mg/
ml Konzentrat zur Herstellung einer Infusionslösung
Belgium Cabazitaxel Fresenius Kabi 20 mg/
ml, Concentraat voor oplossing voor infusie Cabazitaxel Fresenius Kabi 20 mg/ml, Solution à diluer pour perfusion
Cabazitaxel Fresenius Kabi 20 mg/ ml, Konzentrat zur Herstellung einer Infusionslösung
Bulgaria Cabazitaxel Fresenius Kabi 20 mg/ml
concentrate for solution for infusion Кабазитаксел Фрезениус Каби 20 mg/ml концентрат за инфузионен разтвор
Croatia Kabazitaksel Fresenius Kabi 20 mg/ml
koncentrat za otopinu za infuziju Cyprus Cabazitaxel Fresenius Kabi 20 mg/
mL πυκνό διάλυμα για παρασκευή διαλύματος προς έγχυση
Czechia Cabazitaxel Fresenius Kabi Denmark Cabazitaxel Fresenius Kabi Estonia Cabazitaxel Fresenius Kabi Finland Cabazitaxel Fresenius Kabi 20 mg/ml,
infuusiokonsentraatti, liuosta varten France Cabazitaxel Fresenius Kabi 20 mg/mL,
solution à diluer pour perfusion Germany Cabazitaxel Fresenius Kabi 20 mg/
ml Konzentrat zur Herstellung einer Infusionslösung
Greece Cabazitaxel Fresenius Kabi 20 mg/
mL πυκνό διάλυμα για παρασκευή διαλύματος προς έγχυση
Hungary Cabazitaxel Fresenius Kabi 20 mg/ml
koncentrátum oldatos infúzióhoz Ireland Cabazitaxel Fresenius Kabi 20 mg/ml
concentrate for solution for infusion Italy Cabazitaxel Fresenius Kabi
Malta Cabazitaxel Fresenius Kabi 20 mg/ml concentrate for solution for infusion Latvia Cabazitaxel Fresenius Kabi 20 mg/ ml koncentrāts infūziju šķīduma pagatavošanai
Lithuania Cabazitaxel Fresenius Kabi 20 mg/ml koncentratas infuziniam tirpalui The
Netherlands
Cabazitaxel Fresenius Kabi 20mg/ ml, Concentraat voor oplossing voor infusie
Norway Cabazitaxel Fresenius Kabi Poland Cabazitaxel Fresenius Kabi Portugal Cabazitaxel Fresenius Kabi Romania Cabazitaxel Fresenius Kabi 20 mg/ml concentrat pentru soluție perfuzabil Slovakia Cabazitaxel Fresenius Kabi 20 mg/ml Slovenia Kabazitaksel Fresenius Kabi 20 mg/ml koncentrat za raztopino za infundiranje
Spain Cabazitaxel Fresenius Kabi 20 mg/ mL concentrado para solución para perfusión
Sweden Cabazitaxel Fresenius Kabi 20 mg/ml koncentrat till infusionsvätska. lösning United
Kingdom
(Northern
Ireland)
Cabazitaxel Fresenius Kabi 20 mg/ml concentrate for solution for infusion