Cabazitaxel Accord - patient leaflet, side effects, dosage

Patient leaflet - Cabazitaxel Accord

B. PACKAGE LEAFLET

Package leaflet: Information for the patient

Cabazitaxel Accord 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.

Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor, pharmacist or nurse.
If you get any side effects talk to your doctor, pharmacist or nurse. This includes any possible

side effects not listed in this leaflet. See section 4.

What is in this leaflet

1 What Cabazitaxel Accord is and what it is used for
2 What you need to know before you are given Cabazitaxel Accord
3 How to use Cabazitaxel Accord
4 Possible side effects
5 How to store Cabazitaxel Accord
6 Contents of the pack and other information

1. What Cabazitaxel Accord is and what it is used for

The name of your medicine is Cabazitaxel Accord. Its common name is cabazitaxel. It belongs to a group of medicines called “taxanes” used to treat cancers.

Cabazitaxel Accord is used to treat adults with 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 Accord

Do not use Cabazitaxel Accord 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 Accord if any of the above apply to you. If you are not sure,

talk to your doctor before having Cabazitaxel Accord.

Warnings and precautions

Before each treatment with Cabazitaxel Accord, you will have blood tests to check that you have enough blood cells and sufficient liver and kidney functions to receive Cabazitaxel Accord.

Tell your doctor immediately if:

you have 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. 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 Accord.
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 Accord. This is because Cabazitaxel Accord may increase the risk of bleeding or developing holes in the gut wall.

you have kidney problems.
liver problems occur during the treatment.
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 Accord or stop the treatment.

Other medicines and Cabazitaxel Accord

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 Accord works or Cabazitaxel Accord 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 Accord.

Pregnancy, breast-feeding and fertility

Cabazitaxel Accord should not be used in pregnant women or women of childbearing age not using contraception.

Cabazitaxel Accord should not be used during breast-feeding.

Use a condom during sex if your partner is or could become pregnant. Cabazitaxel Accord 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 Accord 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 Accord contains ethanol (alcohol)

This medicine contains 1,185 mg of alcohol (ethanol) in each vial, which is equivalent to 16.33 Vol %. The amount in dose 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.

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 addicted to alcohol, talk to your doctor or pharmacist before taking this medicine.

3. How to use Cabazitaxel Accord

Instructions for use

Anti-allergic medicines will be given to you before you have Cabazitaxel Accord to reduce the risk of allergic reactions.

Cabazitaxel Accord will be given to you by a doctor or a nurse.
Cabazitaxel Accord must be prepared (diluted) before it is given. Practical information for handling and administration of Cabazitaxel Accord for doctors, nurses and pharmacists is provided with this leaflet.
Cabazitaxel Accord 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 very common (may affect more than 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)
alteration in sense of taste
shortness of breath
cough
stomach upsets including feeling sick (nausea), being sick (vomiting), diarrhoea or constipation
abdominal pain
short term hair loss (in most cases normal hair growth should return)
back pain
joint pain
blood in the urine
feeling tired, weak or lack of energy.

Common (may affect up to 1 in 10 people):

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
low blood potassium
mental confusion
feeling anxious
abnormal feeling or loss of sensation or pain in hands and feet
ringing in the ear
trouble with balance
rapid or irregular heartbeat
blood clot in the leg
skin feeling hot or flushed
pain in mouth or throat
rectal bleeding
redness of the skin
muscle discomfort, aches or pain
swelling of the feet or legs
chills

Uncommon (may affect up to 1 in 100 people):

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).

5. How to store Cabazitaxel Accord

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 vial label after EXP. The expiry date refers to the last day of that month.

This medicine does not require any special temperature storage conditions.

Store in the original package in order to protect from light.

After opening

Each vial is for single use and should be used immediately after opening. If not used immediately, inuse 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 ambient temperature (15°C – 30°C) including the 1-hour infusion time and for 48 hours at refrigerated conditions including the 1-hour infusion time.

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 hour at 2°C – 8°C, unless dilution has taken place in controlled and validated aseptic conditions.

Disposal

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 Accord contain

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, citric acid and ethanol anhydrous (see section 2 “Cabazitaxel Accord contains alcohol”).

What Cabazitaxel Accord looks like and contents of the pack

Cabazitaxel Accord is a concentrate for solution for infusion (sterile concentrate). The concentrate is a clear colourless to pale yellow or brownish 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

Accord Healthcare S.L.U

World Trade Center, Moll de Barcelona s/n,

Edifici Est, 6a planta, Barcelona,

08039 Barcelona, Spain

Manufacturer

LABORATOŘI FUNDACIÓ DAU C/ C, 12–14 Pol. Ind. Zona Franca, Barcelona, 08040, Spain

Pharmadox Healthcare Ltd.

KW20A Kordin Industrial Park

Paola, PLA 3000

Malta

Accord Healthcare Polska Sp. z o.o., ul. Lutomierska 50, Pabianice, 95–200 Poland

Accord Healthcare B.V

Winthontlaan 200, UTRECHT, 3526KV Paola

Netherlands

This leaflet was last revised in {MM/YYYY}

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site:

The following information is intended for healthcare professionals only.

PRACTICAL INFORMATION FOR MEDICAL OR HEALTHCARE PROFESSIONALS ON PREPARATION, ADMINISTRATION AND HANDLING OF CABAZITAXEL ACCORD 20 mg/ ml CONCENTRATE FOR SOLUTION FOR INFUSION

This information supplements sections 3 and 5 for the user.

It is important that you read the entire content of this procedure prior to the preparation of the infusion solution.

Incompatibilities

This medicine must not be mixed with other medicines except those used for the dilutions.

Shelf life and special precautions for storage

For the pack of Cabazitaxel Accord 20 mg/ml concentrate for solution for infusion

This medicinal product does not require any special storage conditions.

Store in the original package in order to protect from light.

After opening

Each vial is for single use and should be used immediately after opening. If not used immediately, inuse storage times and conditions are the responsibility of the user.

After final dilution in the infUsion bag/bottle

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 hour at 2°C-8°C, unless dilution has taken place in controlled and validated aseptic conditions.

Preparation and administration precautions

As for any other antineoplastic agent, caution should be exercised when handling and preparing Cabazitaxel Accord solutions, taking into account the use of containment devices, personal protective equipment (e.g. gloves), and preparation procedures.

If Cabazitaxel Accord, at any step of its handling, should come into contact with the skin, wash immediately and thoroughly with soap and water. If it should come into contact with mucous membranes, wash immediately and thoroughly with water.

Cabazitaxel Accord should only be prepared and administered by personnel trained in handling cytotoxic agents. Pregnant staff should not handle it.

Preparation steps

DO NOT use together with other cabazitaxel medicinal products with a different concentration cabazitaxel. Cabazitaxel Accord contains 20 mg/ml of cabazitaxel (at least 3 ml deliverable volume).

Each vial is of single use and should be used immediately. Discard any unused solution.

More than one vial of Cabazitaxel Accord may be necessary to administer the prescribed dose.

The dilution process must be carried out in an aseptic manner for preparing the solution for infusion.

Preparation of the infusion solution

Step 1

Aseptically withdraw the required volume of Cabazitaxel Accord (which contains 20 mg/ml of cabazitaxel), with a graduated syringe fitted with a needle. As an example, a dose of 45 mg cabazitaxel would require 2.25 ml of the Cabazitaxel Accord.

Step 2

Inject in a sterile PVC-free container of either 5% glucose solution or sodium chloride 9 mg/ml (0.9%) solution for infusion. The concentration of the infusion solution should be between 0.10 mg/ml and 0.26 mg/ml.

Step 3

Remove the syringe and mix the content of the infusion bag or bottle manually using a rocking motion. The infusion solution is clear colourless solution.

Step 4

As with all parenteral products, the resulting infusion solution should be visually inspected prior to use. As the infusion solution is supersaturated, it may crystallize over time. In this case, the solution must not be used and should be discarded.

The infusion solution should be used immediately. Information on shelf life and special precautions for storage are above.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

Method of administration

Cabazitaxel Accord is administered as a 1 hour infusion.

An in-line filter of 0.22 micrometer nominal pore size (also referred to as 0.2 micrometer) is recommended during administration.

PVC infusion containers or polyurethane infusion sets should not be used for the preparation and administration of the infusion solution.