CABAZITAXEL 20 mg /Ml Concentrate For Infusion Solution

Зміст інструкції

1. Cabazitaxel Accord 20 mg/ml concentrate for solution for infusion
   1. What is Cabazitaxel Accord and what is it used for
   2. What you need to know before you use 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

Cabazitaxel Accord 20 mg/ml concentrate for solution for infusion

cabazitaxel

Read this leaflet carefully before you use this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• If any side effect occurs, including any not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4. Contents of this leaflet: What is Cabazitaxel Accord and what it is used for  What you need to know before you use Cabazitaxel Accord  How to use Cabazitaxel Accord  Possible side effects  How to store Cabazitaxel Accord  Contents of the pack and other information

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

The name of the medicine is Cabazitaxel Accord. The common name is cabazitaxel. It belongs to a group
of medicines called “taxanes” used to treat cancer.
Cabazitaxel Accord is used for the treatment of prostate cancer that has progressed after having
received other chemotherapeutic treatments. It works by blocking the growth and proliferation of cells.
As part of the treatment, you will also take a corticosteroid (prednisone or
prednisolone) daily by mouth. Consult your doctor for information on this second medicine.

2. What you need to know before you use Cabazitaxel Accord

Do not use Cabazitaxel Accord if:

• you are allergic to cabazitaxel, to other taxanes or to polysorbate 80 or to any of the other ingredients of this medicine (listed in section 6),
• your white blood cell count is too low (neutrophil count less than or equal to
• 1,500/mm³),
• you have a severe impairment of liver function,
• you have recently received or are about to receive the vaccination against yellow fever. If any of these applies to you, do not receive Cabazitaxel Accord. If you have any doubts, consult your doctor before using Cabazitaxel Accord. Warnings and precautionsBefore each treatment with Cabazitaxel Accord, you will need to have blood tests to check that your blood cells are sufficient and that your liver and kidney function are such as to allow the administration of Cabazitaxel Accord. Tell your doctor immediately:
• if you have a fever. During treatment with Cabazitaxel Accord, your white blood cell count is more likely to decrease. The doctor will monitor your blood and your condition

general to identify any signs of infections. They may prescribe other medicines to
keep your blood cell count stable. People with a low number of
blood cells may develop potentially life-threatening infections. The first sign of
an infection may be a fever, so if you have a fever, tell your doctor immediately;

• if you have ever had any allergies. Serious allergic reactions may occur during treatment with Cabazitaxel Accord;
• if you suffer from severe or prolonged diarrhea, if you have nausea or vomiting. Any of these events can cause severe dehydration. The doctor may deem it necessary to subject you to treatment;
• if you have a feeling of numbness, tingling, burning or reduced sensitivity in your hands or feet;
• if you have intestinal bleeding problems or have noticed changes in the color of your stools or stomach pain. If the bleeding or pain is severe, your doctor will stop treatment with Cabazitaxel Accord. This is necessary because Cabazitaxel Accord may increase the risk of bleeding or the development of perforations in the intestinal wall;
• if you suffer from kidney problems;
• if you notice yellowing of the skin and eyes, dark urine, severe nausea (feeling unwell) or vomiting, as these may be signs or symptoms of liver problems.
• if you notice a significant increase or decrease in your daily urine output;
• if you have blood in your urine. If any of the above applies to you, tell your doctor immediately. The doctor may reduce the dose of Cabazitaxel Accord or stop treatment. Other medicines and Cabazitaxel AccordTell your doctor, pharmacist or nurse if you are taking or have recently taken any other medicines, including those available without a prescription. This is necessary because some medicines may affect how Cabazitaxel Accord works or Cabazitaxel Accord may affect the effect of other medicines. These medicines include the following:
• ketoconazole, rifampicin (for infections);
• carbamazepine, phenobarbital or phenytoin (for epilepsy);
• St. John's wort (Hypericum perforatum) (herbal product for depression and other conditions);
• statins (such as simvastatin, lovastatin, atorvastatin, rosuvastatin, or pravastatin) (for lowering blood cholesterol);
• valsartan (for high blood pressure);
• repaglinide (for diabetes). Consult your doctor before getting any vaccination during treatment with Cabazitaxel Accord. Pregnancy, breastfeeding and fertilityCabazitaxel Accord is not indicated for use in women. Women should not be exposed to Cabazitaxel Accord during breastfeeding with breast milk. Use a condom during sexual intercourse if your partner is pregnant or may become pregnant. Cabazitaxel Accord may be present in sperm and have effects on the fetus. It is recommended not to conceive a child during and for 4 months after treatment and to seek advice on sperm preservation before treatment, as Cabazitaxel Accord may impair male fertility. Driving and operating machineryWhile taking this medicine you may feel tired or dizzy. If this happens, do not drive vehicles or use machinery until you feel better.

Cabazitaxel Accord contains ethanol (alcohol)
This medicine contains 1185 mg of alcohol (ethanol) in each vial, which is equivalent to 395
mg/ml. The amount in each vial of this medicine is equivalent to less than 30 ml of beer or 12
of wine.
The amount of alcohol in this medicine is unlikely to have an effect on adults and adolescents and its
effects in children are not evident. Some effects may occur in young 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 or breastfeeding, talk to your doctor or pharmacist before taking this
medicine.
If you have an alcohol dependence, talk to your doctor or pharmacist before taking this medicine

3. How to use Cabazitaxel Accord

Instructions for use
Before starting treatment with Cabazitaxel Accord, you will need to take anti-allergic medications to
reduce the risk of allergic reactions:

• Cabazitaxel Accord will be administered to you by a doctor or nurse.
• Cabazitaxel Accord must be prepared (diluted) before administration. This is for doctors, nurses and pharmacists using Cabazitaxel Accord.
• Cabazitaxel Accord will be administered to you in hospital via intravenous infusion (intravenous infusion) lasting approximately 1 hour.
• As part of the treatment, you will also take a corticosteroid (prednisone or prednisolone) orally daily. What doses and how often is the administration
• The usual dose depends on the body surface area. The doctor will calculate the body surface area in square meters (m²) and decide what dose should be administered to you.
• Normally you will be given an infusion every 3 weeks. If you have any questions about 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 everyone gets them.
You will discuss these with your doctor, who will also explain the potential risks and
benefits of treatment.

Seek immediate medical attention if you notice any of the following side effects:

• fever (high body temperature). This is a very common effect (may affect up to 1 in 10 people);
• severe loss of body fluids (dehydration). This is a common effect (may affect up to 1 in 10 people). This can occur if you have severe or prolonged diarrhea, fever, or vomiting;
• severe stomach pain or upset stomach that does not go away. This can happen if you have a perforation in the stomach, esophagus, or intestine (gastrointestinal perforation). This can lead to death. If any of these apply to you, inform your doctor immediately.

Other side effects:
Very common(may affect more than 1 in 10 people):

• low number of red blood cells (anemia) or white blood cells (which are important in fighting infections)
• low number of platelets (which causes an increased risk of bleeding)
• loss of appetite (anorexia)
• stomach problems including nausea, vomiting, diarrhea, or constipation
• back pain
• blood in the urine
• feeling tired, weak, or lacking energy. Common(may affect up to 1 in 10 people):
• altered taste
• shortness of breath
• cough
• abdominal pain
• temporary hair loss (in most cases the hair will grow back)
• joint pain
• urinary tract infection
• low white blood cell count associated with fever and infection
• feeling of numbness, tingling, burning, or decreased sensitivity in hands and feet
• dizziness
• headache
• low or high blood pressure
• feeling of discomfort in the stomach, heartburn, or belching
• upset stomach
• hemorrhoids
• muscle spasm
• pain or increased frequency of urination
• urinary incontinence
• kidney diseases or disorders
• ulcers in the mouth or on the lips
• infections or risk of infections
• high blood sugar
• insomnia
• mental confusion
• feeling of anxiety
• abnormal sensation or loss of sensation or pain in hands and feet
• balance problems
• fast or irregular heartbeat
• blood clots in the legs or lungs
• skin redness
• pain in the mouth or throat
• rectal bleeding
• discomfort, weakness, or muscle pain
• swelling of feet or legs
• chills
• nail disorders (change in nail color; nails may detach). Uncommon(may affect up to 1 in 100 people):
• low levels of potassium in the blood
• ringing in the ears
• burning of the skin
• skin redness
• bladder inflammation, which can occur when the bladder has been previously exposed to radiation therapy (cystitis due to radiation recall phenomenon). Frequency not known(the frequency cannot be estimated from available data)
• interstitial lung diseases (inflammation of the lungs causing cough and difficulty breathing) Reporting of side effectsIf you get any side effects, talk to your doctor, pharmacist or nurse. You can also report side effects directly through the national reporting system listed in Annex V. By reporting side effects you can help provide more information on the safety of this medicine.

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 pack and on the label of the
vial after Exp. The expiry date refers to the last day of that month.
This medicine does not require any particular storage temperature.
Store in the original package to protect the medicine from light.
After opening
Each vial is for single use and must be used immediately. If not used immediately,
the storage times and conditions in use are the responsibility of the user.
After final dilution in the infusion bag/bottle
The chemical and physical stability of the infusion solution has been demonstrated for 8 hours at room
temperature (15°C-30°C) including the 1-hour infusion time and for 48 hours in the refrigerator, including the
1-hour infusion time.
From a microbiological point of view, the infusion solution must be used immediately. If
not used immediately, the storage times and conditions of the ready-to-use preparation
are the responsibility of the user and should normally not exceed 24 hours at 2°C – 8°C, unless the
dilution has been carried out under controlled and validated aseptic conditions.
Disposal
Unused medicine and waste derived from this medicine must be disposed of in accordance with
current local regulations. This will help to protect the environment.

6. Contents of the pack and other information

What Cabazitaxel Accord contains
The active ingredient is cabazitaxel. One ml of concentrate contains 20 mg of cabazitaxel. Each
vial of 3 ml concentrate contains 60 mg of cabazitaxel.
The other ingredients in the concentrate are polysorbate 80, citric acid and anhydrous ethanol (see
section 2 “Cabazitaxel Accord contains alcohol”).

Description of the appearance of Cabazitaxel Accord and contents of the pack
Cabazitaxel Accord is a concentrate for infusion solution (sterile concentrate). The concentrate is
a clear solution from colourless to pale yellow or yellowish-brown.
It is supplied in a transparent glass vial for single use of 6 ml and provides an injectable volume of 3
ml of concentrate.
Pack size:
each pack contains one single-use vial.

Marketing Authorisation Holder
Accord Healthcare S.L.U
World Trade Center, Moll de Barcelona s/n,
Edifici Est, 6 planta, Barcelona,
08039 Barcelona, Spain

Manufacturer
LABORATORI 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
For further information on this medicinal product, contact the local representative of the marketing
authorisation holder:
AT / BE / BG / CY / CZ / DE / DK / EE / FI / FR / HR / HU / IE / IS / IT / LT / LV / LU / MT / NL
/ NO / PT / PL / RO / SE / SI / SK / ES
Accord Healthcare S.L.U.
Tel: +34 93 301 00 64
EL
Win Medica Α.Ε.
Tel: : +30 210 7488 821

Other sources of information
Detailed information on this medicinal product is available on the website of the European Medicines
Agency: http://www.ema.europa.eu

The following information is intended exclusively for healthcare professionals.
PRACTICAL INFORMATION FOR DOCTORS OR HEALTHCARE PROFESSIONALS ON THE
PREPARATION, ADMINISTRATION AND HANDLING OF CABAZITAXEL
ACCORD 20 mg/ml CONCENTRATE FOR INFUSION SOLUTION
This information supplements sections 3 and 5 for the user.
Before preparing the infusion solution it is important to read the entire content of this
procedure.

Incompatibilities
This medicinal product must not be mixed with other medicinal products other than those used for
dilution.

Shelf life and special precautions for storage
For the pack of Cabazitaxel Accord 20 mg/ml concentrate for infusion solution
This medicinal product does not require any special storage conditions.
Store in the original package to protect the medicinal product from light.
After opening
Each vial is for single use and must be used immediately after opening. If not used
immediately, the storage times and conditions in use are the responsibility of the user.
After final dilution in the bag/bottle for infusion
The chemical and physical stability of the infusion solution has been demonstrated for 8 hours at room
temperature (15°C - 30°C) including the 1-hour infusion time and for 48 hours in the refrigerator including the
1-hour infusion time.
From a microbiological point of view, the infusion solution must be used immediately. If
not used immediately, the storage times and conditions in use are
the responsibility of the user and generally should not exceed 24 hours at 2°C – 8°C, unless the
dilution was carried out under controlled and validated aseptic conditions.

Precautions for preparation and administration
As with any other antineoplastic agent, caution is recommended when
handling and preparing solutions containing Cabazitaxel Accord and consideration should be given to the use of
containment devices, personal protective equipment (e.g.
gloves) and preparation procedures.
If Cabazitaxel Accord, at any stage of handling, should come into contact with the
skin, wash the affected area immediately and thoroughly with water and soap. If it should
come into contact with mucous membranes, wash immediately and thoroughly with water.
Cabazitaxel Accord must be administered and prepared only by qualified personnel in the
handling of cytotoxic agents. The medicinal product must not be handled by pregnant personnel.

Preparation steps
DO NOT use in conjunction with other medicinal products containing cabazitaxel with different
concentration. Cabazitaxel Accord contains 20 mg/ml of cabazitaxel (at least 3 ml of injectable volume
).
Each vial is for single use and must be used immediately. Dispose of unused solution.
To administer the prescribed dose, more than one vial of Cabazitaxel
Accord may be required.
The dilution process must be carried out aseptically for the preparation of the infusion solution.

Preparation of the infusion solution

Step 1
Aseptically draw up with a graduated syringe fitted with a needle the
required amount of Cabazitaxel Accord (20 mg/ml of cabazitaxel).
For example, a dose of 45 mg of cabazitaxel requires 2.25 ml
of Cabazitaxel Accord.

Step 2
Inject the solution into a sterile, PVC-free container containing
an infusion solution of 5% glucose or sodium chloride
9 mg/ml (0.9%). The concentration of the infusion solution
must be between 0.10 mg/ml and 0.26 mg/ml.

Step 3
Remove the syringe and mix the contents of the bag or
infusion bottle manually with an oscillating movement.
The infusion solution appears clear and colourless.

Concentrate 20 mg/ml

Glucose solution at
5% or sodium chloride 9
mg/ml (0.9%) for
infusion

Required amount of concentrate

Step 4
As with all products for parenteral use, the obtained infusion solution
must be visually inspected. As the infusion solution is supersaturated, it may crystallize over time.
In this case, the solution must not be used and must be
discarded.
The infusion solution must be used immediately. Information on the shelf life
and special precautions for storageare reported above.
Unused medicinal product and waste derived from such medicinal product must be disposed of in accordance
with local regulations.

Route of administration
Cabazitaxel Accord is administered as an infusion lasting 1 hour.
During administration, the use of an in-line filter with a nominal pore size of 0.22 micrometers (also referred to as 0.2 micrometers) is recommended.
Do not use PVC infusion containers or polyurethane infusion sets for the preparation and
administration of the infusion solution.