Cabazitaxel EG

Package leaflet: Information for the patient

Cabazitaxel EG 20 mg/ml concentrate for solution for infusion

Equivalent medicine
Please read this leaflet carefully before using 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 you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

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

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

The name of the medicine is Cabazitaxel EG. The common name is cabazitaxel. It belongs to a group of
medicines called “taxanes” used to treat cancer.
Cabazitaxel EG is used to treat prostate cancer that has progressed after treatment with other chemotherapy agents. It works by blocking the growth and spread of cancer cells.
As part of your treatment, you will also take a corticosteroid (prednisone or prednisolone) orally on a daily basis. Please ask your doctor for information about these other medicines.

2. What you need to know before you are given Cabazitaxel EG

DO NOT use Cabazitaxel EG if:

• you are allergic to cabazitaxel, to other taxanes, 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);
• your liver function is severely impaired;
• you have recently received or are about to receive yellow fever vaccination.

Cabazitaxel EG must not be administered to you if any of the above conditions apply. If you are unsure, consult your doctor before receiving Cabazitaxel EG.

Warnings and precautions

Before each treatment with Cabazitaxel EG, you will need to have blood tests to ensure that your blood cell counts are adequate and that your liver and kidney functions are sufficient to allow administration of Cabazitaxel EG.

Immediately inform your doctor if:

• you have a fever. During treatment with Cabazitaxel EG, it is more likely that your white blood cell count will decrease. Your doctor will monitor your blood and your general condition to detect any signs of infection. You may be given additional medicines to maintain stable blood cell counts. People with low blood cell counts may develop potentially life-threatening infections. Fever may be the first sign of an infection, so inform your doctor immediately if you develop a fever;
• you have ever had any allergies. Severe allergic reactions may occur during treatment with Cabazitaxel EG;
• you have severe or prolonged diarrhoea, nausea or vomiting. Any of these may cause severe dehydration. Your doctor may consider treatment necessary;
• you experience numbness, tingling, burning sensations, or reduced sensitivity in your hands or feet;
• you have intestinal bleeding problems or have noticed changes in the colour of your stools or stomach pain. If bleeding or pain is severe, your doctor will stop treatment with Cabazitaxel EG. This is because Cabazitaxel EG may increase the risk of bleeding or the development of perforations in the intestinal wall;
• you have kidney problems;
• you develop yellowing of the skin or eyes, dark-coloured urine, or severe nausea or vomiting, as these may be signs or symptoms of liver problems;
• you notice a significant increase or decrease in your daily urine volume;
• you have blood in your urine.

If any of the above conditions apply to you, inform your doctor immediately. Your doctor may reduce the dose of Cabazitaxel EG or discontinue treatment.

Other medicines and Cabazitaxel EG

Inform your doctor, pharmacist, or nurse if you are taking or have recently taken any other medicines, including those not requiring a prescription. This is because some medicines may affect the activity of Cabazitaxel EG, or Cabazitaxel EG may affect the activity of other medicines. These include:

• ketoconazole, rifampicin (for infections);
• carbamazepine, phenobarbital, or phenytoin (for epileptic seizures);
• St John’s wort (Hypericum perforatum) (herbal remedy for depression or other conditions);
• statins (such as simvastatin, lovastatin, atorvastatin, rosuvastatin, or pravastatin) (for lowering blood cholesterol);
• valsartan (for hypertension);
• repaglinide (for diabetes).

Consult your doctor before receiving any vaccination during treatment with Cabazitaxel EG.

Pregnancy, breastfeeding, and fertility

Cabazitaxel EG is not recommended during pregnancy and in women of childbearing age who are not using contraception.

Cabazitaxel EG must not be used during breastfeeding.

Use a condom during sexual intercourse if your partner is pregnant or could become pregnant. Cabazitaxel EG may be present in semen and could affect the fetus. It is recommended not to father a child during treatment and for 6 months after treatment ends. You should seek advice about sperm preservation before starting treatment, as Cabazitaxel EG may impair male fertility.

Driving and using machines

While taking this medicine, you may feel tired or experience dizziness. If this occurs, do not drive or operate tools or machinery until you feel better.

Cabazitaxel EG contains alcohol (ethanol)

This medicine contains 50 vol % alcohol (ethanol) in each dosage unit, equivalent to 1185 mg per vial. The alcohol content of this medicine is equivalent to less than 30 ml of beer or 12 ml of wine.

The alcohol in this medicine may alter the effects of other medicines. Speak with your doctor or pharmacist if you are taking other medicines.

If you are pregnant or breastfeeding, speak with your doctor or pharmacist before taking this medicine.

If you have alcohol dependence, speak with your doctor or pharmacist before taking this medicine.

3. How to use Cabazitaxel EG

Instructions for use
Before starting treatment with Cabazitaxel EG, you must take antiallergic medicines to reduce the risk of allergic reactions.

• Cabazitaxel EG will be administered to you by a doctor or a nurse.
• Cabazitaxel EG must be prepared (diluted) before administration. This patient information leaflet contains practical information on the handling and administration of Cabazitaxel EG for doctors, nurses, and pharmacists.
• Cabazitaxel EG will be administered in hospital by intravenous infusion (into one of your veins) over approximately 1 hour.
• As part of your treatment, you will also take an oral corticosteroid (prednisone or prednisolone) daily.

Dosage and frequency of administration

• The usual dose depends on body surface area. Your doctor will calculate your body surface area in square meters (m²) and determine the dose to be administered.
• Normally, you will receive one infusion every 3 weeks.

If you have any doubts about how to use this medicine, consult 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 explain these side effects to you and will discuss with you the risks and benefits related to your
treatment.
Contact your doctor immediately if you experience any of the following side effects:

• fever (high body temperature). This is a common side effect (may affect up to 1 in 10 people);
• severe loss of body fluids (dehydration). This is a common side effect (may occur in up to 1 in 10 people);
  This may happen if you have severe or prolonged diarrhoea, fever, or feel unwell (vomiting);
• severe stomach pain or persistent stomach discomfort. This may occur if you have a perforation in the stomach, oesophagus, or intestine (gastrointestinal perforation). This may be fatal. If any of the above cases apply to you, inform your doctor immediately.

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

• decrease in the number of red blood cells (anaemia) or white blood cells (important components in fighting infections);
• reduction in platelet count (which increases the risk of bleeding);
• loss of appetite (anorexia);
• stomach problems including feeling unwell (nausea), discomfort (vomiting), diarrhoea or constipation;
• back pain;
• blood in the urine;
• feeling tired, weak, or lacking energy.

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

• changes in taste sensation;
• shortness of breath;
• cough;
• abdominal pain;
• temporary hair loss (in most cases, normal hair growth will return);
• joint pain;
• urinary tract infections;
• decrease in white blood cells associated with fever and infection;
• numbness, tingling, burning, or reduced sensation in hands and feet;
• dizziness;
• headache;
• increased or decreased blood pressure;
• stomach discomfort, burning sensation, or burping;
• stomach pain;
• haemorrhoids;
• muscle spasms;
• pain or increased frequency of urination;
• urinary incontinence;
• kidney diseases and problems;
• mouth or lip ulcers;
• infections or increased risk of infections;
• high blood sugar levels;
• insomnia;
• mental confusion;
• feeling anxious;
• abnormal sensation, loss of sensation, or pain in hands and feet;
• balance problems;
• rapid or irregular heartbeat;
• blood clots in the legs or lungs (thrombosis);
• skin redness;
• pain in the mouth or throat;
• rectal bleeding;
• discomfort, weakness, or muscle pain;
• swelling of feet or legs;
• chills;
• nail problems (nail discolouration, nails that may detach).

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

• low levels of potassium in the blood;
• ringing in the ears;
• skin burning;
• skin redness;
• inflammation of the bladder, which may occur when the bladder has previously been exposed to radiotherapy (radiation recall cystitis).

Not known (frequency cannot be estimated from the available data):

• interstitial lung disease (lung inflammation causing cough and breathing difficulties).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse.
You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Cabazitaxel EG

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 carton and on the label of the
vial after the word EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
For information on storage and duration of use of Cabazitaxel EG, refer to the section
“GUIDE TO PREPARATION FOR USE WITH CABAZITAXEL EG 20 mg/ml CONCENTRATE
FOR INFUSION SOLUTION”.
Unused medicine and waste material must be disposed of in accordance with local regulations.
This will help protect the environment.

6. Package contents and other information

What Cabazitaxel EG contains

• The active substance is cabazitaxel. Each ml of concentrate for solution for infusion contains 20 mg of cabazitaxel. Each 3 ml vial of concentrate for solution for infusion contains 60 mg of cabazitaxel.
• The other components are polysorbate 80; ethanol, anhydrous (see section 2 “Cabazitaxel EG contains alcohol (ethanol)”) and citric acid.

Description of the appearance of Cabazitaxel EG and contents of the pack
Cabazitaxel EG is a sterile concentrate for solution for infusion.
The concentrate is a clear, oily solution ranging from yellow to brownish-yellow.
Each vial contains 3 ml of concentrate. Packs containing a single vial are available.
Marketing Authorization Holder
EG S.p.A. Via Pavia, 6 - 20136 Milan, Italy
Manufacturer
STADA Arzneimittel, Stadastrasse 2-18, 61118 Bad Vilbel (Germany)
AqVida GmbH, Kaiser-Wilhelm-Strasse 89, 20355 Hamburg (Germany)
This medicinal product is authorized in the European Economic Area (EEA) Member States under the following names:
AT Cabazitaxel STADA 20 mg/ml Konzentrat zur Herstellung einer Infusionslösung
DE Cabazitaxel STADA Arzneimittel AG 20 mg/ml Konzentrat zur Herstellung einer Infusionslösung
ES Cabazitaxel STADA 20 mg/ml concentrado para solución para perfusión
FR Cabazitaxel EG 20 mg/ml solution à diluer pour perfusion
HU Cabazitaxel Stada 20 mg/ml koncentrátum oldatos infúzióhoz
IT Cabazitaxel EG
PT Cabazitaxel Stada
RO Cabazitaxel Stada 20 mg/ml concentrat pentru solutie perfuzabilă

The following information is intended exclusively for healthcare professionals.

GUIDE FOR PREPARATION FOR USE WITH CABAZITAXEL EG 20 mg/ml CONCENTRATE
FOR INFUSION SOLUTION
This information supplements sections 3 and 5 of the package leaflet for the user.
Before preparing the infusion solution, it is essential to read the entire content of this procedure.

Recommendations for safe handling
Cabazitaxel is an antineoplastic medicinal product and, as with other potentially toxic compounds, caution should be exercised when handling and preparing solutions. The use of gloves is recommended.
If the cabazitaxel concentrate or the infusion solution comes into contact with the skin, wash immediately and thoroughly with water and soap. If contact occurs with mucous membranes, wash the affected area immediately and thoroughly with water.
Cabazitaxel EG must be prepared and administered only by personnel trained in the handling of cytotoxic agents. Pregnant personnel must not handle this medicinal product.

Incompatibilities
This medicinal product must not be mixed with other medicinal products except those used for the preparation of the ready-to-use infusion solution.

Shelf life and special precautions for storage
This medicinal product requires no special storage conditions.

After opening
The concentrate must be used immediately. If not used immediately, the storage times and conditions are the responsibility of the user. From a microbiological point of view, the dilution procedure must be carried out under controlled and aseptic conditions (see below “Preparation of the ready-to-use infusion solution”).

Preparation of the ready-to-use infusion solution
DO NOT use other cabazitaxel-containing medicinal products consisting of 2 vials (concentrate and solvent) or other cabazitaxel-containing medicinal products consisting of 1 vial (concentrate only) with a different cabazitaxel concentration (e.g. 10 mg/ml) together with Cabazitaxel EG 20 mg/ml concentrate for infusion solution, which contains only one vial with 3 ml (60 mg/3 ml) of concentrate.

Cabazitaxel EG 20 mg/ml concentrate for infusion solution does NOT require prior dilution with a solvent and is ready to be added directly to the infusion solution.

Step 1
If vials have been stored in the refrigerator, allow the required number of vials of cabazitaxel concentrate for infusion solution to reach 20–25°C for 5 minutes before use.
To achieve the required dose for an individual patient, more than one vial of 20 mg/ml cabazitaxel concentrate for infusion solution may be necessary. Aseptically withdraw the required amount of cabazitaxel concentrate for infusion solution using a calibrated syringe fitted with a 21G needle.
Each ml of concentrate contains 20 mg of cabazitaxel.

Step 2
The required volume of cabazitaxel concentrate for infusion solution (20 mg/ml of cabazitaxel) must be injected into a sterile, non-PVC container containing either 5% glucose solution or 9 mg/ml (0.9%) sodium chloride solution for infusion. For example, a 45 mg dose of cabazitaxel requires 2.25 ml of concentrate withdrawn directly from the vial. The concentration of the resulting infusion solution must be between 0.10 mg/ml and 0.26 mg/ml.

Step 3
Remove the syringe and manually mix the contents of the infusion bag or vial by gentle agitation.

Step 4
As with all parenteral products, the resulting infusion solution must be inspected visually before use. Since the infusion solution is supersaturated, crystallization may occur over time. In such cases, the solution must not be used and must be discarded.

The infusion solution must be used immediately. However, the in-use storage duration may be longer under the specific conditions mentioned in “Shelf life and special precautions for storage”.

During administration, a 0.22-micron nominal pore size in-line filter (also referred to as 0.2 microns) must be used.

Non-PVC infusion containers and polyurethane infusion sets must not be used for the preparation and administration of cabazitaxel.

Cabazitaxel must not be mixed with other medicinal products except those specified.

Disposal
Unused medicinal product and waste materials resulting from its use must be disposed of in accordance with local regulations.