Cabazitaxel G.l.

Leaflet included in the packaging: patient information

Cabazitaxel G.L., 20 mg/ml, concentrate for solution for infusion
cabazitaxel
You should carefully read the contents of this leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any further questions, you should ask your doctor, pharmacist, or nurse.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Cabazitaxel G.L. and what is it used for
• 2. Important information before using Cabazitaxel G.L.
• 3. How to use Cabazitaxel G.L.
• 4. Possible side effects
• 5. How to store Cabazitaxel G.L.
• 6. Contents of the packaging and other information

1. What is Cabazitaxel G.L. and what is it used for

The name of the medicine is Cabazitaxel G.L. The common name is cabazitaxel. It belongs to a group of medicines called "taxanes", which are used to treat cancer.
Cabazitaxel G.L. is used to treat prostate cancer when the disease has progressed after other chemotherapy. The medicine works by stopping the growth and division of cells.
Part of the treatment is also the daily, oral intake of a corticosteroid (prednisone or prednisolone) by the patient. You should consult your doctor for information about this medicine.

2. Important information before using Cabazitaxel G.L.

When not to use Cabazitaxel G.L.

• if the patient is allergic (hypersensitive) to cabazitaxel, other taxanes, or polysorbate 80 or any of the other ingredients of this medicine (listed in section 6).
• if the patient has a low white blood cell count (neutrophil count less than or equal to 1500/mm^3).
• if the patient has severe liver function disorders.
• if the patient has recently received or is going to receive a yellow fever vaccine.

Cabazitaxel G.L. should not be used if any of the above applies to the patient. In case of doubt, the doctor should be consulted before using Cabazitaxel G.L.

Warnings and precautions

Before each administration of Cabazitaxel G.L., the patient's blood is tested to check if the number of blood cells and liver and kidney function are suitable for the administration of Cabazitaxel G.L.
The doctor should be informed immediately in case of:

• fever. During the use of Cabazitaxel G.L., there is a possibility of a decrease in the number of white blood cells. The doctor will examine the blood and monitor the patient's general condition

for the occurrence of infection symptoms. The doctor may also prescribe other medicines to maintain a normal white blood cell count. In patients with low blood cell counts, life-threatening infections may occur. The earliest sign of infection may be fever, so if it occurs, the doctor should be informed immediately.

• early onset of any allergies (allergic reactions). During the use of Cabazitaxel G.L., severe allergic reactions may occur.
• severe or prolonged diarrhea, nausea, or vomiting. All of these symptoms can lead to severe dehydration. They may also require treatment.
• feeling of tingling, numbness, burning, or decreased sensation in the hands or feet.
• occurrence of any gastrointestinal bleeding, change in stool color, or abdominal pain. If the bleeding or pain is severe, the doctor will stop the treatment with Cabazitaxel G.L. This is because Cabazitaxel G.L. may increase the risk of bleeding or perforation of the intestinal wall.
• kidney disorders.
• occurrence of jaundice of the skin and eyes, dark urine, severe nausea (vomiting), or vomiting, which may be symptoms of liver disease.
• significant increase or decrease in the amount of urine excreted during the day.
• occurrence of blood in the urine.

The doctor should be informed immediately if any of the above applies to the patient.
The doctor may reduce the dose of Cabazitaxel G.L. or stop the treatment.

Cabazitaxel G.L. and other medicines

The doctor, pharmacist, or nurse should be told about all medicines that the patient is currently taking or has recently taken, including those that are available without a prescription. This is because some medicines may affect the action of Cabazitaxel G.L. or Cabazitaxel G.L. may affect the action of other medicines. This applies to the following medicines:

• ketokonazole, rifampicin (medicines used to treat infections);
• carbamazepine, phenobarbital, or phenytoin (medicines used to treat epilepsy);
• St. John's wort (Hypericum perforatum) (herbal medicine for depression and other conditions);
• statins (such as simvastatin, lovastatin, atorvastatin, rosuvastatin, or pravastatin) (medicines that lower blood cholesterol levels);
• valsartan (a medicine used to treat high blood pressure);
• repaglinide (a medicine used to treat diabetes).

Before vaccination, the doctor should be informed about the use of Cabazitaxel G.L.

Pregnancy, breastfeeding, and fertility

Cabazitaxel G.L. should not be used by pregnant women and women of childbearing age who do not use contraception.
Cabazitaxel G.L. should not be used during breastfeeding.
The patient should use condoms during sexual intercourse if their partner is pregnant or may become pregnant. Cabazitaxel G.L. may be present in semen and may affect the fetus. Patients taking Cabazitaxel G.L. should not become fathers during the 6 months following the end of treatment, and before starting treatment, they should consult about storing their semen, as Cabazitaxel G.L. may affect fertility in men.

Driving and using machines

During the use of the medicine, fatigue or dizziness may occur. In this case, the patient should not drive vehicles, operate machines, or use tools until these symptoms disappear.

Cabazitaxel G.L. contains ethanol (alcohol)

This medicine contains 50% v/v ethanol (alcohol), i.e., up to 1185 mg (1.5 ml) per dose, which is equivalent to 30 ml of beer or 12 ml of wine.
The medicine may be harmful to people with alcoholism.
This should be taken into account in the case of pregnant or breastfeeding women, children, and high-risk groups, such as patients with liver or epilepsy.

3. How to use Cabazitaxel G.L.

Instructions for use

Before using Cabazitaxel G.L., patients are given anti-allergic medicines to reduce the risk of allergic reactions.

• Cabazitaxel G.L. is administered by a doctor or nurse.
• Cabazitaxel G.L. must be properly prepared (diluted) before administration. This leaflet contains practical information for doctors, nurses, and pharmacists on handling Cabazitaxel G.L. and its administration.
• Cabazitaxel G.L. is administered in a hospital as an intravenous infusion lasting about 1 hour into one of the patient's veins.
• Part of the treatment is also the daily, oral intake of a corticosteroid (prednisone or prednisolone) by the patient.

Dose and frequency of administration

• The usual dose depends on the patient's body surface area. The doctor calculates the patient's body surface area in square meters (m^2) and determines the dose to be administered based on this.
• Infusions are usually given every 3 weeks.

In case of any further doubts about the use of this medicine, the doctor, pharmacist, or nurse should be consulted.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The attending doctor should discuss the possible side effects with the patient and explain the risks and benefits of the treatment.

The doctor should be informed immediately if any of the following side effects occur:

• Fever (high body temperature). This occurs frequently (may affect up to 1 in 10 people).
• Severe loss of fluids from the body (dehydration). This occurs frequently (may affect up to 1 in 10 people). Dehydration may occur due to severe or prolonged diarrhea, fever, or vomiting.
• Severe abdominal pain or abdominal pain that does not go away. These symptoms may occur if the patient has a blocked intestine (intestinal obstruction; occurs rarely, may affect up to 1 in 100 people) or has perforated the lining of the stomach, esophagus, or intestine (perforation of the gastrointestinal tract; occurs rarely, may affect up to 1 in 100 people). This can lead to death.

The doctor should be informed immediately if any of the above applies to the patient.

Other side effects:

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

• decrease in the number of red blood cells (anemia) or white blood cells (important for fighting infections)
• decrease in the number of platelets (which increases the risk of bleeding)
• loss of appetite (anorexia)
• stomach upset, including nausea, vomiting, diarrhea, or constipation
• back pain
• blood in the urine
• feeling of tiredness, weakness, or lack of energy

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

• taste disorders
• shortness of breath
• cough
• abdominal pain
• temporary hair loss (in most cases, normal hair growth should return)
• joint pain
• urinary tract infections
• lack of white blood cells associated with fever and infection
• feeling of tingling, numbness, burning, or decreased sensation in the hands and feet
• dizziness
• headache
• decrease or increase in blood pressure
• discomfort in the stomach, heartburn, or belching
• stomach pain
• hemorrhoids
• muscle cramps
• pain when urinating or frequent urination
• urinary incontinence
• kidney disease or kidney function disorders
• mouth ulcers or lip ulcers
• infections or risk of infections
• increased blood sugar levels
• insomnia
• disorientation
• feeling of sadness
• abnormal sensation, loss of sensation, or pain in the hands and feet
• difficulty maintaining balance
• rapid or irregular heartbeat
• blood clots in the legs or lungs
• flushing
• nail disorders (change in nail color; nails may become detached)
• mouth or throat pain
• rectal bleeding
• discomfort in the muscles, weakness, or muscle pain
• swelling of the feet or legs
• chills

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

• low potassium levels in the blood
• ringing in the ears
• stomach lining inflammation (gastritis)
• inflammation of the intestine (colitis)
• gastrointestinal bleeding
• feeling of hot skin
• skin redness
• inflammation of the urinary bladder, which may occur if the patient has previously undergone radiation therapy (radiation-induced cystitis)

Unknown(frequency cannot be estimated from the available data):

• non-infectious lung inflammation (pneumonitis causing cough and difficulty breathing)

Reporting side effects

If any side effects occur, including those not listed in this leaflet, the doctor or pharmacist should be informed. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Al. Jerozolimskie 181C,
02-222 Warsaw
tel.: +48 22 49 21 301
fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects helps to gather more information on the safety of the medicine.

5. How to store Cabazitaxel G.L.

The medicine should be stored out of sight and reach of children.
The medicine should not be used after the expiry date stated on the carton and label on the vial after "EXP". The expiry date refers to the last day of the month stated.
There are no special precautions for storing the medicine.
Information on the storage conditions and shelf life of Cabazitaxel G.L. after dilution and preparation for use is described in the section "Practical information for doctors and healthcare professionals on the preparation, administration, and handling of the medicinal product Cabazitaxel G.L.".
Any unused medicinal product or waste material should be disposed of in accordance with local regulations. This will help protect the environment.

6. Contents of the packaging and other information

What Cabazitaxel G.L. contains

• The active substance of the medicine is cabazitaxel. One milliliter of the concentrate for solution for infusion contains 20 mg of cabazitaxel. One vial of the concentrate for solution for infusion contains 60 mg of cabazitaxel.
• The other ingredients are: polysorbate 80, anhydrous ethanol (see section 2 "Cabazitaxel G.L. contains alcohol"), and citric acid.

What Cabazitaxel G.L. looks like and contents of the pack

Cabazitaxel G.L. is a concentrate for solution for infusion (sterile concentrate).
The concentrate is a clear, oily solution with a yellow to brownish-yellow color.
One vial contains 3 ml (nominal volume) of the concentrate.
One pack contains one vial of the concentrate.

Marketing authorization holder

G.L. Pharma GmbH
Schlossplatz 1
8502 Lannach
Austria

Manufacturer

AqVida GmbH
Kaiser-Wilhelm-Str. 89
20355 Hamburg
Germany

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Austria
Cabazitaxel G.L. 20 mg/ml Konzentrat zur Herstellung einer Infusionslösung
Bulgaria
Cabazitaxel G.L. 20 mg/ml concentrate for solution for infusion
Czech Republic
Cabazitaxel G.L. Pharma
Hungary
Cabazitaxel G.L. 20 mg/ml koncentrátum oldatos infúzióhoz
Poland
Cabazitaxel G.L.
Romania
Cabazitaxel G.L. Pharma 20 mg/ml concentrat pentru solutie perfuzabila

For more information, you should contact the representative of the marketing authorization holder:

G.L. PHARMA POLAND Sp. z o.o.
Al. Jana Pawła II 61/313
01-031 Warsaw, Poland
Tel: 022/ 636 52 23; 636 53 02
biuro@gl-pharma.pl

Date of last revision of the leaflet:

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Information intended exclusively for healthcare professionals.

PRACTICAL INFORMATION FOR DOCTORS AND HEALTHCARE PROFESSIONALS ON THE PREPARATION, ADMINISTRATION, AND HANDLING OF THE MEDICINAL PRODUCT CABAZITAXEL G.L. 20 mg/ml CONCENTRATE FOR SOLUTION FOR INFUSION
The following information supplements section 3 and 5 of the patient leaflet.
Before preparing the infusion solution, the entire procedure should be read.

Recommendations for safe preparation

Cabazitaxel is a cytotoxic agent and, like other potentially toxic compounds, caution should be exercised when handling it and preparing its solutions. The use of gloves is recommended.
In case of contact of the concentrate or solution of Cabazitaxel G.L. with the skin, the area should be washed immediately with soap and water. In case of contact with the mucous membrane, the area should be rinsed immediately with water.
Cabazitaxel G.L. should be prepared and administered only by personnel trained in the handling of cytotoxic agents. Pregnant women in the personnel should not have contact with the product.

Incompatibilities

This medicine should not be mixed with other medicines, except for those used for dilution.

Shelf life and special precautions for storage of the medicinal product Cabazitaxel G.L., 20 mg/ml, concentrate for solution for infusion

There are no special precautions for storing the medicine.

After opening the vial

Chemical and physical stability has been demonstrated for 4 weeks at 2-8°C.
From a microbiological point of view, the product should be used immediately. If not used immediately, the user is responsible for the storage conditions and the storage time, which should not exceed 24 hours at 2-8°C. From a microbiological point of view, the dilution should be carried out under controlled and validated aseptic conditions (see below "Preparation of the ready-to-use infusion solution").

After addition to the infusion container

Chemical and physical stability has been demonstrated for 14 days at 2-8°C and for 48 hours at 25°C.
From a microbiological point of view, the product should be used immediately. If not used immediately, the user is responsible for the storage conditions and the storage time, which should not exceed 24 hours at 2-8°C, unless the dilution was carried out under controlled and validated aseptic conditions.

Preparation of the ready-to-use infusion solution

DO NOT use other medicinal products containing cabazitaxel in 2 vials (concentrate and solvent) with the medicinal product Cabazitaxel G.L., 20 mg/ml, concentrate for solution for infusion, which contains only 1 vial with 3 ml (60 mg/3 ml).

Cabazitaxel G.L. 20 mg/ml concentrate for solution for infusion DOES NOT require prior dilution with a solvent and is ready for addition to the infusion solution.

Step 1

If the vials are stored in the refrigerator, before use, the required number of vials of Cabazitaxel G.L. 20 mg/ml concentrate for solution for infusion should be removed from the refrigerator and left at room temperature (20-25°C) for 5 minutes.
To obtain the required dose for the patient, more than one vial of Cabazitaxel G.L. 20 mg/ml concentrate for solution for infusion may be needed. The required amount of cabazitaxel concentrate for solution for infusion should be aseptically drawn into a calibrated syringe equipped with a 21G needle.

Each ml of the medicinal product contains 20 mg of cabazitaxel.

Step 2

The required volume of cabazitaxel concentrate for solution for infusion (20 mg/ml cabazitaxel) should be injected into a sterile container that does not contain PVC, containing 5% glucose solution or 9 mg/ml (0.9%) sodium chloride solution for infusion. For example, a dose of 45 mg of cabazitaxel would require 2.25 ml of the concentrate drawn directly from the vial of the product.
The concentration of the infusion solution should be between 0.10 mg/ml and 0.26 mg/ml.

Step 3

The syringe should be removed and the contents of the bag or bottle should be manually mixed by rocking.

Step 4

As with all products for parenteral administration, the obtained infusion solution should be inspected before use. Since the infusion solution is supersaturated, it may crystallize over time. In this case, the solution should not be used and should be discarded.

Disposal

All materials used for dilution and administration should be disposed of in accordance with standard procedures. Medicines should not be disposed of via wastewater. The pharmacist should be asked how to dispose of medicines that are no longer needed. This will help protect the environment.
The infusion solution should be used immediately. The storage time of the prepared solution may be longer under certain conditions described in the section "Shelf life and special precautions for storage".
A 0.22-micron filter (also known as 0.2 micron) is required during administration.
Cabazitaxel should not be prepared or administered using PVC or polyurethane infusion sets.
Cabazitaxel should not be mixed with other medicinal products except those mentioned.
Any unused medicinal product or waste material should be disposed of in accordance with local regulations.