Cabazitaxel g.l.

Package leaflet: Information for the patient

Cabazitaxel G.L., 20 mg/ml, concentrate for solution for infusion
cabazitaxel
Please read carefully all the information in this leaflet before using this medicine, because it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any doubts, please consult your doctor, pharmacist, or nurse.
• If you experience any adverse reactions while taking this medicine, including any adverse reactions not listed in this leaflet, you must inform your doctor, pharmacist, or nurse. See section 4.

Contents of the leaflet

1. What Cabazitaxel G.L. is and what it is 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 pack and other information

1. What Cabazitaxel G.L. is and what it is 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 in cancer treatment.
Cabazitaxel G.L. is used to treat cancer of the prostate gland, when disease progression has been observed after treatment with another chemotherapy. The medicine works by stopping the growth and division of cells.
As part of the treatment, you must also take an oral corticosteroid (prednisone or prednisolone) daily. Please consult your doctor for further information about this medicine.

2. Important information before using Cabazitaxel G.L.

When Cabazitaxel G.L. must not be used

• if the patient is allergic (hypersensitive) to cabazitaxel, other taxanes, or polysorbate 80, or to any of the other ingredients of this medicine (listed in section 6).
• if the patient has too low a number of white blood cells (neutrophil count less than or equal to 1500/mm³).
• if the patient has severe liver function disorders.
• if the patient has recently received or is due to receive the yellow fever vaccine.

Cabazitaxel G.L. must not be used if any of the above apply to the patient.
If in doubt, consult a doctor before using Cabazitaxel G.L.

Warnings and precautions

Before each administration of Cabazitaxel G.L., blood tests will be performed to check whether blood cell counts, liver function, and kidney function are adequate for treatment with Cabazitaxel G.L.

Immediately inform the doctor if:

• fever occurs. Treatment with Cabazitaxel G.L. may reduce the number of white blood cells. The doctor will monitor blood counts and the patient's general condition for signs of infection. The doctor may also prescribe other medications to maintain adequate white blood cell counts. Patients with low blood counts may develop life-threatening infections. Fever may be the earliest sign of infection; therefore, if fever occurs, contact the doctor immediately.

• there has been a previous occurrence of any allergies (hypersensitivity). Severe allergic reactions may occur during treatment with Cabazitaxel G.L.

• severe or prolonged diarrhoea, nausea, or vomiting occur. These symptoms may lead to severe dehydration and may require medical treatment.

• tingling, numbness, burning sensations, or reduced sensation in the hands or feet.

• any intestinal bleeding, change in stool colour, or abdominal pain occur. If bleeding or pain is severe, the doctor will discontinue treatment with Cabazitaxel G.L. This is because Cabazitaxel G.L. may increase the risk of intestinal bleeding or perforation.

• kidney problems occur.

• yellowing of the skin or eyes (jaundice), dark-coloured urine, severe nausea or vomiting occur, which may be symptoms of liver disease.

• a significant increase or decrease in daily urine output.

• blood appears in the urine.

Immediately inform the doctor if any of the above occur.
The doctor may reduce the dose of Cabazitaxel G.L. or discontinue treatment.

Cabazitaxel G.L. and other medicines

Tell the doctor, pharmacist, or nurse about all medicines currently or recently taken, including those obtained 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:

• ketoconazole, rifampicin (medicines used to treat infections);
• carbamazepine, phenobarbital, or phenytoin (medicines used to treat seizures);
• St John's wort (Hypericum perforatum) (a herbal remedy 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 receiving any vaccinations, inform the doctor that the patient is being treated with Cabazitaxel G.L.

Pregnancy, breastfeeding, and effects on fertility

Cabazitaxel G.L. must not be used in pregnant women or women of childbearing potential who are not using contraception.

Cabazitaxel G.L. must not be used during breastfeeding.

The patient should use condoms during sexual intercourse if his partner is pregnant or could become pregnant. Cabazitaxel G.L. may be present in semen and may affect the unborn child. Patients receiving Cabazitaxel G.L. should not father a child for at least 6 months after treatment ends. Before starting treatment, patients should discuss sperm storage with their doctor, as Cabazitaxel G.L. may affect male fertility.

Driving and operating machinery

During treatment, fatigue or dizziness may occur. In such cases, do not drive, operate machinery, or use tools until these symptoms have resolved.

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, equivalent to 30 ml of beer or 12 ml of wine.

The medicine may be harmful to patients with alcohol-related disease.

This should be taken into account in pregnant or breastfeeding women, children, and high-risk groups such as patients with liver disease or epilepsy.

3. How to use Cabazitaxel G.L.

Instructions for use
Before administering Cabazitaxel G.L., patients are given antiallergic medications to reduce the risk of allergic reactions.

• Cabazitaxel G.L. is administered by a doctor or nurse.
• Cabazitaxel G.L. must be appropriately 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 hospital as an intravenous infusion lasting approximately one hour into one of the patient's veins (intravenous administration).
• Treatment also includes daily oral administration of a corticosteroid (prednisone or prednisolone) by the patient.

Dosage 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 (m²) and determines the dose accordingly.
• Infusions are usually administered every 3 weeks.

If you have any further doubts regarding the use of this medicinal product, please consult your doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this medicinal product may cause adverse reactions, although not everyone experiences them.
The treating physician should discuss with the patient possible adverse reactions and explain the risks and benefits associated with the treatment.
You should contact your doctor immediately if any of the following adverse reactions occur:

• Fever (high body temperature). This is 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). Dehydration may occur as a result of severe or prolonged diarrhoea, 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; rare, may affect up to 1 in 100 people) or perforation of the stomach, oesophagus, or intestine (gastrointestinal perforation; rare, may affect up to 1 in 100 people). This may lead to death.

You should immediately inform your doctor if any of the above conditions affect you.

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

• decrease in the number of red blood cells (anaemia) or white blood cells (important for fighting infections)
• decrease in the number of platelets (increasing the risk of bleeding)
• loss of appetite (anorexia)
• stomach irritation, including nausea, vomiting, diarrhoea, or constipation
• back pain
• presence of blood in the urine
• feeling of fatigue, weakness, or lack of energy

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

• taste disturbances
• shortness of breath
• cough
• abdominal pain
• temporary hair loss (in most cases, normal hair regrowth should return)
• joint pain
• urinary tract infections
• absence of white blood cells associated with fever and infection
• tingling, pricking, burning sensation, or impaired sensation in hands and feet
• dizziness
• headache
• decreased or increased blood pressure
• feeling of discomfort in the stomach, heartburn, or burping
• stomach pain
• haemorrhoids
• muscle cramps
• pain during urination or frequent urination
• urinary incontinence
• kidney disease or impaired kidney function
• mouth or lip ulcers
• infections or risk of infections
• increased blood glucose levels
• insomnia
• disorientation
• feeling of anxiety
• abnormal sensation, loss of sensation, or pain in hands and feet
• difficulty maintaining balance
• rapid or irregular heartbeat
• blood clots in the legs or lungs
• episodes of skin flushing
• nail disorders (change in nail colour; nails may detach)
• mouth or throat pain
• rectal bleeding
• discomfort in muscles, weakness, or muscle pain
• swelling of feet or legs
• chills

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

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

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

• interstitial non-infectious pneumonia (lung inflammation causing cough and breathing difficulties)

Reporting of adverse reactions
If any adverse symptoms occur, including any adverse reactions not listed in this leaflet, you should inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C,
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Cabazitaxel G.L.

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

6. Contents of the package and other information

What Cabazitaxel G.L. contains

• The active substance is cabazitaxel. One millilitre of concentrate for solution for infusion contains 20 mg of cabazitaxel. One vial of concentrate for solution for infusion contains 60 mg of cabazitaxel.
• Other ingredients are: polysorbate 80, ethanol anhydrous (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 ranging in colour from yellow to brownish-yellow.
One vial contains 3 ml (nominal volume) of concentrate.
One pack contains one vial of concentrate.

Marketing Authorisation Holder
G.L. Pharma GmbH
Schlossplatz 1
8502 Lannach
Austria

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

This medicinal product is authorised in the European Economic Area Member States 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 detailed information, please contact the representative of the Marketing Authorisation 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
[email protected]

Information intended exclusively for healthcare professionals.

PRACTICAL INFORMATION FOR PHYSICIANS AND HEALTHCARE PROFESSIONALS
REGARDING THE PREPARATION, ADMINISTRATION, AND HANDLING OF
CABAZITAXEL G.L. 20 mg/ml CONCENTRATE FOR SOLUTION FOR INFUSION
The following information supplements sections 3 and 5 of the patient leaflet.
Before preparing the infusion solution, the entire procedure described below must be read and understood.

Recommendations for safe handling
Cabazitaxel is an antineoplastic agent and, like other potentially toxic compounds, should be handled with care. It is recommended to wear gloves when handling this product.
In case of contact of the concentrate or solution with the skin, wash the affected area immediately and thoroughly with soap and water. In case of contact with mucous membranes, immediately and thoroughly rinse the area with water.
Cabazitaxel G.L. should be prepared and administered only by personnel trained in handling cytotoxic agents. Pregnant healthcare workers should not handle this product.

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

Shelf life and special precautions during storage
Applies to the medicinal product packaging: Cabazitaxel G.L., 20 mg/ml, concentrate for solution for infusion
No special storage requirements apply.

After opening the vial
Chemical and physical stability has been demonstrated for 4 weeks at 2–8°C.
From a microbiological standpoint, the product should be used immediately after opening. If not used immediately, the user is responsible for the storage duration and conditions, which generally should not exceed 24 hours at 2–8°C. Dilution should be performed 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 in infusion containers not containing PVC for 14 days at 2–8°C and for 48 hours at 25°C.
From a microbiological standpoint, the product should be used immediately. If not used immediately, the user is responsible for the storage duration and conditions, which generally should not exceed 24 hours at 2–8°C, unless the dilution was performed 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) together 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 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 solution for infusion to reach room temperature (20–25°C) for approximately 5 minutes before use.
Depending on the required patient dose, more than one vial of Cabazitaxel G.L. 20 mg/ml concentrate for solution for infusion may be needed. Aseptically withdraw the required volume of cabazitaxel concentrate using a calibrated syringe equipped with a 21G needle.
Each ml of the medicinal product contains 20 mg of cabazitaxel.

Step 2
Inject the required volume of cabazitaxel concentrate (20 mg/ml) aseptically into a sterile, non-PVC infusion 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 drawn directly from the vial.
The final concentration of the infusion solution should be between 0.10 mg/ml and 0.26 mg/ml.

Step 3
Remove the syringe and gently mix the contents of the infusion bag or bottle by manual agitation (rocking motion).

Step 4
As with all parenteral products, visually inspect the prepared infusion solution before administration. Since the infusion solution is supersaturated, crystallization may occur over time. If crystals are observed, the solution must not be used and should be discarded.

Disposal
All materials used for dilution and administration must be disposed of according to standard procedures. Medicinal products must not be disposed of via wastewater. Consult a pharmacist for proper disposal methods of unused or expired medicines. This helps protect the environment.

The infusion solution should be used immediately. However, storage time of the prepared solution may be extended under specific conditions as described in the section "Shelf life and special precautions during storage."

An in-line filter with a nominal pore size of 0.22 micrometers (also referred to as 0.2 micrometers) is required during administration.

Infusion bags made of PVC or polyurethane infusion sets must not be used for the preparation or administration of cabazitaxel.

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

Any unused medicinal product or waste material must be disposed of in accordance with local regulations.