Cabazitaxel Ever Pharma

PATIENT INFORMATION LEAFLET: USER INFORMATION

Cabazitaxel EVER Pharma, 10 mg/ml, concentrate for solution for infusion

Cabazitaxel

Read the contents of the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• If the patient experiences any side effects, including any side effects 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 EVER Pharma and what is it used for
• 2. Important information before using Cabazitaxel EVER Pharma
• 3. How to use Cabazitaxel EVER Pharma
• 4. Possible side effects
• 5. How to store Cabazitaxel EVER Pharma
• 6. Contents of the pack and other information

1. What is Cabazitaxel EVER Pharma and what is it used for

The name of the medicine is Cabazitaxel EVER Pharma. The common name is cabazitaxel. It belongs to a group of medicines called "taxanes", which are used to treat cancer.
Cabazitaxel EVER Pharma is used to treat prostate cancer when the disease has progressed after using another type of chemotherapy. The medicine works by stopping the growth and division of cells.
Part of the treatment also includes taking a corticosteroid (prednisone or prednisolone) orally every day. You should consult your doctor for information about this medicine.

2. Important information before using Cabazitaxel EVER Pharma

When not to use Cabazitaxel EVER Pharma:

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

Do not take Cabazitaxel EVER Pharma if any of the above apply to you. If in doubt, consult your doctor before using Cabazitaxel EVER Pharma.

Warnings and precautions

Before each administration of Cabazitaxel EVER Pharma, blood tests are performed to check if the patient's blood cell count and liver and kidney function are suitable for administration of Cabazitaxel EVER Pharma.
Inform your doctor immediately if:

• Fever occurs. During treatment with Cabazitaxel EVER Pharma, there is a risk of a decrease in the number of white blood cells. The doctor will examine the blood and monitor the patient's general condition for signs of infection. They 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, inform your doctor immediately.
• There is a history of any allergies. During treatment with Cabazitaxel EVER Pharma, severe allergic reactions may occur.
• Severe or prolonged diarrhea, nausea, or vomiting occur. All of these symptoms can lead to severe dehydration and may require treatment.
• There is a feeling of numbness, tingling, burning, or decreased sensation in the hands or feet.
• Any gastrointestinal bleeding, changes in stool color, or abdominal pain occur. If the bleeding or pain is severe, the doctor will stop treatment with Cabazitaxel EVER Pharma. This is because Cabazitaxel EVER Pharma may increase the risk of bleeding or perforation of the gastrointestinal tract.
• Kidney disorders occur.
• Jaundice, dark urine, severe nausea (vomiting), or vomiting occur, which may be signs of liver disease.
• There is a significant increase or decrease in the amount of urine produced in 24 hours.
• Blood appears in the urine.

Inform your doctor immediately if any of the above apply to you. The doctor may reduce the dose of Cabazitaxel EVER Pharma or stop treatment.

Cabazitaxel EVER Pharma and other medicines

Tell your doctor, pharmacist, or nurse about all medicines you are currently taking or have recently taken, including those obtained without a prescription. This is because some medicines may affect the action of Cabazitaxel EVER Pharma or Cabazitaxel EVER Pharma 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 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, inform your doctor that you are taking Cabazitaxel EVER Pharma.

Pregnancy, breastfeeding, and fertility

Do not use Cabazitaxel EVER Pharma in pregnant women or women of childbearing age who are not using effective contraception.
Do not use Cabazitaxel EVER Pharma during breastfeeding.
The patient should use condoms during sexual intercourse if their partner is pregnant or may become pregnant. Cabazitaxel EVER Pharma may be present in semen and may affect the fetus. Patients taking Cabazitaxel EVER Pharma should not become fathers for 6 months after the end of treatment, and before starting treatment, they should consult about storing their semen, as Cabazitaxel EVER Pharma may affect fertility in men.

Driving and using machines

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

Cabazitaxel EVER Pharma contains ethanol (alcohol)

Vial of 4.5 ml
This medicine contains 888.8 mg of alcohol (ethanol) in each 4.5 ml vial, which is equivalent to 22.5 ml of beer or 9.4 ml of wine.
Vial of 5 ml
This medicine contains 987.5 mg of alcohol (ethanol) in each 5 ml vial, which is equivalent to 25 ml of beer or 10.4 ml of wine.
Vial of 6 ml
This medicine contains 1,185 mg of alcohol (ethanol) in each 6 ml vial, which is equivalent to 30 ml of beer or 12.5 ml of wine.
The amount of alcohol in this medicine is unlikely to have an effect in adults and adolescents.
The alcohol in this medicine may affect the action of other medicines. Inform your doctor about other medicines you are taking.
If you are addicted to alcohol, inform your doctor or pharmacist before taking this medicine.

3. How to use Cabazitaxel EVER Pharma

Instructions for use

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

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

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.

If you have any further doubts about using the 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. The attending doctor should discuss possible side effects with the patient and explain the potential risks and benefits of treatment.

Inform your doctor immediately if you experience any of the following side effects:

• Fever (high body temperature). This occurs frequently (may affect up to 1 in 10 people).
• Severe 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 perforated stomach, esophagus, or intestine (gastrointestinal perforation). This can lead to death.

Inform your doctor immediately if any of the above apply to you.

Other side effects include:

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

• decreased red blood cell count (anemia) or white blood cell count (important for fighting infections)
• decreased platelet count (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 tired, weak, or lacking 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 infection
• low white blood cell count associated with fever and infection
• feeling of numbness, tingling, burning, or decreased sensation in the hands and feet
• dizziness
• headache
• decreased or increased blood pressure
• discomfort in the stomach, heartburn, or belching
• stomach pain
• hemorrhoids
• muscle spasms
• pain when urinating or frequent urination
• urinary incontinence
• kidney disease or kidney function disorders
• mouth or lip ulcers
• infections or risk of infections
• high blood sugar levels
• insomnia
• confusion
• feeling anxious
• 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
• mouth or throat pain
• rectal bleeding
• discomfort, weakness, or muscle pain
• swelling of the feet or legs
• chills
• nail disorders (change in nail color; nails may detach).

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

• low potassium levels in the blood
• ringing in the ears
• feeling of heat in the skin
• redness of the skin
• urinary bladder inflammation, which may occur if the patient has previously undergone radiation therapy (radiation-induced cystitis).

Frequency not known(cannot be estimated from the available data):

• non-infectious interstitial lung disease (lung disease causing cough and difficulty breathing).

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, inform your doctor. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, PL-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 will help to gather more information on the safety of this medicine.

5. How to store Cabazitaxel EVER Pharma

Store the medicine in a place inaccessible to children.
Do not use this medicine after the expiry date stated on the carton and label on the vial after "Expiry Date (EXP)". The expiry date refers to the last day of the month stated.
This medicine does not require any special storage conditions.
Do not freeze.
Multi-dose vials: After the first opening, the chemical and physical stability of the solution has been demonstrated for 28 days at a temperature below 25°C. The medicinal product Cabazitaxel EVER Pharma is suitable for multiple use.
Information on the storage conditions and shelf life of Cabazitaxel EVER Pharma 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 EVER PHARMA".
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Cabazitaxel EVER Pharma contains

The active substance of the medicine is cabazitaxel. One milliliter of the concentrate for solution for infusion contains cabazitaxel monohydrate or anhydrous, equivalent to 10 mg of cabazitaxel.
Each vial of 4.5 ml of the concentrate for solution for infusion contains cabazitaxel monohydrate or anhydrous, equivalent to 45 mg of cabazitaxel.
Each vial of 5 ml of the concentrate for solution for infusion contains cabazitaxel monohydrate or anhydrous, equivalent to 50 mg of cabazitaxel.
Each vial of 6 ml of the concentrate for solution for infusion contains cabazitaxel monohydrate or anhydrous, equivalent to 60 mg of cabazitaxel.
Each vial of the medicinal product Cabazitaxel EVER Pharma contains an excess of the concentrate for solution for infusion to ensure that 4.5 ml, 5 ml, or 6 ml containing 10 mg/ml of cabazitaxel can be withdrawn.
The other ingredients of the medicine are polysorbate 80, macrogol 300, citric acid, and anhydrous ethanol (see section 2 "Cabazitaxel EVER Pharma contains ethanol (alcohol)").

What Cabazitaxel EVER Pharma looks like and contents of the pack

Cabazitaxel EVER Pharma is a concentrate for solution for infusion (sterile concentrate).
The concentrate is a clear, oily solution with a slightly yellow color.
One pack of Cabazitaxel EVER Pharma contains:
One vial made of colorless glass type I, closed with a gray rubber stopper and an aluminum seal, which has a plastic cap (flip-off closure), containing 4.5 ml (5 ml or 6 ml) of the concentrate.
The vials may, but do not have to be, protected by a protective sleeve.

Marketing authorization holder

EVER Valinject GmbH
Oberburgau 3
4866 Unterach am Attersee
Austria

Manufacturer

EVER Pharma Jena GmbH
Otto-Schott-Straße 15
07745 Jena
Germany
EVER Pharma Jena GmbH
Brüsseler Str. 18
07747 Jena
Germany

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

Austria
Cabazitaxel EVER Pharma 10 mg/ml Konzentrat zur Herstellung einer Infusionslösung
Belgium
Cabazitaxel EVER Pharma 10 mg/ml concentraat voor oplossing voor infusie/solution à diluer pour perfusion / Konzentrat zur Herstellung einer Infusionslösung
Germany
Cabazitaxel EVER Pharma 10 mg/ml Konzentrat zur Herstellung einer Infusionslösung
Denmark
Cabazitaxel EVER Pharma
Spain
Cabazitaxel EVER Pharma 10 mg/ml concentrado para solución para perfusión
Finland
Cabazitaxel EVER Pharma 10 mg/ml infuusiokonsentraatti, liuosta varten
France
Cabazitaxel EVER Pharma 10 mg/ml, solution à diluer pour perfusion
Croatia
Cabazitaxel EVER Pharma 10 mg/ml koncentrat za otopinu za infuziju
Hungary
Cabazitaxel EVER Pharma 10 mg/ml koncentrátum oldatos infúzióhoz
Ireland
Cabazitaxel EVER Pharma 10 mg/ml concentrate for solution for infusion
Italy
Cabazitaxel EVER Pharma
Netherlands
Cabazitaxel EVER Pharma 10 mg/ml concentraat voor oplossing voor infusie
Norway
Cabazitaxel EVER Pharma 10 mg/ml konsentrat til infusjonsvæske, oppløsning
Poland
Cabazitaxel EVER Pharma
Portugal
Cabazitaxel EVER Pharma
Slovenia
Kabazitaksel EVER Pharma 10 mg/ml koncentrat za raztopino za infundiranje
Sweden
Cabazitaxel EVER Pharma 10 mg/ml koncentrat till infusionsvätska, lösning
Slovakia
Cabazitaxel EVER Pharma 10 mg/ml infúzny koncentrát
United Kingdom
Cabazitaxel EVER Pharma 10 mg/ml concentrate for solution for infusion
Date of last revision of the leaflet: 01.07.2023

Information intended for healthcare professionals only:

PRACTICAL INFORMATION FOR DOCTORS AND HEALTHCARE PROFESSIONALS ON THE PREPARATION, ADMINISTRATION, AND HANDLING OF THE MEDICINAL PRODUCT CABAZITAXEL EVER PHARMA

The following information is a supplement to sections 3 and 5 for the user.
Before preparing the infusion solution, read the entire description of the procedure.

Incompatibilities

Do not mix this medicinal product with other medicinal products, except those used for dilution.

Shelf life and special precautions for storage

This medicine does not require any special storage conditions.
Do not freeze.
After the first opening:
Multi-dose vials: The chemical and physical stability of the solution has been demonstrated for 28 days at a temperature below 25°C. The medicinal product Cabazitaxel EVER Pharma is suitable for multiple use.

After dilution in a bag and (or) bottle for infusion:

The chemical and physical stability of the infusion solution has been demonstrated for 48 hours at a temperature below 25°C and for 14 days under refrigeration.
From a microbiological point of view, the infusion solution should be used immediately after preparation. Otherwise, the user is responsible for the storage time and conditions, and the storage time should not normally exceed 24 hours at a temperature below 25°C, provided that the dilution has been made in controlled and validated aseptic conditions.

Precautions for preparation and administration

The medicinal product Cabazitaxel EVER Pharma should be prepared and administered only by personnel trained in the handling of cytotoxic substances. Female personnel who are pregnant should not handle the product.
As with other anticancer medicines, caution should be exercised when handling the medicinal product Cabazitaxel EVER Pharma and preparing its solutions, taking into account the use of equipment that minimizes exposure to the medicinal product, personal protective equipment (e.g., gloves), and procedures for preparing the medicinal product for use. In case of contact with the medicinal product Cabazitaxel EVER Pharma on the skin at any stage of handling, the affected area should be washed immediately with soap and water. In case of contact with the mucous membranes, the affected area should be rinsed immediately with water.

Preparation stages

Read ALLof this section carefully. The medicinal product Cabazitaxel EVER Pharma requires ONLY ONEdilution before administration.
The dilution process described below must be performed aseptically to prepare the infusion solution.

Dilution for preparation of the infusion solution

Step 1: Using a syringe with a scale, aseptically withdraw the required amount of concentrate (10 mg/ml of cabazitaxel). For example, a dose of 45 mg of Cabazitaxel EVER Pharma requires the withdrawal of 4.5 ml of the concentrate.
Each vial of the medicinal product Cabazitaxel EVER Pharma contains an excess of the concentrate for solution for infusion to ensure that 4.5 ml, 5 ml, or 6 ml containing 10 mg/ml of cabazitaxel can be withdrawn.
Step 2: Inject into a sterile container, other than one made of PVC, containing 5% glucose solution or 9 mg/ml (0.9%) sodium chloride infusion solution. The concentration of the infusion solution should be between 0.10 mg/ml and 0.26 mg/ml.
Step 3: Remove the syringe and manually mix the contents of the bag or bottle for infusion by shaking it.
Step 4: As with all products for parenteral administration, the 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.
The infusion solution should be used immediately after preparation. However, the storage time of the prepared solution may be longer under certain conditions described in the section Shelf life and special precautions for storageabove.
The medicinal product Cabazitaxel EVER Pharma should not be mixed with other medicinal products except those mentioned.
Any unused product or waste material should be disposed of in accordance with local requirements.

Method of administration

The medicinal product Cabazitaxel EVER Pharma is administered as a 1-hour infusion.
When preparing and administering the medicinal product Cabazitaxel EVER Pharma, do not use infusion bags made of PVC or polyurethane infusion sets.