Cabazitaxel ever pharma

Cabazitaxel Ever Pharma, 10 mg/ml, concentrate for solution for infusion
cabazitaxel

Please read the entire leaflet carefully before using this medicine, as it contains important information for the patient.

• Keep this leaflet for future reference.
• If you have any questions, please consult your doctor, pharmacist, or nurse.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents:

1. What Cabazitaxel Ever Pharma is and what it is 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 Cabazitaxel Ever Pharma is and what it is 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 in cancer treatment.

Cabazitaxel Ever Pharma is used to treat prostate cancer when disease progression has occurred after prior chemotherapy. The medicine works by stopping the growth and division of cells.

As part of the treatment, you must also take a corticosteroid (prednisone or prednisolone) orally every day. Please consult your doctor for further 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 white blood cell count is too low (neutrophil count less than or equal to 1500/mm³).
• If the patient has impaired liver function.
• If the patient has recently received or is scheduled to receive the yellow fever vaccine.

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

Warnings and precautions

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

Immediately inform the doctor if any of the following occur:

• Fever. Treatment with Cabazitaxel EVER Pharma 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 an adequate white blood cell count. Patients with low blood counts may develop life-threatening infections. Fever may be the earliest sign of infection; therefore, it is essential to inform the doctor immediately if fever occurs.
• History of any allergies (allergic reactions). Severe allergic reactions may occur during treatment with Cabazitaxel EVER Pharma.
• Severe or prolonged diarrhoea, nausea, or vomiting. These symptoms may lead to severe dehydration and may require medical treatment.
• Numbness, tingling, burning sensations, or reduced sensation in the hands or feet.
• Any gastrointestinal bleeding, change in stool color, or abdominal pain. If bleeding or pain is severe, the doctor will discontinue treatment with Cabazitaxel EVER Pharma. This is because Cabazitaxel EVER Pharma may increase the risk of gastrointestinal bleeding or bowel perforation.
• Kidney problems.
• Yellowing of the skin or eyes, dark-colored urine, severe nausea or vomiting, which may be symptoms of liver disease.
• Significant increase or decrease in daily urine output.
• Presence of blood in the urine.

Immediately inform the doctor if any of the above apply to the patient.
The doctor may reduce the dose of Cabazitaxel EVER Pharma or discontinue treatment.

Cabazitaxel EVER Pharma and other medicines

Inform the doctor, pharmacist, or nurse about all medicines currently used or recently used, 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 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).

Inform the doctor about using Cabazitaxel EVER Pharma before receiving any vaccinations.

Pregnancy, breastfeeding, and effects on fertility

Cabazitaxel EVER Pharma must not be used in pregnant women or in women of childbearing potential who are not using an effective method of contraception.

Cabazitaxel EVER Pharma must not be used during breastfeeding.

Patients should use condoms during sexual intercourse if their partner is pregnant or could become pregnant. Cabazitaxel EVER Pharma may be present in semen and may harm the unborn child. Patients receiving Cabazitaxel EVER Pharma should not father a child within 6 months after the end of treatment. Before starting treatment, patients should consult their doctor about sperm storage, as Cabazitaxel EVER Pharma may impair fertility in men.

Driving and operating machinery

During treatment, fatigue or dizziness may occur. In such cases, patients should not drive, operate machinery, or use tools until these symptoms resolve.

Cabazitaxel EVER Pharma contains ethanol (alcohol)

4.5 ml vial
This medicine contains 888.8 mg of alcohol (ethanol) per 4.5 ml vial, equivalent to 22.5 ml of beer or 9.4 ml of wine.

5 ml vial
This medicine contains 987.5 mg of alcohol (ethanol) per 5 ml vial, equivalent to 25 ml of beer or 10.4 ml of wine.

6 ml vial
This medicine contains 1,185 mg of alcohol (ethanol) per 6 ml vial, equivalent to 30 ml of beer or 12.5 ml of wine.

The amount of alcohol contained in this medicine is unlikely to have an effect in adults and adolescents.

The alcohol in this medicine may interact with other medicines. Inform the doctor about any other medicines being taken.

If the patient is alcohol-dependent, inform the doctor or pharmacist before receiving this medicine.

3. How to use Cabazitaxel EVER Pharma

Instructions for use
Before administration of Cabazitaxel EVER Pharma, patients are given antiallergic medications
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. Practical information for doctors, nurses, and pharmacists on handling and administration of Cabazitaxel EVER Pharma is provided in this leaflet.
• Cabazitaxel EVER Pharma is administered in a hospital setting 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 is based 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 given every 3 weeks.

If you have any further questions regarding the use of this medicine, please consult your
doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
The treating physician should discuss with the patient the possible adverse reactions and explain the potential risks and benefits of treatment.
It is necessary to contact a doctor immediately if any of the following adverse reactions occur:

• Fever (high body temperature). Occurs frequently (may affect up to 1 in 10 people).
• Severe loss of body fluids (dehydration). Occurs frequently (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 perforated stomach, oesophagus, or intestine (gastrointestinal perforation). This may lead to death.

Patients should immediately inform their doctor if any of the above apply.
Other adverse reactions include:
Very common (may affect more than 1 in 10 people):

• decrease in red blood cells (anaemia) or white blood cells (important for fighting infections)
• decrease in 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 infection
• lack of white blood cells associated with fever and infection
• sensation of numbness, tingling, burning, or reduced sensation in hands and feet
• dizziness
• headache
• decreased or increased blood pressure
• feeling of stomach discomfort, 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 sugar levels
• insomnia
• confusion
• feeling of anxiety
• abnormal sensation, loss of sensation, or pain in hands and feet
• difficulty maintaining balance
• fast or irregular heartbeat
• blood clot in the legs or lungs
• sudden skin flushing
• pain in the mouth or throat
• bleeding from the rectum
• discomfort, weakness, or muscle pain
• swelling of the feet or legs
• chills
• nail disorders (change in nail colour; nails may detach).

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

• decreased potassium levels in the blood
• ringing in the ears
• sensation of skin warmth
• skin redness
• bladder inflammation, which may occur if the patient has previously undergone radiotherapy (radiation cystitis due to recurrence of radiation-induced symptoms).

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

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

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, patients should inform their doctor. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions, 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
Adverse reactions can also be reported to the responsible entity.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Cabazitaxel Ever Pharma

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 on the vial
after "Expiry date (EXP)". The expiry date refers to the last day of the stated month.
This medicine does not require any special storage conditions.
Do not freeze.
Multiple-dose vials: After first opening, 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 regarding storage conditions and duration of Cabazitaxel Ever Pharma 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 THE MEDICINAL PRODUCT CABAZITAXEL EVER PHARMA".
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Cabazitaxel EVER Pharma contains
The active substance is cabazitaxel. One ml of concentrate for solution for infusion contains
cabazitaxel monohydrate or anhydrous cabazitaxel equivalent to 10 mg of cabazitaxel.
Each vial containing 4.5 ml of concentrate for solution for infusion contains cabazitaxel
monohydrate or anhydrous cabazitaxel equivalent to 45 mg of cabazitaxel.
Each vial containing 5 ml of concentrate for solution for infusion contains cabazitaxel
monohydrate or anhydrous cabazitaxel equivalent to 50 mg of cabazitaxel.
Each vial containing 6 ml of concentrate for solution for infusion contains cabazitaxel
monohydrate or anhydrous cabazitaxel equivalent to 60 mg of cabazitaxel.
Each vial of Cabazitaxel EVER Pharma medicinal product contains an overage of concentrate for
solution for infusion to ensure withdrawal of a volume of 4.5 ml, 5 ml or 6 ml containing 10 mg/ml
of cabazitaxel.
The other ingredients 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, slightly yellow solution.
One pack of Cabazitaxel EVER Pharma contains:
One type I colourless glass vial closed with a grey bromobutyl rubber stopper and an aluminium
cap with a plastic flip-off cap, containing 4.5 ml (5 ml or 6 ml) of concentrate.
Vials may, but do not have to, be protected with a protective cover.

Marketing Authorisation 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 authorised in the European Economic Area countries 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

Information intended exclusively for medical professionals:

PRACTICAL INFORMATION FOR PHYSICIANS AND HEALTHCARE WORKERS
REGARDING THE PREPARATION, ADMINISTRATION, AND HANDLING
OF THE MEDICINAL PRODUCT CABAZITAXEL EVER PHARMA
The following information supplements sections 3 and 5 of the user instructions.
Before preparing the infusion solution, the entire procedure described below must be read thoroughly.

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

Shelf life and special precautions during storage
This medicinal product does not require any special storage conditions.
Do not freeze.

After first opening:
Multiple-dose vials: Chemical and physical stability of the solution has been demonstrated for 28 days at temperatures below 25°C. The medicinal product Cabazitaxel Ever Pharma is suitable for multiple use.

After dilution in an infusion bag and (or) bottle:
Chemical and physical stability of the infusion solution has been demonstrated for 48 hours at temperatures below 25°C and for 14 days under refrigerated conditions.

From a microbiological standpoint, the infusion solution should be used immediately after preparation. Otherwise, the user is responsible for the storage time and conditions, and the storage period should generally not exceed 24 hours at temperatures below 25°C, provided dilution was performed under controlled and validated aseptic conditions.

Precautions during preparation and administration
The medicinal product Cabazitaxel Ever Pharma must be prepared and administered only by personnel trained in handling cytotoxic substances. Pregnant women among the medical staff should not handle this product.

As with other antineoplastic agents, caution must be exercised when handling Cabazitaxel Ever Pharma and preparing its solutions, including the use of equipment limiting exposure to the medicinal product, personal protective equipment (e.g., gloves), and procedures for preparing the product for use. In case of contact of the medicinal product Cabazitaxel Ever Pharma with the skin at any stage of handling, the contaminated area must be washed immediately and thoroughly with soap and water. In case of contact with mucous membranes, the affected area must be rinsed immediately and thoroughly with water.

Preparation steps
Please read ALL of this section carefully. The medicinal product Cabazitaxel Ever Pharma requires ONLY A SINGLE dilution step before administration.

The dilution process described below must be performed aseptically to prepare the infusion solution.
Preparation of the appropriate dose may require the use of more than one vial of concentrate.

Dilution for preparation of the infusion solution
Step 1: Using a graduated syringe, aseptically withdraw the appropriate amount of concentrate (10 mg/mL of cabazitaxel). For example, a 45 mg dose of Cabazitaxel Ever Pharma requires withdrawal of 4.5 mL of concentrate.

Each vial of the medicinal product Cabazitaxel Ever Pharma contains an excess of concentrate to allow withdrawal of 4.5 mL, 5 mL, or 6 mL of solution containing 10 mg/mL of cabazitaxel, ensuring accurate dosing.

Step 2: Inject into a sterile container other than one made of PVC, containing either 5% glucose solution or 9 mg/mL (0.9%) sodium chloride solution for infusion. The final concentration of the infusion solution should range between 0.10 mg/mL and 0.26 mg/mL.

Step 3: Remove the syringe and mix the contents of the infusion bag or bottle manually by gentle swirling.

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

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

Cabazitaxel Ever Pharma must not be mixed with any other medicinal products than those specified.

Any unused residues or waste materials must be disposed of in accordance with local regulations.

Method of administration
The medicinal product Cabazitaxel Ever Pharma is administered as a 1-hour infusion.

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