Cabazitaxel Medical Vallei

Patient Information Leaflet: User Information

Cabazitaxel Medical Valley

60 mg, concentrate and solvent for solution for infusion

Cabazitaxel

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

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor, pharmacist, or nurse.
• If the patient experiences any side effects, including any 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 Medical Valley and what is it used for
• 2. Important information before using Cabazitaxel Medical Valley
• 3. How to use Cabazitaxel Medical Valley
• 4. Possible side effects
• 5. How to store Cabazitaxel Medical Valley
• 6. Contents of the pack and other information

1. What is Cabazitaxel Medical Valley and what is it used for

The common name is cabazitaxel. It belongs to a group of medicines called "taxanes," which are used to treat cancer. Cabazitaxel Medical Valley 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. Patients should consult their doctor for information about this medicine.

2. Important information before using Cabazitaxel Medical Valley

When not to use Cabazitaxel Medical Valley:

• If the patient is allergic (hypersensitive) to cabazitaxel, other taxanes, or polysorbate 80 or any of the other ingredients of the 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.

Do not use Cabazitaxel Medical Valley if any of the above apply to the patient. In case of doubts, consult a doctor before using Cabazitaxel Medical Valley.

Warnings and precautions

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

• Fever occurs. During the use of Cabazitaxel Medical Valley, there is a possibility of a reduced white blood cell count. The doctor will examine the blood and monitor the patient's overall condition for signs of infection and 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 the doctor immediately.
• There is a history of any allergies. During the use of Cabazitaxel Medical Valley, 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.
• There is 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 Medical Valley. This is because Cabazitaxel Medical Valley may increase the risk of bleeding or perforation of the intestinal wall.
• There are kidney disorders.
• There is yellowing of the skin and eyes, dark urine, severe nausea (vomiting), or vomiting, which may be symptoms of liver disease.
• There is a significant increase or decrease in the volume of urine excreted in 24 hours.
• There is blood in the urine.

Inform the doctor immediately if any of the above apply to the patient. The doctor may reduce the dose of Cabazitaxel Medical Valley or stop the treatment. Inform the doctor, pharmacist, or nurse about all medicines 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 Medical Valley or Cabazitaxel Medical Valley may affect the action of other medicines. This includes 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) (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 the doctor about the use of Cabazitaxel Medical Valley.

Pregnancy, breastfeeding, and fertility

Cabazitaxel Medical Valley is not indicated for use in women. The patient should use condoms during sexual intercourse if their partner is pregnant or may become pregnant. Cabazitaxel Medical Valley may be present in semen and may affect the fetus. Patients taking Cabazitaxel Medical Valley should not become fathers during the 4 months following the end of treatment, and before starting treatment, they should consult about storing their semen, as Cabazitaxel Medical Valley may affect fertility in men.

Driving and using machines

During the use of the medicine, fatigue or dizziness may occur. In such cases, do not drive vehicles, operate machinery, or use tools until these symptoms have resolved. This medicine contains 573 mg of alcohol (ethanol) in each vial of solvent. The amount of alcohol in a dose of this medicine is equivalent to less than 11 ml of beer or 5 ml of wine. The small amount of alcohol in this medicine is unlikely to have noticeable effects. If the patient is addicted to alcohol, has liver disease, or has epilepsy, they should consult their doctor or pharmacist before using this medicine. Polysorbates may affect the circulatory system and heart function (e.g., low blood pressure, heart rhythm disorders).

3. How to use Cabazitaxel Medical Valley

Instructions for use

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

• Cabazitaxel Medical Valley is administered by a doctor or nurse.
• Cabazitaxel Medical Valley must be properly prepared (diluted) before administration. This leaflet contains practical information for doctors, nurses, and pharmacists on handling Cabazitaxel Medical Valley and its administration.
• Cabazitaxel Medical Valley is administered in a hospital as an intravenous infusion lasting about an 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.

In case of any further doubts about the use of the medicine, consult a 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 and explain the potential risks and benefits of the treatment.

Inform the doctor 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 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 (perforation of the gastrointestinal tract). This can lead to death.

Inform the doctor immediately if any of the above apply to the patient.

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)
• Irritation of the stomach, 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
• Lack of white blood cells 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 reflux
• Stomach pain
• Hemorrhoids
• Muscle cramps
• Pain when urinating or frequent urination
• Urinary incontinence
• Kidney disease or kidney function disorders
• Mouth or lip ulcers
• Infections or risk of infections
• Increased blood sugar levels
• Insomnia
• Confusion
• Anxiety
• Abnormal sensation, loss of sensation, or pain in the hands and feet
• Difficulty maintaining balance
• Fast 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 or flushing
• Redness of the skin
• Cystitis, which may occur if the patient has previously undergone radiation therapy (radiation recall cystitis).

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

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

Reporting side effects

If any side effects occur, including any not listed in this leaflet, inform the doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the 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. By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Cabazitaxel Medical Valley

Store the medicine out of 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 month stated. This medicine does not require any special storage conditions. Information on the storage conditions and shelf life of Cabazitaxel Medical Valley 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 MEDICAL VALLEY". Any unused product or waste material should be disposed of in accordance with local requirements. This will help protect the environment.

6. Contents of the pack and other information

What Cabazitaxel Medical Valley contains

The active substance is cabazitaxel. One milliliter of concentrate contains 40 mg of cabazitaxel. Each vial of concentrate contains 60 mg of cabazitaxel. The other ingredients are polysorbate 80 and citric acid in the concentrate and ethanol 96% and water for injection in the solvent (see section 2 "Cabazitaxel Medical Valley contains alcohol"). Note: Both the vial of Cabazitaxel Medical Valley concentrate 60 mg/1.5 ml (fill volume: 73.2 mg cabazitaxel/1.83 ml) and the vial of solvent (fill volume: 5.67 ml) contain excess liquid to compensate for losses during preparation. This excess ensures that after dilution with the entire contents of the accompanying solvent, the resulting solution contains 10 mg/ml of cabazitaxel.

What Cabazitaxel Medical Valley looks like and contents of the pack

Cabazitaxel Medical Valley is a concentrate and solvent for solution for infusion (sterile concentrate). The concentrate is a clear, colorless or slightly yellowish, oily solution. The solvent is a clear, colorless solution. One pack of Cabazitaxel Medical Valley contains:

• One single-dose vial made of colorless glass (Type I), closed with a chlorobutyl rubber stopper and an aluminum seal with a plastic flip-off cap, containing 1.5 ml (nominal volume) of concentrate.
• One single-dose vial made of colorless glass (Type I), closed with a chlorobutyl rubber stopper and an aluminum seal with a plastic flip-off cap, containing 4.5 ml (nominal volume) of solvent.

Marketing authorization holder

Medical Valley Invest AB
Brädgårdsvägen 28
236 32 Höllviken
Sweden

Importer

Pharmadox Healthcare Ltd.

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

Date of last revision of the leaflet: 13.09.2023

Information intended for healthcare professionals only.

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

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

Incompatibilities

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

Shelf life and special precautions for storage

For the packaging of the medicinal product Cabazitaxel Medical Valley 60 mg, concentrate and solvent: After opening, the vials of concentrate and solvent should be used immediately. Otherwise, the user is responsible for the storage time and conditions. From a microbiological point of view, the two-step dilution process must be carried out under controlled and aseptic conditions (see below "Precautions during preparation and administration").

After initial dilution

The vial of Cabazitaxel Medical Valley concentrate diluted with the entire contents of the accompanying solvent has been shown to be physically and chemically stable for 1 hour at room temperature.

After final dilution in the infusion bag and/or bottle

The infusion solution has been shown to be chemically and physically stable for 8 hours at room temperature (15°C-30°C), including the 1-hour infusion time, and for 48 hours under refrigeration, including the 1-hour infusion time. 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 exceed 24 hours at 2°C-8°C if the dilution is performed under controlled and validated aseptic conditions.

Precautions during preparation and administration

As with other anticancer medicines, handle the medicinal product Cabazitaxel Medical Valley and prepare its solutions with caution, 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 Medical Valley on the skin at any stage of handling, wash the affected area immediately with soap and water. In case of contact with the mucous membranes, rinse the affected area immediately with water. Cabazitaxel Medical Valley should be prepared and administered only by personnel trained in handling cytotoxic substances. Female personnel who are pregnant should not handle the medicinal product.

Steps for preparation

Read the entire section carefully before mixing and diluting. Preparation of Cabazitaxel Medical Valley before administration requires TWO dilution steps. Follow the instructions below. Note: Both the vial of Cabazitaxel Medical Valley concentrate 60 mg/1.5 ml (fill volume: 73.2 mg cabazitaxel/1.83 ml) and the vial of solvent (fill volume: 5.67 ml) contain excess liquid to compensate for losses during preparation. This excess ensures that after dilution with the entire contents of the accompanying solvent, the resulting solution contains 10 mg/ml of cabazitaxel.

Step 1: Initial dilution of the concentrate for solution for infusion using the accompanying solvent.

Step 1.1

Inspect the vial of concentrate and the vial of solvent. The solutions of concentrate and solvent should be clear and practically free of particles.

Step 1.2

Using a syringe with a needle, with asepsis, draw up the entire contents of the accompanying solvent, partially inverting the vial. Vial of solvent, Vial of concentrate (60 mg - 1.5 ml)

Vial of solvent

Step 1.3

Inject the entire contents of the solvent into the corresponding vial of concentrate. To minimize foaming during the injection of the solvent, direct the needle to the inner wall of the vial of concentrate solution and inject slowly. After the first dilution, the resulting solution contains 10 mg/ml of cabazitaxel.

Mixture of concentrate and solvent, 10 mg/ml, Vial of solvent

Step 1.4

Remove the syringe and needle, and gently mix the contents of the vial by hand through multiple inversions until a clear and homogeneous solution is obtained. This may take about 45 seconds.

Mixture of concentrate and solvent 10 mg/ml

Step 1.5

Let the solution stand for about 5 minutes, then check if the solution is homogeneous and clear. Persistence of foam after this time is a normal phenomenon.

Mixture of concentrate and solvent 10 mg/ml, The resulting mixture of concentrate and solvent contains 10 mg/ml of cabazitaxel (at least 6 ml of the volume to be administered). The second dilution should be performed immediately (within 1 hour) as described in the section "Step 2". To administer the prescribed dose, more than one vial of the mixture of concentrate and solvent may be needed.

Step 2: Second (final) dilution of the infusion solution

Step 2.1

With asepsis, transfer the required volume of the mixture of concentrate and solvent (10 mg/ml of cabazitaxel) using a syringe with graduations and a needle. For example, a dose of 45 mg of Cabazitaxel Medical Valley will require 4.5 ml of the mixture of concentrate and solvent prepared as described in Step 1.

Mixture of concentrate and solvent 10 mg/ml

Step 2.2

Inject into a sterile bag or bottle of 5% glucose solution or 9 mg/ml (0.9%) sodium chloride solution for infusion. The concentration of the infusion solution should be between 0.10 mg/ml and 0.26 mg/ml.

5% glucose solution, or 9 mg/ml (0.9%), sodium chloride solution for infusion, Required amount of mixture of concentrate and solvent

Step 2.3

Remove the syringe and mix the contents of the bag or bottle by hand, performing a rocking motion.

Step 2.4

As with any medicinal product for parenteral administration, the resulting infusion solution should be inspected before use. Since the infusion solution is supersaturated, it may crystallize over time. In such cases, 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 above in the section "Shelf life and special precautions for storage". Any unused product or waste material should be disposed of in accordance with local requirements.

Method of administration

Cabazitaxel Medical Valley is administered as a 1-hour infusion. During the administration of the medicinal product, it is recommended to use a filter with a nominal pore size of 0.22 microns (also known as 0.2 microns) on the infusion set. Do not use infusion bags made of PVC or polyurethane infusion sets to prepare and administer the medicinal product.