Cabazitaxel Msn

Package Leaflet: Information for the User

Cabazitaxel MSN, 60 mg, Concentrate and Solvent for Solution for Infusion

Cabazitaxel

Read All of This Leaflet Carefully Before You Start Using This Medicine Because It Contains Important Information for You.

• You should keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Pack:

• 1. What is Cabazitaxel MSN and What is it Used For
• 2. Before You Use Cabazitaxel MSN
• 3. How to Use Cabazitaxel MSN
• 4. Possible Side Effects
• 5. How to Store Cabazitaxel MSN
• 6. Contents of the Pack and Other Information

1. What is Cabazitaxel MSN and What is it Used For

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

2. Before You Use Cabazitaxel MSN

When Not to Use Cabazitaxel MSN:

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

Do not use Cabazitaxel MSN if any of the above applies to you.
In case of doubt, consult your doctor before using Cabazitaxel MSN.

Warnings and Precautions

Before each administration of Cabazitaxel MSN, blood tests are performed to check if the number of blood cells and liver and kidney function are suitable for the administration of Cabazitaxel MSN.
You should immediately inform your doctor if:

• you have a fever. During treatment with Cabazitaxel MSN, there is a risk of a decrease in the number of white blood cells. Your doctor will check your blood and monitor your overall 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 a fever, so if it occurs, you should immediately inform your doctor.
• you have a history of any allergies. During treatment with Cabazitaxel MSN, severe allergic reactions may occur.
• you have severe or prolonged diarrhea, nausea, or vomiting. All of these symptoms can lead to severe dehydration. They may also require treatment.
• you have a feeling of numbness, tingling, burning, or decreased sensation in your hands or feet.
• you have any bleeding from the intestines, change in stool color, or abdominal pain. If the bleeding or pain is severe, your doctor will stop the treatment with Cabazitaxel MSN. This is because Cabazitaxel MSN may increase the risk of bleeding or perforation of the intestinal wall.
• you have kidney problems.
• you have yellowing of the skin and eyes, dark urine, severe nausea (vomiting), or vomiting, which may be symptoms of liver disease.
• you have a significant increase or decrease in the amount of urine excreted in 24 hours.
• you have blood in your urine.

You should immediately inform your doctor if any of the above applies to you.
Your doctor may reduce the dose of Cabazitaxel MSN or stop the treatment.

Cabazitaxel MSN and Other Medicines

Tell your doctor, pharmacist, or nurse about all medicines you are taking or have recently taken, including those obtained without a prescription. This is because some medicines may affect the action of Cabazitaxel MSN or Cabazitaxel MSN may affect the action of other medicines. These medicines include:

• 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, inform your doctor that you are using Cabazitaxel MSN.

Pregnancy, Breast-feeding, and Fertility

Cabazitaxel MSN 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 MSN may be present in semen and may affect the fetus. Patients using Cabazitaxel MSN 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 MSN may affect fertility in men.

Driving and Using Machines

During treatment with this medicine, fatigue or dizziness may occur. In this case, do not drive vehicles, operate machines, or use tools until these symptoms have resolved.

Cabazitaxel MSN Contains Ethanol (Alcohol)

This medicine contains 573 mg of ethanol (alcohol) 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 you are addicted to alcohol, have liver disease, or have epilepsy, you should consult your doctor or pharmacist before using this medicine.

Cabazitaxel MSN Contains Polysorbate 80

Polysorbates may have an effect on circulation and the heart (e.g., low blood pressure, changes in heart rhythm).

3. How to Use Cabazitaxel MSN

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

• Cabazitaxel MSN is administered by a doctor or nurse.
• Cabazitaxel MSN must be properly prepared (diluted) before administration. This leaflet contains practical information for doctors, nurses, and pharmacists on handling Cabazitaxel MSN and its administration.
• Cabazitaxel MSN is administered in a hospital as an intravenous infusion lasting about one 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 calculation.
• Infusions are usually given every 3 weeks.

If you have any further questions about the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible Side Effects

Like all medicines, Cabazitaxel MSN can cause side effects, although not everybody gets them.
Your doctor should discuss the possible side effects with you and explain the risks and benefits of the treatment.

You Should Immediately Consult Your Doctor 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 loss of fluids (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 you have a perforated stomach, esophagus, or intestine (perforation of the gastrointestinal tract). This can lead to death.

You should immediately inform your doctor if any of the above applies to you.

Other Side Effects:

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

• decrease in red blood cells (anemia) or white blood cells (important for fighting infections)
• decrease in platelet count (which increases the risk of bleeding)
• loss of appetite (anorexia)
• stomach upset, including nausea, vomiting, diarrhea, or constipation
• back pain
• blood in urine
• feeling tired, weak, or lacking 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 growth should return)
• joint pain
• urinary tract infection
• low white blood cell count with fever and infection
• feeling of numbness, tingling, burning, or decreased sensation in hands and feet
• dizziness
• headache
• decrease or increase in blood pressure
• discomfort in the stomach, heartburn, or reflux
• stomach pain
• hemorrhoids
• muscle spasms
• pain when urinating or frequent urination
• urinary incontinence
• kidney disease or kidney problems
• 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 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 on the skin
• redness of the skin
• inflammation of the bladder, which may occur if you have 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 of Side Effects

If you experience any side effects, including those not listed in this leaflet, you should inform your 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, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
By reporting side effects, you can help provide more information on the safety of this medicine.
Side effects can also be reported to the marketing authorization holder.

5. How to Store Cabazitaxel MSN

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and vial label after EXP. The expiry date refers to the last day of that month.
There are no special storage instructions for this medicine.
Information on the storage conditions and shelf life of Cabazitaxel MSN after dilution and preparation for use is described in the section “PRACTICAL INFORMATION FOR HEALTHCARE PROFESSIONALS ON THE PREPARATION, ADMINISTRATION, AND HANDLING OF CABAZITAXEL MSN, 60 mg, CONCENTRATE AND SOLVENT FOR SOLUTION FOR INFUSION”.
Medicines should 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 MSN Contains

The active substance is cabazitaxel. One mL 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 96% ethanol and water for injection in the solvent (see section 2 “Cabazitaxel MSN contains alcohol”).
Note: Both the vial of Cabazitaxel MSN 60 mg/1.5 mL concentrate (fill volume: 73.2 mg cabazitaxel/1.83 mL) and the vial of solvent (fill volume: 5.67 mL) contain an excess of liquid to compensate for liquid loss during preparation. This excess ensures that after dilution with the ENTIREcontents of the accompanying solvent vial, the resulting solution contains 10 mg/mL of cabazitaxel.

What Cabazitaxel MSN Looks Like and Contents of the Pack

Cabazitaxel MSN is a concentrate and solvent for solution for infusion (sterile concentrate).
The concentrate is a clear, oily, colorless to pale yellow solution.
The solvent is a clear and colorless solution.
One pack of Cabazitaxel MSN contains:

• One single-dose vial made of colorless glass (type I), closed with a chlorobutyl rubber stopper sealed with an aluminum cap 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 sealed with an aluminum cap with a plastic flip-off cap, containing 4.5 mL (nominal volume) of solvent.

Marketing Authorization Holder and Manufacturer:

Marketing Authorization Holder:

MSN Labs Europe Limited
KW20A, Corradino Park
Paola, PLA 3000
Malta
tel.: (+48) 699 711 147

Importer:

Pharmadox Healthcare Ltd.
KW20A, Kordin Industrial Park
Paola, PLA 3000
Malta
MSN Labs Europe Limited
KW20A, Corradino Park
Paola, PLA 3000
Malta

This Medicinal Product is Authorized in the Member States of the European Economic Area Under the Following Names:

Netherlands:
Cabazitaxel MSN 60 mg concentrate and solvent for solution for infusion
Czech Republic: Cabazitaxel MSN
Hungary:
Cabazitaxel MSN 60 mg koncentrátum és oldószer oldatos infúzióhoz
Poland:
Cabazitaxel MSN
Romania:
Cabazitaxel MSN 60 mg concentrat şi solvent pentru soluţie perfuzabilă
Slovakia:
Cabazitaxel MSN

Date of Last Revision of the Leaflet: 09/2023

Information Intended for Healthcare Professionals Only:

PRACTICAL INFORMATION FOR HEALTHCARE PROFESSIONALS ON THE PREPARATION, ADMINISTRATION, AND HANDLING OF CABAZITAXEL MSN, 60 mg, CONCENTRATE AND SOLVENT FOR SOLUTION FOR INFUSION

The following information is a supplement to sections 3 and 5 for the user.
It is essential to read the entire description before preparing the infusion solution.

Incompatibilities

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

Shelf Life and Special Precautions for Storage

For the pack of Cabazitaxel MSN, 60 mg, concentrate and solvent for solution for infusion
After opening
The vials of concentrate and solvent should be used immediately. If the product is not used immediately, the in-use storage times and conditions are the responsibility of the user. From a microbiological point of view, the two-step dilution process must be carried out under controlled and aseptic conditions (see below “Precautions for preparation and administration”).
After initial dilutionof the Cabazitaxel MSN 60 mg concentrate vial with the entirecontents of the accompanying solvent vial: the physical and chemical stability has been demonstrated for 1 hour at room temperature.

After final dilution in an infusion bag and/or bottle:

The chemical and physical stability of the infusion solution has been demonstrated for 8 hours at room temperature (15°C-30°C), including the 1-hour infusion time, and for 48 hours under refrigeration conditions, including the 1-hour infusion time.
From a microbiological point of view, the infusion solution should be used immediately. If not used immediately, the in-use storage times and conditions are the responsibility of the user and would normally not be longer than 24 hours at 2°C-8°C, provided that the dilution has been made in a controlled and validated aseptic environment.

Precautions for Preparation and Administration

As with other anticancer medicines, caution should be exercised when handling Cabazitaxel MSN 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 Cabazitaxel MSN at any stage of handling, the affected area should be washed immediately with soap and water. In case of contact with mucous membranes, the area should be flushed with water. Cabazitaxel MSN should only be prepared and administered by personnel trained in the handling of cytotoxic substances. Pregnant women in the personnel should not handle the product.

Preparation Steps

Before mixing and diluting, read the ENTIREsection carefully. Preparation of Cabazitaxel MSN before administration requires TWOdilution steps. Follow the instructions below.
Note: Both the vial of Cabazitaxel MSN 60 mg/1.5 mL concentrate (fill volume: 73.2 mg cabazitaxel/1.83 mL) and the vial of solvent (fill volume: 5.67 mL) contain an excess of liquid to compensate for liquid loss during preparation. This excess ensures that after dilution with the ENTIREcontents of the accompanying solvent vial, 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 concentrate and solvent solutions should be clear.

Vial of concentrate
Vial of solvent

Step 1.2

Using a syringe with a needle, with asepsis, withdraw the entirecontents of the accompanying solvent vial, partially inverting the vial.

Vial of solvent

Step 1.3

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

Step 1.4

Remove the syringe and needle, and gently mix by hand through repeated inversion until a clear and homogeneous solution is obtained.
This may take about 45 seconds.

Step 1.5

Allow the solution to 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
Vial of solvent

Mixture of concentrate and solvent 10 mg/mL

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 solution 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 cabazitaxel) using a syringe with graduations and a needle. For example, a dose of 45 mg of cabazitaxel will require the administration of 4.5 mL of the mixture of concentrate and solvent prepared as described in Step 1.
During extraction, it is recommended to insert the syringe needle in the center, following the instructions in Step 1, as foam may persist on the walls of the vial of solution.

Step 2.2

Inject into a sterile infusion bag or bottle made of a material other than PVC containing 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.

Step 2.3

Remove the syringe and mix the contents of the infusion bag or bottle by gently rocking.

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 this case, the solution should not be used and should be discarded.

Mixture of concentrate and solvent 10 mg/mL

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

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.

Administration Method

Cabazitaxel MSN is administered as a 1-hour infusion.
During administration, it is recommended to use a filter with a nominal pore size of 0.22 microns (also known as 0.2 microns) attached to the infusion set.
Infusion bags or sets made of PVC or polyurethane infusion sets should not be used for preparation or administration.