Cabazitaxel msn

Package leaflet: Information for the user

Cabazitaxel MSN, 60 mg, concentrate and solvent for solution for infusion
Cabazitaxelum
Please read all of this leaflet carefully before this medicine is administered, because it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor, pharmacist or nurse.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of the leaflet:

1. What Cabazitaxel MSN is and what it is used for
2. Important information before receiving 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 Cabazitaxel MSN is and what it is used for

The name of the medicine is Cabazitaxel MSN. The common name is cabazitaxel. It belongs to a group of medicines called "taxanes", which are used in cancer treatment.
Cabazitaxel MSN 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, a corticosteroid (prednisone or prednisolone) must also be taken orally every day. Please consult your doctor for information about this medicine.

2. Important information before using Cabazitaxel MSN

When not to use Cabazitaxel MSN:

• if the patient is allergic to cabazitaxel, other taxanes, or polysorbate 80, or any of the other ingredients of this medicine (listed in section 6),
• if the patient has too low a white blood cell count (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 MSN must not be used if any of the above apply to the patient.
If in doubt, consult a doctor before using Cabazitaxel MSN.
Warnings and precautions
Before each administration of Cabazitaxel MSN, blood tests will be performed to check whether blood cell counts, and liver and kidney function, are adequate for administration of Cabazitaxel MSN.
Immediately inform the doctor if:

• Fever occurs. During treatment with Cabazitaxel MSN, there is a risk of reduced white blood cell count. 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. Life-threatening infections may occur in patients with low blood counts. Fever may be the earliest sign of infection, so the doctor must be informed immediately if fever develops.
• The patient has previously experienced any allergies (hypersensitivity). Severe allergic reactions may occur during treatment with Cabazitaxel MSN.
• Severe or prolonged diarrhoea, nausea, or vomiting occur. Any of these symptoms may lead to severe dehydration and may require medical treatment.
• Numbness, tingling, burning sensations, or reduced sensation in the hands or feet occur.
• Bleeding from the intestines, changes in stool color, or abdominal pain occur. If bleeding or pain is severe, the doctor will discontinue treatment with Cabazitaxel MSN. This is because Cabazitaxel MSN may increase the risk of intestinal bleeding or perforation.
• Kidney disorders occur.
• Yellowing of the skin or eyes, dark-colored urine, severe nausea or vomiting occur, which may be symptoms of liver disease.
• A significant increase or decrease in daily urine output occurs.
• Blood appears in the urine.

Immediately inform the doctor if any of the above occur.
The doctor may reduce the dose of Cabazitaxel MSN or discontinue treatment.
Cabazitaxel MSN 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 MSN or Cabazitaxel MSN may affect the action of other medicines. These include:

• 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 MSN.
Pregnancy, breastfeeding, and fertility
Cabazitaxel MSN is not indicated for use in women.
The patient should use condoms during sexual intercourse if his partner is pregnant or could become pregnant. Cabazitaxel MSN may be present in semen and may harm the unborn child. Patients receiving Cabazitaxel MSN should not father a child within 4 months after the end of treatment. Before starting treatment, patients should consult their doctor about sperm storage, as Cabazitaxel MSN may affect male fertility.
Driving and operating machinery
Fatigue or dizziness may occur during treatment with this medicine. If these symptoms occur, the patient should not drive, operate machinery, or use tools until these symptoms resolve.
Cabazitaxel MSN contains ethanol (alcohol)
This medicine contains 573 mg of alcohol (ethanol) per 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 cause noticeable effects. However, if the patient is alcohol-dependent, has liver disease, or epilepsy, the doctor or pharmacist should be consulted before using this medicine.
Cabazitaxel MSN contains polysorbate 80
Polysorbates may affect circulation and the heart (e.g. low blood pressure, changes in heart rhythm).

3. How to use Cabazitaxel MSN

Before receiving Cabazitaxel MSN, patients are given antiallergic medications 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. Practical information for doctors, nurses, and pharmacists on handling and administration of Cabazitaxel MSN can be found in this leaflet.
• Cabazitaxel MSN is administered in a hospital setting as an intravenous infusion lasting approximately one hour, delivered into one of the patient's veins (intravenous administration).
• As part of the treatment, patients must also take a corticosteroid (prednisone or prednisolone) orally every day.

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 appropriate dose accordingly.
• Infusions are usually given every 3 weeks.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
The treating physician should discuss possible side effects with the patient and explain
the risks and benefits of treatment.
Patients should immediately contact their doctor if any of the following
side effects occur:

• Fever (high body temperature). This is common (may affect up to 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 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 side effects:
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 urine
• Feeling of fatigue, weakness, or lack of energy.

Common (may affect less than 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 kidney function disorders
• 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
• Flushing (sudden redness of the skin)
• Pain in the mouth or throat
• Bleeding from the rectum
• Discomfort, weakness, or muscle pain
• Swelling of feet or legs
• Chills
• Nail disorders (change in nail colour; nails may detach).

Uncommon (may affect less than 1 in 100 people):

• Low blood potassium levels
• Ringing in the ears
• Sensation of warmth on the skin
• Redness of the skin
• Cystitis, which may occur if the patient has previously undergone radiotherapy (radiation-induced cystitis).

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

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

Reporting of side effects
If any side effects occur, including any not listed in this leaflet, patients should inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring Adverse Drug Reactions 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
Reporting side effects helps provide more information on the safety of this medicine.
Side effects can also be reported to the marketing authorisation 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 stated on the carton and vial label after:
EXP. The expiry date refers to the last day of the stated month.
No special storage conditions are required for this medicine.
Information regarding the storage conditions and duration for Cabazitaxel MSN after dilution and
preparation for use is provided in the section “PRACTICAL INFORMATION FOR PHYSICIANS AND
HEALTHCARE PROFESSIONALS ON THE PREPARATION, ADMINISTRATION, AND HANDLING OF
THE MEDICINAL PRODUCT CABAZITAXEL MSN”.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This 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 injections in the solvent (see section 2, “Cabazitaxel MSN contains alcohol”).
Note: Both the vial containing the Cabazitaxel MSN concentrate 60 mg/1.5 mL (fill volume:
73.2 mg cabazitaxel/1.83 mL) and the vial containing the solvent (fill volume: 5.67 mL) contain an
overage of liquid to compensate for losses during preparation. This overage ensures that after dilution with THE ENTIRE contents of the supplied solvent, 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, colourless to pale yellow solution.
The solvent is a clear, colourless solution.
One pack of Cabazitaxel MSN contains:

• One single-use vial made of colourless glass (Type I), closed with a chlorobutyl rubber stopper sealed with an aluminium cap and a plastic flip-off cap, containing 1.5 mL (nominal volume) of concentrate.
• One single-use vial made of colourless glass (Type I), closed with a chlorobutyl rubber stopper sealed with an aluminium cap and a plastic flip-off cap, containing 4.5 mL (nominal volume) of solvent.

Marketing Authorisation Holder and Manufacturer:
Marketing Authorisation 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 authorised in the Member States of the European Economic Area under the following names:
Netherlands: Cabazitaxel MSN 60 mg concentraat en oplosmiddel voor oplossing voor infusie
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

Information intended exclusively for healthcare professionals:

PRACTICAL INFORMATION FOR PHYSICIANS AND HEALTHCARE PROFESSIONALS
REGARDING THE PREPARATION, ADMINISTRATION, AND HANDLING
OF CABAZITAXEL MSN, 60 MG, CONCENTRATE AND SOLVENT FOR
PREPARATION OF INFUSION SOLUTION
The following information supplements sections 3 and 5 of the user instructions.
It is important to read the entire procedure description before preparing the infusion solution.

Pharmaceutical 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 Cabazitaxel MSN 60 mg concentrate and solvent pack:
After opening
Vials of concentrate and solvent should be used immediately. If the product is not used immediately, the user is responsible for the storage time and conditions. From a microbiological standpoint, the two-step dilution process must be carried out under controlled and aseptic conditions (see below "Precautions for preparation and administration").

After initial dilution, when the 60 mg Cabazitaxel MSN concentrate vial is diluted using the entire contents of the solvent vial: physical and chemical stability has been demonstrated for 1 hour at room temperature.

After final dilution in an infusion bag and/or bottle:
Chemical and physical stability of the infusion solution has been demonstrated for 8 hours at room temperature (15°C–30°C), including a 1-hour infusion time, and for 48 hours under refrigerated conditions (2°C–8°C), including a 1-hour infusion time.

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 storage should generally not exceed 24 hours at 2°C–8°C, provided the dilution was performed under controlled and validated aseptic conditions.

Precautions for preparation and administration
As with other antineoplastic agents, caution should be exercised when handling Cabazitaxel MSN and preparing its solutions, including the use of equipment to limit exposure to the medicinal product, personal protective equipment (e.g., gloves), and procedures for preparing the medicinal product for use.

If Cabazitaxel MSN comes into contact with the skin at any stage of handling, the affected area should be washed immediately and thoroughly with soap and water. In case of contact with mucous membranes, the area should be rinsed immediately and thoroughly with water. Cabazitaxel MSN should be prepared and administered only by personnel trained in handling cytotoxic substances. Pregnant healthcare workers should not handle this medicinal product.

The concentrate for infusion solution must always be diluted with the entire provided solvent before being added to the infusion solution.

Preparation steps
Before mixing and diluting, carefully read the entire section. Preparation of Cabazitaxel MSN prior to administration requires TWO dilution steps. Follow the instructions provided below.

Note: both the 60 mg/1.5 mL Cabazitaxel MSN concentrate vial (fill volume: 73.2 mg cabazitaxel/1.83 mL) and the solvent vial (fill volume: 5.67 mL) contain an overage of liquid to compensate for losses during preparation. This overage ensures that after dilution with the entire contents of the provided solvent, the resulting solution contains 10 mg/mL cabazitaxel.

The two-step dilution process described below must be performed aseptically to prepare the infusion solution.

Step 1: Initial dilution of the concentrate for infusion solution using the provided solvent
Step 1.1

Carefully inspect the concentrate vial and the vial containing the provided solvent.
The concentrate solution and solvent should be clear.
Concentrate vial (60 mg – 1.5 mL) Solvent vial

Step 1.2

Using a syringe with an attached needle, aseptically withdraw the entire contents of the provided solvent, partially inverting the vial if necessary.
Solvent vial

Step 1.3

Inject the entire contents into the appropriate concentrate vial.
To minimize foam formation during solvent injection, direct the needle against the inner wall of the concentrate vial and inject slowly.
After the first dilution, the resulting solution contains 10 mg/mL cabazitaxel.
Concentrate and solvent mixture
Solvent vial
10 mg/mL

Step 1.4

Remove the syringe and needle and gently mix by repeated inversion until a clear, homogeneous solution is obtained.
This may take approximately 45 seconds.
Concentrate and solvent mixture 10 mg/mL

Step 1.5

Allow the solution to stand for approximately 5 minutes, then check whether the solution is homogeneous and clear.
The presence of foam after this time is normal.
Concentrate and solvent mixture 10 mg/mL

The resulting concentrate and solvent mixture contains 10 mg/mL cabazitaxel (at least 6 mL volume for administration). The second dilution must be performed immediately (within 1 hour) as described in Step 2.

More than one vial of the concentrate and solvent mixture may be required to administer the prescribed dose.

Step 2: Second (final) dilution for infusion solution
Step 2.1

Aseptically transfer the required volume of the concentrate and solvent mixture (10 mg/mL cabazitaxel) using a graduated syringe with an attached needle. For example, a 45 mg cabazitaxel dose will require 4.5 mL of the mixture prepared as described in Step 1.
During extraction, it is recommended to insert the syringe needle in the center, as described in Step 1, since foam may persist on the vial walls.
Concentrate and solvent mixture 10 mg/mL

Step 2.2

Inject into a sterile non-PVC infusion bag containing either 5% glucose solution or 9 mg/mL (0.9%) sodium chloride solution for infusion. The final concentration of the infusion solution should be between 0.10 mg/mL and 0.26 mg/mL.
Required volume of concentrate and solvent mixture 5% glucose solution or
9 mg/mL (0.9%) sodium chloride solution for infusion

Step 2.3
Remove the syringe and manually mix the contents of the bag or infusion bottle by gentle agitation.

Step 2.4
As with any parenteral medicinal product, the resulting infusion solution should be visually inspected before use. Since the infusion solution is supersaturated, crystallization may occur over time. In such cases, the solution must 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 specific conditions described above in the section "Shelf life and special precautions for storage".

Any unused portions of the medicinal product or waste materials should be disposed of in accordance with local regulations.

Administration method
Cabazitaxel MSN is administered as a 1-hour infusion.
A filter with a nominal pore size of 0.22 microns (also referred to as 0.2 microns) should be used during administration, placed in-line on the infusion set.

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