CABAZITAXEL DR. REDDYS 60 mg CONCENTRATE AND SOLVENT FOR SOLUTION FOR INFUSION

Introduction

Package Leaflet: Information for the User

Cabazitaxel Dr. Reddys 60 mg concentrate and solvent for solution for infusion EFG

cabazitaxel

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

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

Contents of the pack

1. What is Cabazitaxel Dr. Reddys and what is it used for
2. What you need to know before you are given Cabazitaxel Dr. Reddys
3. How to use Cabazitaxel Dr. Reddys
4. Possible side effects
5. Storage of Cabazitaxel Dr. Reddys
6. Contents of the pack and other information

1. What is Cabazitaxel Dr. Reddys and what is it used for

The name of your medicine is Cabazitaxel Dr. Reddys. Its common name is cabazitaxel. It belongs to a group of medicines called "taxanes", used to treat cancers.

This medicine is used to treat prostate cancer that has progressed after receiving other chemotherapy. It works by stopping the growth and multiplication of cells.

As part of your treatment, you will also take a corticosteroid (prednisone or prednisolone) every day by mouth. Ask your doctor for information about this other medicine.

2. What you need to know before you are given Cabazitaxel Dr. Reddys

Do not use Cabazitaxel Dr. Reddys:

• if you are allergic (hypersensitive) to cabazitaxel, other taxanes, polysorbate 80, or any of the other excipients of this medicine (included in section 6),
• if your white blood cell count is very low (neutrophil count less than or equal to 1,500/mm3),
• if you have severe liver problems,
• if you have recently been or are going to be vaccinated against yellow fever.

Do not receive this medicine if any of the above circumstances apply to you. If you are not sure, consult your doctor before receiving this medicine.

Warnings and precautions

Before starting treatment with this medicine, you will have blood tests to check that you have enough blood cells and that your kidneys and liver are working properly to receive this medicine.

Tell your doctor immediately if:

• you have a fever. During treatment with this medicine, it is more likely that your white blood cell count will decrease. Your doctor will check your blood and general condition to detect signs of infection. You may be given other medicines to keep your blood cell count up. People with low cell counts can develop life-threatening infections. The first sign of infection may be a fever, so if you have a fever, tell your doctor immediately.

• you have ever had any allergy. During treatment with this medicine, severe allergic reactions can occur.

• you have severe or persistent diarrhea, feel unwell (nausea) or are being sick (vomiting). Any of these situations can cause severe dehydration. Your doctor should give you treatment.

• you have a feeling of numbness, tingling, burning, or decreased sensation in your hands and feet.

• you have any bleeding problems in the intestine or have changes in the color of your stool or stomach pain. If the bleeding or pain is severe, your doctor will interrupt your treatment with this medicine. This is because this medicine may increase the risk of bleeding or development of perforations in the intestinal wall.

• you have kidney problems.

• liver problems appear during treatment.

• you notice yellowing of the skin and eyes, dark urine, severe nausea (feeling of sickness) or vomiting, as these may be signs or symptoms of liver problems.

• you notice that the volume of your urine increases or decreases significantly.

• you have blood in your urine.

If any of the above circumstances apply to you, tell your doctor immediately. Your doctor may reduce the dose of this medicine or interrupt treatment.

Using Cabazitaxel Dr. Reddys with other medicines

Tell your doctor, pharmacist, or nurse if you are using or have recently used other medicines, including those obtained without a prescription. This is because some medicines can affect the effectiveness of this medicine or this medicine can affect the effectiveness of other medicines.

These medicines include:

• ketoconazole, rifampicin (for infections);
• carbamazepine, phenobarbital, or phenytoin (for seizures);
• St. John's Wort or hypericum (herbal medicine used to treat depression and other problems);
• statins (such as simvastatin, lovastatin, atorvastatin, rosuvastatin, or pravastatin) (to lower cholesterol in your blood);
• valsartan (for high blood pressure);
• repaglinide (for diabetes).

While you are being treated with this medicine, consult your doctor before getting vaccinated.

Pregnancy, breastfeeding, and fertility

Cabazitaxel is not indicated in women.

This medicine should not be used in pregnant or breastfeeding women.

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

This medicine should not be used during breastfeeding.

Use condoms during sexual intercourse if your partner is or may become pregnant. This medicine may be present in your semen and may affect the fetus. It is recommended not to father a child during and up to 6 months after treatment and to ask for information about sperm preservation before treatment, as this medicine may alter male fertility.

Driving and using machines

During treatment with this medicine, you may feel tired or dizzy. If this happens, do not drive or use tools or machines until you feel better.

Cabazitaxel Dr. Reddys contains ethanol (alcohol)

This medicine contains 573.3 mg of alcohol (ethanol) in each vial of solvent. The amount in the dose of this medicine is equivalent to less than 15 ml of beer or 6 ml of wine. The small amount of alcohol in this medicine will not have noticeable effects. If you are addicted to alcohol, have liver disease, or epilepsy, consult your doctor or pharmacist before taking this medicine.

3. How to use Cabazitaxel Dr. Reddys

Instructions for use

Before receiving this medicine, you will be given anti-allergic medicines to reduce the risk of allergic reactions.

• This medicine will be administered by a doctor or nurse.

• This medicine must be prepared (diluted) before administration. This leaflet provides practical information for the handling and administration of this medicine for doctors, nurses, and pharmacists.

• This medicine will be administered in the hospital through a drip (infusion) in one of your veins (intravenously) for approximately 1 hour.

• As part of your treatment, you will also take a corticosteroid medicine (prednisone or prednisolone) by mouth every day.

How much and how often it is administered

• The usual dose depends on your body surface area. Your doctor will calculate your body surface area in square meters (m2) and decide the dose you should receive.
• Usually, you will receive an infusion every 3 weeks.

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount ingested.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Your doctor will discuss this with you and explain the risks and potential benefits of your treatment.

Go to your doctor immediately if you notice any of the following side effects:

• fever (high temperature). This is very common (may affect more than 1 in 10 people).
• severe loss of body fluids (dehydration). This is common (may affect up to 1 in 10 people). This can happen if you have severe or persistent diarrhea, or fever, or if you have been vomiting.
• severe stomach pain or stomach pain that does not go away. This can happen if you have a perforation in the stomach, esophagus, or intestine (gastrointestinal perforation). This can cause death.

If any of the above circumstances apply to you, tell your doctor immediately.

Other side effects include:

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

• reduction in the number of red blood cells (anemia), or white blood cells (which are important for fighting infections)
• reduction in the number of platelets (which results in an increased risk of bleeding)
• loss of appetite (anorexia)
• alteration of taste
• shortness of breath
• cough
• stomach upset, including nausea, vomiting, diarrhea, or constipation
• abdominal pain
• hair loss in the short term (in most cases, hair grows back normally)
• back pain
• joint pain
• blood in the urine
• fatigue, weakness, or lack of energy.

Common(may affect up to 1 in 10 people):

• alteration of taste
• difficulty breathing
• cough
• abdominal pain
• hair loss in the short term (in most cases, hair grows back normally)
• joint pain
• urinary tract infection
• low white blood cell count associated with fever and infection
• feeling of numbness, tingling, burning, or decreased sensation in hands and feet
• dizziness
• headache
• increase or decrease in blood pressure
• stomach upset, heartburn, or belching
• stomach pain
• hemorrhoids
• muscle spasms
• frequent or painful urination
• urinary incontinence
• kidney problems
• mouth or lip ulcers
• infections or risk of infections
• high blood sugar levels
• insomnia
• mental confusion
• feeling of anxiety
• feeling of numbness or loss of sensation or pain in hands and feet
• ringing in the ears
• balance problems
• rapid or irregular heartbeat
• blood clots in the legs or lungs
• feeling of heat or flushing of the skin
• mouth or throat pain
• rectal bleeding
• red skin
• muscle disorders, weakness, or pain
• swelling of feet or legs
• chills
• nail disorders (change in nail color; nails may come off).

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

• low potassium levels in the blood
• ringing in the ears
• heat in the skin
• redness of the skin.

• inflammation of the bladder, which can occur when your bladder has been previously exposed to radiation therapy (radiation recall cystitis).

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

• interstitial lung disease (inflammation of the lungs causing cough and difficulty breathing).

Reporting of side effects:

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Cabazitaxel Dr. Reddys

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiration date that appears on the packaging and on the label of the vials after CAD. The expiration date is the last day of the month indicated.

Do not refrigerate.

In the section "PRACTICAL INFORMATION FOR DOCTORS OR HEALTHCARE PROFESSIONALS ON THE PREPARATION, ADMINISTRATION, AND HANDLING OF CABAZITAXEL DR. REDDYS" includes information on the storage and use time of this medicine, once it has been diluted and is ready to use.

The disposal of unused medicine and all materials that have come into contact with it will be carried out in accordance with local regulations. These measures will help protect the environment.

6. Container Contents and Additional Information

Composition of Cabazitaxel Dr. Reddys

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 components are polysorbate 80 and citric acid in the concentrate, and ethanol 96% and water for injectable preparations in the solvent (see section 2 "Cabazitaxel Dr. Reddys contains ethanol (alcohol)").

Note: Both the vial of Cabazitaxel Dr. Reddys 60 mg/1.5 ml concentrate (fill volume: 73.2 mg of cabazitaxel/1.83 ml) and the vial of solvent (fill volume: 5.70 ml) contain an overfill to compensate for liquid loss during preparation. This overfill ensures that after dilution with the complete contents of the provided solvent, there is a solution containing 10 mg/ml of cabazitaxel.

Appearance and Container Contents of the Product

Cabazitaxel Dr. Reddys is a concentrate and solvent for solution for infusion (sterile concentrate).

The concentrate is a clear, oily solution, yellow to yellowish-brown in color.

The solvent is a clear, colorless solution.

A pack of Cabazitaxel Dr. Reddys contains:

• A single-use glass vial, closed with an orange chlorobutyl rubber stopper, sealed with an aluminum cap, covered with a greenish-clear plastic flip-off cap, containing 1.5 ml (nominal volume) of concentrate.
• A single-use glass vial, closed with a gray chlorobutyl rubber stopper, sealed with a golden aluminum cap, covered with a colorless plastic flip-off cap, containing 4.5 ml (nominal volume) of solvent.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Reddy Pharma Iberia, S.A.

Avda. Josep Tarradellas nº 38

08029 Barcelona (Spain)

Phone Number: 93.355.49.16

Fax Number: 93.355.49.61

Manufacturer

betapharm Arzneimittel GmbH,

Kobelweg 95,

86156 Augsburg

Germany

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

Date of Last Revision of this Leaflet:April 2024

The Following Information is Intended for Healthcare Professionals Only.

PRACTICAL INFORMATION FOR DOCTORS OR HEALTHCARE PROFESSIONALS ON

THE PREPARATION, ADMINISTRATION, AND HANDLING OF CABAZITAXEL DR. REDDYS 60 mg

CONCENTRATE AND SOLVENT FOR SOLUTION FOR INFUSION

This information complements sections 3 and 5 for the user.

It is essential that you read the entire content of this procedure before preparing the infusion solution.

Incompatibilities

This medicinal product must not be mixed with other medicinal products except those used for dilutions.

PVC infusion containers or polyurethane infusion sets must not be used for the preparation and administration of the infusion solution.

Shelf Life and Special Precautions for Storage

For the pack of Cabazitaxel Dr. Reddys 60 mg concentrate and solvent

Do not refrigerate.

After opening the vial

The vials of concentrate and solvent must be used immediately. If not used immediately, the time and storage conditions are the responsibility of the user. From a microbiological point of view, the two-stage dilution process must be carried out under controlled and aseptic conditions (see below "Precautions for Preparation and Administration").

After Initial Dilutionof Cabazitaxel Dr. Reddys 60 mg concentrate with the complete contents of the vial of solvent: chemical and physical stability in use has been demonstrated for 1 hour at room temperature and for 21 days at 2°C - 8°C.

After Final Dilution in the Infusion Bag/Bottle

Chemical and physical stability of the infusion solution has been demonstrated for 8 hours at room temperature (15°C - 30°C) including 1 hour of infusion time and for 48 hours in the refrigerator including infusion time.

From a microbiological point of view, the infusion solution must be used immediately. If not used immediately, the times and storage conditions are the responsibility of the user and should not normally exceed 24 hours at 2°C - 8°C, unless the dilution has been carried out under controlled and validated aseptic conditions.

Precautions for Preparation and Administration

As with other antineoplastic agents, caution should be exercised during the preparation and administration of Cabazitaxel Dr. Reddys solutions, taking into account the use of safety devices, personal protective equipment (e.g., gloves), and preparation procedures.

If, at any stage of preparation, Cabazitaxel Dr. Reddys comes into contact with the skin, wash immediately and thoroughly with water and soap. If it comes into contact with mucous membranes, wash immediately and thoroughly with water.

Cabazitaxel Dr. Reddys should only be prepared and administered by personnel trained in the handling of cytotoxic agents. Pregnant workers should not handle it.

Always dilute the concentrate for solution for infusion with the complete solvent provided before adding it to the infusion solutions.

Preparation Stages

Read this entire section carefully before mixing and diluting. Cabazitaxel Dr. Reddys requires TWO dilutions before administration. Follow the preparation instructions provided below.

Note: Both the vial of Cabazitaxel Dr. Reddys 60 mg/1.5 ml concentrate (fill volume: 73.2 mg of cabazitaxel/1.83 ml) and the vial of solvent (fill volume: 5.67 ml) contain an overfill to compensate for liquid loss during preparation. This overfill ensures that after dilution with the complete contents of the provided solvent, there is a solution containing 10 mg/ml of cabazitaxel.

To prepare the infusion solution, the following two-stage dilution process must be carried out aseptically.

Stage 1: Initial Dilution of Concentrate for Solution for Infusion with the Provided Solvent.

Stage 1.1

Stage 1.2

Stage 1.3

Stage 1.4

Stage 1.5

This resulting concentrate-solvent mixture contains 10 mg/ml of cabazitaxel (at least 6 ml of released volume). The second dilution should be carried out immediately (before 1 hour) as detailed in Stage 2.

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

Stage 2: Final Dilution for Infusion

Stage 2.1

Stage 2.2

Stage 2.3

Stage 2.4

The infusion solution should be used immediately. However, the in-use storage time may be longer under the specific conditions mentioned in the section Shelf Life and Special Precautions for Storage.

Disposal of unused medicinal products and all materials that have come into contact with them will be carried out in accordance with local regulations.

Method of Administration

Cabazitaxel Dr. Reddys is administered by infusion over 1 hour.

The use of an in-line filter with a 0.22-micron nominal pore size (also known as 0.2 microns) is recommended during administration.

PVC infusion containers or polyurethane infusion sets must not be used for the preparation and administration of the infusion solution.