Cabazitaxel Dr. Reddy's 60 mg concentrate and solvent for solution for infusion EFG

Package leaflet: Information for the user

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, as you may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• If you experience any adverse reactions, talk to your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

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

This medicine is used to treat prostate cancer that has progressed after prior 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) orally every day. Ask your doctor for information about this other medicine.

2. What you need to know before starting Cabazitaxel Dr. Reddys

Do not use Cabazitaxel Dr. Reddys:

• if you are allergic (hypersensitive) to cabazitaxel, to other taxanes, to polysorbate 80, or to any of the other excipients of this medicine (listed 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 received or are scheduled to receive the yellow fever vaccine.

You must not receive this medicine if any of the above apply to you. If you are unsure, consult your doctor before receiving this medicine.

Warnings and precautions

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

Inform your doctor immediately if:

• you have a fever. During treatment with this medicine, your white blood cell count is more likely to decrease. Your doctor will monitor your blood and general condition for signs of infection. You may be given other medicines to help maintain your blood cell counts. People with low blood cell counts may develop infections that could be life-threatening. Fever may be the first sign of infection, so if you develop a fever, inform your doctor immediately.

• you have ever had any allergies. Severe allergic reactions may occur during treatment with this medicine.

• you have severe or persistent diarrhea, feel unwell (nausea), or are vomiting. Any of these conditions may cause severe dehydration. Your doctor will need to treat you accordingly.

• you experience numbness, tingling, burning sensations, or reduced sensation in your hands and feet.

• you have intestinal bleeding problems, changes in the color of your stools, or stomach pain. If bleeding or pain is severe, your doctor will stop 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 develop during treatment.

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

• you notice a significant increase or decrease in your urine volume.

• you have blood in your urine.

If any of the above occur, inform your doctor immediately. Your doctor may reduce the dose of this medicine or stop treatment.

Use of Cabazitaxel Dr. Reddys with other medicines

Inform your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription. This is because some medicines may affect the effectiveness of this medicine, or this medicine may affect the effectiveness of other medicines.

These medicines include:

• ketoconazole, rifampicin (for infections);
• carbamazepine, phenobarbital, or phenytoin (for seizures);
• St. John’s wort (Hypericum perforatum) (a herbal remedy used to treat depression and other conditions);
• statins (such as simvastatin, lovastatin, atorvastatin, rosuvastatin, or pravastatin) (to lower cholesterol in your blood);
• valsartan (for hypertension);
• repaglinide (for diabetes).

While receiving treatment with this medicine, consult your doctor before getting vaccinated.

Pregnancy, breastfeeding, and fertility

Cabazitaxel is not indicated for use in women.

This medicine must not be used in pregnant women or women of childbearing age who are not using contraception.

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 must not be used during breastfeeding.

Use condoms during sexual intercourse if your partner is or could be pregnant. This medicine may be present in your semen and could harm the fetus. It is recommended that you avoid fathering a child during treatment and for 6 months after treatment ends. You should also seek advice about sperm preservation before starting treatment, as this medicine may impair male fertility.

Driving and using machines

During treatment with this medicine, you may feel tired or dizzy. If this happens, do not drive or operate tools or machinery 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. However, if you are alcohol-dependent, have liver disease, or have epilepsy, consult your doctor or pharmacist before taking this medicine.

3. How to use Cabazitaxel Dr. Reddy's

Instructions for use

Before receiving this medicine, you will be given antiallergic 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 patient information leaflet provides practical guidance on the handling and administration of this medicine for doctors, nurses, and pharmacists.

• This medicine will be administered in the hospital through an intravenous infusion (drip) into one of your veins over approximately 1 hour.

• As part of your treatment, you will also take an oral corticosteroid medicine (prednisone or prednisolone) daily by mouth.

Dosage and frequency

• The usual dose depends on your body surface area. Your doctor will calculate your body surface area in square meters (m²) and determine the dose you should receive.
• You will usually 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 at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them. Your doctor will discuss this with you and explain the potential risks and benefits of your treatment.

Contact your doctor immediately if you notice any of the following adverse 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 may occur if you have severe or prolonged diarrhea, fever, or have been vomiting.
• severe stomach pain or stomach pain that does not go away. This may occur if you have a perforation in the stomach, esophagus, or intestine (gastrointestinal perforation). This may be fatal.

If any of the above situations occur, inform your doctor immediately.

Other adverse 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 (resulting in an increased risk of bleeding)
• loss of appetite (anorexia)
• altered taste
• shortness of breath
• cough
• stomach discomfort, including nausea, vomiting, diarrhea, or constipation
• abdominal pain
• short-term hair loss (in most cases, hair grows back normally)
• back pain
• joint pain
• blood in the urine
• tiredness, weakness, or lack of energy.

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

• altered taste
• difficulty breathing
• cough
• abdominal pain
• short-term hair loss (in most cases, normal hair growth should occur)
• joint pain
• urinary tract infection
• low white blood cell count associated with fever and infections
• sensation of numbness, tingling, burning, or reduced sensation in hands and feet
• dizziness
• headache
• increased or decreased blood pressure
• stomach discomfort, heartburn, or burping
• stomach pain
• hemorrhoids
• muscle spasms
• frequent or painful urination
• urinary incontinence
• kidney problems or impairment
• mouth or lip ulcers
• infections or increased risk of infections
• high blood sugar levels
• insomnia
• mental confusion
• feeling of anxiety
• unusual sensation 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
• sensation of warmth or flushing of the skin
• mouth or throat pain
• rectal bleeding
• redness of the skin
• discomfort, disorders, weakness, or muscle pain
• swelling of feet or legs
• chills
• nail disorders (change in nail color; nails may become detached).

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

• low potassium levels in the blood
• ringing in the ear
• warmth of the skin
• redness of the skin
• inflammation of the bladder, which may occur when your bladder has previously been exposed to radiotherapy (radiation recall cystitis).

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

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

Reporting of adverse effects:

If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are possible adverse effects not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse 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 expiry date stated on the container and on the label of the vials after EXP. The expiry date refers to the last day of the month indicated.

Do not refrigerate.

Information on the storage and duration of use of this medicine once diluted and ready for administration is provided in the section “PRACTICAL INFORMATION FOR PHYSICIANS OR HEALTHCARE PROFESSIONALS ON THE PREPARATION, ADMINISTRATION AND HANDLING OF CABAZITAXEL DR. REDDYS”.

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

6. Contents of the pack and other information

Composition of Cabazitaxel Dr. Reddys

The active substance is cabazitaxel. One ml of concentrate contains 40 mg of cabazitaxel. Each concentrate vial contains 60 mg of cabazitaxel.

The other components are polysorbate 80 and citric acid in the concentrate, and 96% ethanol and water for injections in the solvent (see section 2 “Cabazitaxel Dr. Reddys contains ethanol (alcohol)”).

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

Nature and contents of the container

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

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

The solvent is a clear, colourless solution.

One pack of Cabazitaxel Dr. Reddys contains:

• One single-use, clear glass vial, closed with an orange chlorobutyl rubber stopper, sealed with an aluminium cap, and covered with a light green plastic flip-off cap, containing 1.5 ml (nominal volume) of concentrate.
• One single-use, clear glass vial, closed with a grey chlorobutyl rubber stopper, sealed with a golden aluminium cap, and covered with a colourless plastic flip-off cap, containing 4.5 ml (nominal volume) of solvent.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Reddy Pharma Iberia, S.A.

Avda. Josep Tarradellas nº 38

08029 Barcelona (Spain)

Telephone: 93.355.49.16

Fax: 93.355.49.61

Manufacturer

betapharm Arzneimittel GmbH,

Kobelweg 95,

86156 Augsburg

Germany

This medicinal product is authorised in the Member States of the European Economic Area under the following names:

Country	Proposed Name
DE	Cabazitaxel beta 60 mg concentrate and solvent for solution for infusion
ES	Cabazitaxel Dr. Reddys 60 mg concentrate and solvent for infusion solution EFG
FR	CABAZITAXEL REDDY PHARMA 60 mg, solution to be diluted and solvent for solution for infusion
IT	Cabazitaxel Dr. Reddy's
UK	Cabazitaxel 60 mg Concentrate And Solvent For Solution For Infusion

Date of the most recent review of this leaflet: April 2024

The following information is intended for healthcare professionals only.

PRACTICAL INFORMATION FOR PHYSICIANS OR HEALTHCARE PROFESSIONALS ON

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

CONCENTRATE AND SOLVENT FOR PERFUSION SOLUTION

This information supplements sections 3 and 5 for the user.

It is important to read the entire content of this procedure before preparing the perfusion solution.

Incompatibilities

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

Polyvinyl chloride (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 Cabazitaxel Dr. Reddys 60 mg concentrate and solvent pack

Do not refrigerate.

After opening the vial

The concentrate and solvent vials should be used immediately. If not used immediately, the duration and conditions of storage are the responsibility of the user. From a microbiological standpoint, the two-step dilution process must be carried out under controlled and aseptic conditions (see below "Preparation and administration precautions").

After initial dilution of Cabazitaxel Dr. Reddys 60 mg concentrate with the complete contents of the solvent vial: chemical and physical in-use stability 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 perfusion solution has been demonstrated for 8 hours at room temperature (15°C – 30°C), including 1 hour of infusion time, and for 48 hours under refrigeration (2°C – 8°C), including the 1 hour infusion time.

From a microbiological standpoint, the perfusion solution should be used immediately. If not used immediately, the duration and conditions of storage are the responsibility of the user and normally should not exceed 24 hours at 2°C – 8°C, unless the dilution has been carried out under controlled, validated aseptic conditions.

Preparation and administration precautions

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 soap and water. If contact occurs with mucous membranes, rinse immediately and thoroughly with water.

Cabazitaxel Dr. Reddys must only be prepared and administered by personnel trained in the handling of cytotoxic agents. Pregnant healthcare workers must not handle this product.

The concentrate for perfusion solution must always be diluted with the complete solvent provided before being added to perfusion solutions.

Steps of preparation

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

Note: both the Cabazitaxel Dr. Reddys 60 mg/1.5 ml concentrate vial (fill volume: 73.2 mg cabazitaxel/1.83 ml) and the solvent vial (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, a solution containing 10 mg/ml of cabazitaxel is obtained.

To prepare the perfusion solution, the following two-step dilution process must be performed aseptically.

Step 1: Initial dilution of the perfusion solution concentrate with the provided solvent.

Step 1.1

Inspect the vial of concentrate with orange flip-off cap and the provided solvent. The concentrate solution and solvent should be clear and transparent.

Step 1.2

Using a syringe fitted with a fixed needle, aseptically withdraw the entire contents of the provided solvent by partially inverting the vial.

Step 1.3

Inject the entire contents into the corresponding concentrate vial with orange flip-off closure. To minimize foam formation as much as possible when injecting the solvent, direct the needle against the inner wall of the concentrate vial and inject slowly. After reconstitution, the resulting solution contains 10 mg/mL of cabazitaxel.

Step 1.4

Remove the syringe and needle and mix manually and gently by repeated inversions until a clear and homogeneous solution is obtained. This may take about 45 seconds.

Step 1.5

Leave the solution to stand for approximately 5 minutes and then check that the solution is homogeneous and transparent. It is normal for foam to persist after this time.

This resulting concentrate-solvent mixture contains 10 mg/mL of cabazitaxel (at least 6 mL of delivered volume). The second dilution must be performed immediately (within 1 hour) as detailed in Step 2.

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

Step 2: Final dilution for infusion

Step 2.1

Aseptically withdraw the required amount of the concentrate-solvent mixture (10 mg/mL of cabazitaxel) using a graduated syringe equipped with a fixed needle. For example, a 45 mg dose of Cabazitaxel Dr. Reddy's would require 4.5 mL of the mixture prepared in Step 1. Since foam may still be present on the vial wall after the preparation described in Step 1, it is preferable to position the syringe needle in the middle of the vial contents during withdrawal.

Stage 2.2

Inject into a sterile, non-PVC container of 5% glucose solution or 9 mg/ml (0.9%) sodium chloride solution for infusion. The concentration of the infusion solution must 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 manually by gently rocking.

Step 2.4

As with all parenteral products, the resulting infusion solution must be inspected visually before use. Since the infusion solution is supersaturated, it may crystallize over time. In such a case, the solution must not be used and should be discarded.

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 product and of all materials that have been in contact with it should be carried out in accordance with local regulations.

Method of administration

Cabazitaxel Dr. Reddys is administered as a 1-hour infusion.

Use of an in-line filter with a nominal pore size of 0.22 micrometers (also referred to as 0.2 micrometers) during administration is recommended.

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