Prospecto: information for the user

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

cabazitaxel

Read this prospect carefully before starting to use this medicine, because it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor, pharmacist or nurse.
• If you experience adverse effects, consult your doctor, pharmacist or nurse, even if they are not listed in this prospect. See section 4.

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

2.What you need to know before Cabazitaxel Dr. Reddys is administered to you

3.How to use Cabazitaxel Dr. Reddys

4.Possible adverse effects

5.Storage of Cabazitaxel Dr. Reddys

6.Contents of the package and additional information

Your medication is called Cabazitaxel Dr. Reddys. Its common name is cabazitaxel. It belongs to a group of medications called “taxanes”, used to treat cancers.

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

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 medication.

No use Cabazitaxel Dr. Reddys:

• if you are allergic (hypersensitive) to cabazitaxel, other taxanes, polysorbate 80, or any of the other excipients of this medication (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 been or are to be vaccinated against yellow fever.

Do not take this medication if any of the above circumstances apply to you. If you are unsure, consult your doctor before taking this medication.

Warnings and precautions

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

Inform your doctor immediately if:

• you have a fever. During treatment with this medication, it is more likely that your white blood cell count will decrease. Your doctor will monitor your blood and overall condition to detect signs of infection. Your doctor may prescribe other medications to maintain your blood cell count. People with low blood cell counts may develop life-threatening infections. The first sign of infection may be fever, so if you have a fever, inform your doctor immediately.

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

• you have severe or prolonged diarrhea, feel unwell (nausea) or are vomiting. Any of these situations may cause severe dehydration. Your doctor will need to provide treatment.

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

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

• you have kidney problems.

• liver problems develop during treatment.

• you have yellow skin and eyes, dark urine, severe nausea (feeling sick) 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 circumstances occur, inform your doctor immediately. Your doctor may reduce the dose of this medication or interrupt treatment.

Use of Cabazitaxel Dr. Reddys with other medications

Inform your doctor, pharmacist, or nurse if you are using or have recently used other medications, including those purchased without a prescription. This is because some medications may affect the efficacy of this medication or this medication may affect the efficacy of other medications.

These medications include:

• ketoconazole, rifampicin (for infections);
• carbamazepine, phenobarbital, or phenytoin (for seizures);
• St. John's Wort or hypericum (Hypericum perforatum) (medicinal plant used to treat depression and other conditions);
• statins (such as simvastatin, lovastatin, atorvastatin, rosuvastatin, or pravastatin) (to reduce cholesterol in your blood);
• valsartan (for hypertension);
• repaglinide (for diabetes).

While taking this medication, consult your doctor before being vaccinated.

Pregnancy, breastfeeding, and fertility

Cabazitaxel is not indicated for women.

This medication should not be used in pregnant women or in fertile women who are not using contraceptives.

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

This medication should not be used during breastfeeding.

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

Driving and operating machinery

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

Usage Instructions

Before receiving this medication, you will be administered antiallergic medications to reduce the risk of allergic reactions.

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

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

• This medication will be administered in the hospital through an infusion (infusion) into one of your veins (intravenous route) for approximately 1 hour.

• As part of your treatment, you will also take a corticosteroid medication (prednisone or prednisolone) orally 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 on the dose you should receive.
• You will usually receive an infusion every 3 weeks.

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

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

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

Seek medical attention immediately if you notice any of the following side effects:

• fever (high temperature). This is very common (it could affect more than 1 in 10 people).
• severe loss of body fluids (dehydration). This is common (it could 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 resolve. This may happen if you have a perforation in the stomach, esophagus, or intestine (gastrointestinal perforation). This can be fatal.

Inform your doctor immediately if any of the above circumstances occur.

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 increases the risk of bleeding)
• loss of appetite (anorexia)
• alteration of taste
• labored breathing
• cough
• stomach discomfort, including nausea, vomiting, diarrhea, or constipation
• abdominal pain
• temporary hair loss (in most cases, hair will grow 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
• temporary hair loss (in most cases, hair should grow back normally)
• joint pain
• urinary tract infection
• low white blood cell count associated with fever and infections
• sensation of numbness, tingling, burning, or decreased sensation in hands and feet
• dizziness
• headache
• increase or decrease in blood pressure
• stomach discomfort, heartburn, or belching
• abdominal pain
• hemorrhoids
• muscle spasms
• urinating frequently or with pain
• urinary incontinence
• kidney problems or alteration
• ulcers in the mouth or lips
• infections or risk of infections
• elevated blood sugar levels
• insomnia
• confusion
• sensation of anxiety
• sensation of numbness or loss of sensation or pain in hands and feet
• ringing in the ears
• balance problems
• irregular or rapid heartbeats
• blood clots in the legs or lungs
• sensation of heat or suffocation in the skin
• mouth or throat pain
• rectal bleeding
• red skin
• muscle aches, disorders, weakness, or pains
• inflammation of feet or legs
• chills
• nail disorders (change in nail color; nails may fall off).

Rare (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 may occur when the bladder has previously been exposed to radiation therapy (radiation-induced cystitis).

Unknown frequency(cannot be estimated from available data)

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

Reporting of side effects:

If you experience any type of side effect, consult your doctor, pharmacist, or nurse even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

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

Do not refrigerate.

For information on the conservation and use time of this medication, once it has been diluted and is ready to use, refer to the “PRACTICAL INFORMATION FOR PHYSICIANS OR HEALTHCARE PROFESSIONALS ABOUT THE PREPARATION, ADMINISTRATION, AND HANDLING OF CABAZITAXEL DR. REDDYS” section.

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

Composition of Cabazitaxel Dr. Reddys

The active ingredient 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 96% ethanol and water for injectable preparations in the solvent (see section 2 “Cabazitaxel Dr. Reddys contains ethanol (alcohol)”).

Nota: 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: 5.7 ml) contain an overfill to compensate for the loss of liquid during preparation. This overfill ensures that after dilution with the complete content of the provided solvent, there is a solution containing 10 mg/ml of cabazitaxel.

Aspect of the product and content of the package

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

The concentrate is a transparent, yellow to yellow-brown oily solution.

The solvent is a transparent and colorless solution.

A package of Cabazitaxel Dr. Reddys contains:

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

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

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

Responsible for manufacturing

betapharm Arzneimittel GmbH,

Kobelweg 95,

86156 Augsburg

Germany

This medicinal product is authorized in the Member States of the European Economic Area with the following names:

Last review date of this leaflet:April 2024

This information is intended solely for healthcare professionals.

INFORMATION FOR MEDICAL PRACTITIONERS OR HEALTHCARE PROFESSIONALS ABOUT

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 to read the entire procedure before preparing the infusion solution.

Incompatibilities

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

Do not use PVC infusion containers or polyurethane infusion sets for the preparation and administration of the infusion solution.

Period of validity and special precautions for storage

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

Do not refrigerate.

After opening the vial

The concentrate and solvent vials 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 in controlled and aseptic conditions (see below “Precautions for preparation and administration”).

After the initial dilutionof Cabazitaxel Dr. Reddys 60 mg concentrate with the complete contentof the solvent vial: chemical and physical stability has been demonstrated for 1 hour at room temperature and for 21 days at 2°C - 8°C.

After the 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 the 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 normally should not be more than 24 hours at 2°C - 8°C, unless the dilution was carried out in controlled and validated aseptic conditions.

Precautions for preparation and administration

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

If 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 trained personnel in the handling of cytotoxic agents. Pregnant women should not handle it.

Dilute the concentrate for infusion solution with the complete contentof the provided solventbefore adding it to the infusion solutions.

Steps of preparation

Read this section carefully before mixing and diluting. Cabazitaxel Dr. Reddys requirestwodilutions before administration. Follow the preparation instructions provided below.

Nota: 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: 5.7 ml) contain an overfill to compensate for the loss of liquid during preparation. This overfill ensures that after dilution with the complete contentof the solvent provided, 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.

Step 1: initial dilution of the concentrate for infusion solution with the provided solvent.

Step 1.1

Step 1.2

Step 1.3

Step 1.4

Step 1.5

This concentrate-solvent mixture resulting from the first dilution contains 10 mg/ml of cabazitaxel (at least 6 ml of released volume). The second dilution must be carried out immediately (within 1 hour) as detailed in Step 2.

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

Step 2: final dilution (second) for infusion

Step 2.1

Step 2.2

Step 2.3

Step 2.4

The infusion solution must be used immediately. However, the storage time in use may be longer under the specific conditions mentioned in the sectionPeriod ofvalidity and special precautions for storage.

The disposal of unused medicinal product and all materials that have come into contact with it 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 pore size of 0.22 micrometers (also known as 0.2 micrometers) during administration is recommended.

Do not use PVC infusion bags or polyurethane infusion sets for the preparation and administration of the infusion solution.