Cabazitaxel Dr. Reddy's

Patient Information Leaflet

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

Generic medicine
Please read all of this leaflet carefully before you are given this medicine because it contains important information for you.

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

Contents of this leaflet:

1. What Cabazitaxel Dr. Reddy’s is and what it is used for
2. What you need to know before receiving Cabazitaxel Dr. Reddy’s
3. How to receive Cabazitaxel Dr. Reddy’s
4. Possible side effects
5. How to store Cabazitaxel Dr. Reddy’s
6. Contents of the pack and other information

1. What Cabazitaxel Dr. Reddy’s is and what it is used for

The name of the medicine is Cabazitaxel Dr. Reddy’s. Its common name is cabazitaxel. It belongs to a
group of medicines called "taxanes" used to treat cancer.
Cabazitaxel Dr. Reddy’s is used for the treatment of prostate cancer that has progressed after
prior chemotherapy treatments. It works by preventing cancer cells from growing and multiplying.
As part of your treatment, you will also take an oral corticosteroid medicine (prednisone or
prednisolone) every day. Please ask your doctor for information about this second medicine.

2. What you need to know before using Cabazitaxel Dr. Reddy’s

Do not use Cabazitaxel Dr. Reddy’s:

• if you are allergic (hypersensitive) to cabazitaxel, to other taxanes, to polysorbate 80, or to 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 1,500/mm³);
• if you have severe liver function impairment;
• if you have recently received or are about to receive a yellow fever vaccine.

You should not receive Cabazitaxel Dr. Reddy’s if any of the above conditions apply to you. If in doubt, consult your doctor before receiving Cabazitaxel Dr. Reddy’s.

Warnings and precautions

Before each treatment with Cabazitaxel Dr. Reddy’s, you will undergo blood tests to check that your blood cells, liver function, and kidney function are adequate for receiving Cabazitaxel Dr. Reddy’s.

Inform your doctor immediately if:

• you have a fever. During treatment with Cabazitaxel Dr. Reddy’s, 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 stabilize your blood cell count. People with low blood cell counts may develop potentially life-threatening infections. Fever may be the first sign of infection, so inform your doctor immediately if you develop a fever.
• you have ever had allergies. Severe allergic reactions may occur during treatment with Cabazitaxel Dr. Reddy’s.
• you have severe or prolonged diarrhoea, feel sick (nausea), or are about to vomit. Any of these events could lead to severe dehydration. Your doctor may consider it necessary to treat you.
• you experience numbness, tingling, burning sensations, or reduced sensitivity in your hands or feet.
• you have intestinal bleeding problems, changes in stool colour, or stomach pain. If bleeding or pain is severe, your doctor will stop treatment with Cabazitaxel Dr. Reddy’s. This is because Cabazitaxel Dr. Reddy’s may increase the risk of bleeding or the development of perforations in the intestinal wall.
• you have kidney problems.
• liver problems occur during treatment.
• you experience a significant increase or decrease in daily urine volume.
• you notice blood in your urine.

If any of the above conditions occur, inform your doctor immediately. Your doctor may reduce the dose of Cabazitaxel Dr. Reddy’s or discontinue treatment.

Other medicines and Cabazitaxel Dr. Reddy’s

Inform your doctor, pharmacist, or nurse if you are taking or have recently taken any other medicines, including those obtained without a prescription. This is because some medicines may affect how Cabazitaxel Dr. Reddy’s works, or Cabazitaxel Dr. Reddy’s may affect how other medicines work. These medicines include:

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

Consult your doctor before receiving any vaccination during treatment with Cabazitaxel Dr. Reddy’s.

Pregnancy, breastfeeding, and fertility

Cabazitaxel Dr. Reddy’s must not be used in women who are pregnant or of childbearing age who are not using contraceptive measures.

Cabazitaxel Dr. Reddy’s must not be used during breastfeeding.

Use a condom during sexual intercourse if your partner is or could become pregnant. Cabazitaxel Dr. Reddy’s may be present in your semen and could affect the unborn baby. It is recommended not to father a child during treatment and for 6 months after treatment. You should also seek advice about sperm preservation before starting treatment, as Cabazitaxel Dr. Reddy’s may impair male fertility.

Driving and using machines

You may experience fatigue or dizziness while taking this medicine. If so, do not drive or operate tools or machinery until you feel better.

Cabazitaxel Dr. Reddy’s contains ethanol (alcohol)

This medicine contains 15% v/v ethanol (alcohol), equivalent to 14 ml of beer or 6 ml of wine. This medicine may be harmful to patients suffering from alcoholism.

This should be taken into account if you belong to a high-risk group, such as patients with liver disease or epilepsy.

3. How to take Cabazitaxel Dr. Reddy’s

Instructions for use
You will be given anti-allergic medicines before starting treatment with Cabazitaxel Dr. Reddy’s to reduce the risk of allergic reactions.

• Cabazitaxel Dr. Reddy’s will be administered to you by a doctor or nurse.
• Cabazitaxel Dr. Reddy’s must be prepared (diluted) before administration. Practical handling and administration information for Cabazitaxel Dr. Reddy’s for doctors, nurses, and pharmacists is provided in this package leaflet.
• Cabazitaxel Dr. Reddy’s will be given to you as an intravenous infusion (IV infusion) in a hospital setting over approximately one hour.
• As part of your treatment, you will also take an oral corticosteroid medicine (prednisone or prednisolone) daily.

Dosage and frequency of administration

• The usual dose depends on your body surface area. Your doctor will calculate your body surface area in square meters (m²) and determine the appropriate dose for you.
• You will generally receive one infusion every 3 weeks.

If you have any doubts about how to use this medicine, 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.
Your doctor will discuss these with you and explain the potential risks and benefits of the treatment.
Contact a doctor immediately if you notice any of the following side effects:

• fever (high body temperature). This is a very common side effect (may affect more than 1 in 10 people).
• severe loss of body fluids (dehydration). This is a common side effect (may affect up to 1 in 10 people). It may occur in case of severe or prolonged diarrhoea, fever, or illness (vomiting).
• severe stomach pain or stomach pain that does not go away. This may occur if you have a perforation in the stomach, oesophagus, colon, or intestine (gastrointestinal perforation). This may lead to death.

If any of the conditions listed above occur, inform your doctor immediately.
Other possible side effects:
Very common (may affect more than 1 in 10 people):

• decrease in the number of red blood cells (anaemia) or white blood cells (which are important in fighting infections)
• decrease in the number of platelets (resulting in an increased risk of bleeding)
• loss of appetite (anorexia)
• altered sense of taste
• shortness of breath
• cough
• stomach problems, including feeling unwell (nausea), feeling unwell (vomiting), diarrhoea, or constipation
• abdominal pain
• temporary hair loss (in most cases, normal hair growth should return)
• back pain
• joint pain
• blood in the urine
• feeling tired, weak, or lacking energy

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

• urinary tract infection
• low white blood cell count associated with fever and infection
• tingling, numbness, burning, or reduced sensation in hands and feet
• dizziness
• headache
• decrease or increase in blood pressure
• stomach discomfort, burning sensation, or belching
• stomach pain
• haemorrhoids
• muscle spasms
• pain or increased frequency of urination
• urinary incontinence
• kidney disease or disorders
• mouth or lip ulcers
• infections or increased risk of infections
• high blood sugar
• low potassium levels in the blood
• mental confusion
• feeling anxious
• unusual sensation, loss of sensation, or pain in hands and feet
• ringing in the ears (tinnitus)
• balance problems
• rapid or irregular heartbeat
• blood clots in the legs
• feeling of warmth or skin redness
• mouth or throat pain
• rectal bleeding
• skin redness
• muscle discomfort or pain
• swelling of feet or legs
• chills

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

• inflammation of the bladder, which may occur when the bladder has previously been exposed to radiotherapy (radiation recall cystitis)

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

• interstitial lung disease (lung inflammation causing cough and breathing difficulties)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse.
You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Cabazitaxel Dr. Reddy’s

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 on the label of the vials after Exp. The expiry date refers to the last day of that month.
Do not store in the refrigerator.
For information on storage and duration of use of Cabazitaxel Dr. Reddy’s after dilution and readiness for use, refer to the section on “PRACTICAL INFORMATION FOR PHYSICIANS OR HEALTHCARE PROFESSIONALS ON THE PREPARATION, ADMINISTRATION AND HANDLING OF CABAZITAXEL DR. REDDY’S”.
Unused medicine and waste materials derived from this medicine should be disposed of in accordance with local regulations. This will help protect the environment.

6. Package contents and other information

What Cabazitaxel Dr. Reddy’s contains
The active substance is Cabazitaxel. 1 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
injections in the solvent (see section 2 “Cabazitaxel Dr. Reddy’s contains alcohol”).
Note: both the vial containing the Cabazitaxel Dr. Reddy’s concentrate 60 mg/1.5 ml (fill volume: 73.2 mg of cabazitaxel/1.83 ml) and the vial containing the solvent (fill volume: 5.70 ml) contain an overfill to compensate for liquid loss during preparation. The overfill ensures that after dilution with the ENTIRE content of the provided solvent, a solution containing 10 mg/ml of cabazitaxel is obtained.
Description of the appearance of Cabazitaxel Dr. Reddy’s and contents of the pack
Cabazitaxel Dr. Reddy’s is presented as a concentrate and solvent for infusion solution (sterile concentrate).
The concentrate is an oily solution ranging in colour from pale yellow to yellowish-brown.
The solvent is a clear, slightly yellow solution.
A pack of Cabazitaxel Dr. Reddy’s contains:

• One single-use 15 ml tubular glass vial closed with a rubber stopper and sealed with a tamper-evident cap, containing 1.5 ml (nominal volume) of concentrate.
• One single-use 15 ml tubular glass vial closed with a rubber stopper and sealed with a tamper-evident cap, containing 4.5 ml (nominal volume) of solvent.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Dr. Reddy’s S.r.l.
Piazza Santa Maria Beltrade 1,
20123 Milano
Manufacturer:
Betapharm Arzneimittel GmbH - Kobelweg 95, Kriegshaber, Augsburg, Bavaria, 86156, Germany
Dr. Reddy´s Laboratories (UK) Ltd. - 6 Riverview Road, Beverley, East Riding of Yorkshire, HU17
0LD, United Kingdom
This medicinal product is authorised in the European Economic Area Member States under the
following names:
France CABAZITAXEL REDDY PHARMA 60mg, solution to be diluted and solvent for
perfusion solution
Germany Cabazitaxel beta 60 mg concentrate and solvent for preparation of an infusion solution
Italy Cabazitaxel Dr. Reddy’s
Spain Cabacitaxel Dr. Reddys 60 mg concentrate and solvent for perfusion solution EFG
United Kingdom Cabazitaxel 60 mg Concentrate And Solvent For Solution For Infusion
The following information is intended exclusively for healthcare professionals.
PRACTICAL INFORMATION FOR PHYSICIANS OR HEALTHCARE PROFESSIONALS ON THE
PREPARATION, ADMINISTRATION AND HANDLING OF CABAZITAXEL DR. REDDY’S 60 mg
CONCENTRATE AND SOLVENT FOR INFUSION SOLUTION
This information supplements sections 3 and 5 for the user.
Before preparing the infusion solution, it is important to read the entire content of this procedure.
Incompatibilities
This medicinal product must not be mixed with other medicinal products except those used for dilution. For the preparation and administration of the infusion solution, PVC infusion containers or polyurethane infusion sets must not be used.
Shelf life and special precautions for storage
For the Cabazitaxel Dr. Reddy’s 60 mg concentrate and solvent pack
Do not store in the refrigerator.
After opening
The concentrate and solvent vials must be used immediately. If not used immediately, the times and conditions of in-use storage are the responsibility of the user.
From a microbiological standpoint, the two-step dilution procedure must be carried out under controlled and aseptic conditions (see the section “Precautions for preparation and administration” below).
After initial dilution of Cabazitaxel Dr. Reddy’s 60 mg concentrate with the ENTIRE content 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.
From a microbiological standpoint, the infusion solution must be used immediately. If not used immediately, the times and conditions of in-use storage are the responsibility of the user and normally should not exceed 24 hours at 2°C – 8°C, unless dilution has been performed under validated and controlled aseptic conditions.
After final dilution in the infusion bag/vial
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 in the refrigerator (2°C – 8°C), including a 1-hour infusion time in an infusion bag, and for 8 hours at room temperature (15°C - 30°C), including a 1-hour infusion time in a glass bottle.
From a microbiological standpoint, the infusion solution must be used immediately. If not used immediately, the times and conditions of in-use storage are the responsibility of the user and normally should not exceed 24 hours at 2°C – 8°C, unless dilution has been performed under validated and controlled aseptic conditions.
Precautions for preparation and administration
As with any other antineoplastic agent, caution should be exercised during handling and preparation of Cabazitaxel Dr. Reddy’s solutions, and consideration should be given to using containment devices, personal protective equipment (e.g. gloves), and preparation procedures.
If Cabazitaxel Dr. Reddy’s comes into contact with the skin at any stage of handling, wash the affected area immediately and thoroughly with soap and water. If contact occurs with mucous membranes, rinse immediately and thoroughly with water.
Cabazitaxel Dr. Reddy’s must be administered and prepared only by personnel qualified in handling cytotoxic agents. The product must not be handled by pregnant personnel.
The concentrate for infusion solution must always be diluted with the ENTIRE provided solvent before being added to the infusion solution.
Steps of preparation
Read carefully the ENTIRE section before mixing and diluting. Cabazitaxel Dr. Reddy’s requires TWO dilutions before administration. Follow the instructions below for preparation.
Note: both the vial containing the Cabazitaxel Dr. Reddy’s concentrate 60 mg/1.5 ml (fill volume: 73.2 mg of cabazitaxel/1.83 ml) and the vial containing the solvent (fill volume: 5.70 ml) contain an overfill to compensate for liquid loss during preparation. The overfill ensures that after dilution of the concentrate with the ENTIRE content of the provided solvent vial, a solution containing 10 mg/ml of cabazitaxel is obtained.
For the preparation of the infusion solution, the two-step dilution process described below must be performed aseptically.
Step 1: Initial dilution of the concentrate for infusion solution with the provided solvent

Step 1.1
Inspect the concentrate vial and the provided
solvent. The concentrate solution and solvent
must be clear.
Concentrate vial
Solvent vial
(60 mg-1.5 ml)

Step 1.2
Using a syringe with a needle, aseptically withdraw the ENTIRE content of the provided solvent by partially inverting the solvent vial.
Solvent vial
Step 1.3

Inject the ENTIRE content into the corresponding concentrate vial.
To minimize foam formation during solvent injection, 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.
Concentrate-solvent mixture 10 mg/ml
Solvent vial
Step 1.4

Remove the syringe and needle and mix gently by repeated inversions until a clear, homogeneous solution is obtained. This may take approximately 45 seconds.
Concentrate-solvent mixture 10 mg/ml
Step 1.5

Allow this solution to stand for approximately 5 minutes, then check that the solution is homogeneous and clear.
It is normal for foam to persist after this period.
Concentrate-solvent mixture 10 mg/ml
This resulting concentrate-solvent mixture contains 10 mg/ml of cabazitaxel (with at least 6 ml of deliverable volume). The second dilution must be performed immediately (within 1 hour) as described in Step 2.
More than one vial of concentrate-solvent mixture may be required to administer the prescribed dose.
Step 2: Second (final) dilution for infusion

Step 2.1
Aseptically withdraw the required amount of
concentrate-solvent mixture (10 mg/ml of
cabazitaxel) using a graduated syringe with a
needle. For example, a 45 mg dose of
Cabazitaxel Dr. Reddy’s would require 4.5 ml
of the concentrate-solvent mixture prepared in
Step 1.
Since foam may persist on the wall of this
solution’s vial after preparation as described
in Step 1, it is preferable to position the
syringe needle in the center of the vial during withdrawal.
Concentrate-solvent mixture 10 mg/ml

Step 2.2
Inject the solution into a sterile, non-PVC container containing either 5% glucose solution or 0.9% sodium chloride infusion solution (9 mg/ml). The final concentration of the infusion solution must be between 0.10 mg/ml and 0.26 mg/ml.
5% glucose solution
Required amount of
or 0.9% sodium chloride
concentrate-solvent mixture
infusion solution

Step 2.3
Remove the syringe and mix the contents of the infusion bag or bottle manually using an oscillating motion.
Step 2.4
As with all parenteral products, the resulting infusion solution must 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 must be discarded.
The infusion solution must 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 above.
Any unused medicine and waste material derived from this medicine must be disposed of in accordance with local regulations.
Method of administration
Cabazitaxel Dr. Reddy’s is administered as a 1-hour infusion.
During administration, use of an in-line filter with a nominal pore size of 0.22 micrometers (also referred to as 0.2 micrometers) is recommended.
Do not use PVC infusion containers or polyurethane infusion sets for the preparation and administration of the infusion solution.