Cabazitaxel Glenmark

Patient Information Leaflet

Cabazitaxel Glenmark 20 mg/ml concentrate for solution for infusion

cabazitaxel
Please read this leaflet carefully before you start using this medicine as 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 experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

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

1. What Cabazitaxel Glenmark is and what it is used for

The name of your medicine is Cabazitaxel Glenmark. The common name is cabazitaxel. It belongs to a
group of medicines known as “taxanes” used to treat cancer.
Cabazitaxel Glenmark is used to treat prostate cancer that has progressed after receiving other chemotherapy treatments. It works by blocking the growth and spread of cancer cells.
As part of your treatment, you will also take a corticosteroid (prednisone or prednisolone) orally on a daily basis. Please consult your doctor for information about this second medicine.

2. What you need to know before you are given Cabazitaxel Glenmark

Do not use Cabazitaxel Glenmark

• if you are allergic 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 the yellow fever vaccine.

If you think any of these apply to you, you must not receive Cabazitaxel Glenmark. If you are unsure,
please consult your doctor before using Cabazitaxel Glenmark.
Warnings and precautions
Before each treatment with Cabazitaxel Glenmark, you will need to have blood tests to check
that your blood cells are sufficient and that your liver and kidney functions are adequate for
administration of Cabazitaxel Glenmark.
Immediately inform your doctor:

• if you have a fever. During treatment with Cabazitaxel Glenmark, your white blood cell count is more likely to decrease. Your doctor will monitor your blood and general condition to detect any signs of infection. You may be given additional medicines to maintain stable blood cell counts. People with low blood cell counts
  may develop potentially life-threatening infections. Fever may be the first sign of an infection, so inform your doctor immediately if you develop a fever;
• if you have ever had any allergies. Severe allergic reactions may occur during treatment with Cabazitaxel Glenmark;
• if you have severe or prolonged diarrhoea, nausea, or vomiting. Any of these events may lead to severe dehydration. Your doctor may consider treatment necessary;
• if you experience numbness, tingling, burning sensations, or reduced sensitivity in your hands or feet;
• if you have intestinal bleeding problems or have noticed changes in the colour of your stools or stomach pain. If bleeding or pain is severe, your doctor will stop treatment with Cabazitaxel Glenmark. This is because Cabazitaxel Glenmark may increase the risk of bleeding or the development of perforations in the intestinal wall;
• if you have kidney problems;
• if you notice yellowing of the skin or eyes, dark-coloured urine, or severe nausea or vomiting (feeling unwell), as these may be signs or symptoms of liver problems;
• if you notice a significant increase or decrease in your daily urine volume;
• if you notice blood in your urine.

If any of the conditions listed above apply to you, inform your doctor immediately. Your doctor may
reduce the dose of Cabazitaxel Glenmark or discontinue treatment.
Other medicines and Cabazitaxel Glenmark
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 important because some medicines
may affect how Cabazitaxel Glenmark works, or Cabazitaxel Glenmark may affect the action of other medicines.
These include the following:

• ketoconazole, rifampicin (for infections);
• carbamazepine, phenobarbital, or phenytoin (for epileptic seizures);
• St John’s wort (Hypericum perforatum) (a herbal product used 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 Glenmark.
Pregnancy, breastfeeding, and fertility
Cabazitaxel Glenmark must not be used in pregnant women or in women of childbearing age who do not use contraception.
Cabazitaxel Glenmark must not be used during breastfeeding.
Use a condom during sexual intercourse if your partner is pregnant or could become pregnant. Cabazitaxel Glenmark may be present in semen and may affect the fetus. It is recommended not to father a child during treatment and for 4 months after treatment ends, and to seek advice on sperm preservation before starting treatment, as Cabazitaxel Glenmark may impair male fertility.
Driving and using machines
While taking this medicine, you may feel tired or dizzy. If this occurs, do not drive or operate machinery until you feel better.
Cabazitaxel Glenmark contains ethanol (alcohol)
This medicine contains 1185 mg of alcohol (ethanol) per vial, equivalent to 395 mg/ml. The volume of this medicine is equivalent to less than 30 ml of beer or 12 ml of wine.
The amount of alcohol in this medicine is unlikely to have an effect in adults and adolescents, and its effects in children are not evident. However, some effects may occur in young children, for example drowsiness.
The alcohol in this medicine may alter the effects of other medicines. Talk to your doctor or pharmacist if you are taking other medicines.
If you are pregnant or breastfeeding, speak with your doctor or pharmacist before taking this medicine.
If you are alcohol-dependent, or if you have liver disease or epilepsy, speak with your doctor or pharmacist before taking this medicine.

3. How to use Cabazitaxel Glenmark

Instructions for use
Before starting treatment with Cabazitaxel Glenmark, you must take antiallergic medicines to reduce the risk of allergic reactions:

• Cabazitaxel Glenmark will be administered to you by a doctor or nurse.
• Cabazitaxel Glenmark must be prepared (diluted) before administration. This patient information leaflet contains practical information on the handling and administration of Cabazitaxel Glenmark for doctors, nurses, and pharmacists.
• Cabazitaxel Glenmark will be administered to you in a hospital setting by intravenous infusion lasting approximately 1 hour.
• As part of your treatment, you will also take an oral corticosteroid (prednisone or prednisolone) daily.

What doses and how often will it be administered

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

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
You should discuss this with your doctor, who will also explain the potential risks and benefits of treatment.
Contact your doctor immediately if you notice any of the following side effects:

• fever (high body temperature). This is a common side effect (may occur in up to 1 in 10 people);
• severe loss of body fluids (dehydration). This is a common side effect (may occur in up to 1 in 10 people). It may happen if you have severe or prolonged diarrhoea, fever, or vomiting;
• severe stomach pain or persistent stomach discomfort. This may occur if you have a perforation in the stomach, oesophagus, or intestine (gastrointestinal perforation). This may be fatal.

If any of these apply to you, inform your doctor immediately.
Other side effects:
Very common (may affect more than 1 in 10 people):

• decrease in red blood cells (anaemia) or white blood cells (which are important in fighting infections)
• decrease in platelets (which increases the risk of bleeding)
• loss of appetite (anorexia)
• stomach problems including nausea, vomiting, diarrhoea, or constipation
• back pain
• blood in the urine
• feeling tired, weak, or lacking energy.

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

• altered taste
• shortness of breath
• cough
• abdominal pain
• temporary hair loss (in most cases, hair will regrow)
• joint pain
• urinary tract infection
• decrease in white blood cells associated with fever and infection
• numbness, tingling, burning, or reduced sensation in hands and feet
• dizziness
• headache
• decrease or increase in blood pressure
• stomach discomfort, burning sensation, or burping
• stomach pain
• haemorrhoids
• muscle spasms
• pain or increased frequency when urinating
• urinary incontinence
• kidney diseases or disorders
• mouth or lip ulcers
• infections or increased risk of infections
• high blood sugar
• insomnia
• mental confusion
• feeling anxious
• unusual sensation, loss of sensation, or pain in hands and feet
• balance problems
• rapid or irregular heartbeat
• blood clots in the legs or lungs (thrombosis)
• skin redness
• mouth or throat pain
• rectal bleeding
• discomfort, weakness, or muscle pain
• swelling of feet or legs
• chills
• nail disorders (change in nail colour; nails may fall off).

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

• low levels of potassium in the blood
• ringing in the ears
• skin burning sensation
• skin redness
• 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 effects, 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 Glenmark

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 label of the vials after Exp. The expiry date refers to the last day of the month.
This medicine requires no special storage conditions.
For information on storage and duration of use of Cabazitaxel Glenmark, refer to the section “Practical information for physicians or healthcare professionals on the preparation, administration and handling of Cabazitaxel Glenmark”.
Unused medicine and waste material derived from this medicine must be disposed of in accordance with local regulations. This will help protect the environment.

6. Package contents and other information

What Cabazitaxel Glenmark contains

• The active substance is cabazitaxel. One mL of concentrate for infusion solution contains 20 mg of cabazitaxel. Each vial of concentrate for infusion solution contains 60 mg of cabazitaxel.
• The other components in the concentrate are polysorbate 80, anhydrous ethanol (see section 2 “Cabazitaxel Glenmark contains ethanol (alcohol)”) and citric acid.

Description of the appearance of Cabazitaxel Glenmark and contents of the pack
Cabazitaxel Glenmark consists of a concentrate for infusion solution (sterile concentrate).
The concentrate is an oily, transparent solution ranging from yellow to brownish-yellow.
Each vial contains 3 mL (nominal volume) of concentrate. Packs containing 1 or 10 vials are available. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Glenmark Arzneimittel GmbH
Industriestr. 31
82194 Gröbenzell
Bayern
Germany

Manufacturer
AqVida GmbH
Kaiser-Wilhelm-Strasse 89
Neustadt, Hamburg 20355
Germany

The following information is intended exclusively for physicians or healthcare professionals:
“PRACTICAL INFORMATION FOR PHYSICIANS OR HEALTHCARE PROFESSIONALS ON THE
PREPARATION, ADMINISTRATION AND HANDLING OF CABAZITAXEL
GLENMARK”.
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.
Recommendation for safe handling
Cabazitaxel is an antineoplastic agent and, like other potentially toxic compounds, care should be taken during handling and preparation of solutions containing it. The use of gloves is recommended.
If the concentrated Cabazitaxel Glenmark or the infusion solution comes into contact with the skin, wash the affected area immediately and thoroughly with soap and water. If contact occurs with mucous membranes, rinse immediately and thoroughly with water.
Cabazitaxel Glenmark must be administered and prepared only by personnel qualified in the handling of cytotoxic agents. Pregnant personnel should not handle the medicinal product.
Incompatibilities
This medicinal product must not be mixed with other medicinal products except those used for dilution.
Shelf life and special precautions for storage
For the Cabazitaxel Glenmark 20 mg/mL concentrate for infusion solution pack
This medicinal product requires no special storage conditions.
After opening
Chemical and physical in-use stability has been demonstrated for 4 weeks at 2 °C – 8 °C.
From a microbiological point of view, the product should be used immediately. If not used immediately, the times and conditions of in-use storage and before use are the responsibility of the user and normally should not exceed 24 hours at 2 °C – 8 °C.
Once added to the infusion vial
Chemical and physical in-use stability has been demonstrated in non-PVC infusion containers for 14 days at 2 °C – 8 °C and for 48 hours at 25 °C. From a microbiological point of view, the product should be used immediately. If not used immediately, the times and conditions of storage before use are the responsibility of the user and normally should not exceed 24 hours at 2 °C – 8 °C, unless dilution has taken place under validated sterile and controlled conditions.
Preparation of the ready-to-use solution
DO NOT use other cabazitaxel-containing medicinal products consisting of 2 vials (concentrate and solvent) with Cabazitaxel Glenmark 20 mg/mL concentrate for infusion solution, which contains only 1 vial of 3 mL (60 mg/3 mL).
Cabazitaxel Glenmark 20 mg/mL concentrate for infusion solution does NOT require preliminary dilution with a solvent and is ready to be added directly to the infusion solution.
Step 1
If vials have been stored in the refrigerator, allow the required number of vials of Cabazitaxel concentrate for infusion solution to stand at 20–25 °C for 5 minutes before use.
More than one vial of Cabazitaxel 20 mg/mL concentrate for infusion solution may be needed to achieve the required patient dose. Using aseptic technique, withdraw the required amount of cabazitaxel concentrate for infusion solution using a calibrated syringe equipped with a 21 G needle. Do not completely empty the entire contents of the vial without volume control, as overfilling may occur.
Each mL of medicinal product contains 20 mg of cabazitaxel.
Step 2
The required volume of cabazitaxel concentrate for infusion solution must be injected into a sterile, non-PVC container containing either 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 3
Remove the syringe and mix the contents of the infusion bag or vial manually by gentle swirling.
Step 4
As with all parenteral products, the resulting infusion solution should be inspected visually 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.
Disposal
All materials used for dilution and administration must be disposed of according to standard procedures. Do not dispose of any medicinal product via wastewater. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.
The infusion solution should be used immediately. However, the in-use storage time may be longer if the specific conditions mentioned in the section “Shelf life and special precautions for storage” are met.
During administration, use of an in-line filter with a nominal pore size of 0.22 micrometres (also referred to as 0.2 micrometres) is recommended.
Do not use PVC infusion containers or polyurethane infusion sets for the preparation and administration of cabazitaxel.
Cabazitaxel must not be mixed with other medicinal products except those mentioned.
Unused medicinal product or waste material must be disposed of in accordance with local regulations.