Package Insert: Information for the User

Cabazitaxel Accord 20 mg/ml Concentrate for Solution for Infusion

cabazitaxel

Read this package insert carefully before starting to use this medication, as it contains important information for you.

?Keep this package insert, as you may need to refer to it again.

?If you have any questions, consult your doctor, pharmacist, or nurse.

?If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package insert. See section4.

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

Cabazitaxel Accord is used for the treatment of adult patients with prostate cancer that has progressed after receiving another chemotherapy. It acts 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 medicine.

No use Cabazitaxel Accord:

• if you are allergic (hypersensitive) to cabazitaxel, other taxanes, polysorbate 80, or any of the other components 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.

You should not receive Cabazitaxel Accord if any of the above circumstances apply. If you are unsure, consult your doctor before receiving Cabazitaxel Accord.

Warnings and precautions

Before starting treatment with Cabazitaxel Accord, blood tests will be performed to check that you have sufficient blood cells and that your kidneys and liver are functioning properly to receive Cabazitaxel Accord.

Inform your doctor immediately if:

• you have a fever. During treatment with Cabazitaxel Accord, 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. You may be given 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 Cabazitaxel Accord, 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 should 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 Cabazitaxel Accord. This is because Cabazitaxel Accord may increase the risk of bleeding or development of intestinal wall perforations.
• you have kidney problems.
• you develop liver problems during treatment.
• 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 Cabazitaxel Accord or interrupt treatment.

Use of Cabazitaxel Accord 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 Cabazitaxel Accord or Cabazitaxel Accord 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 receiving treatment with Cabazitaxel Accord, consult your doctor before being vaccinated.

Pregnancy, breastfeeding, and fertility

Cabazitaxel Accord should not be used in pregnant women or fertile women who do not use contraception.

Cabazitaxel Accord should not be used during breastfeeding.

Use condoms in your sexual relations if your partner is or may be pregnant. Cabazitaxel Accord may be present in your semen and can 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 Cabazitaxel Accord may alter male fertility.

Driving and operating machines

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 Accord contains ethanol (alcohol)

This medication contains 1,185 mg of alcohol (anhydrous ethanol) in each vial, equivalent to 16.33% by volume. The amount per dose of this medication is equivalent to 30 ml of beer or 12 ml of wine.

It is unlikely that the amount of alcohol in this medication will affect adults.

The alcohol in this medication may interact with other medications. Consult your doctor or pharmacist if you are taking other medications.

If you are an alcoholic, consult your doctor or pharmacist before taking this medication.

Usage Instructions

Before receiving Cabazitaxel Accord, you will be given antiallergic medications to reduce the risk of allergic reactions.

• Cabazitaxel Accord will be administered by a doctor or a nurse.
• Cabazitaxel Accord must be prepared (diluted) before administration. This leaflet provides practical information for the manipulation and administration of Cabazitaxel Accord for doctors, nurses, and pharmacists.
• Cabazitaxel Accord will be administered in the hospital through a drip (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.
• Usually, you will receive an infusion every 3 weeks.

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

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 (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 occur if you have severe or prolonged diarrhea, fever, or have been vomiting.
• severe stomach pain or stomach pain that does not resolve. This can 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 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):

• urinary tract infection
• leukopenia 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 level
• low potassium level in the blood
• confusion
• sensation of anxiety
• sensation 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
• sensation of heat or suffocation in the skin
• mouth or throat pain
• rectal bleeding
• red skin
• muscle aches, disorders, or pains
• inflammation of feet or legs
• chills.

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

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

Unknown frequency(cannot be estimated from available data)

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

Reporting of side effects:

If you experienceany type of side effect, consult your doctor, pharmacist, or nurse, even if it is apossibleside effect not listed in this prospectus.You can also report them directly through thenational notification system included in theAppendixV. 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.

This medication does not require special temperature conditions for its conservation.

Store in the original packaging to protect from light.

After opening the vial

Each vial is for single use, and must be used immediately after opening. If not used immediately, the time and storage conditions in use are the responsibility of the user.

After final dilution in the infusion bag/bottle

The 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 under refrigerated conditions including a 1-hour 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 was performed under controlled and validated aseptic conditions.

Disposaln

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

Composition of Cabazitaxel Accord

The active ingredient is cabazitaxel. One ml of concentrate contains 20 mg of cabazitaxel. Each vial of 3 ml of concentrate contains 60 mg of cabazitaxel.

The other components are polysorbate 80, citric acid and anhydrous ethanol (see section 2 “Cabazitaxel Accord contains alcohol”).

Appearance of Cabazitaxel Accord and contents of the container

Cabazitaxel Accord is a concentrate for solution for infusion (sterile concentrate).

The concentrate is a transparent, colourless to pale yellow to yellowish-brown solution.

It is presented as a single-use glass vial of 6 ml with a usable volume of 3 ml of concentrate.

Package size:

Each box contains a single-use vial.

Marketing authorisation holder

Accord Healthcare S.L.U

World Trade Center, Moll de Barcelona s/n,

Edifici Est, 6th floor, Barcelona,

08039 Barcelona, Spain

Responsible person

Accord Healthcare Limited

Sage House, 319 Pinner Road

Harrow, Middlesex, HA1 4HF

UK

LABORATORI FUNDACIÓ DAU

C/ C, 12-14 Pol. Ind. Zona Franca,

Barcelona, 08040, Spain

Pharmadox Healthcare Ltd.

KW20A Kordin Industrial Park

Paola, PLA 3000

Malta

Accord Healthcare Polska Sp. z o.o.,

ul. Lutomierska 50, Pabianice, 95-200

Poland

Accord Healthcare B.V

Winthontlaan 200, UTRECHT, 3526KV Paola

Netherlands

Date of the last revision of this leaflet: {MM/AAAA}

Other sources of information

The detailed information on this medicine is available on the website of the European Medicines Agency: http://www.ema.europa.eu.

The following information is intended solely for healthcare professionals.

INFORMATION FOR MEDICAL PRACTITIONERS OR HEALTHCARE PROFESSIONALS ON THE PREPARATION, ADMINISTRATION AND HANDLING OF CABAZITAXEL ACCORD 20 mg/ml CONCENTRATE FOR SOLUTION FOR INFUSION

This information complements sections 3 and 5 for the user.

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

Incompatibilities

This medicine should not be mixed with other medicines except those used for dilutions.

Period of validity and special precautions for storage

For the container of Cabazitaxel Accord 20 mg/ml concentrate for solution for infusion

This medicine does not require special temperature conditions for its storage.

Store in the original container to protect from light.

After opening the vial

Each vial is for single use, and it must be used immediately. If not used immediately, the time and storage conditions in use are the responsibility of the user.

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 the 1-hour infusion time and for 48 hours under refrigerated conditions including the 1-hour 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 was performed under 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 Accord infusion solutions, taking into account the use of safety devices, personal protective equipment (e.g. gloves) and preparation procedures.

If Cabazitaxel Accord 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 Accord should only be prepared and administered by trained personnel in the handling of cytotoxic agents. Pregnant women should not handle it.

Preparation steps

NEVER use with other medicines that contain cabazitaxel in different concentrations. Cabazitaxel Accord contains 20 mg/ml of cabazitaxel (usable volume of at least 3 ml).

Each vial is for single use, and it must be used immediately. Any unused solution must be discarded. It may be necessary to use more than one vial of Cabazitaxel Accord to administer the prescribed dose.

The dilution process for preparing the infusion solution must be performed aseptically.

Preparation of the infusion solution

The infusion solution must be used immediately. See the sections onperiod of validityand special precautions for storageabove.

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

Method of administration

Cabazitaxel Accord 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.

Infusion bags or sets of polyurethane should not be used for the preparation and administration of the infusion solution.