Cabazitaxel 60 mg Concentrate and Solvent For Solution For Infusion

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

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

• you are allergic (hypersensitive) to cabazitaxel, to other taxanes, or polysorbate 80 or any of the other ingredients of this medicine (listed in section 6)
• the number of your white blood cells is too low (neutrophil counts less than or equal to 1,500 /mm³)
• you have severe abnormal liver function
• you have recently received or are about to receive a vaccine against yellow fever.

You should not be given Cabazitaxel if any of the above apply to you. If you are not sure, talk to your doctor before having Cabazitaxel.

Before each treatment with Cabazitaxel you will have blood tests to check that you have enough blood cells and sufficient liver and kidney functions to receive Cabazitaxel.

Tell your doctor immediately if:

• you have fever. During treatment with Cabazitaxel it is more likely that your white blood cell count may be reduced. Your doctor will monitor your blood and general condition for signs of infections. He/she may give you other medicines to maintain the number of your blood cells. People with low blood counts can develop life-threatening infections. The earliest sign of infection may be fever, so if you experience fever, tell your doctor right away
• you have ever had any allergies. Serious allergic reactions can occur during treatment with Cabazitaxel
• you have severe or long-lasting diarrhoea, you feel sick (nausea) or you are being sick (vomiting). Any of these events could cause severe dehydration. Your doctor may need to treat you
• you have feeling of numbness, tingling, burning or decreased sensation in your hands or feet
• you have any bleeding problems from the gut or have changes in the colour of your stool or stomach pain. If the bleeding or pain is severe, your doctor will stop your treatment with Cabazitaxel. This is because Cabazitaxel may increase the risk of bleeding or developing holes in the gut wall
• you have kidney problems
• you have yellowing of the skin and eyes, darkening of the urine, severe nausea (feeling sick) or vomiting as they could be signs or symptoms of liver problems.
• you experience any significant increase or decrease in daily urinary volume
• you have blood in your urine.

If any of the above applies to you, tell your doctor immediately. Your doctor may reduce the dose of Cabazitaxel or stop the treatment.

Please tell your doctor, pharmacist or nurse if you are taking or have recently taken any other medicines. This includes medicines obtained without a prescription. This is because some medicines can affect the way cabazitaxel works or cabazitaxel can affect how other medicines work. These medicines include the following:

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

Talk to your doctor before getting vaccinations while you are receiving Cabazitaxel.

Cabazitaxel is not indicated for use in women.

Use a condom during sex if your partner is or could become pregnant. Cabazitaxel could be present in your semen and may affect the foetus. You are advised not to father a child during and up to 4 months after treatment and to seek advice on conservation of sperm prior to treatment because Cabazitaxel may alter male fertility.

You may feel tired or dizzy when having this medicine. If this happens, do not drive or use any tools or machines until you feel better.

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

Anti-allergic medicines will be given to you before you have Cabazitaxel to reduce the risk of allergic reactions.

• Cabazitaxel will be given to you by a doctor or a nurse.
• Cabazitaxel must be prepared (diluted) before it is given. Practical information for handling and administration of Cabazitaxel for doctors, nurses and pharmacists is provided with this leaflet.
• Cabazitaxel will be given by a drip (infusion) into one of your veins (intravenous use) in hospital for about an hour.
• As part of your treatment, you will also take a corticosteroid medicine (prednisone or prednisolone) by mouth every day.

• The usual dose depends on your body surface area. Your doctor will calculate your body surface area in square meters (m²) and will decide the dose you should have.
• You will usually have an infusion once every 3 weeks.

• fever (high temperature). This is common (may affect up to 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 long-lasting diarrhoea, or fever, or if you are being sick (vomiting)
• severe stomach pain or stomach pain that doesn't go away. This can occur if you have a hole in the stomach, food pipe, gut or bowel (gastrointestinal perforation). This can lead to death.

If any of the above applies to you, tell your doctor immediately.

Very common (may affect more than 1 in 10 people):

• decrease in the number of red (anaemia), or white blood cells (which are important in fighting infection)
• decrease in the number of platelets (which results in increased risk of bleeding)
• loss of appetite (anorexia)
• stomach upsets including feeling sick (nausea), being sick (vomiting), diarrhoea or constipation
• back pain
• blood in the urine
• feeling tired, weak or lack of energy

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

• alteration of taste
• shortness of breath
• cough
• abdominal pain
• short term hair loss (in most cases normal hair growth should return)
• joint painurinary tract infection
• lack of white blood cells associated with fever and infection
• feeling of numbness, tingling, burning or decreased sensations in hands and feet
• dizziness
• headache
• decrease or increase in blood pressure
• uncomfortable feeling in the stomach, heart burn or belching
• stomach pain
• haemorrhoids
• muscle spasm
• painful or frequent urination
• urinary incontinence
• kidney disease or problems
• sore in the mouth or on lips
• infections or risk of infections
• high blood sugar
• insomnia
• mental confusion
• feeling anxious
• abnormal feeling or loss of sensation or pain in hands and feet
• trouble with balance
• rapid or irregular heartbeat
• blood clot in the leg or in the lung
• skin feeling flushed
• pain in mouth or throat
• rectal bleeding
• muscle discomfort, weakness aches or pain
• swelling of the feet or legs
• chills
• nail disorder (change in the colour of your nails; nails may detach).

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

• low blood potassium
• ringing in the ear
• skin feeling hot
• redness of the skin
• inflammation of the bladder, which can occur when your bladder has been previously exposed to radiation therapy (cystitis due to radiation recall phenomenon)

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

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

If you get any side effects, talk to your doctor, or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme website www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

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

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

Note: Both the Cabazitaxel 60 mg/1.5 ml concentrate vial (fill volume: 73.2 mg of cabazitaxel/1.83 ml) and the solvent vial (fill volume: 5.70 ml) contain an overfill to compensate for liquid loss during preparation. This overfill ensures that after dilution with the ENTIRE contents of the accompanying solvent, there is solution containing 10 mg/ml cabazitaxel.

Cabaziatxel is a concentrate and solvent for solution for infusion (sterile concentrate).

The concentrate is a clear yellow to brownish-yellow oily solution.

The solvent is a clear and slightly yellow solution.

One pack of Cabazitaxel contains:

• One single use 15 ml tubular glass vial, stoppered with rubber stopper and sealed with orange flip-off seal, containing 1.5 ml (nominal volume) concentrate.
• One single use 15 ml tubular glass vial, stoppered with rubber stopper and sealed with flip-off seal, containing 4.5 ml (nominal volume) solvent.