The name of your medicine is Cabazitaxel SPC 60 mg Concentrate and Solvent for Solution for Infusion. Its common name is cabazitaxel. It belongs to a group of medicines called "taxanes" used to treat cancers.
Cabazitaxel SPC is used to treat prostate cancer that has progressed after having had other chemotherapy. It works by stopping cells from growing and multiplying.
As part of your treatment, you will also take a corticosteroid medicine (prednisone or prednisolone) by mouth every day. Ask your doctor to give you information about this other medicine.

Do not use Cabazitaxel SPC
• you are allergic (hypersensitive) to cabazitaxel, to other taxanes, or polysorbate 80 or any of the other excipients of this medicine
• 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 SPC if any of the above apply to you. If you are not sure, talk to your doctor before having Cabazitaxel SPC.

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

Tell your doctor immediately if:
• You have fever. During treatment with Cabazitaxel SPC, 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 SPC
• 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 color of your stool or stomach pain. If the bleeding or pain is severe, your doctor will stop your treatment with Cabazitaxel SPC. This is because Cabazitaxel SPC may increase the risk of bleeding or developing holes in the gut wall
• You have kidney problems
• Liver problems occur during the treatment
• 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 SPC or stop the treatment.

Other medicines and Cabazitaxel SPC
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 SPC works or Cabazitaxel SPC 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 SPC.

Pregnancy, breastfeeding and fertility
Cabazitaxel SPC should not be used in pregnant women or women of childbearing age not using contraception.
Cabazitaxel SPC should not be used during breastfeeding.

Use a condom during sex if your partner is or could become pregnant. Cabazitaxel SPC could be present in your semen and may affect the foetus. You are advised not to father a child during and up to 6 months after treatment and to seek advice on conservation of sperm prior to treatment because Cabazitaxel SPC may alter male fertility.

Driving and using machines
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.

Cabazitaxel SPC Concentrate 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 for those suffering fromalcoholism.

To be taken into account if you are in a high-risk group such as patients with liver disease, or epilepsy.

Instructions for use
Anti-allergic medicines will be given to you before you have Cabazitaxel SPC to reduce the risk of allergic reactions.
• Cabazitaxel SPC will be given to you by a doctor or a nurse.
• Cabazitaxel SPC must be prepared (diluted) before it is given. Practical information for handling and administration of Cabazitaxel SPC for doctors, nurses and pharmacists is provided with this leaflet.
• Cabazitaxel SPC 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.

How much and how often to have
• 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 3weeks.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

Like all medicines, this medicine can cause side effects, although not everybody gets them. Your doctor will discuss these with you and will explain the potential risks and benefits of your treatment.
See a doctor 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 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.

Other side effects include:

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 ofbleeding)
• loss of appetite (anorexia)
• alteration in sense of taste
• shortness of breath
• cough
• stomach upsets including feeling sick (nausea), being sick (vomiting), diarrhoea or constipation
• abdominal pain
• short term hair loss (in most cases normal hair growth should return)
• back pain
• joint pain
• blood in the urine
• feeling tired, weak or lack of energy

Common (may affect up to 1 in 10 people):
• urinary tract infection
• lack of white blood cells associated with fever and infection
• feeling of numbness, tingling, burning or decreased sensations in hands andfeet

• 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
• low blood potassium
• mental confusion
• feeling anxious
• abnormal feeling or loss of sensation or pain in hands and feet
• ringing in the ear
• trouble with balance
• rapid or irregular heartbeat
• blood clot in the leg
• skin feeling hot or flushed
• pain in mouth or throat
• rectal bleeding
• redness of the skin
• muscle discomfort, aches or pain
• swelling of the feet or legs
• chills

Uncommon (may affect up to 1 in 100 people):
• inflammation of the bladder, which can occur when your bladder has been previously exposed to radiation therapy (cystitis due to radiation recallphenomenon)

Frequency not known (cannot be estimated from the available data):
• interstitial lung disease (inflammation of the lungs causing coughing and difficulty breathing)

Reporting of side effects
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 contact details listed below. By reporting side affects you can help provide more information on the safety of this medicine.

The National Pharmacovigilance and Drug Safety Centre (NPC)
Fax: +966-11-205-7662
Call NPC at +966-11-2038222, Ext’s: 2317-2356-2353-2354-2334-2340.
Toll free phone: 8002490000
E-mail: npc.drug@sfda.gov.sa
Website: www.sfda.gov.sa/npc

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the outer carton and on the label of the vials after EXP. The expiry date refers to the last day of that month.
Do not store above 30°C. Do not refrigerate.
Information about storage and the time to use Cabazitaxel SPC, once it has been diluted and is ready to use, are described in the section “PRACTICAL INFORMATION FOR MEDICAL OR HEALTHCARE PROFESSIONALS ON PREPARATION, ADMINISTRATION AND HANDLING OF Cabazitaxel SPC “.
Any unused product or waste material should be disposed of in accordance with local requirements. These measures will help to protect the environment