Cabxel 60 mg/1,5 ml

CABXEL 60 mg/1,5 ml INJ belongs to a group of medicines called “taxanes” used to treat cancers. CABXEL 60 mg/1,5 ml INJ is used to treat prostate cancer that has progressed after having had other chemotherapy. It works by stopping cells from growing and multiplying.

CABXEL 60 mg/1,5 ml INJ should not be administered to you:

• if you are hypersensitive (allergic) to cabazitaxel or to other taxanes or polysorbate 80 or to any of the other ingredients of CABXEL 60 mg/1,5 ml INJ (listed in section 6).
• if the number of your white blood cells is too low (neutrophil counts less than or equal to 1 500/mm3)
• if you have severe abnormal liver function
• if you have recently received or are about to receive a vaccine against yellow fever.

Warnings and precautions

Before each treatment with CABXEL 60 mg/1,5 ml INJ, you will have blood tests to check that you have enough blood cells and sufficient liver and kidney functions to receive CABXEL 60 mg/1,5 ml INJ. Tell your doctor or health care provider before being given the CABXEL 60 mg/1,5 ml INJ:

• If you have fever. During treatment with CABXEL 60 mg/1,5 ml INJ, 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.
• If you have ever had any allergies. Serious allergic reactions can occur during treatment with CABXEL 60 mg/1,5 ml INJ.
• If 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.
• If you have feeling of numbness, tingling, burning or decreased sensation in your hands or feet.
• If 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 CABXEL 60 mg/1,5 ml INJ. This is because CABXEL 60 mg/1,5 ml INJ may increase the risk of bleeding or developing holes in the gut wall.
• If you have kidney problems.
• If liver problems occurring during the treatment.

Do not share medicines prescribed for you with any other person. You will not be expected to give yourself CABXEL 60 mg/1,5 ml INJ. It will be given to you by a person who is qualified to do so. Anti-allergic medicines will be given to you before you have CABXEL 60 mg/1,5 ml INJ to reduce the risk of allergic reactions. CABXEL 60 mg/1,5 ml INJ must be prepared (diluted) before it is given. CABXEL 60 mg/1,5 ml INJ will be given by a drip (infusion) into one of your veins (intravenously) 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. Method of administration: CABXEL 60 mg/1,5 ml INJ is administered as a 1 hour infusion. An in-line filter of 0,22 micrometer nominal pore size (also referred to as 0,2 micrometer) is recommended during administration.

CABXEL 60 mg/1,5 ml INJ can have side effects. Not all side effects reported for CABXEL 60 mg/1,5 ml INJ are included in this leaflet. Should your general health worsen or if you experience any untoward effects while receiving CABXEL 60 mg/1,5 ml INJ, please consult your health care provider for advice. If any of the following happens, stop administration of CABXEL 60 mg/1,5 ml INJ and tell your doctor immediately or go to the casualty department at your nearest hospital:

• ‘swelling of your hands, feet, ankles, face, lips and mouth or throat, which may cause difficulty in swallowing or breathing’,
• ‘rash or itching’,
• ‘fainting’

These are all very serious side effects. If you have them, you may have had a serious allergic reaction to CABXEL 60 mg/1,5 ml INJ. You may need urgent medical attention or hospitalisation. Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

• Urinary tract infection
• Blood poisoning, Deep pyogenic infection, Influenza,
• Upper respiratory tract infection,
• Shingles (blistering skin rash),
• Thrush (oral cavity, gastrointestinal tract, vagina penis),
• Decrease in the number of red blood cells (anaemia), or white blood cells (which are important in fighting infection)
• Decrease in the number of platelets (which results in increased risk of bleeding)
• Lack of white blood cells associated with fever and infection
• Hay fever
• Loss of appetite (anorexia)
• Severe loss of body fluids (dehydration). This can occur if you have severe or long lasting diarrhoea, or fever, or if you are being sick (vomiting).
• Anxiety, Confusional state.
• Dullness,
• Back pain,
• Decrease of sensitivity (hypoesthesia).
• Alteration in sense of taste
• Feeling of numbness, tingling, burning or decreased sensations in hands and feet
• Conjunctivitis
• Excessive tearing eyes.
• Ear buzzing,
• Atrial fibrillation (abnormal heart rate),
• Decrease in blood pressure
• Shortness of breath

• Store at or below 25 °C. Do not refrigerate.
• Store all medicines out of reach of children.
• Protect from light and moisture.
• Keep the vials in the outer carton until required for use.
• After opening: Concentrate and solvent vials must be used immediately. If not used immediately, in-use storage times and conditions are the responsibility of the user.
• After initial dilution: Chemical and physical in-use stability for the resulting concentrate-solvent mixture has been demonstrated for one hour at ambient temperature. From a microbiological point of view, the concentrate-solvent mixture should be used immediately.
• After final dilution: Chemical and physical stability of the infusion solution has been demonstrated for 8 hours at ambient temperature (including the 1-hour infusion time) and for 48 hours under refrigerated conditions. From a microbiological point of view, the infusion solution should be used immediately. If not used immediately, in-use storage times and conditions are the responsibility of the user and would normally not be longer than 24 hours at 2 °C to 8 °C unless dilution has taken place in controlled and validated aseptic conditions.
• As the infusion solution is supersaturated, it may crystallise over time. In this case, the solution must not be used and should be discarded.
• Do not store in a bathroom.
• Do not use after the expiry date stated on the label/carton/vial.
• Return all unused medicine to your pharmacist.
• Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets). For single use only. Discard any unused contents.