Jevtana

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• 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

What is in this leaflet:

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

Do not use JEVTANA if:

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

Warnings and precautions

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

Tell your doctor immediately if:

• you have fever. During treatment with JEVTANA, 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 JEVTANA.
• 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 JEVTANA. This is because JEVTANA 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 JEVTANA or stop the treatment.

Other medicines and JEVTANA

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 JEVTANA works or JEVTANA 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 JEVTANA.

Pregnancy, breast-feeding and fertility

JEVTANA should not be used in pregnant women or women of childbearing age not using contraception.

JEVTANA should not be used during breast feeding.

Use a condom during sex if your partner is or could become pregnant. JEVTANA 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 JEVTANA 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.

JEVTANA 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 from alcoholism.

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 JEVTANA to reduce the risk of allergic reactions.

• JEVTANA will be given to you by a doctor or a nurse.
• JEVTANA must be prepared (diluted) before it is given. Practical information for handling and administration of JEVTANA for doctors, nurses and pharmacists is provided with this leaflet.
• JEVTANA 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 3 weeks.

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 of bleeding)
• 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 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
• 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 recall phenomenon).

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. 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 effects you can help provide more information on the safety of this medicine.

United Kingdom

Ireland

Malta

What JEVTANA contains

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 "JEVTANA contains alcohol").

Note: Both the JEVTANA 60mg/1.5ml concentrate vial (fill volume: 73.2 mg of cabazitaxel/1.83ml) and the solvent vial (fill volume: 5.67ml) 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 10mg/ml cabazitaxel.

What JEVTANA looks like and contents of the pack

JEVTANA 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 colourless solution.

One pack of JEVTANA contains:

One single use clear glass vial, closed with a grey chlorobutyl rubber closure sealed by an aluminium cap with a light green plastic flip-off cover containing 1.5ml (nominal volume) concentrate.

• One single use clear glass vial, closed with a grey chlorobutyl rubber closure sealed by a gold colour aluminium cap with a colourless plastic flip-off cover, containing 4.5ml (nominal volume) solvent.

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