CABAZITAXEL EVER PHARMA 10 MG / ML CONCENTRATE FOR SOLUTION FOR INFUSION - patient leaflet, side effects, dosage

Patient leaflet - CABAZITAXEL EVER PHARMA 10 MG / ML CONCENTRATE FOR SOLUTION FOR INFUSION

Package leaflet: Information for the patient

Cabazitaxel

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

1. what cabazitaxel ever pharma is and what it is used for

The name of your medicine is Cabazitaxel EVER Pharma. Its common name is “cabazitaxel”. It belongs to a group of medicines called “taxanes” used to treat cancers.

Cabazitaxel EVER Pharma 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.

2. what you need to know before you are given cabazitaxel ever pharmado not use cabazitaxel ever pharma 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 Cabazitaxel EVER Pharma if any of the above apply to you. If you are not sure, talk to your doctor before having Cabazitaxel EVER Pharma.

Warnings and precautions

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

Tell your doctor immediately if:

you have fever. During treatment with Cabazitaxel EVER Pharma, 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 EVER Pharma.
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 EVER Pharma. This is because Cabazitaxel EVER Pharma 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 EVER Pharma or stop the treatment.

Other medicines and Cabazitaxel EVER Pharma

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 EVER Pharma works or Cabazitaxel EVER Pharma 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 EVER Pharma.

Pregnancy, breast-feeding and fertility

Cabazitaxel EVER Pharma should not be used in pregnant women or women of childbearing age not using contraception.

Cabazitaxel EVER Pharma should not be used during breast-feeding.

Use a condom during sex if your partner is or could become pregnant. Cabazitaxel EVER Pharma 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 EVER Pharma 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 EVER Pharma contains ethanol (alcohol)

Vial 4.5 ml

This medicine contains 888.8 mg of alcohol (ethanol) in each vial. The amount of 4.5 ml in this medicine is equivalent to 22.5 ml beer or 9.4 ml wine.

Vial 5 ml

This medicine contains 987.5 mg of alcohol (ethanol) in each vial. The amount of 5 ml in this medicine is equivalent to 25 ml beer or 10.4 ml wine.

Vial 6 ml

This medicine contains 1185 mg of alcohol (ethanol) in each vial. The amount of 6 ml in this medicine is equivalent to 30 ml beer or 12.5 ml wine.

The amount of alcohol in this medicine is not likely to have an effect in adults and adolescents.

The amount of alcohol in this medicine may alter the effects of other medicines. Talk to your doctor or pharmacist if you are taking other medicines.

If you are addicted to alcohol, talk to your doctor or pharmacist before taking this medicine.

3. how to use cabazitaxel ever pharmainstructions for useanti-allergic medicines will be given to you before you have cabazitaxel ever pharma to reduce the risk of allergic reactions.

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

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

4. possible side effects

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 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.

The following information is intended for healthcare professionals only:

PRACTICAL INFORMATION FOR MEDICAL OR HEALTHCARE PROFESSIONALS ON PREPARATION, ADMINISTRATION AND HANDLING OF Cabazitaxel EVER Pharma 10 mg/ml CONCENTRATE FOR SOLUTION FOR INFUSION

This information supplements sections 3 and 5 for the user.

It is important that you read the entire content of this procedure prior to the preparation of the infusion solution.

Incompatibilities

This medicine must not be mixed with other medicines except those used for the dilution.

Shelf life and special precautions for storage

This medicinal product does not require any special storage conditions. Do not freeze.

After first opening

Multi-dose vials: Chemical, physical and microbiological stability of the solution after first opening has been demonstrated for 28 days below 25°C. Cabazitaxel EVER Pharma is suitable for multi-dose use.

After dilution in the infusion bag/bottle

Chemical and physical stability of the infusion solution has been demonstrated for 48 hours below 25°C including the 1-hour infusion time and for 14 days at refrigerated conditions including the 1-hour infusion time.

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 below 25°C, unless dilution has taken place in controlled and validated aseptic conditions.

Preparation and administration precautions

Cabazitaxel EVER Pharma should only be prepared and administered by personnel trained in handling cytotoxic agents. Pregnant staff should not handle it.

As for any other antineoplastic agent, caution should be exercised when handling and preparing Cabazitaxel EVER Pharma solutions, taking into account the use of containment devices, personal protective equipment (e.g. gloves), and preparation procedures.

If Cabazitaxel EVER Pharma, at any step of its handling, should come into contact with p\/pn the skin, wash immediately and thoroughly with soap and water. If it should come into b ( vjiuni jicT contact with mucous membranes, wash immediately and thoroughly with water.

point of reference for Laetus code

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)
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 pain
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
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, aches, weakness or pain
swelling of the feet or legs
chills.

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

low blood potassium
ringing in the ear
skin feeling hot
redness of the skin
nail disorder (change in the colour of your nails; nails may detach)
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).

5. how to store cabazitaxel ever pharma

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.

This medicinal product does not require any special storage conditions.

Do not freeze.

Information about storage and the time to use Cabazitaxel EVER Pharma, 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 EVER Pharma “.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

6. contents of the pack and other informationwhat cabazitaxel ever pharma containsthe active substance is cabazitaxel. one ml of the concentrate for solution for infusion contains cabazitaxel monohydrate or anhydrous equivalent to 10 mg cabazitaxel.

Each vial of 4.5 ml of concentrate for solution for infusion contains cabazitaxel monohydrate or anhydrous equivalent to 45 mg cabazitaxel.

Each vial of 5 ml of concentrate for solution for infusion contains cabazitaxel monohydrate or anhydrous equivalent to 50 mg cabazitaxel.

Each vial of 6 ml of concentrate for solution for infusion contains cabazitaxel monohydrate or anhydrous equivalent to 60 mg cabazitaxel.

Cabazitaxel EVER Pharma 10 mg/ml concentrate for solution for infusion contains an overfill. This overfill ensures that there is extractable volume of 4.5 ml, 5 ml or 6 ml containing 10 mg/ml cabazitaxel.

The other ingredients are polysorbate 80; macrogol; citric acid; and ethanol, anhydrous (see section 2 “Cabazitaxel EVER Pharma contains alcohol”).

What Cabazitaxel EVER Pharma looks like and contents of the pack

Cabazitaxel EVER Pharma is a concentrate for solution for infusion (sterile concentrate).

The concentrate is a clear slightly yellow oily solution.

One pack of Cabazitaxel EVER Pharma contains:

Clear glass vial closed with a grey bromobutyl rubber stopper sealed by an aluminium cap with a plastic flip-off cover containing 4.5 ml (5 ml or 6 ml) concentrate.

Vials may or may not be sheathed in a protective sleeve.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

EVER Valinject GmbH

Oberburgau 3

4866 Unterach am Attersee

Austria

Manufacturer

EVER Pharma Jena GmbH

Otto-Schott-StraBe 15

07745 Jena

Germany

This leaflet was last revised in 09/2021.

Preparation steps

Read this ENTIRE section carefully. Cabazitaxel EVER Pharma requires ONE dilution prior to administration. Follow the preparation instructions provided below.

The following dilution process must be carried out in an aseptic manner for preparing the solution for infusion. More than one vial of the concentrate may be necessary to administer the prescribed dose.

Dilution for infusion

Step 1: Aseptically withdraw the required amount of concentrate (10 mg/ml of cabazitaxel), with a graduated syringe fitted with a needle. As an example, a dose of 45 mg Cabazitaxel EVER Pharma would require 4.5 ml of the concentrate.

Step 2: Inject in a sterile PVC-free container of either 5% glucose solution or sodium chloride 9 mg/ml (0.9%) solution for infusion. The concentration of the infusion solution should be between 0.10 mg/ml and 0.26 mg/ml. Step 3: Remove the syringe and mix the content of the infusion bag or bottle manually using a rocking motion. Step 4: As with all parenteral products, the resulting infusion solution should be visually inspected prior to use. As the infusion solution is supersaturated, it may crystallize over time. In this case, the solution must not be used and should be discarded.

The infusion solution should be used immediately. However, in-use storage times can be longer under specific conditions mentioned in the section Shelf life and special precautions for storage above.

Cabazitaxel EVER Pharma must not be mixed with any medicinal products other than those mentioned.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements. Method of administration

Cabazitaxel EVER Pharma is administered as a 1-hour infusion.

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

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