Cabazitaxel Accord 20 mg/ml concentrate for solution for infusion
Spain
Table of Contents
- Package leaflet: Information for the user
- Introduction
- 1. What Cabazitaxel Accord is and what it is used for
- 2. What you need to know before being given Cabazitaxel Accord
- 3. How to use Cabazitaxel Accord
- 4. Possible side effects
- 5. Storage of Cabazitaxel Accord
- 6. Pack contents and other information
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Cabazitaxel Accord 20 mg/ml concentrate for solution for infusion
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 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.
Contents of this leaflet
- What Cabazitaxel Accord is and what it is used for
- What you need to know before you are given Cabazitaxel Accord
- How to use Cabazitaxel Accord
- Possible side effects
- How to store Cabazitaxel Accord
- Contents of the pack and other information
1. What Cabazitaxel Accord is and what it is used for
The name of your medicine is Cabazitaxel Accord. Its common name is cabazitaxel. It belongs to a group of medicines called "taxanes", which are used to treat cancers.
Cabazitaxel Accord is used to treat adult patients with prostate cancer that has progressed after receiving another chemotherapy treatment. It works by stopping the growth and multiplication of cancer cells.
As part of your treatment, you will also take a corticosteroid (prednisone or prednisolone) orally every day. Ask your doctor for information about this other medicine.
2. What you need to know before being given Cabazitaxel Accord
Do not use Cabazitaxel Accord:
- if you are allergic (hypersensitive) to cabazitaxel, to other taxanes, to polysorbate 80, or to any of the other ingredients of this medicine (listed in section 6),
- if your white blood cell count is very low (neutrophil count less than or equal to 1,500/mm³),
- if you have severe liver problems,
- if you have recently been vaccinated or are about to be vaccinated against yellow fever.
You must not receive Cabazitaxel Accord if any of the above apply to you. If you are unsure, consult your doctor before receiving Cabazitaxel Accord.
Warnings and precautions
Before starting treatment with Cabazitaxel Accord, you will have blood tests to check that you have enough blood cells and that your kidneys and liver are functioning properly enough to receive Cabazitaxel Accord.
Tell your doctor immediately if:
- you have a fever. During treatment with Cabazitaxel Accord, your white blood cell count is more likely to decrease. Your doctor will monitor your blood and general condition for signs of infection. You may be given other medicines to maintain your blood cell counts. People with low blood cell counts may develop infections that could be life-threatening. Fever may be the first sign of infection, so inform your doctor immediately if you develop a fever.
- you have ever had any allergies. Severe allergic reactions may occur during treatment with Cabazitaxel Accord.
- you have severe or persistent diarrhea, feel unwell (nausea), or are vomiting. Any of these may cause severe dehydration. Your doctor will need to provide treatment.
- you experience numbness, tingling, burning, or reduced sensation in your hands and feet.
- you have intestinal bleeding problems, changes in the color of your stools, or stomach pain. If bleeding or pain is severe, your doctor will stop your treatment with Cabazitaxel Accord. This is because Cabazitaxel Accord may increase the risk of bleeding or the development of perforations in the intestinal wall.
- you have kidney problems.
- liver problems develop during treatment.
- you notice a significant increase or decrease in the volume of your urine.
- you have blood in your urine.
If any of the above occur, inform your doctor immediately. Your doctor may reduce the dose of Cabazitaxel Accord or stop treatment.
Using Cabazitaxel Accord with other medicines
Tell your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription. This is because some medicines may affect the effectiveness of Cabazitaxel Accord or Cabazitaxel Accord may affect the effectiveness of other medicines. These medicines include:
- ketoconazole, rifampicin (for infections);
- carbamazepine, phenobarbital, or phenytoin (for seizures);
- St. John’s wort (Hypericum perforatum) (a herbal remedy used to treat depression and other conditions);
- statins (such as simvastatin, lovastatin, atorvastatin, rosuvastatin, or pravastatin) (to reduce cholesterol in your blood);
- valsartan (for high blood pressure);
- repaglinide (for diabetes).
While being treated with Cabazitaxel Accord, consult your doctor before getting vaccinated.
Pregnancy, breastfeeding, and fertility
Cabazitaxel Accord must not be used in pregnant women or women of childbearing age who are not using contraception.
Cabazitaxel Accord must not be used during breastfeeding.
Use condoms during sexual intercourse if your partner is or could be pregnant. Cabazitaxel Accord may be present in your semen and could harm the fetus. It is recommended not to father a child during treatment and for up to 6 months after treatment ends. You should also seek advice about sperm preservation before starting treatment, as Cabazitaxel Accord may impair male fertility.
Driving and using machines
During treatment with this medicine, you may feel tired or dizzy. If this happens, do not drive or operate tools or machinery until you feel better.
Cabazitaxel Accord contains ethanol (alcohol)
This medicine contains 1,185 mg of alcohol (anhydrous ethanol) per vial, equivalent to 16.33% by volume. The amount per dose of this medicine is equivalent to 30 ml of beer or 12 ml of wine.
The amount of alcohol in this medicine is unlikely to affect adults.
The alcohol in this medicine may alter the effects of other medicines. Consult your doctor or pharmacist if you are taking other medicines.
If you are an alcoholic, consult your doctor or pharmacist before taking this medicine.
3. How to use Cabazitaxel Accord
Instructions for use
Before receiving Cabazitaxel Accord, you will be given antiallergic medications to reduce the risk of allergic reactions.
- Cabazitaxel Accord will be administered by a doctor or nurse.
- Cabazitaxel Accord must be prepared (diluted) before administration. This patient information leaflet provides practical information on the handling and administration of Cabazitaxel Accord for doctors, nurses, and pharmacists.
- Cabazitaxel Accord will be administered in the hospital via an intravenous infusion (drip) into one of your veins over approximately 1 hour.
- As part of your treatment, you will also take an oral corticosteroid medication (prednisone or prednisolone) daily.
Dosage and frequency
- The usual dose depends on your body surface area. Your doctor will calculate your body surface area in square meters (m²) and determine the dose you should receive.
- You will usually receive an infusion every 3 weeks.
If you have any further questions about 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 everyone gets them. Your doctor will discuss this with you and explain the potential risks and benefits of your treatment.
Contact your 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 may occur if you have severe or prolonged diarrhoea, fever, or have been vomiting.
- severe stomach pain or stomach pain that does not go away. This may happen if you have a perforation in the stomach, oesophagus, or intestine (gastrointestinal perforation). This may cause death.
If any of the above occur, inform your doctor immediately.
Other side effects include:
Very common (may affect more than 1 in 10 people):
- reduction in the number of red blood cells (anaemia), or white blood cells (which are important for fighting infections)
- reduction in the number of platelets (resulting in an increased risk of bleeding)
- loss of appetite (anorexia)
- altered taste
- shortness of breath
- cough
- stomach discomfort, including nausea, vomiting, diarrhoea or constipation
- abdominal pain
- temporary hair loss (in most cases, hair grows back normally)
- back pain
- joint pain
- blood in the urine
- tiredness, weakness or lack of energy.
Common (may affect up to 1 in 10 people):
- urinary tract infection
- low white blood cell count associated with fever and infections
- sensation of numbness, tingling, burning, or reduced sensation in hands and feet
- dizziness
- headache
- increase or decrease in blood pressure
- stomach discomfort, heartburn or burping
- stomach pain
- haemorrhoids
- muscle spasms
- frequent or painful urination
- urinary incontinence
- kidney problems or disturbances
- mouth or lip ulcers
- infections or risk of infections
- high blood sugar level
- low blood potassium level
- mental confusion
- feeling of anxiety
- unusual sensation or loss of sensation or pain in hands and feet
- ringing in the ears
- balance problems
- rapid or irregular heartbeat
- blood clots in the legs
- sensation of warmth or flushing of the skin
- mouth or throat pain
- rectal bleeding
- red skin
- muscle discomfort, disturbances or pain
- swelling of feet or legs
- chills.
Uncommon (may affect up to 1 in 100 people):
- inflammation of the bladder, which may occur when your bladder has previously been exposed to radiotherapy (radiation recall cystitis).
Frequency not known (cannot be estimated from the available data):
- interstitial lung disease (inflammation of the lungs causing cough and difficulty breathing).
Reporting of side effects:
If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if they are possible side effects not listed in this leaflet. You can also report them directly through the national reporting system included in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.
5. Storage of Cabazitaxel Accord
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and on the label of the vial after EXP. The expiry date refers to the last day of the month indicated.
This medicine does not require special temperature conditions for storage.
Store in the original container to protect from light.
After opening the vial
Each vial is for single use only and should be used immediately after opening. If not used immediately, the time and conditions of storage during use are the responsibility of the user.
After final dilution in the infusion bag/bottle
Chemical and physical stability of the infusion solution has been demonstrated for 8 hours at room temperature (15°C - 30°C), including a 1-hour infusion time, and for 48 hours under refrigerated conditions, including a 1-hour infusion time.
From a microbiological standpoint, the infusion solution should be used immediately. If not used immediately, the time and conditions of storage are the responsibility of the user and should normally not exceed 24 hours at 2°C - 8°C, unless the dilution was carried out under controlled and validated aseptic conditions.
Disposal
Disposal of unused medicine and of all materials that have come into contact with it must be carried out in accordance with local regulations. These measures will help protect the environment.
6. Pack contents and other information
Composition of Cabazitaxel Accord
The active substance is cabazitaxel. One ml of concentrate contains 20 mg of cabazitaxel. Each 3 ml vial of concentrate contains 60 mg of cabazitaxel.
The other components are polysorbate 80, citric acid and anhydrous ethanol (see section 2 “Cabazitaxel Accord contains alcohol”).
Appearance of Cabazitaxel Accord and contents of the container
Cabazitaxel Accord is a concentrate for solution for infusion (sterile concentrate).
The concentrate is a clear solution, colourless to pale yellow or yellowish-brown.
It is supplied as a single-use transparent glass vial of 6 ml with a deliverable volume of 3 ml of concentrate.
Pack size:
Each carton contains one single-use vial.
Marketing Authorisation Holder
Accord Healthcare S.L.U
World Trade Center, Moll de Barcelona s/n,
Edifici Est, 6th floor, Barcelona,
08039 Barcelona, Spain
Manufacturer
Accord Healthcare Limited
Sage House, 319 Pinner Road
Harrow, Middlesex, HA1 4HF
United Kingdom
LABORATORI FUNDACIÓ DAU
C/ C, 12-14 Pol. Ind. Zona Franca,
Barcelona, 08040, Spain
Pharmadox Healthcare Ltd.
KW20A Kordin Industrial Park
Paola, PLA 3000
Malta
Accord Healthcare Polska Sp. z o.o.,
ul. Lutomierska 50, Pabianice, 95-200
Poland
Accord Healthcare B.V
Winthontlaan 200, UTRECHT, 3526KV
Netherlands
Date of the most recent revision of this leaflet: {MM/YYYY}
Other sources of information
Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.
The following information is intended for healthcare professionals only.
PRACTICAL INFORMATION FOR PHYSICIANS OR HEALTHCARE PROFESSIONALS ON THE PREPARATION, ADMINISTRATION AND HANDLING OF CABAZITAXEL ACCORD 20 mg/ml CONCENTRATE FOR SOLUTION FOR INFUSION
This information complements sections 3 and 5 for the user.
It is important to read the entire content of this procedure before preparing the infusion solution.
Incompatibilities
This medicinal product must not be mixed with other medicinal products except those used for dilution.
Shelf life and special precautions for storage
For the pack of Cabazitaxel Accord 20 mg/ml concentrate for solution for infusion
This medicinal product does not require special temperature conditions for storage.
Keep in the original packaging to protect from light.
After opening the vial
Each vial is for single use only and must be used immediately after opening. If not used immediately, the time and conditions of storage in use are the responsibility of the user.
After final dilution in the infusion bag/bottle
Chemical and physical stability of the infusion solution has been demonstrated for 8 hours at room temperature (15°C - 30°C), including a 1-hour infusion time, and for 48 hours under refrigerated conditions (2°C - 8°C), including a 1-hour infusion time.
From a microbiological standpoint, the infusion solution should be used immediately. If not used immediately, the time and conditions of storage are the responsibility of the user and normally should not exceed 24 hours at 2°C - 8°C, unless the dilution has been carried out under controlled and validated aseptic conditions.
Preparation and administration precautions
As with other antineoplastic agents, caution should be exercised during the preparation and administration of Cabazitaxel Accord solutions, taking into account the use of safety devices, personal protective equipment (e.g. gloves), and preparation procedures.
If at any stage of preparation Cabazitaxel Accord comes into contact with the skin, wash immediately and thoroughly with soap and water. If contact occurs with mucous membranes, rinse immediately and thoroughly with water.
Cabazitaxel Accord must only be prepared and administered by personnel trained in the handling of cytotoxic agents. Pregnant healthcare workers should not handle this product.
Preparation steps
NEVER use with other medicinal products containing cabazitaxel at different concentrations. Cabazitaxel Accord contains 20 mg/ml of cabazitaxel (deliverable volume of at least 3 ml).
Each vial is for single use only and must be used immediately. Any unused solution must be discarded. More than one vial of Cabazitaxel Accord may be required to administer the prescribed dose.
The dilution process for preparing the infusion solution must be carried out aseptically.
Preparation of the infusion solution
Step 1 Aseptically withdraw the required volume from the Cabazitaxel Accord vial (containing 20 mg/mL of cabazitaxel) using a graduated syringe equipped with a fixed needle. For example, a 45 mg dose of cabazitaxel would require 2.25 mL of Cabazitaxel Accord. |
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Step 2 Inject into a sterile, non-PVC container of 5% glucose solution or 9 mg/ml (0.9%) sodium chloride solution for infusion. The concentration of the infusion solution must be between 0.10 mg/ml and 0.26 mg/ml. |
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Step 4 As with all parenteral products, the resulting infusion solution should be inspected visually before use. Since the infusion solution is supersaturated, it may crystallize over time. In this case, the solution must not be used and should be discarded. |
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The infusion solution should be used immediately. See the sections on shelf life and special storage precautions above.
Disposal of unused medicinal product and all materials that have been in contact with it should be carried out in accordance with local regulations.
Administration method
Cabazitaxel Accord is administered as an infusion over 1 hour.
The use of an in-line filter with a nominal pore size of 0.22 micrometers (also referred to as 0.2 micrometers) is recommended during administration.
PVC infusion containers or polyurethane infusion sets must not be used for the preparation and administration of the infusion solution.