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The product code(s) for this leaflet is: PL 17780/1220.
Eribulin 0.44 mg/ml solution for injection
Eribulin 0.44 mg/ml solution for injection
1. What Eribulin is and what it is used for
2. What you need to know before you are given Eribulin
3. How Eribulin is given
4. Possible side effects
5. How to store Eribulin
6. Contents of the pack and other information
The name of your medicine is Eribulin Zentiva 0.44 mg/ml solution for injection (called Eribulin throughout this leaflet). Eribulin contains the active substance eribulin and is an anti-cancer medicine which works by stopping the growth and spread of cancer cells.
It is used in adults for locally advanced or metastatic breast cancer (breast cancer that has spread beyond the original tumour) when at least one other therapy has been tried but has lost its effect.
It is also used in adults for advanced or metastatic liposarcoma (a type of cancer that arises from fat tissue) when previous therapy has been tried but has lost its effect.
Talk to your doctor or nurse before you are given Eribulin if you:
If any of these affects you, tell your doctor who may wish to stop treatment or reduce the dose.
Do not give this medicine to children between the ages of 0 to 18 years because it does not work.
Tell your doctor if you are using, have recently used or might use any other medicines.
Eribulin may cause serious birth defects and should not be used if you are pregnant unless it is thought clearly necessary after carefully considering all the risk to you and the baby. It may also cause future permanent fertility problems in men if they take it and they should discuss this with their doctor before starting treatment. Women of childbearing potential must use highly effective contraception during treatment with Eribulin and for 7 months after treatment.
Eribulin must not be used during breast-feeding because of the possibility of risk to the child.
Men with a partner of childbearing potential should not father a child while receiving treatment with Eribulin. Men must use an effective method of contraception while taking Eribulin and for 4 months after treatment.
Eribulin may cause side effects such as tiredness (very common) and dizziness (common). Do not drive or use machines if you feel tired or dizzy.
This medicine contains 80 mg of ethanol (alcohol) in each vial. The amount in a vial of this medicine is equivalent to less than 2 ml beer or 1 ml wine. The small amount of alcohol in this medicine will not have any noticeable effects.
Eribulin will be given to you by a qualified healthcare professional as an injection into a vein, over a period of 2 to 5 minutes. The dose you will receive is based on your body surface area (expressed in squared metres, or m2) which is calculated from your weight and height. The usual dose of Eribulin is 1.23 mg/m2, but this may be adjusted by your doctor based on your blood test results or other factors. To ensure that the whole dose of Eribulin is given it is recommended that a saline solution is flushed into the vein after Eribulin is given.
Eribulin is usually given on Days 1 and 8 of every 21-day cycle. Your doctor will determine how many cycles of treatment you should receive. Depending on the results of your blood tests, the doctor may need to delay administration of the medicine until the blood tests return to normal. The doctor may also then decide to reduce the dose you are given.
If you have any further questions about the use of this medicine, ask your doctor.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience any of the following serious symptoms, stop taking Eribulin and seek medical attention straightaway:
Other side effects:
Very common (may affect more than 1 in 10 people):
Common (may affect up to 1 in 10 people):
Uncommon (may affect up to 1 in 100 people):
Rare (may affect up to 1 in 1000 people):
If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play and Apple App store. By reporting side effects you can help provide more information on the safety of this medicine.
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 carton and the vial after EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Chemical and physical in-use stability of the undiluted solution in a syringe has been demonstrated for 24 hours at 20 to 25 °C and 96 hours at 2 to 8 °C.
Chemical and physical in-use stability of the diluted solution (0.018 mg/ml to 0.18 mg/ml eribulin in sodium chloride (0.9%)) has been demonstrated for 48 hours at 2 to 8 °C.
From a microbiological point of view, the product 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 to 8 °C, unless dilution has taken place in controlled and validated aseptic conditions.
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 protect the environment.
Your doctor or nurse is responsible for storage, preparation and disposal of this medicine.
Eribulin is a clear, colourless aqueous solution for injection with pH 6.0-9.0 provided in glass vials containing 2 ml of solution. Each carton contains either 1 or 6 vials.
Not all pack sizes may be marketed.
This leaflet was last revised in November 2024
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