Eribulin Zentiva

PACKAGE LEAFLET

Package leaflet: Information for the user

Eribulina Zentiva 0.44 mg/ml injection solution

Generic medicine
Please read this leaflet carefully before 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 or nurse.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or nurse. See section 4.

Contents of this leaflet:

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

1. What Eribulina Zentiva is and what it is used for

Eribulina Zentiva contains the active substance eribulin and is an antitumour medicine that works by
stopping the growth and spread of cancer cells.
It is used in adults for metastatic or locally advanced breast cancer (breast cancer that has spread beyond
the original tumour) when at least one other therapy has been tried but was not effective.
It is also used in adults for advanced or metastatic liposarcoma (a type of tumour originating from fatty
tissue) when a previous therapy has been tried but was not effective.

2. What you need to know before using Eribulina Zentiva

Do not use Eribulina Zentiva:

• if you are allergic to eribulin mesilate or to any of the other ingredients of this medicine (listed in section 6).
• if you are breastfeeding.

Warnings and precautions
Talk to your doctor or nurse before using Eribulina Zentiva:

• if you have liver problems.
• if you have fever or an infection.
• if you experience pain, tingling, prickling sensations, sensitivity to touch, or muscle weakness.
• if you have heart problems.

If any of these apply to you, inform your doctor, who may decide to stop treatment or reduce the dose.
Children and adolescents
Do not administer this medicine to children aged between 0 and 18 years, as it is not effective.
Other medicines and Eribulina Zentiva
Inform your doctor if you are taking, have recently taken, or might take any other medicines.
Pregnancy, breastfeeding and fertility
Eribulina Zentiva can cause severe congenital malformations and must not be used during pregnancy unless absolutely necessary and only after careful consideration of all risks to you and the baby. It may also cause long-term fertility problems in men undergoing treatment; therefore, this issue should be discussed with your doctor before starting treatment.
Women of childbearing age must use effective contraception during treatment and for at least 3 months after treatment with Eribulina Zentiva.
Eribulina Zentiva must not be used during breastfeeding due to possible risks to the infant.
Driving and using machines
Eribulina Zentiva can cause side effects such as fatigue (very common) and dizziness (common).
Do not drive or operate machinery if you feel fatigued or dizzy.
Eribulina Zentiva contains ethanol (alcohol)
This medicine contains 80 mg of alcohol (ethanol) per vial. The amount contained in one vial of this medicine is equivalent to less than 2 ml of beer or 1 ml of wine.
The small amount of alcohol contained in this medicine will not have noticeable effects.

3. How to use Eribulina Zentiva

Eribulina Zentiva will be administered to you by a qualified healthcare professional as an intravenous injection over 2 to 5 minutes. The dose is based on body surface area (expressed in square meters, m\²), calculated according to your weight and height. The usual dose of Eribulina Zentiva is 1.23 mg/m\², but your doctor may adjust this dose based on blood test results or other factors. To ensure the entire dose of Eribulina Zentiva is delivered, it is recommended that a saline solution be flushed through the intravenous line after administration of Eribulina Zentiva.

How often will Eribulina Zentiva be administered?
Eribulina Zentiva is usually administered on day 1 and day 8 of each 21-day cycle. Your doctor will determine the number of treatment cycles. Depending on blood test results, your doctor may decide to delay administration of the medicine until values return to normal. Your doctor may also decide to reduce the dose to be administered.

If you have any doubts about how to use this medicine, consult your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
If you experience any of the following serious symptoms, stop taking Eribulina Zentiva and consult your
doctor immediately:

• Fever, with rapid heartbeat, fast shallow breathing, cold, pale, moist or mottled skin and/or confusion. These may be signs of a condition called sepsis – a severe and intense reaction to an infection. Sepsis is not uncommon (may affect up to 1 in 100 people) and can be life-threatening and may result in death.
• Difficulty breathing or swelling of the face, mouth, tongue or throat. These may be signs of an uncommon allergic reaction (may affect up to 1 in 100 people).
• Severe skin rashes with blistering of the skin, mouth, eyes and genitals, which may be signs of a condition called Stevens-Johnson syndrome/toxic epidermal necrolysis. The frequency of this condition is unknown but it may be life-threatening.

Other side effects:
Very common side effects (may affect more than 1 in 10 people) are:

• Decrease in the number of white blood cells or red blood cells
• Tiredness or weakness
• Nausea, vomiting, constipation, diarrhoea
• Numbness, tingling or prickling sensations
• Fever
• Loss of appetite, weight loss
• Difficulty breathing, cough
• Pain in joints, muscles and back
• Headache
• Hair loss

Common side effects (may affect up to 1 in 10 people) are:

• Reduction in the number of platelets (which may cause bruising or increased time needed to stop bleeding)
• Infection with fever, pneumonia, chills
• Rapid heartbeat, hot flushes
• Dizziness, lightheadedness
• Increased tear production, conjunctivitis (redness and pain on the surface of the eye), nosebleeds
• Dehydration, dry mouth, cold sores, oral thrush, indigestion, heartburn, abdominal pain or swelling
• Swelling of soft tissues, pain (particularly in the chest, back and bones), muscle spasms or muscle weakness
• Infections of the mouth, respiratory tract and urinary tract, pain when urinating
• Sore throat, irritated or runny nose, flu-like symptoms, throat pain
• Abnormalities in liver function tests, altered levels of sugars, bilirubin, phosphates, potassium, magnesium or calcium in the blood
• Inability to sleep, depression, altered sense of taste
• Skin rash, itching, nail problems, dry or red skin
• Excessive sweating (including night sweats)
• Ringing in the ears
• Blood clots in the lungs
• Herpes zoster (shingles)
• Swelling of the skin and numbness of hands and feet

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

• Blood clots
• Abnormalities in liver function tests (hepatotoxicity)
• Kidney failure, blood or protein in urine
• Widespread inflammation of the lungs, which may lead to scarring
• Inflammation of the pancreas
• Mouth ulcers

Rare side effects (may affect up to 1 in 1,000 people) are:

• Severe blood clotting disorder, causing widespread blood clots and internal bleeding

Reporting of side effects
If you get any side effects, including ones not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Eribulina Zentiva

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 vial after EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.

In-use stability
The chemical and physical in-use stability of the undiluted solution in a syringe has been demonstrated for 24 hours at a temperature between 20 and 25 °C and for 96 hours at a temperature between 2 and 8 °C.
The chemical and physical in-use stability of the diluted solution (from 0.018 mg/ml to 0.18 mg/ml eribulin in sodium chloride (0.9%)) has been demonstrated for 48 hours at a temperature between 2 and 8 °C.
From a microbiological standpoint, the product should be used immediately. If not used immediately, the storage times and conditions during use are the responsibility of the user and normally should not exceed 24 hours at a temperature between 2 and 8 °C, unless dilution has been carried out under controlled and validated aseptic conditions.

Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Eribulina Zentiva contains

• The active substance is eribulin. Each 2 ml vial contains eribulin mesylate equivalent to 0.88 mg of eribulin.
• The other components are anhydrous ethanol and water for injections, with hydrochloric acid (for pH adjustment) and sodium hydroxide (for pH adjustment).

Description of the appearance of Eribulina Zentiva and package contents
Eribulina Zentiva is a clear, colourless aqueous injectable solution with a pH between 6.0 and 9.0,
supplied in glass vials containing 2 ml of solution. Each carton contains 1 or 6 vials.
Marketing Authorization Holder
Zentiva Italia Srl
Via P. Paleocapa, 7
20121 Milan
Italy
Manufacturer
Aqvida GmbH
Kaiser-Wilhelm-Strasse 89
Neustadt, Hamburg
20355 Germany
This medicinal product is authorized in the European Economic Area Member States under the
following names:
Czech Republic, Denmark, Germany, Lithuania, Norway, Sweden: Eribulin Zentiva
Bulgaria: Ерибулин Зентива
France: Eribuline Zentiva
Italy, Spain: Eribulina Zentiva