Eribulin EG

Package leaflet: Information for the user

Eribulina EG 0.44 mg/ml solution for injection

Generic medicine
Please 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 or nurse.
• If you get any side effects, talk to your doctor or nurse. This includes any side effects not listed in this leaflet. See section 4.

What is in this leaflet:

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

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

Eribulina EG contains the active substance eribulin and is an anticancer 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 in fatty tissue) when a previous therapy has been tried but was not effective.

2. What you need to know before using Eribulina EG

Do not use Eribulina EG

• if you are allergic to eribulin mesylate 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 EG:

• if you have liver problems
• if you have fever or an infection
• if you experience soreness, 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 discontinue treatment or
reduce the dose.
Children and adolescents
Do not administer this medicine to children and adolescents aged between 0 and 18 years, as it is not effective.
Other medicines and Eribulina EG
Tell your doctor if you are taking, have recently taken, or might take any other medicines.
Pregnancy, breastfeeding and fertility
Eribulina EG may cause severe congenital malformations and must not be used during
pregnancy, except when strictly necessary and after careful consideration of all risks to you
and your baby.
It may also cause permanent 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 3 months after
treatment with ERIBULINA EG.
Eribulina EG must not be used during breastfeeding due to possible risks to the infant.
Driving and using machines
Eribulina EG may cause side effects such as fatigue (very common) and dizziness (common).
Do not drive or operate machinery if you feel fatigued or dizzy.
Eribulina EG contains ethanol (alcohol)
This medicine contains 40 mg of alcohol (ethanol) per ml of injectable solution. The amount in
each ml of this medicine is equivalent to less than 1 ml of beer or 0.4 ml of wine.
The small amount of alcohol in this medicine will not produce significant effects.

3. How to use Eribulina EG

Method of administration
Eribulina EG will be administered to you by a qualified healthcare professional, by injection through an intravenous infusion line, into a vein over 2 to 5 minutes.

Dosage
The dose is based on body surface area (expressed in square meters, m²), calculated according to your weight and height. The usual dose of Eribulina EG is 1.23 mg/m², but your doctor may adjust this dose based on blood test results or other factors. To ensure the entire dose of Eribulina EG is administered, it is recommended that a saline solution be flushed through the same infusion line into the vein immediately after administration of Eribulina EG.

How often will Eribulina EG be administered?
Eribulina EG 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 the use of this medicine, consult your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
If you experience any of the following serious symptoms, stop taking Eribulina EG and contact 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 widespread response to infection. Sepsis is uncommon (may affect up to 1 in 100 people), and can be life-threatening and lead to 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 on 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:

• decreased number of white blood cells or red blood cells
• fatigue or weakness
• nausea, vomiting, constipation, diarrhoea
• sensations of numbness, tingling or prickling
• fever
• loss of appetite, weight loss
• difficulty breathing, cough
• joint, muscle and back pain
• headache
• hair loss

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

• reduced 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 or urinary tract, painful urination
• irritated throat, irritated or runny nose, flu-like symptoms, sore throat
• abnormalities in liver function tests, altered levels of sugar, bilirubin, phosphates, potassium, magnesium or calcium in the blood
• inability to sleep, depression, altered taste sensation
• 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)
• skin swelling 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 the 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 disorder of blood clotting causing widespread blood clots and internal bleeding.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor or nurse. 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 EG

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 vial after
Exp. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
If Eribulina EG is diluted for infusion, the diluted solution must be used immediately.
If not used immediately, the storage times and conditions prior to use are the responsibility of the user and
normally should not exceed 24 hours at a temperature of 2 °C–8 °C, unless dilution has been carried out under
controlled and validated aseptic conditions.
If undiluted Eribulina EG solution has been transferred into a syringe, it should be stored at
25 °C for a maximum of 24 hours or at 2–8 °C for a maximum of 96 hours.
Do not dispose of medicines 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 EG contains

• The active substance is eribulin. Each 2 ml vial contains eribulin mesylate equivalent to 0.88 mg of eribulin.
• The other components are ethanol and water for injections; hydrochloric acid (diluted) and sodium hydroxide may be present in very small amounts.

Description of the appearance of Eribulina EG and contents of the pack
Eribulina EG is a clear, colourless aqueous injectable solution supplied in glass vials containing 2 ml of solution. Each carton contains 1 or 6 vials.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
EG S.p.A., via Pavia 6, 20136 Milano, Italy.

Manufacturers
Stada Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel, Germany

AqVida GmbH
Kaiser-Wilhelm-Str. 89
20355 Hamburg, Germany

This medicinal product is authorised in the European Economic Area Member States under the following names:
Belgium Eribulin EG 0.44 mg/ml solution for injection
Denmark Eribulin STADA
Estonia Eribulin STADA 0.44 mg/ml süstelahus
Spain Eribulina STADA 0.44 mg/ml solución inyectable EFG
Finland Eribulin STADA 0.44 mg/ml injektioneste, liuos
France ERIBULINE EG 0.44 mg/ml, solution injectable
Croatia Eribulin 0.44 mg/ml otopina za injekciju
Iceland Eribulin STADA 0.44 mg/ml stungulyf, lausn
Italy ERIBULINA EG
Lithuania Eribulin STADA 0.44 mg/ml injekcinis tirpalas
Luxembourg Eribulin EG 0.44 mg/ml solution injectable
Latvia Eribulin STADA 0.44 mg/ml šķīdums injekcijām
Norway Eribulin STADA 0.44 mg/ml injeksjonsvæske, oppløsning
Sweden Eribulin STADA 0.44 mg/ml injektionsvätska, lösning