ERIBULINA 0.44 MG/ML Injectable solution

Зміст інструкції

1. Eribulina Zentiva 0.44 mg/ml injectable solution
   1. What is Eribulina Zentiva and what is it used for
   2. What you need to know before you use 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

Eribulina Zentiva 0.44 mg/ml injectable solution

Generic medicine

Read this leaflet carefully before you start using this medicine as 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, even those not listed in this leaflet, tell 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 you use 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 is Eribulina Zentiva and what is it used for

Eribulina Zentiva contains the active substance eribulina and is an antineoplastic 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 tumor) when at least one other therapy has been attempted, but has not been
effective.
It is also used in adults for advanced or metastatic liposarcoma (a type of tumor that originates from fatty tissue) when a previous therapy has been attempted, but has not been effective.

2. What you need to know before you use Eribulina Zentiva

Do not use Eribulina Zentiva:

• if you are allergic to eribulin mesylate or 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 a 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, tell your doctor, who may decide to stop treatment or to
reduce the dose.

Children and adolescents
Do not give this medicine to children aged between 0 and 18 years because it is not effective.

Other medicines and Eribulina Zentiva
Tell your doctor if you are taking, have recently taken or might take any other
medicines.

Pregnancy, breastfeeding and fertility
Eribulina Zentiva can cause serious birth defects and should not be used during
pregnancy unless absolutely necessary and after careful consideration of all the risks to you and
to the baby. It can also cause future permanent fertility problems in men undergoing
treatment; therefore, you need to discuss this with your doctor before starting treatment.
Women of childbearing potential must use effective contraception during and for up to 3 months after
treatment with Eribulina Zentiva.
Eribulina Zentiva should not be used during breastfeeding, due to the potential
risks to the baby.

Driving and using machines
Eribulina Zentiva can cause side effects such as fatigue (very common) and dizziness (common).
Do not drive or use machines if you feel tired or dizzy.

Eribulina Zentiva contains ethanol (alcohol)
This medicine contains 80 mg of alcohol (ethanol) in each vial. The amount contained in a
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 have no noticeable effects.

3. How to use Eribulina Zentiva

Eribulina Zentiva will be administered to you by a qualified healthcare professional, via injection into a
vein over 2-5 minutes. The dose is based on body surface area (expressed in square meters, or m²),
calculated on the basis of weight and height. The usual dose of Eribulina Zentiva is 1.23 mg/m², but this
dose may be adjusted by the doctor based on blood test results or other factors. To
ensure that the entire dose of Eribulina Zentiva is administered, it is recommended that a saline
solution be injected through a flow regulator into the vein after the administration of Eribulina
Zentiva.

How often will Eribulina Zentiva be administered to you?
Eribulina Zentiva is usually administered on day 1 and day 8 of each 21-day cycle. The doctor
will determine the number of treatment cycles. Depending on blood test results, the doctor may
decide to postpone administration of the medicine until the values return to normal.
The doctor may also decide to reduce the dose to be administered.
If you have any doubts about the use of this medicine, please consult your doctor.

4. Possible side effects

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 Eribulina Zentiva and consult your
doctor immediately:

• Fever, with a rapid heartbeat, shallow rapid breathing, cold, pale, moist or mottled skin and/or confusion. These may be signs of a condition called sepsis - a serious and intense reaction to an infection. Sepsis has an uncommon frequency (may affect up to 1 in 100 people) and can be very dangerous and life-threatening.
• 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 rash with blistering on skin, mouth, eyes and genitals, which may be signs of a condition called Stevens-Johnson syndrome/toxic epidermal necrolysis. This condition has an unknown frequency but can 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, diarrhea
• 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 can cause bruising or an increased time it takes 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, thrush, indigestion, heartburn, pain or swelling in the abdomen
• Swelling of soft tissues, pain (especially in the chest, back and bones), muscle spasm or weakness
• Infections of the mouth, respiratory tract and urinary tract, pain when urinating
• Sore throat, irritated or runny nose, flu-like symptoms, sore throat
• Abnormalities in liver function tests, altered levels of sugars, bilirubin, phosphates, potassium, magnesium or calcium in the blood
• Difficulty sleeping, 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
• Shingles (herpes zoster)
• Swelling of the skin and numbness of the 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 can 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, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national reporting system at the address: 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 which is stated on the package and vial after
Exp. The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Period of validity in use
The chemical and physical stability during use 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 stability during use of the diluted solution (from 0.018 mg/ml to 0.18 mg/ml of eribuline
in sodium chloride (0.9%)) has been demonstrated for 48 hours at a temperature between 2 and 8 °C.
From a microbiological point of view, the product must be used immediately. If not used
immediately, the storage times and conditions during use are the responsibility of the user and
should normally not exceed 24 hours at a temperature between 2 and 8 °C, unless the
dilution has been carried out under controlled and validated aseptic conditions.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack 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 (pH adjustment) and sodium hydroxide (pH adjustment).

Description of the appearance of Eribulina Zentiva and contents of the pack
Eribulina Zentiva is a clear and colorless aqueous solution for injection with a pH between 6.0 and 9.0
supplied in glass vials containing 2 ml of solution. Each pack contains 1 or 6 vials.

Marketing authorization holder
Zentiva Italia Srl
Via P. Paleocapa, 7
20121 Milano
Italy

Manufacturer
Aqvida GmbH
Kaiser-Wilhelm-Strasse 89
Neustadt, Hamburg
20355 Germany

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
Czech Republic, Denmark, Germany, Lithuania, Norway, Sweden: Eribulin Zentiva
Bulgaria: Ерибулин Зентива
France: Eribuline Zentiva
Italy, Spain: Eribulina Zentiva