ERIBULINA 0.44 MG/ML Roztwór do wstrzykiwań

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1. Eribulina Glenmark 0.44 mg/ml injectable solution
   1. What is Eribulina Glenmark and what is it used for
   2. What you need to know before you use Eribulina Glenmark
   3. How to use Eribulina Glenmark
   4. Possible side effects
   5. How to store Eribulina Glenmark
   6. Contents of the pack and other information

Eribulina Glenmark 0.44 mg/ml injectable solution

eribulina

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

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

Eribulina Glenmark 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 Glenmark

Do not use Eribulina Glenmark

• 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 Glenmark:

• 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 Glenmark
Tell your doctor if you are taking, have recently taken or might take any other medicines.

Pregnancy, breastfeeding and fertility
Women of childbearing potential must use effective contraceptive measures during and for at least 7 months after
treatment with Eribulina Glenmark. Men must not father children during treatment with
Eribulina Glenmark. Men must use an effective contraceptive method during treatment
with Eribulina Glenmark and for at least 4 months after treatment.
Eribulina Glenmark can cause serious birth defects and must not be used during
pregnancy, unless absolutely necessary and after careful consideration of all the risks to you
and the baby.
Eribulina Glenmark must not be used during breastfeeding, due to the
possible risks to the baby.
It may also cause future permanent fertility problems in men undergoing treatment;
therefore, this aspect must be discussed with your doctor before starting treatment.

Driving and operating machinery
Eribulina Glenmark can cause side effects, such as fatigue (very common) and dizziness
(common). Do not drive or operate machinery if you feel tired or dizzy.

Eribulina Glenmark contains ethanol (alcohol)
This medicine contains 79 mg of alcohol (ethanol) in each vial, which is equivalent to 40 mg/ml.
The amount in each vial of this medicine is equivalent to less than 2 ml of beer or 1 ml of
wine.
The small amount of alcohol in this medicine will not produce significant effects.

3. How to use Eribulina Glenmark

Eribulina Glenmark will be administered to you by a qualified healthcare professional, by injection,
through an infusion line, into a vein over 2-5 minutes. The dose is based on body surface area
(expressed in square meters, or m²), calculated based on weight and height. The usual dose of
Eribulina Glenmark 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 Glenmark is administered,
it is recommended that a saline solution be injected into the vein through the same infusion line after
the administration of Eribulina Glenmark.

How often will Eribulina Glenmark be administered to you?
Eribulina Glenmark 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 everyone will experience them.
If you experience any of the following serious symptoms, stop taking Eribulina Glenmark and consult your
doctor immediately:

• fever, with a rapid heartbeat, shallow rapid breathing, cold, pale, damp 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 rashes 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:

• reduction in the number of platelets (which can cause bruising or an increase in the time it takes to stop bleeding)
• infection with fever, pneumonia, chills
• rapid heartbeat, hot flushes
• dizziness, lightheadedness
• increased production of tears, 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
• rash, itching, nail problems, dry or red skin
• excessive sweating (including night sweats)
• ringing in the ears
• blood clots in the lungs
• shingles
• swelling of the skin and numbness in 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, which causes widespread blood clots and internal bleeding.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform your
doctor or nurse. You can also report side effects directly through 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 Glenmark

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.
If Eribulina Glenmark is diluted for infusion, the diluted solution must be used
immediately. If not used immediately, the diluted solution must be stored at a
temperature of 2-8 °C for a maximum of 48 hours.
If Eribulina Glenmark as an undiluted solution has been transferred into a syringe, it must be
stored at a temperature of 25 °C for a maximum of 24 hours or at a temperature of 2-8 °C for a maximum
of 96 hours.
From a microbiological point of view, the medicine must be used immediately. If not
used immediately, the storage times and conditions in use are the responsibility of the
user and should generally not exceed 24 hours at a temperature of 2 °C-8 °C.
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 Glenmark contains

• The active substance is eribuline. 1 ml contains eribuline mesylate equivalent to 0.44 mg of eribuline. Each vial of 2 ml contains eribuline mesylate equivalent to 0.88 mg of eribuline.
• The other components are ethanol and water for injections with hydrochloric acid and sodium hydroxide.

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

Marketing authorization holder and manufacturer

Marketing authorization holder
Glenmark Pharmaceuticals s.r.o.
Hvezdova 1716/2b
140 78 - Prague
Czech Republic

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

This medicinal product is authorised in the Member States of the European Economic Area under the
following designations:
Italy: Eribulina Glenmark
Sweden: Eribulin Glenmark 0.44 mg/ml injection solution
Denmark: Eribulin Glenmark
Norway: Eribulin Glenmark 0.44 mg/ml injection solution
Finland: Eribulin Glenmark 0.44 mg/ml injection solution
Spain: Eribulina Glenmark 0.44 mg/ml injectable solution EFG