Eribulina ever pharma 0,44 mg/ml solucion inyectable efg

Package Leaflet: Information for the User

Eribulina EVER Pharma 0.44 mg/ml Injectable Solution EFG

Read this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or nurse.
• If you experience any side effects, consult your doctor or nurse,even if they do not appear in thisleaflet. See section 4.

Eribulina EVER Pharma contains the active ingredient eribulina and is a cancer medication that works by slowing down the growth and spread of cancer cells.

It is used for the treatment of adult patients with locally advanced or metastatic breast cancer (breast cancer that has spread beyond the original tumor) when at least one other treatment has stopped working.

It is also used for the treatment of adult patients with advanced or metastatic liposarcoma (a type of cancer that appears in fatty tissue) when a previous treatment has stopped working.

No use Eribulina EVER Pharma:

• if you are allergic to eribulin mesylate or any of the othercomponents of this medication (listed in section 6).
• if you are breastfeeding.

Warnings and precautions

Consult your doctor or nurse before starting to use Eribulina EVER Pharma

• if you have liver problems
• if you have a fever or an infection
• if you experience numbness, tingling, pins and needles, sensitivity to touch, or muscle weaknessmuscular
• if you have heart problems

If you are affected by any of the above, inform your doctor as they may want to suspend your treatment or reduce your dose.

Children and adolescents

Do not administer this medication to children aged 0 to 18 years as it has no effect on them.

Other medications and Eribulina EVER Pharma

Inform your doctor if you are using, have used recently, or may need to use any other medication.

Pregnancy, breastfeeding, and fertility

Eribulina EVER Pharma may cause severe congenital malformations and should not be used during pregnancy, unless it is clearly necessary after carefully considering all the risks for you and the baby. It may also cause permanent fertility problems in men if taken, and you should consult your doctor before starting treatment. Women of childbearing age should use effective contraceptive methods during and up to 3 months after completing treatment with Eribulina EVER Pharma.

Eribulina EVER Pharma should not be used during breastfeeding due to the possible risk to the child.

Driving and operating machinery

Eribulina EVER Pharma may cause side effects such as fatigue (very common) and dizziness (common). Do not drive or operate machinery if you are feeling tired or dizzy.

Eribulina EVER Pharma contains ethanol (alcohol)

Vial of 2 ml

This medication contains 79 mg of alcohol (ethanol) in each vial. The amount in 2 ml of this medication is equivalent to less than 2 ml of beer or 1 ml of wine.

Vial of 3 ml

This medication contains 118.5 mg of alcohol (ethanol) in each vial. The amount in 3 ml of this medication is equivalent to less than 3 ml of beer or 1 ml of wine.

The reduced amount of alcohol in this medication will not produce observable effects.

Eribulina EVERPharmacontainsless than 23 mg of sodium (1mmol) per ml; this is essentially “sodium-free”.

A qualified healthcare professional will administer Eribulina EVER Pharma as an injection into a vein over a period of 2 to 5 minutes. The dose you receive is based on your body surface area (expressed in square meters, or m2) calculated from your weight and height. The usual dose of Eribulina EVER Pharma is 1.23 mg/m2, although your doctor may adjust it based on blood test results or other factors. After administration of Eribulina EVER Pharma, it is recommended to irrigate the vein with a saline solution to ensure the complete administration of Eribulina EVER Pharma.

Frequency of Eribulina EVER Pharma administration

Eribulina EVER Pharma is usually administered on days 1 and 8 of each 21-day cycle. Your doctor will determine how many treatment cycles you should receive. Depending on blood test results, your doctor may need to delay administration of the medication until blood test results return to normal. At that time, your doctor may also decide to reduce the dose you receive.

If you use more Eribulina EVER Pharma than you should

In case of overdose, call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you have any other questions about the use of this medication, ask your doctor.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

If you experience any of the following severe symptoms, stop taking Eribulina EVER Pharma and see your doctor immediately:

• Fever, with very rapid heart rate, rapid and shallow breathing, cold, pale, moist, or mottled skin, and/or confusion. These may be signs of a condition called septicemia, a severe and life-threatening reaction to an infection. Septicemia is rare (may affect up to 1 in 100 people) and can be life-threatening and fatal.
• Difficulty breathing or swelling of the face, mouth, tongue, or throat. These may be signs of a rare allergic reaction (may affect up to 1 in 100 people).
• Severe skin eruptions with blisters on the skin, mouth, eyes, and genitals. These may be signs of a condition called Stevens-Johnson syndrome/toxic epidermal necrolysis. The frequency of this condition is unknown, but it can be potentially fatal.

Other side effects:

The very common side effects (may affect more than 1 in 10 people) are:

• Decreased white blood cell or red blood cell count
• Fatigue or weakness
• Nausea, vomiting, constipation, diarrhea
• Numbness, tingling, or pins and needles
• Fever
• Loss of appetite, weight loss
• Difficulty breathing, cough
• Pain in the joints, muscles, and back
• Headache
• Hair loss

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

• Decreased platelet count (which may lead to bruising or delayed bleeding)
• Infection with fever, pneumonia, chills
• Rapid heart rate, hot flashes
• Dizziness, vertigo
• Increased tear production, conjunctivitis (redness and itching of the eye surface), nasal bleeding
• Dehydration, dry mouth, herpes labialis, oral thrush, indigestion, stomach pain or swelling
• Swelling of soft tissues, pain (specifically chest, back, and bone pain), muscle spasms or weakness
• Infections in the mouth, respiratory tract, and urinary tract, painful urination
• Sore throat, runny nose, increased nasal secretion, flu-like symptoms, pharyngitis
• Abnormal liver function test results, altered blood sugar, bilirubin, phosphate, potassium, magnesium, or calcium levels
• Inability to sleep, depression, altered sense of taste
• Rash, itching, nail problems, dry or red skin
• Excessive sweating (including nighttime sweating)
• Tinnitus in the ears
• Clots in the lungs
• Herpes zoster
• Swelling of the skin and numbness in the hands and feet

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

• Clots in the blood
• Abnormal liver function test results (hepatotoxicity)
• Failure of the kidneys, blood or protein in the urine
• Extensive pulmonary inflammation that may lead to scarring
• Pancreatitis
• Ulcers in the mouth

The very rare side effects (may affect up to 1 in 1000 people) are:

• A severe blood clotting disorder that may lead to extensive blood clots and internal bleeding

Reporting of side effects

If you experience any type of side effect, consult your doctor or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through theSpanish System for Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the box and vial after CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above 30°C.

Chemical and physical stability has been demonstrated during use as an undiluted solution in a syringe for up to 8 hours between 15 °C and 25 °C and with natural light or up to 32 hours between 2 °C and 8 °C.

Chemical and physical stability has been demonstrated during use as a diluted solution (0.012 mg/ml to 0.18 mg/ml of eribulina in a sodium chloride injectable solution 9 mg/ml [0.9%]) for 8 hours between 15-25ºC and natural light and up to 48 hours between 2- 8ºC, unless the dilution has taken place in controlled and validated aseptic conditions.

From a microbiological standpoint, the product should be used immediately. If not used immediately, the times and conditions of conservation during use are the responsibility of the user and should normally not be stored for more than 24 hours between 2 °C and 8 °C, unless the dilution has taken place in controlled and validated aseptic conditions.

Medications should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. This will help protect the environment.

Composition of Eribulina EVER Pharma

• The active ingredient is eribulina. Each vial of 2 ml contains mesylate of eribulina equivalent to 0.88 mg of eribulina. Each vial of 3 ml contains mesylate of eribulina equivalent to 1.32 mg of eribulina.
• The other components are ethanol and water for injection preparations, with possible presence in very small amounts of hydrochloric acid and sodium hydroxide, to adjust the pH.

Appearance of the product and content of the container

Eribulina EVER Pharma is a transparent and colorless aqueous injectable solution, practically free of visible particles, presented in closed glass vials with a rubber stopper and an aluminum capsule with a plastic flip-off disc. The vials contain 2 ml or 3 ml of solution and are placed in a box.

Each package contains 1 or 6 vials.

Only some sizes of packaging may be commercially marketed.

Marketing authorization holder

EVER Valinject GmbH

Oberburgau 3

4866 Unterach am Attersee,

Austria

Responsible for manufacturing

Oncomed Manufacturing a.s

Karasek 2229/1b

Brno Rechcovice

62100 Republic of Czechia

EVER Pharma Jena GmbH

Brüsseler Str. 18,

07747 Jena,

Germany

For more information about this medication, please contact the local representative of the marketing authorization holder:

EVER Pharma Therapeutics Spain, S.L.

C/ Toledo 170

28005 Madrid

Spain

Last review date of this leaflet: 03/2024

The detailed information about this medication is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/)

This information is intended solely for healthcare professionals.

For further information, please consult the Technical Data Sheet.