Ficha técnica de Eribulina stada 0,44 mg/ml solucion inyectable efg – Espanha

Como usar Eribulina stada 0,44 mg/ml solucion inyectable efg

Introduction

Prospecto: information for the user

Eribulina Stada 0.44 mg/ml injectable solution EFG

Read this entire prospect carefully before starting to use this medication, as it contains important information for you.

Keep this prospect, as you may need to read it again.
If you have any questions, consult your doctor or nurse.
If you experience any adverse effects, consult your doctor or nurse, even if they are not listed in this prospect. See section 4.

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

This medication contains the active ingredient eribulina and is a cancer medication that worksby inhibiting 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 another treatment has stopped being effective.

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 being effective.

2. What you need to know before starting to use Eribulina Stada

DO NOT USE Eribulina Stada

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

Warnings and precautions

Consult your doctor or nurse before starting to use eribulina

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 weakness
if you have heart problems

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

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 Stada

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

Pregnancy, breastfeeding, and fertility

Eribulina 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 the future for men who take it, 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 eribulina treatment.

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

Driving and operating machines

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

Eribulina contains ethanol (alcohol)

This medication contains 40 mg of ethanol in each ml of injectable solution. The amount in each ml is equivalent to less than 1 ml of beer or 0.4 ml of wine.

The small amount of alcohol in this medication does not produce any noticeable effect.

3. How to Use Eribulina Stada

Administration Form

A qualified healthcare professional will administer eribulina as an injection into a vein over a period of 2 to 5 minutes.

Dose

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 is 1.23 mg/m2, although your doctor may adjust it based on blood test results or other factors. After eribulina administration, it is recommended to irrigate the vein with a saline solution to ensure the complete administration of eribulina.

Eribulina Administration Frequency

Eribulina 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 eribulina administration until blood test results return to normal values. At that time, your doctor may also decide to reduce the dose administered.

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

4. Possible Adverse Effects

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

If you experience any of the following severe symptoms, stop taking eribulina and seek medical attention 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 may be potentially fatal.

Other side effects:

Thevery 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

Thecommon 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 nocturnal sweating)
Tinnitus
Pulmonary embolism
Herpes zoster
Swelling of the skin and numbness in hands and feet

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

Clots in the blood
Abnormal liver function test results (hepatotoxicity)
Renal failure, blood or protein in the urine
Pancreatitis
Mouth ulcers

Thevery 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 the Spanish System for the Pharmacovigilance of Medicinal Products for Human Usehttps://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

5. Conservation of Eribulina Stada

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.

This medication does not require special storage conditions.

If eribulina is diluted for infusion, the diluted solution must be used immediately. If not used immediately, storage times and conditions 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.

If eribulina as undiluted solution has been transferred to a syringe, it should be stored at 25 °C for no more than 24 hours, or between 2 °C and 8 °C for no more than 96 hours.

Medications should not be thrown away 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.

6. Contents of the packaging and additional information

Composition of Eribulina Stada

The active ingredient is eribulina. Each vial of 2 ml contains eribulina mesilate equivalent to 0.88 mg of eribulina.
The other components are ethanol and water for injectable preparations, with possible presence in very small quantities of hydrochloric acid (diluted) and sodium hydroxide.

Appearance of the product and contents of the package

Eribulina is a transparent and colorless injectable aqueous solution that comes in glass vials containing 2 ml of solution. Each box contains 1 or 6 vials.

Only some package sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Responsible for manufacturing

STADA Arzneimittel AG

Stadastrasse 2 – 18

61118 Bad Vilbel

Germany

AqVida GmbH

Kaise-Wilhelm-Str. 89

20355 Hamburg

Germany

This medicine is authorized in the member states of the European Economic Area with the following names:

Sweden	Eribulin STADA 0.44 mg/ml injection solution
Belgium	Eribulin EG 0.44 mg/ml injection solution
Denmark	Eribulin STADA
Estonia	Eribulin STADA Strength & form: 0.44 mg/ml injection solution
Spain	Eribulina STADA 0.44 mg/ml injectable solution EFG
Finland	Eribulin STADA 0.44 mg/ml injection solution, liquid
France	ERIBULINE EG 0.44 mg/ml, injectable solution
Croatia	Eribulin 0.44 mg/ml injection solution
Iceland	Eribulin STADA 0.44 mg/ml injection solution, liquid
Italy	ERIBULINA EG
Lithuania	Eribulin STADA 0.44 mg/ml injection solution
Luxembourg	Eribulin EG 0.44 mg/ml injectable solution
Latvia	Eribulin STADA 0.44 mg/ml injection solution
Norway	Eribulin STADA 0.44 mg/ml injection solution, liquid

Last review date of this leaflet: September 2023

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