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.
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
Responsible for manufacturing
STADA Arzneimittel AG
Stadastrasse 2 – 18
61118 Bad Vilbel
Germany
or
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/
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