Eribulin Baxter
Authorised
This medicine is authorised for use in the European Union
eribulin
MedicineHumanAuthorised
Overview
Eribulin Baxter is a cancer medicine used to treat locally advanced or metastatic breast cancer which has continued to spread after at least one previous treatment for advanced cancer. Previous treatment should have included cancer medicines of the types known as anthracyclines and taxanes, unless these treatments were not suitable. ‘Metastatic’ means that the cancer has spread to other parts of the body.
Eribulin Baxter is also used to treat adults with advanced or metastatic liposarcoma (a type of cancer of the soft tissues that develops from fat cells) that cannot be surgically removed. It is used in patients who have already been treated with anthracyclines (unless this treatment was not suitable).
Eribulin Baxter contains the active substance eribulin and is a ‘generic medicine’. This means that Eribulin Baxter contains the same active substance and works in the same way as a ‘reference medicine’ already authorised in the EU. The reference medicine for Eribulin Baxter is Halaven. For more information on generic medicines, see the question-and-answer document here.
Eribulin Baxter can only be obtained with a prescription and treatment should be given under the supervision of a doctor experienced in the use of cancer medicines.
Eribulin Baxter is given as intravenous (into a vein) injections over 21‑day cycles. The dose to be given is calculated using the patient’s height and weight. The calculated dose is given into a vein over two to five minutes on days 1 and 8 of each cycle. Doctors should consider giving patients an antiemetic (a medicine that prevents nausea and vomiting) as Eribulin Baxter may cause nausea or vomiting.
Doses may be delayed or reduced if patients have very low levels of neutrophils (a type of white blood cell) and platelets (components that help the blood to clot) in their blood or if liver or kidney function is impaired.
For more information about using Eribulin Baxter, see the package leaflet or contact your doctor or pharmacist.
The active substance in Eribulin Baxter, eribulin, is similar to an anticancer substance called halichondrin B, which is found in the marine sponge Halichondria okadai. It attaches to a protein in cells called tubulin, which is important in the formation of the internal ‘skeleton’ that cells need to assemble when they divide. By attaching to tubulin in cancer cells, eribulin disrupts the formation of the skeleton, preventing the division and spread of the cancer cells.
Studies on the benefits and risks of the active substance in the authorised uses have already been carried out with the reference medicine, Halaven, and do not need to be repeated for Eribulin Baxter.
As for every medicine, the company provided studies on the quality of Eribulin Baxter. There was no need for ‘bioequivalence’ studies to investigate whether Eribulin Baxter is absorbed similarly to the reference medicine to produce the same level of the active substance in the blood. This is because Eribulin Baxter is given by injection into a vein, so the active substance is delivered straight into the bloodstream.
Because Eribulin Baxter is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine’s.
The European Medicines Agency concluded that, in accordance with EU requirements, Eribulin Baxter has been shown to have comparable quality and to be bioequivalent to Halaven. Therefore, the Agency’s view was that, as for Halaven, the benefits of Eribulin Baxter outweigh the identified risks and it can be authorised for use in the EU.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Eribulin Baxter have been included in the summary of product characteristics and the package leaflet.
Any additional measures in place for Halaven also apply to Eribulin Baxter where appropriate.
As for all medicines, data on the use of Eribulin Baxter are continuously monitored. Suspected side effects reported with Eribulin Baxter are carefully evaluated and any necessary action taken to protect patients.
Eribulin Baxter received a marketing authorisation valid throughout the EU on 27 June 2024.
Product information
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
Product details
- Name of medicine
- Eribulin Baxter
- Active substance
- Eribulin mesylate
- International non-proprietary name (INN) or common name
- eribulin
- Therapeutic area (MeSH)
- Breast Neoplasms
- Liposarcoma
- Anatomical therapeutic chemical (ATC) code
- L01XX41
Pharmacotherapeutic group
Antineoplastic agentsTherapeutic indication
Eribulin Baxter is indicated for the treatment of adult patients with locally advanced or metastatic breast cancer who have progressed after at least one chemotherapeutic regimen for advanced disease. Prior therapy should have included an anthracycline and a taxane in either the adjuvant or metastatic setting unless patients were not suitable for these treatments.
Eribulin Baxter is indicated for the treatment of adult patients with unresectable liposarcoma who have received prior anthracycline containing therapy (unless unsuitable) for advanced or metastatic disease
News on Eribulin Baxter
This page was last updated on