Eribulin Baxter

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.