What is Halaven - eribulin?
Halaven is a solution for injection containing the active substance eribulin.
What is Halaven used for - eribulin?
Halaven monotherapy is indicated for the treatment of patients with locally advanced or metastatic breast cancer who have shown progression after at least two other chemotherapy regimens for advanced disease. Previous therapy must have included the use of an anthracycline and a taxane, unless the patients were not eligible to receive these treatments. Mastastatic means that the tumor has spread to other organs.
The drug can only be obtained with a prescription.
How is Halaven used - eribulin?
Halaven should be administered in units specialized in the administration of chemotherapy and under the supervision of a qualified doctor experienced in the correct use of anticancer drugs.
Halaven is administered intravenously in 21-day cycles. The dose to be administered is calculated based on the patient's body surface area (calculated on the basis of height and weight). The recommended dose is 1.23 mg / m2 to be administered intravenously over 2-5 minutes on day 1 and day 8 of each cycle. The administration of an antiemetic (a drug that prevents nausea and vomiting) should be considered, as Halaven can cause these effects. Doses can be postponed or reduced if patients have very low levels of neutrophils (a type of white blood cell) and platelets (components that promote blood clotting) or if renal or hepatic function is compromised. For more details on the use of Halaven, including recommendations on dosage reduction, please refer to the summary of product characteristics (included with EPAR).
How does Halaven - eribulin work?
The active ingredient in Halaven, eribulin, is analogous to an anticancer substance called alicondrina B, isolated in the Halicondria okadai marine sponge. It binds to a cellular protein called "tubulin", which plays an important role in the formation of the internal "skeleton" that cells must form when they divide. By binding to tubulin in tumor cells, eribulin interrupts the formation of the skeleton, preventing the division and proliferation of tumor cells.
How has Halaven been studied?
The effects of Halaven were first tested in experimental models before being studied in humans.
In a pivotal study, Halaven was compared with other therapeutic regimens on 762 women with advanced or metastatic breast cancer who had previously undergone at least two treatments including an anthracycline and a taxane. Patients were given Halaven or another approved chemotherapy chosen by the doctor. The main measure of effectiveness was overall survival (how long the patients survived).
What benefit has Halaven - eribulin shown during the studies?
Compared to all the other treatments as a whole, Halaven has shown greater efficacy in prolonging survival. The patients in the Halaven group survived on average 13.1 months, compared to 10.6 months in the group that received other treatments.
What are the risks associated with Halaven - eribulin?
The most common side effects of Halaven (seen in more than 1 patient in 10) are neutropenia (low levels of neutrophils, a type of white blood cell that fights infections), leukopenia (low white blood cell count), anemia (low counts of red blood cells), loss of appetite, peripheral neuropathy (damage to nerves in the extremities that cause numbness, tingling and itching), headache, nausea, constipation, diarrhea, vomiting, alopecia (hair loss), muscle and joint pain, fatigue (fatigue) pyrexia (fever). For the full list of all side effects reported with Halaven, see the Package Leaflet.
Halaven should not be used in people who may be hypersensitive (allergic) to eribulin or any of the other ingredients. It should not be given to breastfeeding women.
Why has Halaven - eribulin been approved?
The CHMP noted that, in addition to effects on survival, Halaven also prolonged the aggravation-free duration of the disease (progression-free survival). The CHMP decided that Halaven's benefits are greater than its risks and recommended that it be given marketing authorization.
More information on Halaven - eribulin
On 17 March 2011, the European Commission issued a marketing authorization for Halaven, valid throughout the European Union, to Eisai Europe Ldt. The marketing authorization is valid for five years, after which it can be renewed.
For more information on Halaven therapy read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Last update of this summary: 02-2011.
