Drug

HALAVEN®

eribulin

Halaven Overview

This is a summary of the European public assessment report (EPAR) for Halaven. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Halaven.

Halaven treatment should be given under the supervision of a doctor experienced in the use of anticancer medicines.

Halaven 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 Halaven 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 details on the use of Halaven including recommendations on dose reduction, see the summary of product characteristics (also part of the EPAR).

The active substance in Halaven, 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.

The CHMP noted that, when Halaven was used as a third-line therapy for breast cancer (after at least two previous treatments with cancer medicines for advanced/metastatic disease), it prolonged the length of time that patients lived and the safety profile is within what is expected for chemotherapy medicines. When Halaven was used as breast cancer second-line therapy (after at least one previous cancer treatment for advanced/metastatic disease), Halaven was a valuable treatment option similar to capecitabine and with an acceptable safety profile. Additionally, Halaven prolonged the length of time that liposarcoma patients lived, and this was considered important as these patients have limited treatment options. Safety in this patient population was considered acceptable and similar to that in patients with breast cancer.

The CHMP decided that Halaven’s benefits are greater than its risks and recommended that it be given marketing authorisation.

risk management plan has been developed to ensure that Halaven is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Halaven, including the appropriate precautions to be followed by healthcare professionals and patients.

The European Commission granted a marketing authorisation valid throughout the European Union for Halaven on 17 March 2011.

For more information about treatment with Halaven, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

What are the risks associated with Halaven?

The most common side effects with Halaven (seen in more than 1 patient in 10) are neutropenia (low levels of neutrophils, a type of white blood cell that fights infection), leucopenia (low white blood cell counts), anaemia (low red blood cell counts), reduced appetite, peripheral neuropathy (damage to the nerves in the extremities causing numbness, tingling and prickling sensations), headache, dyspnoea (difficulty breathing), cough, nausea (feeling sick), constipation, diarrhoea, vomiting, alopecia (hair loss), muscle and joint pain or pain in the back or limbs, fatigue (tiredness), pyrexia (fever) and weight loss.

Halaven must not be used in women who are breastfeeding. 

Owner of copyright and other intellectual property rights to European Medicines Agency

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