Special Precaution in Handling

From a microbiological point of view, unless the method of opening precludes the risk of microbial contamination, the product should be used immediately. If not used immediately, in-use storage times and conditions are the responsibility of the user.

If not used immediately Eribulin mesilate (Halaven) as the undiluted solution in a syringe should not normally be stored longer than 4 hours at 25°C and ambient lighting, or 24 hours at 2°C – 8°C.

Diluted solutions of Eribulin mesilate (Halaven) [0.020 mg/ml to 0.205 mg/ml in sodium chloride 9 mg/ml (0.9%)] solution for injection should not be stored longer than 24 hours at 2°C – 8°C, unless dilution has taken place in controlled and validated aseptic conditions.

Disposal and other handling

Eribulin mesilate (Halaven) is a cytotoxic anticancer medicinal product and, as with other toxic compounds, caution should be exercised in its handling. The use of gloves, goggles, and protective clothing is recommended. If the skin comes into contact with the solution it should be washed immediately and thoroughly with soap and water. If it contacts mucous membranes, the membranes should be flushed thoroughly with water. Eribulin mesilate (Halaven) should only be prepared and administered by personnel appropriately trained in handling of cytotoxic agents. Pregnant staff should not handle Eribulin mesilate (Halaven).

Using aseptic technique Eribulin mesilate (Halaven) can be diluted up to 100 ml with sodium chloride 9 mg/ml (0.9%) solution for injection. Following administration, it is recommended that the intravenous line be flushed with sodium chloride 9 mg/ml (0.9%) solution for injection to ensure administration of the complete dose. It must not be mixed with other medicinal products and should not be diluted in glucose 5% infusion solution. If using a spike to administer the product refer to the instructions provided from the device manufacturer. Eribulin Mesilate (Halaven) vials have a 13mm stopper. The device selected should be compatible with small vial stoppers. Any unused product or waste material should be disposed of in accordance with local requirements.