Eribulin mesilate (Halaven) should be administered in units specialized in the administration of cytotoxic chemotherapy and only under the supervision of a qualified physician experienced in the appropriate use of cytotoxic medicinal products.
The recommended dose of eribulin mesilate as the ready to use solution is 1.4 mg/m2 (equivalent to 1.23 mg/m2 eribulin) which should be administered intravenously over 2 to 5 minutes on Days 1 and 8 of every 21-day cycle.
Patients may experience nausea or vomiting. Antiemetic prophylaxis including corticosteroids should be considered.
Dose delays during therapy
The administration of Eribulin mesilate (Halaven) should be delayed on Day 1 or Day 8 for any of the following:
– Absolute neutrophil count (ANC) < 1 x 109/l
– Platelets < 75 x 109/l
– Grade 3 or 4 non-hematological toxicities.
Dose reduction during therapy
Dose reduction recommendations for re-treatment are shown in the following table.
Dose reduction recommendations
|Adverse reactions after previous Eribulin mesilate
|ANC < 0.5 x 109/l lasting more than 7 days
|ANC < 1 x 109/l neutropenia complicated by fever or infection
|Platelets < 25 x 109/l thrombocytopenia
|Platelets < 50 x 109/l thrombocytopenia complicated by haemorrhage or requiring blood or platelet transfusion
|Any Grade 3 or 4 in the previous cycle
|Re-occurrence of any hematological or non-hematological
adverse reactions as specified above
|Despite reduction to 1.1 mg/m2
|Despite reduction to 0.7 mg/m2
Do not re-escalate the eribulin mesilate dose after it has been reduced.
Patients with hepatic impairment
Impaired liver function due to metastases
The recommended dose of eribulin in patients with mild hepatic impairment (Child-Pugh A) is 1.1 mg/m2 administered intravenously over 2 to 5 minutes on Days 1 and 8 of a 21-day cycle. The recommended dose of eribulin in patients with moderate hepatic impairment (Child-Pugh B) is 0.7 mg/m2 administered intravenously over 2 to 5 minutes on Days 1 and 8 of a 21-day cycle.
Severe hepatic impairment (Child-Pugh C) has not been studied but it is expected that a more marked dose reduction is needed if eribulin is used in these patients.
Impaired liver function due to cirrhosis
This patient group has not been studied. The doses above may be used in mild and moderate impairment but close monitoring is advised as the doses may need readjustment.
Patients with renal impairment
Some patients with moderately or severely impaired renal function (creatinine clearance <50 ml/min) may have increased eribulin exposure and may need a reduction of the dose. For all patients with renal impairment, caution and close safety monitoring is advised.
No specific dose adjustments are recommended based on the age of the patient.
There is no relevant use of Eribulin mesilate (Halaven) in children and adolescents in the indication of breast cancer.
There is no relevant use of Eribulin mesilate in pediatric population for the indication of soft tissue sarcoma.
Method of administration
Eribulin mesilate (Halaven) is for intravenous use. The dose may be diluted in up to 100 ml of sodium chloride 9 mg/ml (0.9%) solution for injection. It should not be diluted in glucose 5% infusion solution. For instructions on the dilution of the medicinal product before administration.
Good peripheral venous access, or a patent central line, should be ensured prior to administration. There is no evidence that eribulin mesilate is a vesicant or an irritant. In the event of extravasation, treatment should be symptomatic.
For information relevant to the handling of cytotoxic drugs, see Storage & Handling.