Dosage & Administration

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
(Halaven) administration
Recommended dose
Hematological: 1.1 mg/m2
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
Non-hematological:
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 0.7 mg/m2
Despite reduction to 0.7 mg/m2 Consider discontinuation

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.

 

Elderly patients

No specific dose adjustments are recommended based on the age of the patient.

 

Pediatric patients

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.