Active Ingredient: Eribulin mesylate
Eribulin is indicated for the treatment of adult patients with locally advanced or metastatic breast cancer who have progressed after at least one chemotherapeutic regimen for advanced disease. Prior therapy should have included an anthracycline and a taxane in either the adjuvant or metastatic setting unless patients were not suitable for these treatments.
For this indication, competent medicine agencies globally authorize below treatments:
Intravenous
1.23 - 1.23 mg per m² of body surface area (BSA)
From 1.23 To 1.23 mg per m² of body surface area (BSA) once every 21 day(s)
The recommended dose of eribulin as the ready to use solution is 1.23 mg/m² 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.
The administration of HALAVEN should be delayed on Day 1 or Day 8 for any of the following:
Dose reduction recommendations for retreatment are shown in the following table.
Dose reduction recommendations:
| Adverse reaction after previous HALAVEN administration | Recommended dose of eribulin |
|---|---|
| Haematological: | |
| ANC <0,5 × 109/l lasting more than 7 days | 0,97 mg/m² |
| ANC <1 × 109/l neutropenia complicated by fever or infection | |
| Platelets <25 × 109/l thrombocytopenia | |
| Platelets <50 × 109/l thrombocytopenia complicated by haemorrhage or requiring blood or platelet transfusion | |
| Non-haematological: | |
| Any Grade 3 or 4 in the previous cycle | |
| Reoccurrence of any haematological or non-haematological adverse reactions as specified above | |
| Despite reduction to 0.97 mg/m² | 0,62 mg/m² |
| Despite reduction to 0.62 mg/m² | Consider discontinuation |
The dose of eribulin should not be re-escalated after it has been reduced.
It should be administered intravenously over 2 to 5 minutes on Days 1 and 8 of every 21-day cycle.
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