Locally advanced or metastatic breast cancer

Active Ingredient: Eribulin mesylate

Indication for Eribulin mesylate

Population group: only adults (18 - 65 years old)

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:

1.23 mg/m² once on Days 1 and 8 of every 21-day cycle

Route of admnistration

Intravenous

Defined daily dose

1.23 - 1.23 mg per m² of body surface area (BSA)

Dosage regimen

From 1.23 To 1.23 mg per m² of body surface area (BSA) once every 21 day(s)

Detailed description

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.

Dose delays during therapy

The administration of HALAVEN should be delayed on Day 1 or Day 8 for any of the following:

  • Absolute neutrophil count (ANC) <1 × 109/l
  • Platelets <75 × 109/l
  • Grade 3 or 4 non-hematological toxicities.

Dose reduction during therapy

Dose reduction recommendations for retreatment are shown in the following table.

Dose reduction recommendations:

Adverse reaction after previous HALAVEN administrationRecommended dose of eribulin
Haematological:  
ANC <0,5 × 109/l lasting more than 7 days0,97 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/m²0,62 mg/m²
Despite reduction to 0.62 mg/m²Consider discontinuation

The dose of eribulin should not be re-escalated after it has been reduced.

Dosage considerations

It should be administered intravenously over 2 to 5 minutes on Days 1 and 8 of every 21-day cycle.

Active ingredient

Eribulin mesylate

Eribulin is a microtubule dynamics inhibitor belonging to the halichondrin class of antineoplastic agents. It is a structurally simplified synthetic analogue of halichondrin B, a natural product isolated from the marine sponge Halichondria okadai.

Read more about Eribulin mesylate

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