Halaven Eribulin Mesilate Injection

1. Indications and Usage
Eribulin Mesylate is indicated for the treatment of adult patients with metastatic breast cancer who have received at least two prior regimens for advanced disease. It is also indicated for adult patients with unresectable liposarcoma who have received an anthracycline-containing regimen.
2. Dosage and Administration
Recommended Dosage: The recommended dosage is 1.4 mg/m² administered as an intravenous bolus over 2 to 5 minutes.
Schedule: The drug is administered on Day 1 and Day 8 of each 21-day cycle.
Dose Modifications: For neutrophil count <1×10⁹/L or platelet count <75×10⁹/L, withhold treatment. Dose reductions (to 1.1 mg/m² or 0.9 mg/m²) are recommended for severe neutropenia, febrile neutropenia, or severe non-hematologic toxicities.
Administration: Dilute in 0.9% Sodium Chloride Injection (up to 100 mL). Do not dilute in 5% Dextrose Injection.
3. Mechanism of Action
Eribulin is a synthetic analogue of halichondrin B. It binds to tubulin and inhibits microtubule growth, disrupting the dynamic equilibrium of microtubules. This action arrests cell division at the G2/M phase of the cell cycle, leading to cell death.
4. Safety and Warnings
Myelosuppression: Neutropenia and thrombocytopenia are common. Monitor complete blood counts (CBC) weekly and hold or reduce dose based on severity.
Peripheral Neuropathy: Monitor for sensory or motor neuropathy. Dose reduction or discontinuation may be necessary.
Embryo-Fetal Toxicity: Can cause fetal harm. Advise females of reproductive potential to use effective contraception.
QTc Prolongation: Monitor electrolytes and ECG, especially in patients with risk factors.
5. Adverse Reactions and Clinical Research
Common Adverse Reactions: In metastatic breast cancer, the most common adverse reactions include neutropenia, anemia, fatigue, alopecia, peripheral neuropathy, nausea, and constipation.
Serious Adverse Reactions: Febrile neutropenia and severe peripheral neuropathy.
Clinical Research: In the EMBRACE trial, eribulin demonstrated a significant overall survival benefit compared to physicians’ choice of therapy in heavily pre-treated metastatic breast cancer patients.
6. Drug Interactions
Strong CYP3A4 Inhibitors/Avoid: Co-administration with strong CYP3A4 inhibitors may increase eribulin exposure.
QTc-Prolonging Drugs: Concurrent use with drugs that prolong the QTc interval may increase the risk of arrhythmia.
7. Pharmaceutical Information
Composition: Eribulin Mesylate for Solution.
Appearance: White to off-white lyophilized powder.
Storage: Store at 20°C to 25°C. Protect from light.