Eribulin

What it is and how it works

Mechanism of Action Eribulin inhibits the growth phase of microtubules without affecting the shortening phase and sequesters tubulin into nonproductive aggregates. Eribulin exerts its effects via a tubulin-based antimitotic mechanism leading to G 2 /M cell-cycle block, disruption of mitotic spindles, and, ultimately, apoptotic cell death after prolonged mitotic blockage. In addition, eribulin treatment of human breast cancer cells caused changes in morphology and gene expression as well as decreased migration and invasiveness in vitro .

Indications

Eribulin Mesylate Injection is a microtubule inhibitor indicated for the treatment of patients with: Metastatic breast cancer who have previously received at least two chemotherapeutic regimens for the treatment of metastatic disease. Prior therapy should have included an anthracycline and a taxane in either the adjuvant or metastatic setting. Unresectable or metastatic liposarcoma who have received a prior anthracycline-containing regimen. Metastatic Breast Cancer Eribulin mesylate injection is indicated for the treatment of patients with metastatic breast cancer who have previously received at least two chemotherapeutic regimens for the treatment of metastatic disease. Prior therapy should have included an anthracycline and a taxane in either the adjuvant or metastatic setting . Liposarcoma Eribulin mesylate injection is indicated for the treatment of patients with unresectable or metastatic liposarcoma who have received a prior anthracycline-containing regimen [ see Clinical Studies ].

Dosage and administration (summary)

Administer 1.4 mg/m 2 intravenously over 2 to 5 minutes on Days 1 and 8 of a 21-day cycle. Reduce dose in patients with hepatic impairment or with moderate or severe renal impairment. Do not mix with other drugs or administer with dextrose-containing solutions. Recommended Dose The recommended dose of eribulin mesylate injection is 1.4 mg/m 2 administered intravenously over 2 to 5 minutes on Days 1 and 8 of a 21-day cycle. The recommended dose of eribulin mesylate injection in patients with mild hepatic impairment (Child-Pugh A) is 1.1 mg/m 2 administered intravenously over 2 to 5 minutes on Days 1 and 8 of a 21-day cycle .

Contraindications

None. None

Warnings and precautions

Neutropenia: Monitor peripheral blood cell counts and adjust dose as appropriate. Peripheral Neuropathy : Monitor for signs of neuropathy. Manage with dose delay and adjustment. Embryo-Fetal Toxicity : Can cause fetal harm. Advise females of reproductive potential of the potential risk to the fetus and to use effective contraception. ( 5.3 , 8.1 , 8.3 ) QT Prolongation : Monitor for prolonged QT intervals in patients with congestive heart failure, bradyarrhythmias, drugs known to prolong the QT interval, and electrolyte abnormalities. Avoid in patients with congenital long QT syndrome.

Pregnancy

Pregnancy Risk Summary Based on findings from an animal reproduction study and its mechanism of action, eribulin mesylate injection can cause fetal harm when administered to a pregnant woman . There are no available data on the use of eribulin mesylate injection during pregnancy.

Storage and supply

Eribulin mesylate injection is supplied as a clear colorless solution in a clear glass vial, essentially free of visible foreign particulate matter. NDC 68001-656-41 Injection: 1 mg/2 mL, in a single-dose vial. One vial per carton. Store at 25°C (77°F); excursions permitted to 15° to 30° C (59° to 86° F). Do not freeze or refrigerate.

Source: Eribulin Mesylate (Eribulin Mesylate) — US FDA prescribing information, 2026-03-25, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.