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| Initial U.S. Approval: 2010
HALAVEN (eribulin mesylate) Injection is a non-taxane microtubule dynamics inhibitor. Eribulin mesylate is a synthetic analogue of halichondrin B, a product isolated from the marine sponge Halichondria okadai.
HALAVEN is a clear, colorless, sterile solution for intravenous administration. Each vial contains 1 mg of eribulin mesylate as a 0.5 mg/mL solution in ethanol: water.
| CLINICAL PHARMACOLOGY
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 G2/M cell-cycle block, disruption of mitotic spindles, and, ultimately, apoptotic cell death after prolonged mitotic blockage.
| INDICATIONS AND USAGE
HALAVEN 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
| 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.
Use in Pregnancy: Fetal harm can occur when administered to a pregnant woman.
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.
USE IN SPECIFIC POPULATIONS
Hepatic Impairment: A lower starting dose is recommended for patients with mild (Child-Pugh A) and moderate (Child-Pugh B) hepatic impairment. Patients with severe hepatic impairment (Child-Pugh C) were not studied.
|The most common adverse reactions (incidence ≥25%) were neutropenia, anemia, asthenia/fatigue, alopecia, peripheral neuropathy, nausea, and constipation|
| DOSAGE AND ADMINISTRATION
Administer 1.4 mg/m2 intravenously over 2 to 5 minutes on Days 1 and 8 of a 21-day cycle.
Reduce dose in patients with hepatic impairment and moderate renal impairment.
Do not mix with other drugs or administer with dextrose-containing solutions.
The recommended dose of HALAVEN is 1.4 mg/m2 administered intravenously over 2 to 5 minutes on Days 1 and 8 of a 21-day cycle.
The recommended dose of HALAVEN 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. [see Use in Specific Populations]
The recommended dose of HALAVEN 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. [see Use in Specific Populations]
The recommended dose of HALAVEN in patients with moderate renal impairment (creatinine clearance of 30-50 mL/min) is 1.1 mg/m2 administered intravenously over 2 to 5 minutes on Days 1 and 8 of a 21-day cycle. [see Use in Specific Populations]
| NDC 62856-389-01 Eribulin mesylate injection, 1 mg/2 mL, in a single-use vial. One vial per carton.
Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F). Do not freeze. Store the vials in their original cartons.
National Institutes of Health, U.S. National Library of Medicine, DailyMed Database.
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