Label: ERIBULIN MESYLATE injection

  • NDC Code(s): 10019-080-01
  • Packager: Baxter Healthcare Corporation
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated October 1, 2024

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  • HIGHLIGHTS OF PRESCRIBING INFORMATION
    These highlights do not include all the information needed to use ERIBULIN MESYLATE INJECTION safely and effectively. See full prescribing information for ERIBULIN MESYLATE INJECTION. Eribulin ...
  • Table of Contents
    Table of Contents
  • 1 INDICATIONS AND USAGE
    1.1 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 ...
  • 2 DOSAGE AND ADMINISTRATION
    2.1 Recommended Dose - The recommended dose of Eribulin Mesylate Injection 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 ...
  • 3 DOSAGE FORMS AND STRENGTHS
    Injection: 1 mg/2 mL (0.5 mg/mL) eribulin mesylate is a clear, colorless, sterile solution in a single-dose vial.
  • 4 CONTRAINDICATIONS
    None.
  • 5 WARNINGS AND PRECAUTIONS
    5.1 Neutropenia - In Study 1, severe neutropenia (ANC < 500/mm3) lasting more than one week occurred in 12% (62/503) of patients with metastatic breast cancer, leading to discontinuation in <1 ...
  • 6 ADVERSE REACTIONS
    6.1 Clinical Trials Experience - Because clinical trials are conducted under widely varying conditions, the adverse reaction rates observed in the clinical trials of a drug cannot be directly ...
  • 7 DRUG INTERACTIONS
    7.1 Effects of Other Drugs on Eribulin Mesylate Injection - No drug-drug interactions are expected with CYP3A4 inhibitors, CYP3A4 inducers or P-glycoprotein (P-gp) inhibitors. Clinically ...
  • 8 USE IN SPECIFIC POPULATIONS
    8.1 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 ...
  • 10 OVERDOSAGE
    Overdosage of Eribulin Mesylate Injection has been reported at approximately 4 times the recommended dose, which resulted in Grade 3 neutropenia lasting seven days and a Grade 3 hypersensitivity ...
  • 11 DESCRIPTION
    Eribulin Mesylate Injection contains eribulin mesylate, a microtubule dynamics inhibitor. Eribulin mesylate is a synthetic analogue of halichondrin B, a product isolated from the marine sponge ...
  • 12 CLINICAL PHARMACOLOGY
    12.1 Mechanism of Action - Eribulin inhibits the growth phase of microtubules without affecting the shortening phase and sequesters tubulin into nonproductive aggregates. Eribulin exerts its ...
  • 13 NONCLINICAL TOXICOLOGY
    13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility - Carcinogenicity studies have not been conducted with eribulin mesylate. Eribulin mesylate was not mutagenic in in vitro bacterial ...
  • 14 CLINICAL STUDIES
    14.1 Metastatic Breast Cancer - Study 1 was an open-label, randomized, multicenter trial of 762 patients with metastatic breast cancer who received at least two chemotherapeutic regimens for ...
  • 15 REFERENCES
    1. OSHA Hazardous Drugs. OSHA. http://www.osha.gov/SLTC/hazardousdrugs/index.html
  • 16 HOW SUPPLIED/STORAGE AND HANDLING
    NDC 10019-080-01 - 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. Store ...
  • 17 PATIENT COUNSELING INFORMATION
    Advise the patient to read the FDA-approved patient labeling (Patient Information). Neutropenia - Advise patients to contact their health care provider for a fever of 100.5°F or greater or other ...
  • PACKAGE/LABEL PRINCIPAL DISPLAY PANEL
    Container Label - Lot/Exp - NDC 10019-080-01 - Rx only - Eribulin Mesylate Injection - 1 mg/2 mL - (0.5 mg/mL) For Intravenous Use - STERILE SOLUTION - CAUTION: Cytotoxic Agent - Bar Code - 3 10019 08001 7 - SINGLE ...
  • INGREDIENTS AND APPEARANCE
    Product Information