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 INFORMATIONThese 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 ...
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Table of ContentsTable of Contents
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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 ...
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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 ...
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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.
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4 CONTRAINDICATIONS None.
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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 ...
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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 ...
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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 ...
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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 ...
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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 ...
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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 ...
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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 ...
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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 ...
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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 ...
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15 REFERENCES 1. OSHA Hazardous Drugs. OSHA. http://www.osha.gov/SLTC/hazardousdrugs/index.html
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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 ...
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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 ...
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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 ...
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INGREDIENTS AND APPEARANCEProduct Information