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Brand Name

Halaven

Generic Name

Eribulin

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FDA approval date: November 15, 2010

Classification: Microtubule Inhibitor

Form: Injection, Solution

What is Halaven (Eribulin)?

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.

Approved To Treat

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Brand Information

Halaven (eribulin mesylate)

1DOSAGE 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.

2CONTRAINDICATIONS

None.

3OVERDOSAGE

Overdosage of HALAVEN has been reported at approximately 4 times the recommended dose, which resulted in Grade 3 neutropenia lasting seven days and a Grade 3 hypersensitivity reaction lasting one day.

There is no known antidote for HALAVEN overdose.

4DESCRIPTION

HALAVEN contains eribulin mesylate, a microtubule dynamics inhibitor. Eribulin mesylate is a synthetic analogue of halichondrin B, a product isolated from the marine sponge

a product isolated from the marine sponge Halichondria okadai. The chemical name for eribulin mesylate is 11,15:18,21:24,28-Triepoxy-7,9-ethano-12,15-methano-9H,15H-furo[3,2-i]furo[2',3':5,6]pyrano[4,3-b][1,4]dioxacyclopentacosin-5(4H)-one, 2-[(2S)-3-amino-2-hydroxypropyl]hexacosahydro-3-methoxy-26-methyl-20,27-bis(methylene)-, (2R,3R,3aS,7R,8aS,9S,10aR,11S,12R,13aR,13bS,15S,18S,21S,24S,26R,28R,29aS)-, methanesulfonate (salt). It has a molecular weight of 826.0 (729.9 for free base). The empirical formula is C40H59NO11•CH4O3S. Eribulin mesylate has the following structural formula:

HALAVEN is a clear, colorless, sterile solution for intravenous administration. Each single-dose vial contains 1 mg of eribulin mesylate in 2 mL of solution. Each mL of solution contains 0.5 mg of eribulin mesylate (equivalent to 0.44 mg eribulin) in dehydrated alcohol (5% v/v) and water for injection (95% v/v). Sodium hydroxide or hydrochloric acid may be used for pH adjustment.

5REFERENCES

1. OSHA Hazardous Drugs. OSHA. http://www.osha.gov/SLTC/hazardousdrugs/index.html

6HOW SUPPLIED/STORAGE AND HANDLING

NDC 62856-389-01

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 the vials in their original cartons.

HALAVEN injection is a cytotoxic drug. Follow applicable special handling and disposal procedures.¹

7PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling

Neutropenia

Advise patients to contact their health care provider for a fever of 100.5°F or greater or other signs or symptoms of infection such as chills, cough, or burning or pain on urination

Peripheral Neuropathy

Advise patients to inform their healthcare providers of new or worsening numbness, tingling and pain in their extremities

Embryo-Fetal Toxicity

Advise females of reproductive potential of the potential risk to a fetus and to inform their healthcare provider of a known or suspected pregnancy
Advise females of reproductive potential to use effective contraception during treatment with HALAVEN and for at least 2 weeks after the final dose
Advise males with female partners of reproductive potential to use effective contraception

Lactation

Advise women not to breastfeed during treatment with HALAVEN and for 2 weeks after the final dose

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