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 (1).

DOSAGE AND ADMINISTRATION

• Administer 1.4 mg/m2 intravenously over 2 to 5 minutes on Days 1 and 8 of a 21-day cycle (2.1).
• Reduce dose in patients with hepatic impairment and moderate renal impairment (2.1).
• Do not mix with other drugs or administer with dextrose-containing solutions (2.3).

DOSAGE FORMS AND STRENGTHS

Intravenous administration.

Eribulin mesylate injection, 1 mg per 2 mL (0.5 mg per mL) (3).

CONTRAINDICATIONS

None.

WARNINGS AND PRECAUTIONS

• Neutropenia: Monitor peripheral blood cell counts and adjust dose as appropriate (2.2, 5.1, 6).
• Peripheral Neuropathy: Monitor for signs of neuropathy. Manage with dose delay and adjustment (2.2, 5.2, 6).
• Use in Pregnancy: Fetal harm can occur when administered to a pregnant woman (5.3) (8.1).
• 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 (5.4).

ADVERSE REACTIONS

The most common adverse reactions (incidence ≥25%) were neutropenia, anemia, asthenia/fatigue, alopecia, peripheral neuropathy, nausea, and constipation (6).

To report SUSPECTED ADVERSE REACTIONS, contact Eisai Inc. at (1-877-873-4724) or contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

USE IN SPECIFIC POPULATIONS

• Nursing Mothers: Discontinue drug or nursing, taking into consideration the importance of the drug to the mother (8.3).
• 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 (8.6).
• Renal Impairment: A lower starting dose is recommended for patients with moderate (CrCl 30-50 mL/min) renal impairment. Patients with severe (CrCl < 30 mL/min) renal impairment were not studied (8.7).

1 INDICATIONS AND USAGE

2 DOSAGE AND ADMINISTRATION

2.1 Recommended Dose

2.2 Dose Modification

2.3 Instructions for Preparation and Administration

3 DOSAGE FORMS AND STRENGTHS

4 CONTRAINDICATIONS

5 WARNINGS AND PRECAUTIONS

5.1 Neutropenia

5.2 Peripheral Neuropathy