HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use HALAVEN safely and effectively. See full prescribing information for HALAVEN.
HALAVEN ® (eribulin mesylate) injection, for intravenous use
Initial U.S. Approval: 2010
RECENT MAJOR CHANGES
Indications and Usage (1.2) 01/2016
Warnings and Precautions (5.1, 5.2, 5.3) 01/2016
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. (1.1)
Unresectable or metastatic liposarcoma who have received a prior anthracycline-containing regimen. (1.2)
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 or with moderate or severe renal impairment. (2.1)
Do not mix with other drugs or administer with dextrose-containing solutions. (2.3)
DOSAGE FORMS AND STRENGTHS
Injection: 1 mg per 2 mL (0.5 mg per mL) (3)
CONTRAINDICATIONS
None (4)
WARNINGS AND PRECAUTIONS
Neutropenia: Monitor peripheral blood cell counts and adjust dose as appropriate. (5.1)
Peripheral Neuropathy: Monitor for signs of neuropathy. Manage with dose delay and adjustment. (5.2)
Embryo-Fetal Toxicity: Can cause fetal harm. Advise females of reproductive potential of the potential risk to the fetus and to use effective contraception. (5.3, 8.1, 8.3)
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 (≥25%) in metastatic breast cancer were neutropenia, anemia, asthenia/fatigue, alopecia, peripheral neuropathy, nausea, and constipation. (6.1)
The most common adverse reactions (≥25%) in liposarcoma and leiomyosarcoma were fatigue, nausea, alopecia, constipation, peripheral neuropathy, abdominal pain, and pyrexia. The most common (≥5%) Grade 3-4 laboratory abnormalities in liposarcoma and leiomyosarcoma were neutropenia, hypokalemia, and hypocalcemia. (6.1)
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
Lactation: Do not breastfeed. (8.2)
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 i |
