halaven
HALAVEN® (eribulin mesylate) Injection – for intravenous administration only.
Name | Halaven® (eribulin mesylate) Injection |
Description | Halaven® is a microtubule inhibitor |
Indication | Halaven® is 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. |
Strengths |
Intravenous administration. Eribulin mesylate injection, 1 mg per 2 mL (0.5 mg per mL).
Administer 1.4 mg/m2 intravenously over 2 to 5 minutes on Days 1 and 8 of a 21-day cycle:
The recommended dose of Halaven® in patients with mild hepatic impairment (Child-Pugh A) is 1.1 mg/m2 administered intravenously over 2 to 5 minutes on Days 1 and 8 of a 21-day cycle.
The recommended dose of Halaven® in patients with moderate hepatic impairment (Child-Pugh B) is 0.7 mg/m2 administered intravenously over 2 to 5 minutes on Days 1 and 8 of a 21-day cycle.
The recommended dose of Halaven® in patients with moderate renal impairment (creatinine clearance of 30-50 mL/min) is 0.7 mg/m2 administered intravenously over 2 to 5 minutes on Days 1 and 8 of a 21-day cycle.
Patients with severe Hepatic impairment (Child pugh C) and severe Renal impairment (CrCl ≤ 30 ml/min) were not studied.
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Regulatory Status |
EMA approved in March 2011; FDA approved in November 2010;
Registered in KSA, Kuwait, UAE, Bahrain, Jordan and Morocco
Under registration in Bahrain, Oman, Qatar, Algeria, and Egypt
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Business Partner | EISAI |