halaven

lenvima
abstral

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:
  • Reduce dose in patients with hepatic impairment and moderate renal impairment.
  • Do not mix with other drugs or administer with dextrose-containing solutions.
  • Premedication with steroids and/or antihistamines to prevent hypersensitivity reactions was not necessary in the ERIBULIN trials, and no special tubing was required for its administration.
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.
 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
 Business Partner EISAI
lenvima
abstral