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Eisai Oncology to Present New Research on Eribulin and NEPA at 36th Annual San Antonio Breast Cancer Symposium
Date:12/4/2013

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Important Safety Information

  • Decreased White Blood Cells (Neutropenia)
  • Doctors should do blood tests to monitor patients' blood cells before they receive each dose of HALAVEN, and should monitor them more often if they develop lower white blood cells.
  • If patients develop severe neutropenia lasting longer than 7 days or neutropenia with a fever, their next dose of HALAVEN should be delayed and reduced. Severe neutropenia occurred in 57% of patients who received HALAVEN and lasted more than 1 week in 12% of patients.
  • Neutropenia with a fever occurred in 5% of patients; 2 patients died from complications of neutropenia with a fever. 
  • Neutropenia with a fever can result in serious infections that could lead to hospitalization or death. Patients should call their healthcare providers immediately if they have any of the following symptoms: fever (temperature above 100.5 degrees F), chills, coughing, burning or pain when they urinate.
  • Nerve Disorders (Peripheral Neuropathy)
  • HALAVEN can cause numbness, tingling, or burning in a patient's hands and feet (peripheral neuropathy). Patients should be monitored closely for signs of neuropathy. If they develop severe neuropathy, treatment with HALAVEN should be delayed until the neuropathy improves and the next dose of HALAVEN should be reduced.
  • Severe peripheral neuropathy occurred in 8% of patients who received HALAVEN. Neuropathy lasting more than one year occurred in 5% of patients. 22% of patients developed a new or worsening neuropathy that had not recovered after an average of 269 days. 
  • Peripheral neuropathy was the most common side effect that caused patients to stop receiving HALAVEN.
  • Pregnancy and Nursing
  • HALAVEN may harm a patient's unborn baby. Patients must avoid becoming pregnant while they are receiving HALAVEN. They should tell their healthcare providers right away if they become p
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  • SOURCE Eisai Inc.
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