Assess for peripheral neuropathy and obtain complete blood cell counts prior to each dose
Do not administer HALAVEN® on Day 1 or Day 8 in patients with ≥Grade 3 neutropenia,† ≥Grade 2 thrombocytopenia,‡ or Grade 3/4 nonhematologic toxicities
The Day 8 dose may be delayed for up to 1 week in patients with toxicities
If toxicities resolve or improve to Grade 2 or less by Day 15, administer at a reduced dose and initiate the next cycle no sooner than 2 weeks later
If toxicities do not resolve or improve to Grade 2 or less by Day 15, omit the dose
If a dose has been delayed for toxicities that have recovered to a severity of Grade 2 or less, resume at the recommended reduced dose
If a dose has been reduced due to toxicities, do not re-escalate
PATIENTS WHO RECEIVED DOSE DELAYS, DOSE REDUCTIONS, OR DISCONTINUED THERAPY WERE INCLUDED IN THE OVERALL SURVIVAL ANALYSIS OF EMBRACE2
EMBRACE=Eisai Metastatic Breast Cancer Study Assessing Physician's Choice versus E7389 (Eribulin); ANC=absolute neutrophil count;
TPC=Treatment of Physician's Choice.
*Toxicities graded in accordance with National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0.1
†Greater than or equal to Grade 3 neutropenia=ANC <1,000/mm3.3
‡Greater than or equal to Grade 2 thrombocytopenia=platelets <75,000/mm3.3
The median duration of exposure was 118 days in the HALAVEN arm and 63 days in the TPC arm
aToxicities graded in accordance with National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0.3
bToxicities include ≥Grade 3 neutropenia (ANC <1,000/mm3), ≥Grade 2 thrombocytopenia (platelets <75,000/mm3), or Grade 3/4 nonhematologic toxicities.1,3
For any event requiring permanent dose reduction while receiving 1.1 mg/m2, reduce to 0.7 mg/m2 of HALAVEN1
For any event requiring permanent dose reduction while receiving 0.7 mg/m2, discontinue HALAVEN1
References: 1. HALAVEN [package insert]. Woodcliff Lake, NJ: Eisai Inc. 2. Data on file, Eisai Inc. 3. National Cancer Institute. Cancer Therapy Evaluation Program, Common Terminology Criteria for Adverse Events v3.0. NIH Publication # 03-5410. http://ctep.cancer.gov/protocolDevelopment/electronic_applications/docs/ctcaev3.pdf. Published March 31, 2003. Updated August 9, 2006. Accessed January 31, 2018.