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Eisai Non-CNE Dinner Event

01ONS-SPEC1655_Halaven Reg Event Email

For ONS Chapter Members, A series of regional events throughout the United States. Eisai is pleased to offer this non-CNE dinner event designed for nurses, nurse practitioners and other healthcare providers who care for patients with metastatic breast cancer and advanced liposarcoma.

This dinner event features an interactive case based presentation which reviews the HALAVEN updated indication and mechanism of action as well as the management of side effects.

Indication
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
  • Unresectable or metastatic liposarcoma who have received a prior anthracycline-containing regimen

Important Safety Information for HALAVEN® (eribulin mesylate)
Warnings and Precautions
Neutropenia: Severe neutropenia (ANC <500/mm3) lasting >1 week occurred in 12% of patients with mBC and liposarcoma or leiomyosarcoma. Febrile neutropenia occurred in 5% of patients with mBC and 2 patients (0.4%) died from complications. Febrile neutropenia occurred in 0.9% of patients with liposarcoma or leiomyosarcoma, and fatal neutropenic sepsis occurred in 0.9% of patients. Patients with mBC with elevated liver enzymes >3 × ULN and bilirubin >1.5 × ULN experienced a higher incidence of Grade 4 neutropenia and febrile neutropenia than patients with normal levels. Monitor complete blood cell counts prior to each dose, and increase the frequency of monitoring in patients who develop Grade 3 or 4 cytopenias. Delay administration and reduce subsequent doses in patients who experience febrile neutropenia or Grade 4 neutropenia lasting >7 days.

Please see additional Important Safety Information continued below.

Registration: 6 pm
Program Start: 6:30 pm

NOTE: No continuing nursing education contact hours will be awarded.

Speaker Program Guidelines
Vermont law prohibits, Minnesota law restricts, and Department of Veterans Affairs and Department of Defense policy prohibits Eisai from offering meals at speaker events to certain health care professionals. If you are licensed in either of those states, or employed by either agency, Eisai regrets that due to these restrictions, we will not be able to offer a meal in conjunction with this event. Additionally, Eisai is required by Massachusetts, Vermont, Washington, DC, and the Federal Physician Payment Sunshine Act, and European Federation of Pharmaceutical Industries and Associations (EFPIA) codes to disclose certain value transfers, eg, meals, provided to certain health care professionals. If you have questions regarding how Eisai tracks and reports this information, please contact Eisai at 1-855-643-4328.

This invitation is intended for the recipient only. Spouses or other guests are not permitted to attend Speaker Programs. This promotional event is sponsored by Eisai, and the speaker is a paid consultant presenting on behalf of Eisai. Eisai complies with all relevant laws, regulations, and codes of conduct.

This event is open to ONS members and non-members.

When:

Thursday, November 2, 2017

Northern Virginia

Denim and Pearls
29 Main Street
Warrenton, VA 20186     
Kennon H McCollum, DNP
Georgia Cancer Specialists
Stockbridge, GA                                                                                      
Wednesday, November 15, 2017

Sussex County/Southern Delaware

J.D. Shuckers  
21710 Roth Ave
Georgetown, DE 19947     
Shayma Kazmi, MD
Cancer Treatment Centers of America
Philadelphia, PA                                                                
Tuesday, December 5, 2017

Phoenix

Pappadeaux Seafood Kitchen
11051 North Black Canyon Highway
Phoenix, AZ 85029      
Jody Pelusi, NP
Northern Arizona Hematology & Oncology                                                                                     

Important Safety Information for HALAVEN® (eribulin mesylate) (continued) 
Warnings and Precautions
Neutropenia: Severe neutropenia (ANC <500/mm3) lasting >1 week occurred in 12% of patients with mBC and liposarcoma or leiomyosarcoma. Febrile neutropenia occurred in 5% of patients with mBC and 2 patients (0.4%) died from complications. Febrile neutropenia occurred in 0.9% of patients with liposarcoma or leiomyosarcoma, and fatal neutropenic sepsis occurred in 0.9% of patients. Patients with mBC with elevated liver enzymes >3 × ULN and bilirubin >1.5 × ULN experienced a higher incidence of Grade 4 neutropenia and febrile neutropenia than patients with normal levels. Monitor complete blood cell counts prior to each dose, and increase the frequency of monitoring in patients who develop Grade 3 or 4 cytopenias. Delay administration and reduce subsequent doses in patients who experience febrile neutropenia or Grade 4 neutropenia lasting >7 days.

Peripheral Neuropathy: Grade 3 peripheral neuropathy occurred in 8% of patients with mBC (Grade 4=0.4%) and 22% developed a new or worsening neuropathy that had not recovered within a median follow-up duration of 269 days (range 25-662 days). Neuropathy lasting >1 year occurred in 5% of patients with mBC. Grade 3 peripheral neuropathy occurred in 3.1% of patients with liposarcoma and leiomyosarcoma receiving HALAVEN and neuropathy lasting more than 60 days occurred in 58% (38/65) of patients who had neuropathy at the last treatment visit. Patients should be monitored for signs of peripheral motor and sensory neuropathy. Withhold HALAVEN in patients who experience Grade 3 or 4 peripheral neuropathy until resolution to Grade 2 or less.

Embryo-Fetal Toxicity: HALAVEN can cause fetal harm when administered to a pregnant woman. Advise females of reproductive potential to use effective contraception during treatment with HALAVEN and for at least 2 weeks following the final dose. Advise males with female partners of reproductive potential to use effective contraception during treatment with HALAVEN and for 3.5 months following the final dose.

QT Prolongation: Monitor for prolonged QT intervals in patients with congestive heart failure, bradyarrhythmias, drugs known to prolong the QT interval, and electrolyte abnormalities. Correct hypokalemia or hypomagnesemia prior to initiating HALAVEN and monitor these electrolytes periodically during therapy. Avoid in patients with congenital long QT syndrome.

Adverse Reactions
In patients with mBC receiving HALAVEN, the most common adverse reactions (≥25%) were neutropenia (82%), anemia (58%), asthenia/fatigue (54%), alopecia (45%), peripheral neuropathy (35%), nausea (35%), and constipation (25%). Febrile neutropenia (4%) and neutropenia (2%) were the most common serious adverse reactions. The most common adverse reaction resulting in discontinua¬tion was peripheral neuropathy (5%).

In patients with liposarcoma and leiomyosarcoma receiving HALAVEN, the most common adverse reactions (≥25%) reported in patients receiving HALAVEN were fatigue (62%), nausea (41%), alopecia (35%), constipation (32%), peripheral neuropathy (29%), abdominal pain (29%), and pyrexia (28%). The most common (≥5%) Grade 3-4 laboratory abnormalities reported in patients receiving HALAVEN were neutropenia (32%), hypokalemia (5.4%), and hypocalcemia (5%). Neutropenia (4.9%) and pyrexia (4.5%) were the most common serious adverse reactions. The most common adverse reactions resulting in discontinuation were fatigue and thrombocytopenia (0.9% each).

Use in Specific Populations
Lactation: Because of the potential for serious adverse reactions in breastfed infants from eribulin mesylate, advise women not to breastfeed during treatment with HALAVEN and for 2 weeks after the final dose.

Hepatic and Renal Impairment: A reduction in starting dose is recommended for patients with mild or moderate hepatic impairment and/or moderate or severe renal impairment.

Please see full Prescribing Information

HALAVEN® is a registered trademark used by Eisai Inc. under license fromEisai R&D Management Co., Ltd. Eisai, Inc. 100 Tice Boulevard, Woodcliff Lake, NJ 07677 © 2017 Eisai Inc. All rights reserved. Printed in USA April 2017 HALA-US0534(1)