ASH News Daily 2013 - Day 3 - (Page B-33)

NOW AVAILABLE To learn more about MARQIBO, please visit the Spectrum booth (3409). Indication MARQIBO is indicated for the treatment of adult patients with Philadelphia chromosome-negative (Ph-) acute lymphoblastic leukemia (ALL) in second or greater relapse or whose disease has progressed following 2 or more anti-leukemia therapies. This indication is based on overall response rate. Clinical benefit such as improvement in overall survival has not been verified. IMPORTANT SAFETY INFORMATION WARNING * For Intravenous Use Only-Fatal if Given by Other Routes * Death has occurred with intrathecal administration * MARQIBO has different dosage recommendations than vincristine sulfate injection. Verify drug name and dose prior to preparation and administration to avoid overdosage Contraindications * MARQIBO is contraindicated in patients with demyelinating conditions, including Charcot-Marie-Tooth syndrome; in patients with hypersensitivity to vincristine sulfate or any of the other components of MARQIBO; and for intrathecal administration Warnings and Precautions * MARQIBO is for intravenous use only-fatal if given by other routes. Intrathecal use is fatal. Extravasation causes tissue injury. If extravasation is suspected, discontinue infusion immediately and consider local treatment measures * Sensory and motor neuropathy are common and cumulative. Monitor patients for peripheral motor and sensory, central and autonomic neuropathy and reduce, interrupt, or discontinue dosing. Patients with preexisting severe neuropathy should be treated with MARQIBO only after careful risk-benefit assessment * Neutropenia, thrombocytopenia, or anemia may occur. Monitor blood counts prior to each dose. Consider dose modification or reduction as well as supportive care measures if Grade 3 or 4 myelosuppression develops * Anticipate, monitor for, and manage tumor lysis syndrome * A prophylactic bowel regimen should be instituted with MARQIBO to prevent constipation, bowel obstruction, and/or paralytic ileus * Severe fatigue can occur requiring dose delay, reduction, or discontinuation of MARQIBO * Fatal liver toxicity and elevated levels of aspartate aminotransferase have occurred. Monitor liver function and modify or interrupt dosing for hepatic toxicity * MARQIBO can cause fetal harm. Advise women of potential risk to fetus Adverse Events * The most commonly reported adverse reactions (incidence >30%) in clinical studies include constipation (57%), nausea (52%), pyrexia (43%), fatigue (41%), peripheral neuropathy (39%), febrile neutropenia (38%), diarrhea (37%), anemia (34%), decreased appetite (33%), and insomnia (32%) * A total of 75.9% of patients experienced serious adverse events (SAEs) during the studies. The most commonly reported SAEs included febrile neutropenia (20.5%), pyrexia (13.3%), hypotension (7.2%), respiratory distress (6.0%), and cardiac arrest (6.0%) * Twenty-eight percent of patients experienced adverse reactions leading to treatment discontinuation. The most common adverse reactions that caused treatment discontinuation were peripheral neuropathy (10%), leukemia-related (7%), and tumor lysis syndrome (2%) * Deaths occurred in 23% of patients in study 1. The nonleukemia-related causes of death were brain infarct (1), intracerebral hemorrhage (2), liver failure (1), multisystem organ failure (2), pneumonia and septic shock (3), respiratory failure (4), pulmonary hemorrhage (1), and sudden cardiac death (1) Drug Interactions * MARQIBO is expected to interact with drugs known to interact with non-liposomal vincristine sulfate, therefore the concomitant use of strong CYP3A inhibitors or the use of potent P-glycoprotein inhibitors or inducers should be avoided Use in Specific Populations * The safety and effectiveness of MARQIBO in pediatric patients have not been established * It is not known whether MARQIBO is excreted in human milk Please see Brief Summary of Prescribing Information, including BOXED WARNINGS, on adjacent pages. Please see Prescribing Information at MARQIBO.com. ©2013 Talon Therapeutics, Inc. MARQIBO is a registered trademark of Talon Therapeutics, Inc. All rights reserved. October 2013. Printed in the USA. 0111-079800 www.sppirx.com 5947_Marqibo_tabloid_ASH_M.indd 1 10/22/13 4:41 PM 

Table of Contents for the Digital Edition of ASH News Daily 2013 - Day 3

Table of Contents

ASH News Daily 2013 - Day 3

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