Becker's Clinical Quality & Infection Control

July/August 2019 IC_CQ

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BioSimilar. ValueDifferent. INDICATION UDENYCA® is a leukocyte growth factor indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia. Limitations of Use UDENYCA® is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation. IMPORTANT SAFETY INFORMATION CONTRAINDICATION: Patients with a history of serious allergic reaction to human granulocyte colony-stimulating factors such as pegfilgrastim or filgrastim products. WARNINGS AND PRECAUTIONS: • Fatal splenic rupture: Evaluate patients who report left upper abdominal or shoulder pain for an enlarged spleen or splenic rupture. • Acute respiratory distress syndrome (ARDS): Evaluate patients who develop fever, lung infiltrates, or respiratory distress. Discontinue UDENYCA® in patients with ARDS. • Serious allergic reactions, including anaphylaxis: Permanently discontinue UDENYCA® in patients with serious allergic reactions. • Fatal sickle cell crises: Have occurred. • Glomerulonephritis: Evaluate and consider dose-reduction or interruption of UDENYCA® if causality is likely. ADVERSE REACTIONS: Most common adverse reactions (≥ 5% difference in incidence compared to placebo) are bone pain and pain in extremity. To report SUSPECTED ADVERSE REACTIONS, contact Coherus BioSciences at 1-800-4-UDENYCA (1-800-483-3692) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Please see Brief Summary of Prescribing Information on the following page. References: 1. UDENYCA® (pegfilgrastim-cbqv) package insert. Redwood City, CA: Coherus BioSciences, Inc.; 2019. 2. First Databank, Inc. Pricing Compendia. 3. Data on file. Coherus BioSciences, Inc.; 2018. UDENYCA is a registered trademark of Coherus BioSciences, Inc. Neulasta is a registered trademark of Amgen Inc. © 2019 Coherus BioSciences, Inc. All rights reserved. 0419-UDY-P229r1 FDA APPROVED pegfilgrastim biosimilar for patients at risk for febrile neutropenia-related infection UDENYCA®—the pegfilgrastim biosimilar that delivers high-quality treatment and the reliable outcomes you expect with Neulasta® (pegfilgrastim), but with 32% cost savings for your patients and practice.* 1-3 Learn more at UDENYCA.com *UDENYCA® wholesale acquisition cost (WAC) of $4175 per prefilled syringe vs Neulasta® WAC of ~$6200 per prefilled syringe.

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