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FDA Approved Pegfilgrastim Biosimilar for Patients at Risk for Febrile Neutropenia-Related Infection


BioSimilar. ValueDifferent. 

Udenyca Pegfilgrastim - cbqv

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.


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.


Manufactured by: 

Coherus BioSciences, Inc.

Redwood City, CA 94065-1442


UDENYCA is a registered trademark of

Coherus BioSciences, Inc.

© 2019 Coherus BioSciences, Inc. All rights reserved.

0419-UDY-P103r1






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