
Manufacturing.

Manufacturing value.
Manufacturing
value.
UDENYCA® is manufactured in the United States using state-of-the-art technology. The manufacturing sites are compliant with current Good Manufacturing Practice (cGMP) standards and have satisfied FDA inspection requirements.
The facility1
The US manufacturing facility was purposefully designed to produce PEGylated filgrastim and has successfully completed FDA inspections.
UDENYCA® is manufactured using a continuous process. Manufacturing of UDENYCA® has demonstrated a high level of consistency across multiple production campaigns.
The process1
The product1
Through robust stability studies, the FDA has approved a 36-month shelf life for UDENYCA®, reflecting excellent product quality.
Reference: 1. Data on file. Coherus BioSciences, Inc.; 2020.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATION:
Patients with a history of serious allergic reaction to human granulocyte colony-stimulating factors such as pegfilgrastim or filgrastim products.
- 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.
WARNINGS AND PRECAUTIONS:
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.
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.