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 Practices (cGMP) standards and have satisfied FDA inspection requirements.

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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.

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.

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.

Please see Full Prescribing Information.

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.

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.

Please see Full Prescribing Information.