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Coherus BioSciences

333 Twin Dolphin Drive

Suite 600

Redwood City, CA 94065

Phone: 1-800-794-5434

To report SUSPECTED ADVERSE REACTIONS,

contact Coherus BioSciences Medical Information

at 1-800-4-UDENYCA (1-800-483-3692).

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

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.

G-CSF expanded use during COVID-19 pandemic

As a result of the current COVID-19 pandemic, the National Comprehensive Cancer Network® (NCCN®) and American Society of Clinical Oncology (ASCO®) have offered short-term recommendations specific to issues with COVID-19 (SARS-CoV-2) for hematopoietic growth factors, as related to the on-label use of our product. The recommendations include the expanded prophylactic use of granulocyte colony-stimulating factor (G-CSF), such as pegfilgrastim, to reduce the potential number and length of hospitalizations for cancer patients undergoing various chemotherapy treatments. Please see important limitations to these recommendations outlined below.

UPDATED RECOMMENDATIONS

The short-term recommendations include a lowered threshold for the use of myeloid growth factors from those chemotherapy regimens that have a 20% or higher risk of febrile neutropenia to now include those regimens with a 10%-20% risk of febrile neutropenia, which includes all of the intermediate risk chemotherapy regimens.^1,2

Caution: Physicians may wish to avoid use of or discontinue G-CSF in cases of respiratory infection, respiratory symptoms, or confirmed or suspected COVID-19 to avoid increase in pulmonary inflammation or hypothetical risk of increasing inflammatory cytokines associated with adverse outcome.

For further information from each organization:

NCCN is providing resources from the leading cancer centers that comprise the nonprofit alliance and sharing them all online at NCCN.org/covid-19. The site will be updated as new resources become available. For information specifically on changes to the myeloid growth factors guidelines, please see NCCN.org/covid-19/pdf/HGF_COVID-19.pdf.

ASCO has provided guidance on how to care for patients experiencing potential neutropenic fever and neutropenia who are affected by the ongoing COVID-19 pandemic. This guidance can be found online at ASCO.org.

If you have any questions on these guidelines, please call our Medical Affairs team at 1-800-483-3692.

References: 1. Referenced with permission from the National Comprehensive Cancer Network, Inc. © National Comprehensive Cancer Network, Inc. 2020. All rights reserved. Accessed April 9, 2020. To view the most recent and complete version of the guideline, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way. 2. COVID‑19 patient care information. American Society of Clinical Oncology (ASCO). Updated April 23, 2020. Accessed May 1, 2020. https://www.asco.org/asco-coronavirus-information/care-individuals-cancer-during-covid-19