FIRST OF ITS KIND* The UDENYCA^® Single-Dose Prefilled Autoinjector For at-home and in-office use

WHAT CAN AN AUTOINJECTOR MEAN FOR YOUR PATIENTS?

FIRST OF ITS KIND* The UDENYCA^® Single-Dose Prefilled Autoinjector For at-home and in-office use

UDENYCA^® may reduce the risk of febrile neutropenia while providing more administration options to meet the needs of patients and practices

*For pegfilgrastim-product administration in the United States.

UDENYCA^® may reduce the risk of febrile neutropenia while providing more administration options to meet the needs of patients and practices

*For pegfilgrastim-product administration in the United States.

User-friendly features promote successful delivery

FAST DOSING with delivery in <10 seconds²

INTUITIVE DESIGN promotes ease of use

DUAL COVERAGE May be covered under both pharmacy and medical benefit

Simple administration with 2 clicks³

Help prevent febrile neutropenia by administering in LESS THAN 10 SECONDS PER CYCLE²

Hold the autoinjector with the clear cap facing up and pull the cap straight off.

Press the autoinjector firmly against the skin and you will hear the first "click."

For complete administration directions, please see the Instructions for Use before administering UDENYCA^®.
Only adults can self-administer UDENYCA^® with the prefilled autoinjector.

After you hear the second "click," continue to hold the autoinjector in place and count to 5.

For complete administration directions, please see the Instructions for Use before administering UDENYCA^®.
Only adults can self-administer UDENYCA^® with the prefilled autoinjector.

See the UDENYCA^® autoinjector in action

For complete administration directions, please see the Instructions for Use before administering UDENYCA^®.

Benefits for both in-office and self-administration

IN-OFFICE
ADMINISTRATION

NO VISIBLE
NEEDLE^1,2

May minimize needle anxiety and reduce risk of needlestick injury

INTUITIVE
DESIGN

Easy to use for quick staff onboarding

FAST DOSING and streamlined delivery process²

Medication delivery in less than 10 seconds

AT-HOME
ADMINISTRATION

NO VISIBLE
NEEDLE^1,2

May minimize needle anxiety

INTUITIVE
DESIGN

User-friendly features promote successful delivery

FAST DOSING and streamlined delivery process²

Allows patients to inject on their own time and schedule^†

^†Do not administer between 14 days before and 24 hours after cytotoxic chemotherapy.

Coverage for UDENYCA^® is accessible under both pharmacy and medical benefit.

See dual coverage at Coherus Solutions^™>

UDENYCA Solutions^™ provides a suite of patient support services, programs, and industry-leading electronic services designed to assist with patient access.

Learn about comprehensive support>

UDENYCA^® was confirmed to be highly similar to Neulasta® with no clinically meaningful differences.^1,4

View the proven biosimilarity>

References: 1. UDENYCA^® (pegfilgrastim-cbqv) Prescribing Information. Redwood City, CA: Coherus BioSciences, Inc.; 2023. 2. Data on file. Coherus BioSciences, Inc.; 2023. 3. UDENYCA^® Autoinjector Instructions for Use. Redwood City, CA: Coherus BioSciences, Inc.; 2023. 4. Neulasta^® (pegfilgrastim) Prescribing Information. Thousand Oaks, CA: Amgen Inc.; 2021.

INDICATION

UDENYCA^® (pegfilgrastim-cbqv) 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 reactions to pegfilgrastim products or filgrastim products. Reactions have included anaphylaxis.

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: The majority of reported events occurred upon initial exposure. Allergic reactions, including anaphylaxis, can recur within days after the discontinuation of initial anti-allergic treatment. Permanently discontinue UDENYCA^® in patients with serious allergic reactions.

Sickle cell crises: Severe and sometimes fatal crises have occurred. Discontinue UDENYCA^® if sickle cell crisis occurs.

Glomerulonephritis: The diagnoses were based upon azotemia, hematuria (microscopic and macroscopic), proteinuria, and renal biopsy. Generally, events resolved after dose reduction or discontinuation. Evaluate and consider dose-reduction or interruption of UDENYCA^® if causality is likely.

Leukocytosis: White blood cell (WBC) counts of 100 x 10⁹/L or greater have been observed in patients receiving pegfilgrastim products. Monitoring of complete blood count (CBC) during UDENYCA^® therapy is recommended.

Thrombocytopenia: Thrombocytopenia has been reported in patients receiving pegfilgrastim. Monitor platelet counts.

Capillary Leak Syndrome: Has been reported after G-CSF administration, including pegfilgrastim products, and is characterized by hypotension, hypoalbuminemia, edema, and hemoconcentration. Episodes vary in frequency, severity and may be life-threatening if treatment is delayed. If symptoms develop, closely monitor and give standard symptomatic treatment, which may include a need for intensive care.

Potential for Tumor Growth Stimulatory Effects on Malignant Cells: The granulocyte colony-stimulating factor (G-CSF) receptor through which pegfilgrastim products and filgrastim products act has been found on tumor cell lines. The possibility that pegfilgrastim products act as a growth factor for any tumor type, including myeloid malignancies and myelodysplasia, diseases for which pegfilgrastim products are not approved, cannot be excluded.

Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia (AML) in Patients with Breast and Lung Cancer: MDS and AML have been associated with the use of pegfilgrastim in conjunction with chemotherapy and/or radiotherapy in patients with breast and lung cancer. Monitor patients for sign and symptoms of MDS/AML in these settings.

Aortitis: Has been reported in patients receiving pegfilgrastim products, occurring as early as the first week after start of therapy. Manifestations may include generalized signs and symptoms such as fever, abdominal pain, malaise, back pain, and increased inflammatory markers (e.g., c-reactive protein and white blood cell count). Consider aortitis when signs and symptoms develop without known etiology. Discontinue UDENYCA^® if aortitis is suspected.

Nuclear Imaging: Increased hematopoietic activity of the bone marrow in response to growth factor therapy has been associated with transient positive bone imaging changes. Consider when interpreting bone imaging results.

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.

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

WHAT CAN AN AUTOINJECTOR MEAN FOR YOUR PATIENTS?

User-friendly features promote successful delivery

Simple administration with 2 clicks3

See the UDENYCA® autoinjector in action

Benefits for both in-office and self-administration

IN-OFFICEADMINISTRATION

AT-HOMEADMINISTRATION

INDICATION

IMPORTANT SAFETY INFORMATION

INDICATION

IMPORTANT SAFETY INFORMATION

G-CSF expanded use during COVID-19 pandemic

UPDATED RECOMMENDATIONS

For further information from each organization:

Simple administration with 2 clicks³

See the UDENYCA^® autoinjector in action

IN-OFFICE
ADMINISTRATION

AT-HOME
ADMINISTRATION