UDENYCA® is manufactured in the United States using state-of-the-art
The US drug substance manufacturing facility was
purposefully designed to produce PEGylated filgrastim, is compliant with
current Good Manufacturing Practice (cGMP) standards, and has
successfully completed FDA inspections.
Manufacturing of UDENYCA® has demonstrated
a high level of consistency across multiple production
Since launch, over 428,000 syringes have
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 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 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.
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.
Coherus COMPLETE is a trademark and UDENYCA is a registered trademark of Coherus BioSciences, Inc. Neulasta is a registered trademark of Amgen Inc. ZIEXTENZO is a registered trademark of Novartis AG. Fulphila is a registered trademark of Mylan Institutional Inc.
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.
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
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.