Pegfilgrastim

What it is used for

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. Increase survival in patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Subsyndrome of Acute Radiation Syndrome).

Limitations of Use UDENYCA is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation. Patients with Cancer Receiving Myelosuppressive Chemotherapy UDENYCA is 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. Patients with Hematopoietic Subsyndrome of Acute Radiation Syndrome UDENYCA is indicated to increase survival in patients acutely exposed to myelosuppressive doses of radiation.

Side effects, and when to stop

The following clinically significant adverse reactions are discussed in greater detail in other sections of the labeling:

• Splenic Rupture
• Acute Respiratory Distress Syndrome
• Serious Allergic Reactions
• Use in Patients with Sickle Cell Disorders
• Glomerulonephritis
• Leukocytosis
• Thrombocytopenia
• Capillary Leak Syndrome
• Potential for Tumor Growth Stimulatory Effects on Malignant Cells
• Myelodysplastic Syndrome
• Acute Myeloid Leukemia
• Aortitis

Who should not take it

FYLNETRA is contraindicated in patients with a history of serious allergic reactions to pegfilgrastim products or filgrastim products. Reactions have included anaphylaxis.