HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use NYVEPRIA safely and effectively. See full prescribing information for NYVEPRIA.
NYVEPRIA™ (pegfilgrastim-apgf) injection, for subcutaneous use
Initial U.S. Approval: 2020
NYVEPRIA (pegfilgrastim-apgf) is biosimilar* to NEULASTA (pegfilgrastim) (1)
RECENT MAJOR CHANGES
INDICATIONS AND USAGE
NYVEPRIA 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. (1)
Limitations of Use
NYVEPRIA is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation. (1)
DOSAGE AND ADMINISTRATION
Patients with cancer receiving myelosuppressive chemotherapy
DOSAGE FORMS AND STRENGTHS
Injection: 6 mg/0.6 mL solution in a single-dose prefilled syringe for manual use only. (3)
Patients with a history of serious allergic reactions to human granulocyte colony-stimulating factors such as pegfilgrastim products or filgrastim products. (4)
WARNINGS AND PRECAUTIONS
Most common adverse reactions (≥5% difference in incidence compared to placebo) are bone pain and pain in extremity. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
*Biosimilar means that the biological product is approved based on data demonstrating that it is highly similar to an FDA-approved biological product, known as a reference product, and that there are no clinically meaningful differences between the biosimilar product and the reference product.
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.
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NYVEPRIA Highlights (pegfilgrastim-apgf)
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