NYVEPRIA
(pegfilgrastim-apgf) resources
An FDA-approved biosimilar* to Neulasta® (pegfilgrastim)2
NYVEPRIA Product Monograph
The latest product monograph supporting the biosimilarity of NYVEPRIA. Includes information on the indication, dosing, study data (both analytical and clinical), and safety, as well as reimbursement and access.
NYVEPRIA Billing and Coding Guide
Quick reference highlighting relevant billing and coding information for NYVEPRIA, including HCPCS, NDC, CPT, and ICD-10-CM codes.
NYVEPRIA Quarterly National Coverage Brochure
A helpful resource for your practice, covering how to order NYVEPRIA as well as potential cost savings.
EHR Brochures
A comprehensive overview of how to leverage electronic health record (EHR) functionality, such as implementation processes, benefits verification, medication ordering, and patient communications.
IMPORTANT SAFETY INFORMATION AND INDICATION
Contraindications
- NYVEPRIA is contraindicated in patients with a history of serious allergic reactions to pegfilgrastim products or filgrastim products
- Reactions have included anaphylaxis
Warnings and Precautions
Splenic Rupture
- Splenic rupture, including fatal cases, can occur following the administration of pegfilgrastim products
- Evaluate for an enlarged spleen or splenic rupture in patients who report left upper abdominal or shoulder pain after receiving NYVEPRIA
Acute Respiratory Distress Syndrome (ARDS)
- ARDS can occur in patients receiving pegfilgrastim products
- Evaluate patients who develop fever and lung infiltrates or respiratory distress after receiving NYVEPRIA
- Discontinue NYVEPRIA in patients with ARDS
Serious Allergic Reactions
- Serious allergic reactions, including anaphylaxis, can occur in patients receiving pegfilgrastim products
- 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 NYVEPRIA in patients with serious allergic reactions
- Do not administer NYVEPRIA to patients with a history of serious allergic reactions to pegfilgrastim products or filgrastim products
Use in Patients with Sickle Cell Disorders
- Severe and sometimes fatal sickle cell crises can occur in patients with sickle cell disorders receiving pegfilgrastim products
- Discontinue NYVEPRIA if sickle cell crisis occurs
Glomerulonephritis
- Glomerulonephritis has occurred in patients receiving pegfilgrastim products
- The diagnoses were based on azotemia, hematuria (microscopic and macroscopic), proteinuria, and renal biopsy
- Generally, events of glomerulonephritis resolved after dose-reduction or discontinuation of pegfilgrastim products
- If glomerulonephritis is suspected, evaluate for cause. If causality is likely, consider dose-reduction or interruption of NYVEPRIA
Leukocytosis
- White blood cell counts of 100 x 109/L or greater have been observed in patients receiving pegfilgrastim products
- Monitoring of complete blood count (CBC) during NYVEPRIA therapy is recommended
Thrombocytopenia
- Thrombocytopenia has been reported in patients receiving pegfilgrastim products
- Monitor platelet counts
Capillary Leak Syndrome (CLS)
- CLS has been reported after granulocyte-colony stimulating factor (G‐CSF) administration, including pegfilgrastim products, and is characterized by hypotension, hypoalbuminemia, edema, and hemoconcentration
- Episodes vary in frequency and severity and may be life‐threatening if treatment is delayed
- Patients who develop symptoms of CLS should be closely monitored and receive standard symptomatic treatment, which may include a need for intensive care
Potential for Tumor Growth Stimulatory Effects on Malignant Cells
- The G-CSF receptor through which pegfilgrastim 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 products in conjunction with chemotherapy and/or radiotherapy in patients with breast and lung cancer
- Monitor patients for signs and symptoms of MDS/AML in these settings
Aortitis
- Aortitis has been reported in patients receiving pegfilgrastim products. It may occur 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 (eg,
c-reactive protein and white blood cell count)
- Consider aortitis in patients who develop these signs and symptoms without known etiology. Discontinue NYVEPRIA 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. This should be considered when interpreting bone imaging results
Most Common Adverse Reactions
- Bone pain
- Pain in extremity
INDICATION
NYVEPRIA 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
NYVEPRIA is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.
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.
