Contraindications

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

• 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

• 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, 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

• 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 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

• 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 has been reported in patients receiving pegfilgrastim products
• Monitor platelet counts

• 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

• 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

• 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 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

• 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

• Bone pain
• Pain in extremity

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.

Please see full Prescribing Information, Patient Information, and Instructions for Use for NYVEPRIA.