Product Information & Dosing

Indications: FYLNETRA® 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: FYLNETRA® is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.

Contraindications: Patients with a history of serious allergic reactions to human granulocyte colony-stimulating factors such as filgrastim products or pegfilgrastim products.

Before taking FYLNETRA®, tell your healthcare provider if you are pregnant or plan to breast feed, and if you have sickle cell disorder, kidney problems or receiving radiation therapy.

Warnings and Precautions:

• Fatal splenic rupture: Patients may experience enlarged spleen which can rupture and cause death.
• Acute respiratory distress syndrome (ARDS): Patients may develop fever and lung infiltrates or respiratory distress for ARDS. Discontinue FYLNETRA® in patients with ARDS.
• Serious allergic reactions, including anaphylaxis: Permanently discontinue FYLNETRA® in patients with serious allergic reactions.
• Fatal sickle cell crises: Serious sickle cell crises have been reported in patients with sickle cell disorders receiving FYLNETRA®. Discontinue FYLNETRA® if sickle cell crisis occurs.
• Kidney injury (Glomerulonephritis): Kidney injury have been reported in patients on FYLNETRA®. Consider dose-reduction or interruption of FYLNETRA® in patients with kidney injury.
• 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 FYLNETRA® therapy is recommended.
• Decreased platelet count (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.
• 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): Monitor patients with breast and lung cancer using FYLNETRA® in conjunction with chemotherapy and/or radiotherapy for signs and symptoms of MDS/AML.
• Aortitis has been reported in patients receiving pegfilgrastim products.
• Increased hematopoietic activity of the bone marrow in response to growth factor therapy has been associated with transient positive bone imaging changes.

Adverse Reactions: Most common adverse reactions (≥ 5% difference in incidence compared to placebo) are bone pain and pain in extremity.

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