ZIEXTENZO 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.
IMPORTANT SAFETY INFORMATION
- ZIEXTENZO is contraindicated in patients with a history of serious allergic reactions to pegfilgrastim or filgrastim.
WARNINGS AND PRECAUTIONS
- Splenic rupture, including fatal cases, can occur following the administration of pegfilgrastim. Evaluate for an enlarged spleen or splenic rupture in patients who report left upper abdominal or shoulder pain after receiving ZIEXTENZO.
Acute Respiratory Distress Syndrome (ARDS)
- ARDS can occur in patients receiving pegfilgrastim. Evaluate patients who develop fever and lung infiltrates or respiratory distress after receiving ZIEXTENZO, for ARDS. Discontinue ZIEXTENZO in patients with ARDS.
Serious Allergic Reactions
- Serious allergic reactions, including anaphylaxis, can occur in patients receiving pegfilgrastim. The majority of events occurred upon initial exposure and can recur within days after the discontinuation of initial anti-allergic treatment. Permanently discontinue ZIEXTENZO in patients with serious allergic reactions. Do not administer ZIEXTENZO to patients with a history of serious allergic reactions to pegfilgrastim or filgrastim.
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 ZIEXTENZO if sickle cell crisis occurs.
- Glomerulonephritis has occurred in patients receiving pegfilgrastim. The diagnoses were based upon azotemia, hematuria (microscopic and macroscopic), proteinuria, and renal biopsy. Generally, events resolved after dose-reduction or discontinuation of pegfilgrastim. If glomerulonephritis is suspected, evaluate for cause. If causality is likely, consider dose-reduction or interruption of ZIEXTENZO.
- White blood cell (WBC) counts of 100 x 109/L or greater have been observed in patients receiving pegfilgrastim. Monitoring of CBC during pegfilgrastim therapy is recommended.
Capillary Leak Syndrome (CLS)
- CLS has been reported after G-CSF administration, including pegfilgrastim, and is characterized by hypotension, hypoalbuminemia, edema and hemoconcentration. Episodes vary in frequency, 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 intensive care.
Potential for Tumor Growth Stimulatory Effects on Malignant Cells
- The granulocyte colony-stimulating factor (G-CSF) receptor through which pegfilgrastim and filgrastim act has been found on tumor cell lines. The possibility that pegfilgrastim acts as a growth factor for any tumor type, including myeloid malignancies and myelodysplasia, diseases for which pegfilgrastim is not approved, cannot be excluded.
- Aortitis has been reported in patients receiving pegfilgrastim. 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 (e.g., c-reactive protein and white blood cell count). Consider aortitis in patients who develop these signs and symptoms without known etiology. Discontinue ZIEXTENZO 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.
The most common adverse reactions are bone pain and pain in extremity.
Please see ZIEXTENZO full Prescribing Information.