PegaGen®

Description

Indications

• PegaGen^® 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.
• PegaGen^® is indicated to increase survival in patients acutely exposed to myelosuppressive doses of radiation.

Important safety information

• Capillary leak syndrome (CLS), characterized by hypotension, hypoalbuminemia, edema, and hemoconcentration, may occur in patients receiving human granulocyte colony-stimulating factors (G-CSF), including pegfilgrastim products. CLS episodes vary in frequency and severity. If CLS develops, monitor closely and manage symptomatically (may require intensive care). CLS may be life-threatening if treatment is delayed.
• Hypersensitivity, including serious allergic reactions or anaphylaxis may occur, usually with the initial dose; may recur within days after discontinuation of initial anti-allergic treatment. Permanently discontinue for severe reactions. Do not administer in patients with a history of serious allergic reaction to pegfilgrastim or filgrastim products. Skin rash, urticaria, generalized erythema, and flushing have been reported. ­
• Glomerulonephritis has occurred, and generally resolved after pegfilgrastim dose reduction or discontinuation. Diagnosis was made by the presence of azotemia, microscopic and macroscopic hematuria, proteinuria, and renal biopsy. Evaluate if glomerulonephritis is suspected; if felt due to pegfilgrastim products, consider dose reduction or therapy interruption.
• Leukocytosis (WBC ≥100,000/mm³) has been reported in patients receiving pegfilgrastim products. Monitor complete blood counts during therapy.
• Acute respiratory distress syndrome (ARDS) has been reported with use; evaluate patients with pulmonary symptoms such as fever, pulmonary infiltrates or respiratory distress for ARDS. Discontinue pegfilgrastim products if ARDS occurs.
• Rare cases of splenic rupture have been reported (some fatal); evaluate for an enlarged spleen or splenic rupture in patients who report left upper abdominal pain or shoulder pain.