Inflectra copay assistance1/6/2024 The most common adverse reactions (≥ 5% difference in incidence) in placebo-controlled clinical trials are bone pain and pain in extremity.Do not administer ABRAXANE therapy to patients who have baseline neutrophil counts of less than 1500 cells/mm 3 This should be considered when interpreting bone imaging results. Increased hematopoietic activity of the bone marrow in response to growth factor therapy has been associated with transient positive bone imaging changes. Consider aortitis in patients who develop these signs and symptoms without known etiology and discontinue Fulphila if aortitis is suspected. 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). It may occur as early as the first week after start of therapy. Monitor patients for signs and symptoms of MDS/AML in these settings.Īortitis has been reported in patients receiving pegfilgrastim products. Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia (AML) have been associated with the use of pegfilgrastim in conjunction with chemotherapy and/or radiotherapy in patients with breast and lung cancer. 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. The G-CSF receptor, through which pegfilgrastim and filgrastim products act, has been found on tumor cell lines. Patients who develop symptoms of capillary leak syndrome should be closely monitored and receive standard symptomatic treatment, which may include a need for intensive care. Episodes vary in frequency, severity and may be life-threatening if treatment is delayed. Monitor platelet counts.Ĭapillary leak syndrome has been reported after granulocyte colony-stimulating factor (G-CSF) administration, including pegfilgrastim products, and is characterized by hypotension, hypoalbuminemia, edema, and hemoconcentration. Thrombocytopenia has been reported in patients receiving pegfilgrastim. Monitoring of CBCs during therapy with Fulphila is recommended. White blood cell counts of 100 x 10 9/L or greater have been observed in patients receiving pegfilgrastim products. If causality is likely, consider dose-reduction or interruption of Fulphila. If glomerulonephritis is suspected, evaluate for cause. Generally, events of glomerulonephritis resolved after withdrawal of pegfilgrastim products. The diagnoses were based upon azotemia, hematuria (microscopic and macroscopic), proteinuria, and renal biopsy. Glomerulonephritis has been reported in patients receiving pegfilgrastim products. Discontinue if sickle cell crisis occurs. Severe and sometimes fatal sickle cell crises can occur in patients with sickle cell disorders receiving pegfilgrastim products. Permanently discontinue Fulphila in patients with serious allergic reactions to any pegfilgrastim or filgrastim products. The majority of reported events occurred upon initial exposure and can recur within days after discontinuation of initial anti-allergic treatment. Serious allergic reactions, including anaphylaxis, can occur in patients receiving pegfilgrastim products. Discontinue Fulphila in patients with ARDS. Evaluate patients who develop fever and lung infiltrates or respiratory distress after receiving Fulphila for ARDS. Evaluate for an enlarged spleen or splenic rupture in patients who report left upper abdominal or shoulder pain after receiving Fulphila.Īcute respiratory distress syndrome (ARDS) can occur in patients receiving pegfilgrastim products. Splenic rupture, including fatal cases, can occur following the administration of pegfilgrastim products. IMPORTANT SAFETY INFORMATIONĭo not administer Fulphila to patients with a history of serious allergic reactions, including anaphylaxis, to pegfilgrastim or filgrastim. Fulphila ® is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive anti cancer drugs associated with a clinically significant incidence of febrile neutropenia.įulphila is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.
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