NURS6521: Filgrastim (Neupogen)
NURS6521: Filgrastim (Neupogen)
When planning care for a patient who is receiving filgrastim (Neupogen) for a nonmyeloid malignancy, the nurse should formulate which of the following patient outcomes? (Select all that apply.)
NEUPOGEN is a clear, colorless, preservative-free solution available as:
Injection: 300 mcg/mL in a single-dose vial
Injection: 480 mcg/1.6 mL in a single-dose vial
Injection: 300 mcg/0.5 mL in a single-dose prefilled syringe
Injection: 480 mcg/0.8 mL in a single-dose prefilled syringe
NEUPOGEN is contraindicated in patients with a history of serious allergic reactions to human granulocyte
colony-stimulating factors such as filgrastim or pegfilgrastim [see Warnings and Precautions (5.3)].
5 WARNINGS AND PRECAUTIONS
5.1 Splenic Rupture
Splenic rupture, including fatal cases, has been reported following the administration of NEUPOGEN.
Evaluate patients who report left upper abdominal or shoulder pain for an enlarged spleen or splenic
5.2 Acute Respiratory Distress Syndrome
Acute respiratory distress syndrome (ARDS) has been reported in patients receiving NEUPOGEN.
Evaluate patients who develop fever and lung infiltrates or respiratory distress for ARDS. Discontinue
NEUPOGEN in patients with ARDS.
5.3 Serious Allergic Reactions
Serious allergic reactions, including anaphylaxis, have been reported in patients receiving NEUPOGEN.
The majority of reported events occurred upon initial exposure. Provide symptomatic treatment for allergic
reactions. Allergic reactions, including anaphylaxis, in patients receiving NEUPOGEN can recur within
days after the discontinuation of initial anti-allergic treatment. Permanently discontinue NEUPOGEN in
patients with serious allergic reactions. NEUPOGEN is contraindicated in patients with a history of serious
allergic reactions to human granulocyte colony-stimulating factors such as filgrastim or pegfilgrastim.
5.4 Sickle Cell Disorders
Severe and sometimes fatal sickle cell crises can occur in patients with sickle cell disorders receiving
filgrastim products. Discontinue NEUPOGEN if sickle cell crisis occurs.
Glomerulonephritis has occurred in patients receiving NEUPOGEN. The diagnoses were based upon
azotemia, hematuria (microscopic and macroscopic), proteinuria, and renal biopsy. Generally, events of
glomerulonephritis resolved after dose-reduction or discontinuation of NEUPOGEN. If glomerulonephritis
is suspected, evaluate for cause. If causality is likely, consider dose-reduction or interruption of
5.6 Alveolar Hemorrhage and Hemoptysis
Alveolar hemorrhage manifesting as pulmonary infiltrates and hemoptysis requiring hospitalization have
been reported in NEUPOGEN-treated healthy donors undergoing peripheral blood progenitor cell (PBPC)
collection mobilization. Hemoptysis resolved with discontinuation of NEUPOGEN. The use of
NEUPOGEN for PBPC mobilization in healthy donors is not an approved indication.
5.7 Capillary Leak Syndrome
Capillary leak syndrome (CLS) has been reported after G-CSF administration, including NEUPOGEN, 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
capillary leak syndrome should be closely monitored and receive standard symptomatic treatment, which
may include a need for intensive care.
5.8 Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia (AML)
Patients with Severe Chronic Neutropenia
Confirm the diagnosis of SCN before initiating NEUPOGEN therapy.
MDS and AML have been reported to occur in the natural history of congenital neutropenia without
cytokine therapy. Cytogenetic abnormalities, transformation to MDS, and AML have also been observed
in patients treated with NEUPOGEN for SCN. Based on available data including a postmarketing
surveillance study, the risk of developing MDS and AML appears to be confined to the subset of patients
with congenital neutropenia. Abnormal cytogenetics and MDS have been associated with the eventual
development of myeloid leukemia. The effect of NEUPOGEN on the development of abnormal
cytogenetics and the effect of continued NEUPOGEN administration in patients with abnormal
cytogenetics or MDS are unknown. Monitor patients for signs and symptoms of MDS/AML in these
settings. If a patient with SCN develops abnormal cytogenetics or myelodysplasia‚ the risks and benefits of
continuing NEUPOGEN should be carefully considered.