NEUPOGEN® is administered by subcutaneous injection or IV infusion.
Febrile Neutropenia: NEUPOGEN® (filgrastim) is indicated to decrease the incidence of infection‚ as manifested by febrile neutropenia‚ in patients with nonmyeloid malignancies receiving myelosuppressive anticancer drugs associated with a significant incidence of severe neutropenia with fever.
A complete blood count and platelet count should be obtained prior to chemotherapy, and twice a week during NEUPOGEN® therapy to avoid leukocytosis and to monitor the neutrophil count.
Induction or consolidation chemotherapy: NEUPOGEN® is indicated for reducing the time to neutrophil recovery and the duration of fever, following induction or consolidation chemotherapy treatment of adults with acute myeloid leukemia.
Cancer patients receiving bone marrow transplant: NEUPOGEN® is indicated to reduce the duration of neutropenia and neutropenia-related clinical sequelae, e.g., febrile neutropenia in patients with nonmyeloid malignancies undergoing myeloablative chemotherapy followed by marrow transplantation. It is recommended that complete blood counts (CBCs) and platelet counts be obtained at a minimum of 3 times per week following marrow infusion.
Peripheral blood progenitor cell collection and therapy: NEUPOGEN® is indicated for the mobilization of hematopoietic progenitor cells into the peripheral blood for collection by leukapheresis.
Patients with severe chronic neutropenia (SCN): NEUPOGEN® is indicated for chronic administration to reduce the incidence and duration of sequelae of neutropenia in symptomatic patients with congenital neutropenia, cyclic neutropenia, or idiopathic neutropenia. It is essential that serial CBCs with differential and platelet counts, and an evaluation of bone marrow morphology and karyotype be performed prior to initiation of NEUPOGEN® therapy. The use of NEUPOGEN® prior to confirmation of SCN may impair diagnostic efforts and may thus impair or delay evaluation and treatment of underlying condition, other than SCN, causing the neutropenia.
Important Safety Information
NEUPOGEN® is contraindicated in patients with known hypersensitivity to E coli-derived proteins, such as filgrastim, or any component of the product.
Allergic reactions, including anaphylaxis, occurred with initial or subsequent treatment. Some reactions occurred on initial exposure. Reactions tended to occur within the first 30 minutes after administration and appeared to occur more frequently in patients receiving NEUPOGEN® IV.
SPLENIC RUPTURE, INCLUDING FATAL CASES, HAS BEEN REPORTED. IF PATIENTS REPORT LEFT UPPER ABDOMINAL AND/OR SHOULDER TIP PAIN, THEY SHOULD BE EVALUATED FOR AN ENLARGED SPLEEN OR SPLENIC RUPTURE.
Acute respiratory distress syndrome (ARDS) has been reported. Evaluate patients who develop fever, lung infiltrates, or respiratory distress for ARDS. If patient is diagnosed with ARDS, discontinue and/or withhold NEUPOGEN® until resolution.
Alveolar hemorrhage, manifesting as pulmonary infiltrates and hemoptysis requiring hospitalization, has been reported in healthy donors undergoing peripheral blood progenitor cell mobilization, an unapproved use of NEUPOGEN®. Hemoptysis resolved with discontinuation of NEUPOGEN®. The use of NEUPOGEN® for peripheral blood progenitor cell mobilization in healthy donors is not an approved indication.
Severe sickle cell crises, in some cases resulting in death, have been associated with the use of NEUPOGEN® in patients with sickle cell disorders.
Thrombocytopenia has been reported commonly in patients receiving NEUPOGEN®. Platelet counts should be monitored closely.
The safety and efficacy of NEUPOGEN® in the treatment of neutropenia due to other hematopoietic disorders (eg, myelodysplastic syndrome [MDS]) have not been established.
Cytogenetic abnormalities, transformation to MDS, and acute myeloid leukemia (AML) have been observed in patients treated with NEUPOGEN® for severe chronic neutropenia. The risk of developing MDS and AML appears to be confined to the subset of patients with congenital neutropenia. If a patient with severe chronic neutropenia (SCN) develops abnormal cytogenetics or myelodysplasia‚ the risks and benefits of continuing NEUPOGEN® should be carefully considered.
NEUPOGEN® is a growth factor that primarily stimulates neutrophils. However, the possibility that NEUPOGEN® can act as a growth factor for any tumor type cannot be excluded.
Cutaneous vasculitis has been reported in patients treated with NEUPOGEN®. Most cases were moderate or severe and involved patients with SCN receiving long-term NEUPOGEN® therapy. Symptoms of vasculitis generally developed simultaneously with an increase in the ANC and abated when the ANC decreased. Many patients were able to continue NEUPOGEN® at a reduced dose.
In clinical trials of cancer patients receiving myelosuppressive chemotherapy involving NEUPOGEN®, medullary bone pain was the most frequently reported adverse event attributed to NEUPOGEN® therapy.
In clinical trials of patients with AML, adverse events reported in ≥ 5% of patients and more frequently in patients receiving NEUPOGEN® than placebo included: petechiae, epistaxis, transfusion reactions, and hemorrhagic events (including severe or fatal hemorrhagic events).
In randomized clinical trials of cancer patients receiving bone marrow transplant, the following adverse events were reported in ≥ 5% of patients and more frequently in patients treated with NEUPOGEN® than in controls included: nausea‚ vomiting‚ hypertension, rash, and peritonitis.
In clinical trials of cancer patients undergoing peripheral blood progenitor cell collection and therapy, adverse events reported in ≥5% of patients and related to NEUPOGEN® consisted primarily of mild-to-moderate musculoskeletal symptoms. These symptoms were predominantly events of medullary bone pain. Other reported events included headache and transient increases in alkaline phosphatase (reported in patients who had serum chemistries measured), mild to moderate anemia, and decreased platelet counts.
In clinical trials of patients with severe chronic neutropenia, the following were reported in ≥ 5% of patients: mild-to-moderate bone pain, palpable splenomegaly, epistaxis, anemia, and thrombocytopenia.
For more information, please see the full Prescribing Information for NEUPOGEN®.
Reference: 1. NEUPOGEN® (filgrastim) Prescribing Information, Amgen.