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Hematology

Neutropenia

Use absolute neutrophil count, trajectory, accompanying cytopenias, infection burden, and exposure history to distinguish transient acquired neutropenia from chronic immune, congenital, marrow, or treatment-related disease and to determine when marrow evaluation, G-CSF, or urgent infection management is warranted.

Clinical question: How should clinicians triage, evaluate, and manage neutropenia according to severity, chronicity, cause, and infection risk?

Initial decisions

Triage by ANC, fever, and clinical trajectory

The first decision is whether the low count represents an immediate infectious threat or an outpatient diagnostic problem.

Calculate ANC rather than interpreting the neutrophil percentage alone: ANC equals total WBC count multiplied by the proportion of segmented neutrophils plus bands. A low total WBC can therefore produce severe neutropenia despite a seemingly normal relative neutrophil percentage. ScienceDirectLeukocyte Count - an overview

Classify ANC below 1,500/µL as neutropenia and ANC below 500/µL as severe neutropenia. Infection susceptibility rises with severity and duration; use the nadir, trend, and duration rather than a single recovered value to judge near-term risk. ScienceDirectAbsolute Neutrophil Count - an overviewScienceDirectLeukocyte Count - an overviewScienceDirectNeutrophil Count - an overview

Treat fever or focal infection in a patient with severe neutropenia as an urgent infectious syndrome rather than waiting for etiologic classification. Chemotherapy-associated febrile neutropenia is commonly managed with broad-spectrum antibiotics and hospital admission until fever and neutropenia resolve; outpatient pathways for selected children remain limited by the absence of a fully validated clinical decision rule. Wolters KluwerPredicting the risk of severe infection in... : Current Opinion in HematologyannemergmedCan We Safely Discharge Low-Risk Patients With Febrile ...

ANC categories used to frame infection risk and urgency. ScienceDirectAbsolute Neutrophil Count - an overviewScienceDirectLeukocyte Count - an overviewScienceDirectNeutrophil Count - an overview
ANCCategoryDecision implication
1,000-1,500/µLMild neutropenia ScienceDirectAbsolute Neutrophil Count - an overviewScienceDirectNeutrophil Count - an overviewConfirm persistence and assess for isolated versus multilineage cytopenia. Wolters KluwerThe European Guidelines on Diagnosis and... : HemaSphereScienceDirectAbsolute Neutrophil Count - an overview
500-1,000/µLModerate neutropenia ScienceDirectNeutrophil Count - an overviewIncrease urgency of exposure, infection, medication, and marrow-focused assessment, particularly when persistent or recurrent. Wolters KluwerThe European Guidelines on Diagnosis and... : HemaSphereScienceDirectNeutrophil Count - an overview
<500/µLSevere neutropenia ScienceDirectAbsolute Neutrophil Count - an overviewScienceDirectLeukocyte Count - an overviewScienceDirectNeutrophil Count - an overviewAssess immediately for fever or infection and determine whether urgent antimicrobial management and inpatient care are required. Wolters KluwerPredicting the risk of severe infection in... : Current Opinion in HematologyannemergmedCan We Safely Discharge Low-Risk Patients With Febrile ...

Diagnostic framework

Establish whether neutropenia is transient, chronic, isolated, or marrow-associated

Duration and accompanying hematologic abnormalities determine the scope of testing.

Define chronic neutropenia as persistence beyond 6 months. For an isolated low count, serial CBCs establish persistence, cyclicity, recovery, and development of additional cytopenias before labeling the condition idiopathic. ScienceDirectLeukocyte Count - an overview

Start with acquired causes. Medication-associated neutropenia, recent or active infection, autoimmune disease, nutritional deficiency including copper deficiency, and myeloid disorders are major acquired branches; history should specifically identify temporal drug exposure, systemic infectious symptoms, autoimmune features, dietary or malabsorptive risk, and cytotoxic therapy. ScienceDirectAbsolute Neutrophil Count - an overviewScienceDirectNeutrophil Count - an overview

A patient with rheumatoid arthritis and neutropenia warrants directed consideration of drug-related suppression, Felty syndrome, and T-cell large granular lymphocytic leukemia; severe rheumatoid disease and immunosuppression may each contribute to the low ANC. ScienceDirectNeutrophil Count - an overview

Chronic idiopathic and autoimmune neutropenia are common chronic causes in both children and adults, but these diagnoses require exclusion of congenital, medication-related, systemic autoimmune, and marrow causes when the clinical pattern is atypical or infections recur. Wolters KluwerAn update on the diagnosis and treatment of chronic ...Wolters KluwerThe European Guidelines on Diagnosis and... : HemaSphere

Pattern-based branches that change the next diagnostic step. Wolters KluwerThe European Guidelines on Diagnosis and... : HemaSphereWolters KluwerAn update on the diagnosis and treatment of chronic ...ScienceDirectAbsolute Neutrophil Count - an overviewScienceDirectNeutrophil Count - an overview
PatternHigh-priority etiologiesNext action
New or transient isolated neutropeniaDrug exposure, infection, nutritional deficiency, autoimmune disease ScienceDirectAbsolute Neutrophil Count - an overviewRepeat CBC with differential; review medications, infectious context, dietary or malabsorption risk, and peripheral smear. ScienceDirectAbsolute Neutrophil Count - an overviewScienceDirectLeukocyte Count - an overview
Chronic isolated mild neutropenia, stable over timeChronic idiopathic or autoimmune neutropenia; stable constitutional variants may be considered clinically Wolters KluwerAn update on the diagnosis and treatment of chronic ...Wolters KluwerThe European Guidelines on Diagnosis and... : HemaSphereIn adults, stable long-standing mild isolated neutropenia is an exception to routine diagnostic marrow examination. Wolters KluwerThe European Guidelines on Diagnosis and... : HemaSphere
Chronic moderate or severe neutropenia in a childCongenital neutropenia, marrow failure, autoimmune neutropenia dailymed nlm nihNeupogenWolters KluwerThe European Guidelines on Diagnosis and... : HemaSpherePerform diagnostic marrow morphology, cytogenetics, and myeloid-malignancy gene testing unless primary autoimmune neutropenia with positive antigranulocyte antibodies or drug-induced neutropenia applies. Wolters KluwerThe European Guidelines on Diagnosis and... : HemaSphere
Adult unexplained chronic neutropeniaAutoimmune or idiopathic neutropenia, myeloid malignancy, marrow failure Wolters KluwerThe European Guidelines on Diagnosis and... : HemaSphereWolters KluwerAn update on the diagnosis and treatment of chronic ...ScienceDirectAbsolute Neutrophil Count - an overviewPerform marrow morphology, cytogenetics, and next-generation sequencing for genes related to myeloid malignancies unless the stable mild isolated exception applies. Wolters KluwerThe European Guidelines on Diagnosis and... : HemaSphere
Rheumatoid arthritis with neutropeniaImmunosuppressive drug effect, Felty syndrome, T-cell LGL leukemia ScienceDirectNeutrophil Count - an overviewAssess the rheumatologic and medication context and evaluate for the named associated disorders. ScienceDirectNeutrophil Count - an overview

When autoimmune neutropenia is plausible

In pediatric patients with suspected primary autoimmune neutropenia and positive antigranulocyte antibodies, marrow testing may be deferred. In contrast, suspected autoimmune neutropenia with negative granulocyte antibody testing and recurrent infections should prompt diagnostic marrow examination. Wolters KluwerThe European Guidelines on Diagnosis and... : HemaSphere

Hematology escalation

Use marrow testing to exclude marrow failure and myeloid neoplasia

Marrow evaluation is not a reflex for every low ANC, but it is central in unexplained persistent or severe disease.

For chronic neutropenia requiring marrow evaluation, obtain bone marrow morphology, conventional cytogenetics, and next-generation sequencing of genes related to myeloid malignancies. This combination is recommended for adults with unexplained chronic neutropenia and for pediatric severe or moderate chronic neutropenia, subject to specified exceptions. Wolters KluwerThe European Guidelines on Diagnosis and... : HemaSphere

Perform diagnostic marrow testing before initiating G-CSF in chronic neutropenia. This establishes a baseline and helps distinguish congenital, immune, and marrow-based disorders before treatment changes the neutrophil count. Wolters KluwerThe European Guidelines on Diagnosis and... : HemaSphere

Plan annual marrow and cytogenetic follow-up for congenital bone marrow failure syndromes regardless of ANC or G-CSF treatment status. This surveillance requirement differs from stable mild isolated adult neutropenia, for which routine diagnostic marrow testing may be unnecessary. Wolters KluwerThe European Guidelines on Diagnosis and... : HemaSphere

Situations in which marrow examination or surveillance changes management. Wolters KluwerThe European Guidelines on Diagnosis and... : HemaSphere
Clinical situationMarrow actionException or follow-up
Adult unexplained chronic neutropeniaBone marrow morphology, cytogenetics, and myeloid-malignancy gene NGS. Wolters KluwerThe European Guidelines on Diagnosis and... : HemaSphereMay defer in long-standing, mild, isolated, stable neutropenia. Wolters KluwerThe European Guidelines on Diagnosis and... : HemaSphere
Pediatric moderate or severe chronic neutropeniaBone marrow morphology, cytogenetics, and myeloid-malignancy gene NGS. Wolters KluwerThe European Guidelines on Diagnosis and... : HemaSphereException: primary autoimmune neutropenia with positive antigranulocyte antibodies and drug-induced neutropenia. Wolters KluwerThe European Guidelines on Diagnosis and... : HemaSphere
Suspected autoimmune neutropenia with negative antibody testing and recurrent infectionDiagnostic bone marrow examination. Wolters KluwerThe European Guidelines on Diagnosis and... : HemaSphereReassess for alternative immune or marrow pathology. Wolters KluwerThe European Guidelines on Diagnosis and... : HemaSphere
Before G-CSF in chronic neutropeniaDiagnostic bone marrow examination. Wolters KluwerThe European Guidelines on Diagnosis and... : HemaSphereUse as baseline before chronic growth-factor exposure. Wolters KluwerThe European Guidelines on Diagnosis and... : HemaSphere
Congenital marrow failure syndromeAnnual marrow and cytogenetic follow-up. Wolters KluwerThe European Guidelines on Diagnosis and... : HemaSphereApplies independent of ANC and G-CSF treatment. Wolters KluwerThe European Guidelines on Diagnosis and... : HemaSphere

Cause-directed treatment

Use filgrastim for symptomatic severe chronic neutropenia

G-CSF is a chronic, individualized intervention for selected patients, not a substitute for defining the underlying disorder.

Filgrastim is indicated to reduce fever, infections, and oropharyngeal ulcers in symptomatic adult and pediatric patients with congenital, cyclic, or idiopathic severe chronic neutropenia. In the pivotal randomized trial, febrile neutropenia occurred in 40% of filgrastim-treated patients versus 76% of placebo-treated patients; severe neutropenia, hospital admission, and antibiotic-use duration were also reduced. dailymed nlm nihNeupogendailymed nlm nihThese highlights do not include all the information needed to use NYPOZI safely and effectively. See full prescribing information for NYPOZI. NYPOZI (filgrastim-txid) injection, for subcutaneous or intravenous useInitial U.S. Approval: 2024 NYPOZI (filgrastim-txid) is biosimilar1 to NEUPOGEN® (filgrastim).Biosimilar means that the biological product is approved based on data demonstrating that it is highly similar to an FDA-approved biological product, known as a reference product, and that there are no clinically meaningful differences between the biosimilar product and the reference product. Biosimilarity of NYPOZI has been demonstrated for the condition(s) of use (e.g., indication(s), dosing regimen(s)), strength(s), dosage form(s), and route(s) of administration described in its Full Prescribing Informationdailymed nlm nihThese highlights do not include all the information needed to use ZARXIO safely and effectively. See full prescribing information for ZARXIO. ZARXIO® (filgrastim-sndz) injection, for subcutaneous or intravenous useInitial U.S. Approval: 2015ZARXIO (filgrastim-sndz) is biosimilar* to NEUPOGEN (filgrastim).

Chronic daily administration is required to maintain clinical benefit in severe chronic neutropenia. Individualize the dose to clinical course and ANC, with CBC monitoring used for dose adjustment. dailymed nlm nihNeupogendailymed nlm nihThese highlights do not include all the information needed to use NYPOZI safely and effectively. See full prescribing information for NYPOZI. NYPOZI (filgrastim-txid) injection, for subcutaneous or intravenous useInitial U.S. Approval: 2024 NYPOZI (filgrastim-txid) is biosimilar1 to NEUPOGEN® (filgrastim).Biosimilar means that the biological product is approved based on data demonstrating that it is highly similar to an FDA-approved biological product, known as a reference product, and that there are no clinically meaningful differences between the biosimilar product and the reference product. Biosimilarity of NYPOZI has been demonstrated for the condition(s) of use (e.g., indication(s), dosing regimen(s)), strength(s), dosage form(s), and route(s) of administration described in its Full Prescribing Informationdailymed nlm nihThese highlights do not include all the information needed to use ZARXIO safely and effectively. See full prescribing information for ZARXIO. ZARXIO® (filgrastim-sndz) injection, for subcutaneous or intravenous useInitial U.S. Approval: 2015ZARXIO (filgrastim-sndz) is biosimilar* to NEUPOGEN (filgrastim).

Reported median daily filgrastim doses in postmarketing surveillance were 6 mcg/kg for congenital neutropenia, 2.1 mcg/kg for cyclic neutropenia, and 1.2 mcg/kg for idiopathic neutropenia. Rare patients with congenital neutropenia required at least 100 mcg/kg/day, illustrating the need for disease-specific dose titration rather than a fixed regimen. dailymed nlm nihThese highlights do not include all the information needed to use NYPOZI safely and effectively. See full prescribing information for NYPOZI. NYPOZI (filgrastim-txid) injection, for subcutaneous or intravenous useInitial U.S. Approval: 2024 NYPOZI (filgrastim-txid) is biosimilar1 to NEUPOGEN® (filgrastim).Biosimilar means that the biological product is approved based on data demonstrating that it is highly similar to an FDA-approved biological product, known as a reference product, and that there are no clinically meaningful differences between the biosimilar product and the reference product. Biosimilarity of NYPOZI has been demonstrated for the condition(s) of use (e.g., indication(s), dosing regimen(s)), strength(s), dosage form(s), and route(s) of administration described in its Full Prescribing Informationdailymed nlm nihThese highlights do not include all the information needed to use ZARXIO safely and effectively. See full prescribing information for ZARXIO. ZARXIO® (filgrastim-sndz) injection, for subcutaneous or intravenous useInitial U.S. Approval: 2015ZARXIO (filgrastim-sndz) is biosimilar* to NEUPOGEN (filgrastim).

Filgrastim dose experience in severe chronic neutropenia. dailymed nlm nihThese highlights do not include all the information needed to use NYPOZI safely and effectively. See full prescribing information for NYPOZI. NYPOZI (filgrastim-txid) injection, for subcutaneous or intravenous useInitial U.S. Approval: 2024 NYPOZI (filgrastim-txid) is biosimilar1 to NEUPOGEN® (filgrastim).Biosimilar means that the biological product is approved based on data demonstrating that it is highly similar to an FDA-approved biological product, known as a reference product, and that there are no clinically meaningful differences between the biosimilar product and the reference product. Biosimilarity of NYPOZI has been demonstrated for the condition(s) of use (e.g., indication(s), dosing regimen(s)), strength(s), dosage form(s), and route(s) of administration described in its Full Prescribing Informationdailymed nlm nihThese highlights do not include all the information needed to use ZARXIO safely and effectively. See full prescribing information for ZARXIO. ZARXIO® (filgrastim-sndz) injection, for subcutaneous or intravenous useInitial U.S. Approval: 2015ZARXIO (filgrastim-sndz) is biosimilar* to NEUPOGEN (filgrastim).
Severe chronic neutropenia subtypeReported median daily filgrastim doseMonitoring and treatment principle
Congenital neutropenia6 mcg/kg/day; rare patients required ≥100 mcg/kg/day. dailymed nlm nihThese highlights do not include all the information needed to use NYPOZI safely and effectively. See full prescribing information for NYPOZI. NYPOZI (filgrastim-txid) injection, for subcutaneous or intravenous useInitial U.S. Approval: 2024 NYPOZI (filgrastim-txid) is biosimilar1 to NEUPOGEN® (filgrastim).Biosimilar means that the biological product is approved based on data demonstrating that it is highly similar to an FDA-approved biological product, known as a reference product, and that there are no clinically meaningful differences between the biosimilar product and the reference product. Biosimilarity of NYPOZI has been demonstrated for the condition(s) of use (e.g., indication(s), dosing regimen(s)), strength(s), dosage form(s), and route(s) of administration described in its Full Prescribing Informationdailymed nlm nihThese highlights do not include all the information needed to use ZARXIO safely and effectively. See full prescribing information for ZARXIO. ZARXIO® (filgrastim-sndz) injection, for subcutaneous or intravenous useInitial U.S. Approval: 2015ZARXIO (filgrastim-sndz) is biosimilar* to NEUPOGEN (filgrastim).Chronic daily therapy; individualize to ANC and clinical course with CBC monitoring. dailymed nlm nihThese highlights do not include all the information needed to use NYPOZI safely and effectively. See full prescribing information for NYPOZI. NYPOZI (filgrastim-txid) injection, for subcutaneous or intravenous useInitial U.S. Approval: 2024 NYPOZI (filgrastim-txid) is biosimilar1 to NEUPOGEN® (filgrastim).Biosimilar means that the biological product is approved based on data demonstrating that it is highly similar to an FDA-approved biological product, known as a reference product, and that there are no clinically meaningful differences between the biosimilar product and the reference product. Biosimilarity of NYPOZI has been demonstrated for the condition(s) of use (e.g., indication(s), dosing regimen(s)), strength(s), dosage form(s), and route(s) of administration described in its Full Prescribing Informationdailymed nlm nihThese highlights do not include all the information needed to use ZARXIO safely and effectively. See full prescribing information for ZARXIO. ZARXIO® (filgrastim-sndz) injection, for subcutaneous or intravenous useInitial U.S. Approval: 2015ZARXIO (filgrastim-sndz) is biosimilar* to NEUPOGEN (filgrastim).
Cyclic neutropenia2.1 mcg/kg/day. dailymed nlm nihThese highlights do not include all the information needed to use NYPOZI safely and effectively. See full prescribing information for NYPOZI. NYPOZI (filgrastim-txid) injection, for subcutaneous or intravenous useInitial U.S. Approval: 2024 NYPOZI (filgrastim-txid) is biosimilar1 to NEUPOGEN® (filgrastim).Biosimilar means that the biological product is approved based on data demonstrating that it is highly similar to an FDA-approved biological product, known as a reference product, and that there are no clinically meaningful differences between the biosimilar product and the reference product. Biosimilarity of NYPOZI has been demonstrated for the condition(s) of use (e.g., indication(s), dosing regimen(s)), strength(s), dosage form(s), and route(s) of administration described in its Full Prescribing Informationdailymed nlm nihThese highlights do not include all the information needed to use ZARXIO safely and effectively. See full prescribing information for ZARXIO. ZARXIO® (filgrastim-sndz) injection, for subcutaneous or intravenous useInitial U.S. Approval: 2015ZARXIO (filgrastim-sndz) is biosimilar* to NEUPOGEN (filgrastim).Chronic daily therapy; individualize to ANC and clinical course with CBC monitoring. dailymed nlm nihThese highlights do not include all the information needed to use NYPOZI safely and effectively. See full prescribing information for NYPOZI. NYPOZI (filgrastim-txid) injection, for subcutaneous or intravenous useInitial U.S. Approval: 2024 NYPOZI (filgrastim-txid) is biosimilar1 to NEUPOGEN® (filgrastim).Biosimilar means that the biological product is approved based on data demonstrating that it is highly similar to an FDA-approved biological product, known as a reference product, and that there are no clinically meaningful differences between the biosimilar product and the reference product. Biosimilarity of NYPOZI has been demonstrated for the condition(s) of use (e.g., indication(s), dosing regimen(s)), strength(s), dosage form(s), and route(s) of administration described in its Full Prescribing Informationdailymed nlm nihThese highlights do not include all the information needed to use ZARXIO safely and effectively. See full prescribing information for ZARXIO. ZARXIO® (filgrastim-sndz) injection, for subcutaneous or intravenous useInitial U.S. Approval: 2015ZARXIO (filgrastim-sndz) is biosimilar* to NEUPOGEN (filgrastim).
Idiopathic neutropenia1.2 mcg/kg/day. dailymed nlm nihThese highlights do not include all the information needed to use NYPOZI safely and effectively. See full prescribing information for NYPOZI. NYPOZI (filgrastim-txid) injection, for subcutaneous or intravenous useInitial U.S. Approval: 2024 NYPOZI (filgrastim-txid) is biosimilar1 to NEUPOGEN® (filgrastim).Biosimilar means that the biological product is approved based on data demonstrating that it is highly similar to an FDA-approved biological product, known as a reference product, and that there are no clinically meaningful differences between the biosimilar product and the reference product. Biosimilarity of NYPOZI has been demonstrated for the condition(s) of use (e.g., indication(s), dosing regimen(s)), strength(s), dosage form(s), and route(s) of administration described in its Full Prescribing Informationdailymed nlm nihThese highlights do not include all the information needed to use ZARXIO safely and effectively. See full prescribing information for ZARXIO. ZARXIO® (filgrastim-sndz) injection, for subcutaneous or intravenous useInitial U.S. Approval: 2015ZARXIO (filgrastim-sndz) is biosimilar* to NEUPOGEN (filgrastim).Chronic daily therapy; individualize to ANC and clinical course with CBC monitoring. dailymed nlm nihThese highlights do not include all the information needed to use NYPOZI safely and effectively. See full prescribing information for NYPOZI. NYPOZI (filgrastim-txid) injection, for subcutaneous or intravenous useInitial U.S. Approval: 2024 NYPOZI (filgrastim-txid) is biosimilar1 to NEUPOGEN® (filgrastim).Biosimilar means that the biological product is approved based on data demonstrating that it is highly similar to an FDA-approved biological product, known as a reference product, and that there are no clinically meaningful differences between the biosimilar product and the reference product. Biosimilarity of NYPOZI has been demonstrated for the condition(s) of use (e.g., indication(s), dosing regimen(s)), strength(s), dosage form(s), and route(s) of administration described in its Full Prescribing Informationdailymed nlm nihThese highlights do not include all the information needed to use ZARXIO safely and effectively. See full prescribing information for ZARXIO. ZARXIO® (filgrastim-sndz) injection, for subcutaneous or intravenous useInitial U.S. Approval: 2015ZARXIO (filgrastim-sndz) is biosimilar* to NEUPOGEN (filgrastim).

Oncology

Prevent chemotherapy-associated neutropenia with regimen-appropriate G-CSF

Chemotherapy-associated neutropenia requires prevention planning before the expected nadir and urgent management when fever develops.

Recombinant G-CSF reduces chemotherapy-related neutropenia. In breast cancer treatment settings, long-acting G-CSFs are standard for primary prophylaxis against chemotherapy-induced neutropenia, and G-CSF prophylaxis may be used when febrile-neutropenia risk is high. NEJMReduction by Granulocyte Colony-Stimulating Factor of ...The LancetToxicity profile of antibody-drug conjugates in breast cancerThe LancetComparative efficacy and safety of four long-acting ...

Ryzneuta is an FDA-approved leukocyte growth factor for adults with nonmyeloid malignancies receiving myelosuppressive anticancer drugs associated with a clinically significant incidence of febrile neutropenia; administer one subcutaneous injection approximately 24 hours after cytotoxic chemotherapy. In metastatic breast cancer trials, cycle-1 mean duration of severe neutropenia was 1.4 days with Ryzneuta versus 4.3 days with placebo, and was noninferior to pegfilgrastim in a second study. fdaDrug Trials Snapshots: RYZNEUTA | FDA

For pediatric patients 1 month to younger than 17 years with nonmyeloid malignancies receiving myelosuppressive anticancer drugs associated with clinically significant febrile-neutropenia incidence, tbo-filgrastim labeling supports established safety and effectiveness; pediatric evaluation included a 5 mcg/kg/day study regimen. fdaClinical Review of PMR Report andaccessdata fdatbo-filgrastim Written Request - accessdata.fda.gov

G-CSF use settings with source-supported timing or dosing. dailymed nlm nihThese highlights do not include all the information needed to use NYPOZI safely and effectively. See full prescribing information for NYPOZI. NYPOZI (filgrastim-txid) injection, for subcutaneous or intravenous useInitial U.S. Approval: 2024 NYPOZI (filgrastim-txid) is biosimilar1 to NEUPOGEN® (filgrastim).Biosimilar means that the biological product is approved based on data demonstrating that it is highly similar to an FDA-approved biological product, known as a reference product, and that there are no clinically meaningful differences between the biosimilar product and the reference product. Biosimilarity of NYPOZI has been demonstrated for the condition(s) of use (e.g., indication(s), dosing regimen(s)), strength(s), dosage form(s), and route(s) of administration described in its Full Prescribing Informationdailymed nlm nihThese highlights do not include all the information needed to use ZARXIO safely and effectively. See full prescribing information for ZARXIO. ZARXIO® (filgrastim-sndz) injection, for subcutaneous or intravenous useInitial U.S. Approval: 2015ZARXIO (filgrastim-sndz) is biosimilar* to NEUPOGEN (filgrastim).accessdata fdatbo-filgrastim Written Request - accessdata.fda.govfdaDrug Trials Snapshots: RYZNEUTA | FDA
Clinical settingAgent or regimenOperational rule
Adult chemotherapy prophylaxis in nonmyeloid malignancyRyzneuta, subcutaneous injection. fdaDrug Trials Snapshots: RYZNEUTA | FDAAdminister once approximately 24 hours after cytotoxic chemotherapy. fdaDrug Trials Snapshots: RYZNEUTA | FDA
Pediatric nonmyeloid malignancy receiving myelosuppressive chemotherapyTbo-filgrastim; pediatric study regimen 5 mcg/kg/day. fdaClinical Review of PMR Report andaccessdata fdatbo-filgrastim Written Request - accessdata.fda.govUse within the labeled pediatric age range and chemotherapy context. fdaClinical Review of PMR Report andaccessdata fdatbo-filgrastim Written Request - accessdata.fda.gov
Autologous PBPC mobilizationFilgrastim 10 mcg/kg/day subcutaneously. dailymed nlm nihThese highlights do not include all the information needed to use NYPOZI safely and effectively. See full prescribing information for NYPOZI. NYPOZI (filgrastim-txid) injection, for subcutaneous or intravenous useInitial U.S. Approval: 2024 NYPOZI (filgrastim-txid) is biosimilar1 to NEUPOGEN® (filgrastim).Biosimilar means that the biological product is approved based on data demonstrating that it is highly similar to an FDA-approved biological product, known as a reference product, and that there are no clinically meaningful differences between the biosimilar product and the reference product. Biosimilarity of NYPOZI has been demonstrated for the condition(s) of use (e.g., indication(s), dosing regimen(s)), strength(s), dosage form(s), and route(s) of administration described in its Full Prescribing Informationdailymed nlm nihThese highlights do not include all the information needed to use ZARXIO safely and effectively. See full prescribing information for ZARXIO. ZARXIO® (filgrastim-sndz) injection, for subcutaneous or intravenous useInitial U.S. Approval: 2015ZARXIO (filgrastim-sndz) is biosimilar* to NEUPOGEN (filgrastim).Start at least 4 days before first leukapheresis; continue through last collection; discontinue if WBC >100,000/mm3 after monitoring. dailymed nlm nihThese highlights do not include all the information needed to use NYPOZI safely and effectively. See full prescribing information for NYPOZI. NYPOZI (filgrastim-txid) injection, for subcutaneous or intravenous useInitial U.S. Approval: 2024 NYPOZI (filgrastim-txid) is biosimilar1 to NEUPOGEN® (filgrastim).Biosimilar means that the biological product is approved based on data demonstrating that it is highly similar to an FDA-approved biological product, known as a reference product, and that there are no clinically meaningful differences between the biosimilar product and the reference product. Biosimilarity of NYPOZI has been demonstrated for the condition(s) of use (e.g., indication(s), dosing regimen(s)), strength(s), dosage form(s), and route(s) of administration described in its Full Prescribing Informationdailymed nlm nihThese highlights do not include all the information needed to use ZARXIO safely and effectively. See full prescribing information for ZARXIO. ZARXIO® (filgrastim-sndz) injection, for subcutaneous or intravenous useInitial U.S. Approval: 2015ZARXIO (filgrastim-sndz) is biosimilar* to NEUPOGEN (filgrastim).

Common questions

When can bone marrow evaluation be deferred in chronic neutropenia?

A diagnostic marrow examination may be deferred in adults with long-standing, mild, isolated neutropenia that remains stable over time and in pediatric primary autoimmune neutropenia with positive antigranulocyte antibodies; recurrent infections with negative antibody testing warrant marrow evaluation. Wolters KluwerThe European Guidelines on Diagnosis and... : HemaSphere

What ANC should trigger concern for severe neutropenia?

An ANC below 500/µL defines severe neutropenia and should prompt immediate assessment for fever, focal infection, anticipated further decline, and need for urgent antimicrobial management. ScienceDirectAbsolute Neutrophil Count - an overviewScienceDirectLeukocyte Count - an overviewScienceDirectNeutrophil Count - an overviewannemergmedCan We Safely Discharge Low-Risk Patients With Febrile ...

References

  1. Clinical Review of PMR Report andwww.fda.gov · www.fda.gov
  2. Neupogendailymed.nlm.nih.gov · dailymed.nlm.nih.gov
  3. These highlights do not include all the information needed to use NYPOZI safely and effectively. See full prescribing information for NYPOZI. NYPOZI (filgrastim-txid) injection, for subcutaneous or intravenous useInitial U.S. Approval: 2024 NYPOZI (filgrastim-txid) is biosimilar1 to NEUPOGEN® (filgrastim).Biosimilar means that the biological product is approved based on data demonstrating that it is highly similar to an FDA-approved biological product, known as a reference product, and that there are no clinically meaningful differences between the biosimilar product and the reference product. Biosimilarity of NYPOZI has been demonstrated for the condition(s) of use (e.g., indication(s), dosing regimen(s)), strength(s), dosage form(s), and route(s) of administration described in its Full Prescribing Informationdailymed.nlm.nih.gov · dailymed.nlm.nih.gov
  4. These highlights do not include all the information needed to use ZARXIO safely and effectively. See full prescribing information for ZARXIO. ZARXIO® (filgrastim-sndz) injection, for subcutaneous or intravenous useInitial U.S. Approval: 2015ZARXIO (filgrastim-sndz) is biosimilar* to NEUPOGEN (filgrastim).dailymed.nlm.nih.gov · dailymed.nlm.nih.gov
  5. tbo-filgrastim Written Request - accessdata.fda.govwww.accessdata.fda.gov · www.accessdata.fda.gov
  6. Drug Trials Snapshots: RYZNEUTA | FDAwww.fda.gov · www.fda.gov
  7. highlights of prescribing informationdailymed.nlm.nih.gov · dailymed.nlm.nih.gov
  8. a report from the International Myeloma Working Groupwww.thelancet.com · www.thelancet.com
  9. Toxicity profile of antibody-drug conjugates in breast cancerwww.thelancet.com · www.thelancet.com
  10. Reduction by Granulocyte Colony-Stimulating Factor of ...www.nejm.org · www.nejm.org
  11. Comparative efficacy and safety of four long-acting ...www.thelancet.com · www.thelancet.com
  12. The European Guidelines on Diagnosis and... : HemaSpherejournals.lww.com · journals.lww.com
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