LABELS · 8cb6cfed-487e-4351-8f48-0be3cc5c2d6d

FYLNETRA

Open original source → · Download preserved record

Preserved label snapshot, not confirmation of a current approved indication. Approval/withdrawal status must be checked for the exact disease, setting and regimen.

Label effective date: 2025-04-25
Captured: 2026-09-09T23:37:54.830918+00:00
Current indication reconciliation: Not reconciled

Indications and usage: exact source text

1 INDICATIONS AND USAGE FYLNETRA is a leukocyte growth factor 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. (1.1) Increase survival in patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Subsyndrome of Acute Radiation Syndrome). (1.2) Limitations of Use FYLNETRA is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation. 1.1 Patients with Cancer Receiving Myelosuppressive Chemotherapy FYLNETRA 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 [see Clinical Studies (14.1) ] . Limitations of Use FYLNETRA is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation. 1.2 Patients with Hematopoietic Subsyndrome of Acute Radiation Syndrome FYLNETRA is indicated to increase survival in patients acutely exposed to myelosuppressive doses of radiation [see Dosage and Administration (2.2) and Clinical Studies (14.2) ] .

Full extracted label fields

application numbers

BLA761084

boxed warning exact

brand names

FYLNETRA

current indication status

not_reconciled

dailymed set url

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=eeadd641-573d-47fe-897a-61006e5f9e03

generic names

PEGFILGRASTIM

8cb6cfed-487e-4351-8f48-0be3cc5c2d6d

indications and usage exact

1 INDICATIONS AND USAGE FYLNETRA is a leukocyte growth factor 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. (1.1) Increase survival in patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Subsyndrome of Acute Radiation Syndrome). (1.2) Limitations of Use FYLNETRA is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation. 1.1 Patients with Cancer Receiving Myelosuppressive Chemotherapy FYLNETRA 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 [see Clinical Studies (14.1) ] . Limitations of Use FYLNETRA is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation. 1.2 Patients with Hematopoietic Subsyndrome of Acute Radiation Syndrome FYLNETRA is indicated to increase survival in patients acutely exposed to myelosuppressive doses of radiation [see Dosage and Administration (2.2) and Clinical Studies (14.2) ] .

indications and usage tables exact

is original packager

true

manufacturer names

Amneal Pharmaceuticals LLC

matched search terms

cancer

package ndcs

70121-1627-1

product ndcs

70121-1627

product types

HUMAN PRESCRIPTION DRUG

recent major changes exact

Indications and Usage, Patients with Hematopoietic Subsyndrome of Acute Radiation Syndrome (1.2) 04/2025 Dosage and Administration, Patients with Hematopoietic Subsyndrome of Acute Radiation Syndrome (2.2) 04/2025

record type

complete_spl_indications_section_candidate

routes

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rxcuis

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2602787

source batch

file

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Source passages and status connections

Passage classifications are automated and are not treatment recommendations. Connections apply only to their recorded indication scope.

Passage 1 · positive indication candidate

application numbers

BLA761084

brand names

FYLNETRA

classification reasons

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supportive_or_complication_use_words

clinical review status

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content role

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context span

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exact text: 1 INDICATIONS AND USAGE FYLNETRA is a leukocyte growth factor 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. (1.1) Increase survival in patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Subsyndrome of Acute Radiation Syndrome). (1.2) Limitations of Use FYLNETRA is not indicated
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exact text: is a leukocyte growth factor indicated
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qualifier mentions

regulatory links

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exact text: 1 INDICATIONS AND USAGE FYLNETRA is a leukocyte growth factor 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.
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source url

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spl effective date

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spl set id

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spl version

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structured indication

age: Source null
approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

supportive_care_candidate

Passage 2 · unclassified context

application numbers

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brand names

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classification reasons

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clinical review status

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exact text: 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. (1.1) Increase survival in patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Subsyndrome of Acute Radiation Syndrome). (1.2) Limitations of Use FYLNETRA is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation. 1.1 Patients with Cancer Receiving Myelosuppr
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generic names

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exact text: (1.1) Increase survival in patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Subsyndrome of Acute Radiation Syndrome).
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source url

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structured indication

age: Source null
approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

unclear

Passage 3 · limitation of use

application numbers

BLA761084

brand names

FYLNETRA

classification reasons

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clinical review status

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context span

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exact text: cally significant incidence of febrile neutropenia. (1.1) Increase survival in patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Subsyndrome of Acute Radiation Syndrome). (1.2) Limitations of Use FYLNETRA is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation. 1.1 Patients with Cancer Receiving Myelosuppressive Chemotherapy FYLNETRA is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malig
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exact text: (1.2) Limitations of Use FYLNETRA is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.
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source url

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structured indication

age: Source null
approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

not_applicable

Passage 4 · positive indication candidate

application numbers

BLA761084

brand names

FYLNETRA

classification reasons

explicit_positive_indication_predicate
supportive_or_complication_use_words

clinical review status

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context span

end: 1172
end exclusive: true
exact text: tic Subsyndrome of Acute Radiation Syndrome). (1.2) Limitations of Use FYLNETRA is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation. 1.1 Patients with Cancer Receiving Myelosuppressive Chemotherapy FYLNETRA 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 [see Clinical Studies (14.1) ] . Limitations of Use FYLNETRA is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation. 1.2 Patients with Hematopoietic Subsyndrome of Acut
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exact text: 1.1 Patients with Cancer Receiving Myelosuppressive Chemotherapy FYLNETRA 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 [see Clinical Studies (14.1) ] .
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source url

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limitations: Source null
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prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

supportive_care_candidate

Passage 5 · limitation of use

application numbers

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brand names

FYLNETRA

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context span

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exact text: enia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia [see Clinical Studies (14.1) ] . Limitations of Use FYLNETRA is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation. 1.2 Patients with Hematopoietic Subsyndrome of Acute Radiation Syndrome FYLNETRA is indicated to increase survival in patients acutely exposed to myelosuppressive doses of radiation [see Dosage and A
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exact text: Limitations of Use FYLNETRA is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.
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source url

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limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

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Passage 6 · positive indication candidate

application numbers

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brand names

FYLNETRA

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context span

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exact text: ebrile neutropenia [see Clinical Studies (14.1) ] . Limitations of Use FYLNETRA is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation. 1.2 Patients with Hematopoietic Subsyndrome of Acute Radiation Syndrome FYLNETRA is indicated to increase survival in patients acutely exposed to myelosuppressive doses of radiation [see Dosage and Administration (2.2) and Clinical Studies (14.2) ] .
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source defined aliases

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exact text: 1.2 Patients with Hematopoietic Subsyndrome of Acute Radiation Syndrome FYLNETRA is indicated to increase survival in patients acutely exposed to myelosuppressive doses of radiation [see Dosage and Administration (2.2) and Clinical Studies (14.2) ] .
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source url

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structured indication

age: Source null
approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

supportive_care_candidate

Preserved source evidence · Not medical advice