LABELS · 90fa8a88-1bd6-49cf-a482-ccbc0d315b3d

STIMUFEND

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: 2023-10-24
Captured: 2026-09-09T23:37:54.830918+00:00
Current indication reconciliation: Not reconciled

Indications and usage: exact source text

1 INDICATIONS AND USAGE Stimufend 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 Stimufend is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation. 1.1 Patients with Cancer Receiving Myelosuppressive Chemotherapy Stimufend 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 Stimufend 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 Stimufend 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

BLA761173

boxed warning exact

brand names

STIMUFEND

current indication status

not_reconciled

dailymed set url

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b44bcb82-7e60-4dab-a658-115bdf5c053c

generic names

PEGFLILGRASTIM-FPGK

90fa8a88-1bd6-49cf-a482-ccbc0d315b3d

indications and usage exact

1 INDICATIONS AND USAGE Stimufend 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 Stimufend is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation. 1.1 Patients with Cancer Receiving Myelosuppressive Chemotherapy Stimufend 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 Stimufend 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 Stimufend 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

Fresenius Kabi USA, LLC

matched search terms

cancer

package ndcs

65219-371-10

product ndcs

65219-371

product types

HUMAN PRESCRIPTION DRUG

recent major changes exact

Indications and Usage, Patients with Hematopoietic Subsyndrome of Acute Radiation Syndrome ( 1.2 ) 9/2023 Dosage and Administration, Patients with Hematopoietic Subsyndrome of Acute radiation Syndrome ( 2.2 ) 9/2023

record type

complete_spl_indications_section_candidate

routes

SUBCUTANEOUS

rxcuis

2613763
2613769

source batch

file

/private/tmp/cancer-full-research/indications/raw/labels-00500.json

meta

disclaimer

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.

last updated

2026-09-09

license

https://open.fda.gov/license/

results

limit: 100
skip: 500
total: 830

terms

https://open.fda.gov/terms/

sha256

424ccf5bc67db0a96ee2c35ed913dd5894642716182773d81ca19cdfb9ba32f3

url

source url

https://api.fda.gov/drug/label.json?search=id%3A%2290fa8a88-1bd6-49cf-a482-ccbc0d315b3d%22

spl effective date

2023-10-24

spl effective time

20231024

spl set id

b44bcb82-7e60-4dab-a658-115bdf5c053c

spl version

substance names

PEGFILGRASTIM

uniis

3A58010674

verification flags

oncology_keyword_candidate_not_clinically_classified
spl_text_not_verified_identical_to_latest_approved_label
individual_indications_not_split_or_reconciled
fda_label_posted_after_spl_effective_date_requires_version_review

Drugs@FDA application source records

application number
BLA761173
payload
all indexed label documents
Appl No
761173
Application Docs Date
2022-09-02 00:00:00
Application Docs ID
72007
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761173Orig1s000correctedlbl.pdf
Submission No
1
Submission Type
ORIG
Appl No
761173
Application Docs Date
2023-10-02 00:00:00
Application Docs ID
75635
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761173s002lbl.pdf
Submission No
2
Submission Type
SUPPL
Appl No
761173
Application Docs Date
2025-03-27 00:00:00
Application Docs ID
81755
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761173s008lbl.pdf
Submission No
8
Submission Type
SUPPL
Appl No
761173
Application Docs Date
2025-10-23 00:00:00
Application Docs ID
83875
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761173Orig1s013lbl.pdf
Submission No
13
Submission Type
SUPPL
all submission records
Appl No
761173
Review Priority
STANDARD
Submission Class Code ID
19
Submission No
1
Submission Status
AP
Submission Status Date
2022-09-01 00:00:00
Submission Type
ORIG
Submissions Public Notes
Appl No
761173
Review Priority
STANDARD
Submission Class Code ID
28
Submission No
2
Submission Status
AP
Submission Status Date
2023-09-29 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
761173
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
8
Submission Status
AP
Submission Status Date
2025-03-26 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
761173
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
13
Submission Status
AP
Submission Status Date
2025-10-21 00:00:00
Submission Type
SUPPL
Submissions Public Notes
application number
BLA761173
approval interpretation
Application linkage and approved submission are not indication-level current approval verification
current indication status
not_reconciled
drugsfda url
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761173
has approved submission record
true
latest approved submission date
2025-10-21
latest label selection rule
max FDA ApplicationDocsDate, including all ties; posting date is not approval date and latest indexed document may be incomplete
latest posted label documents
Appl No
761173
Application Docs Date
2025-10-23 00:00:00
Application Docs ID
83875
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761173Orig1s013lbl.pdf
Submission No
13
Submission Type
SUPPL
official application record
Appl No
761173
Appl Public Notes
Appl Type
BLA
Sponsor Name
FRESENIUS KABI USA
openfda application present
true
products
Active Ingredient
PEGFILGRASTIM-FPGK
Appl No
761173
Drug Name
STIMUFEND
Form
SOLUTION; INJECTION
Product No
001
Reference Drug
0
Reference Standard
0
Strength
6MG/0.6ML
marketing status
Prescription

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

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brand names

STIMUFEND

classification reasons

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supportive_or_complication_use_words

clinical review status

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exact text: 1 INDICATIONS AND USAGE Stimufend 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 Stimufend is not indic
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positive predicate support span

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exact text: 1 INDICATIONS AND USAGE Stimufend 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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start: 0

source url

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spl effective date

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spl set id

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spl version

structured fields status

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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

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STIMUFEND

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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 Stimufend is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation. 1.1 Patients with Cancer Receiving Myelosu
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start: 113

current approval status

not_reconciled

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extraction review status

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generic names

PEGFLILGRASTIM-FPGK

ind-span-e6fb2fa5c9ebd63f22d9

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90fa8a88-1bd6-49cf-a482-ccbc0d315b3d

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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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start: 313

source url

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spl effective date

2023-10-24

spl set id

b44bcb82-7e60-4dab-a658-115bdf5c053c

spl version

structured fields status

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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

BLA761173

brand names

STIMUFEND

classification reasons

negative_or_not_established_clause

clinical review status

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content role

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context span

end: 819
end exclusive: true
exact text: lly 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 Stimufend is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation. 1.1 Patients with Cancer Receiving Myelosuppressive Chemotherapy Stimufend is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid mali
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current approval status

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generic names

PEGFLILGRASTIM-FPGK

ind-span-35e1549026b2fa174f9d

label id

90fa8a88-1bd6-49cf-a482-ccbc0d315b3d

positive predicate support span

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exact text: ( 1.2 ) Limitations of Use Stimufend is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.
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start: 463

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

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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

BLA761173

brand names

STIMUFEND

classification reasons

explicit_positive_indication_predicate
supportive_or_complication_use_words

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context span

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exact text: Subsyndrome of Acute Radiation Syndrome). ( 1.2 ) Limitations of Use Stimufend is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation. 1.1 Patients with Cancer Receiving Myelosuppressive Chemotherapy Stimufend 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 Stimufend is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation. 1.2 Patients with Hematopoietic Subsyndrome of Acu
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exact text: 1.1 Patients with Cancer Receiving Myelosuppressive Chemotherapy Stimufend 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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spl effective date

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prior therapy: Source null
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tumor histology: Source null

use intent

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Passage 5 · limitation of use

application numbers

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brand names

STIMUFEND

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exact text: nia, 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 Stimufend 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 Stimufend is indicated to increase survival in patients acutely exposed to myelosuppressive doses of radiation [see Dosage and
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tumor histology: Source null

use intent

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Passage 6 · positive indication candidate

application numbers

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brand names

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exact text: rile neutropenia [see Clinical Studies ( 14.1 )] . Limitations of Use Stimufend 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 Stimufend 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

source span

end: 1383
end exclusive: true
exact text: 1.2 Patients with Hematopoietic Subsyndrome of Acute Radiation Syndrome Stimufend 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 )].
label id: 90fa8a88-1bd6-49cf-a482-ccbc0d315b3d
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: fe2b7f0f647d55cc8d767053e31b7cfc54fa39c9c79e63d40aaa679ba0ea0aa4
start: 1130

source url

https://api.fda.gov/drug/label.json?search=id%3A%2290fa8a88-1bd6-49cf-a482-ccbc0d315b3d%22

spl effective date

2023-10-24

spl set id

b44bcb82-7e60-4dab-a658-115bdf5c053c

spl version

structured fields status

not_extracted_no_values_inferred_from_mentions

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