LABELS · 4ad3993c-6c7f-4a33-8ead-a912636ff4a1

Leukine

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: 2024-12-06
Captured: 2026-09-09T23:37:44.904352+00:00
Current indication reconciliation: Not reconciled

Indications and usage: exact source text

1 INDICATIONS AND USAGE LEUKINE is a leukocyte growth factor indicated: To shorten time to neutrophil recovery and to reduce the incidence of severe and life-threatening infections and infections resulting in death following induction chemotherapy in adult patients 55 years and older with acute myeloid leukemia (AML). ( 1.1 ) For the mobilization of hematopoietic progenitor cells into peripheral blood for collection by leukapheresis and autologous transplantation in adult patients. ( 1.2 ) For the acceleration of myeloid reconstitution following autologous bone marrow or peripheral blood progenitor cell transplantation in adult and pediatric patients 2 years of age and older. ( 1.3 ) For the acceleration of myeloid reconstitution following allogeneic bone marrow transplantation in adult and pediatric patients 2 years of age and older. ( 1.4 ) For treatment of delayed neutrophil recovery or graft failure after autologous or allogeneic bone marrow transplantation in adult and pediatric patients 2 years of age and older. ( 1.5 ) To increase survival in adult and pediatric patients from birth to 17 years of age acutely exposed to myelosuppressive doses of radiation (Hematopoietic Syndrome of Acute Radiation Syndrome [H-ARS]). ( 1.6 ) 1.1 Acute Myeloid Leukemia Following Induction Chemotherapy LEUKINE is indicated to shorten time to neutrophil recovery and to reduce the incidence of severe, life-threatening, or fatal infections following induction chemotherapy in adult patients 55 years and older with acute myeloid leukemia (AML). 1.2 Autologous Peripheral Blood Progenitor Cell Mobilization and Collection LEUKINE is indicated in adult patients with cancer undergoing autologous hematopoietic stem cell transplantation for the mobilization of hematopoietic progenitor cells into peripheral blood for collection by leukapheresis. 1.3 Autologous Peripheral Blood Progenitor Cell and Bone Marrow Transplantation LEUKINE is indicated for the acceleration of myeloid reconstitution following autologous peripheral blood progenitor cell (PBPC) or bone marrow transplantation in adult and pediatric patients 2 years of age and older with non-Hodgkin's lymphoma (NHL), acute lymphoblastic leukemia (ALL) and Hodgkin's lymphoma (HL). 1.4 Allogeneic Bone Marrow Transplantation LEUKINE is indicated for the acceleration of myeloid reconstitution in adult and pediatric patients 2 years of age and older undergoing allogeneic bone marrow transplantation from HLA-matched related donors. 1.5 Allogeneic or Autologous Bone Marrow Transplantation: Treatment of Delayed Neutrophil Recovery or Graft Failure LEUKINE is indicated for the treatment of adult and pediatric patients 2 years and older who have undergone allogeneic or autologous bone marrow transplantation in whom neutrophil recovery is delayed or failed. 1.6 Acute Exposure to Myelosuppressive Doses of Radiation (H-ARS) LEUKINE is indicated to increase survival in adult and pediatric patients from birth to 17 years of age acutely exposed to myelosuppressive doses of radiation (Hematopoietic Syndrome of Acute Radiation Syndrome [H-ARS]).

Full extracted label fields

application numbers

BLA103362

boxed warning exact

brand names

Leukine

current indication status

not_reconciled

dailymed set url

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=bb9a3820-f31a-4dd9-bef4-97094c01a398

generic names

SARGRAMOSTIM

4ad3993c-6c7f-4a33-8ead-a912636ff4a1

indications and usage exact

1 INDICATIONS AND USAGE LEUKINE is a leukocyte growth factor indicated: To shorten time to neutrophil recovery and to reduce the incidence of severe and life-threatening infections and infections resulting in death following induction chemotherapy in adult patients 55 years and older with acute myeloid leukemia (AML). ( 1.1 ) For the mobilization of hematopoietic progenitor cells into peripheral blood for collection by leukapheresis and autologous transplantation in adult patients. ( 1.2 ) For the acceleration of myeloid reconstitution following autologous bone marrow or peripheral blood progenitor cell transplantation in adult and pediatric patients 2 years of age and older. ( 1.3 ) For the acceleration of myeloid reconstitution following allogeneic bone marrow transplantation in adult and pediatric patients 2 years of age and older. ( 1.4 ) For treatment of delayed neutrophil recovery or graft failure after autologous or allogeneic bone marrow transplantation in adult and pediatric patients 2 years of age and older. ( 1.5 ) To increase survival in adult and pediatric patients from birth to 17 years of age acutely exposed to myelosuppressive doses of radiation (Hematopoietic Syndrome of Acute Radiation Syndrome [H-ARS]). ( 1.6 ) 1.1 Acute Myeloid Leukemia Following Induction Chemotherapy LEUKINE is indicated to shorten time to neutrophil recovery and to reduce the incidence of severe, life-threatening, or fatal infections following induction chemotherapy in adult patients 55 years and older with acute myeloid leukemia (AML). 1.2 Autologous Peripheral Blood Progenitor Cell Mobilization and Collection LEUKINE is indicated in adult patients with cancer undergoing autologous hematopoietic stem cell transplantation for the mobilization of hematopoietic progenitor cells into peripheral blood for collection by leukapheresis. 1.3 Autologous Peripheral Blood Progenitor Cell and Bone Marrow Transplantation LEUKINE is indicated for the acceleration of myeloid reconstitution following autologous peripheral blood progenitor cell (PBPC) or bone marrow transplantation in adult and pediatric patients 2 years of age and older with non-Hodgkin's lymphoma (NHL), acute lymphoblastic leukemia (ALL) and Hodgkin's lymphoma (HL). 1.4 Allogeneic Bone Marrow Transplantation LEUKINE is indicated for the acceleration of myeloid reconstitution in adult and pediatric patients 2 years of age and older undergoing allogeneic bone marrow transplantation from HLA-matched related donors. 1.5 Allogeneic or Autologous Bone Marrow Transplantation: Treatment of Delayed Neutrophil Recovery or Graft Failure LEUKINE is indicated for the treatment of adult and pediatric patients 2 years and older who have undergone allogeneic or autologous bone marrow transplantation in whom neutrophil recovery is delayed or failed. 1.6 Acute Exposure to Myelosuppressive Doses of Radiation (H-ARS) LEUKINE is indicated to increase survival in adult and pediatric patients from birth to 17 years of age acutely exposed to myelosuppressive doses of radiation (Hematopoietic Syndrome of Acute Radiation Syndrome [H-ARS]).

indications and usage tables exact

is original packager

true

manufacturer names

Partner Therapeutics, Inc.

matched search terms

cancer
lymphoma
leukemia

package ndcs

71837-5843-1
71837-5843-5

product ndcs

71837-5843

product types

HUMAN PRESCRIPTION DRUG

recent major changes exact

record type

complete_spl_indications_section_candidate

routes

INTRAVENOUS
SUBCUTANEOUS

rxcuis

208083
315199

source batch

file

/private/tmp/cancer-full-research/indications/raw/labels-00200.json

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

BLA103362

brand names

Leukine

classification reasons

explicit_positive_indication_predicate
supportive_or_complication_use_words

clinical review status

pending

content role

positive_indication_candidate

context span

end: 519
end exclusive: true
exact text: 1 INDICATIONS AND USAGE LEUKINE is a leukocyte growth factor indicated: To shorten time to neutrophil recovery and to reduce the incidence of severe and life-threatening infections and infections resulting in death following induction chemotherapy in adult patients 55 years and older with acute myeloid leukemia (AML). ( 1.1 ) For the mobilization of hematopoietic progenitor cells into peripheral blood for collection by leukapheresis and autologous transplantation in adult patients. ( 1.2 ) For the acceleration of
label id: 4ad3993c-6c7f-4a33-8ead-a912636ff4a1
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 51c63480b2c107abc721beaeedb753b07a960e2c49fa55fc745db6df3661971a
start: 0

current approval status

not_reconciled

duplicate text group

dup-771f44256ac63874edb7

extraction review status

automated_candidate_pending_source_review

generic names

SARGRAMOSTIM

ind-span-7525e1778813414a9dc4

label id

4ad3993c-6c7f-4a33-8ead-a912636ff4a1

positive predicate support span

end: 70
end exclusive: true
exact text: is a leukocyte growth factor indicated
label id: 4ad3993c-6c7f-4a33-8ead-a912636ff4a1
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 51c63480b2c107abc721beaeedb753b07a960e2c49fa55fc745db6df3661971a
start: 32

qualifier mentions

context exact
ions resulting in death following induction chemotherapy in adult patients 55 years and older with acute myeloid leukemia (AML).
kind
age
polarity
not_inferred
span
end
265
end exclusive
true
exact text
adult patients
label id
4ad3993c-6c7f-4a33-8ead-a912636ff4a1
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
51c63480b2c107abc721beaeedb753b07a960e2c49fa55fc745db6df3661971a
start
251
context exact
in death following induction chemotherapy in adult patients 55 years and older with acute myeloid leukemia (AML).
kind
age
polarity
not_inferred
span
end
284
end exclusive
true
exact text
55 years and older
label id
4ad3993c-6c7f-4a33-8ead-a912636ff4a1
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
51c63480b2c107abc721beaeedb753b07a960e2c49fa55fc745db6df3661971a
start
266

regulatory links

schema version

0.1.0

source batch sha256

d918de6bede8f776ad4fea2bc639292f8454d9733fbbdfdd7fd4414b6200e571

source defined aliases

source span

end: 319
end exclusive: true
exact text: 1 INDICATIONS AND USAGE LEUKINE is a leukocyte growth factor indicated: To shorten time to neutrophil recovery and to reduce the incidence of severe and life-threatening infections and infections resulting in death following induction chemotherapy in adult patients 55 years and older with acute myeloid leukemia (AML).
label id: 4ad3993c-6c7f-4a33-8ead-a912636ff4a1
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 51c63480b2c107abc721beaeedb753b07a960e2c49fa55fc745db6df3661971a
start: 0

source url

https://api.fda.gov/drug/label.json?search=id%3A%224ad3993c-6c7f-4a33-8ead-a912636ff4a1%22

spl effective date

2024-12-06

spl set id

bb9a3820-f31a-4dd9-bef4-97094c01a398

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

Passage 2 · unclassified context

application numbers

BLA103362

brand names

Leukine

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

unclassified_context

context span

end: 527
end exclusive: true
exact text: duce the incidence of severe and life-threatening infections and infections resulting in death following induction chemotherapy in adult patients 55 years and older with acute myeloid leukemia (AML). ( 1.1 ) For the mobilization of hematopoietic progenitor cells into peripheral blood for collection by leukapheresis and autologous transplantation in adult patients. ( 1.2 ) For the acceleration of myeloid
label id: 4ad3993c-6c7f-4a33-8ead-a912636ff4a1
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 51c63480b2c107abc721beaeedb753b07a960e2c49fa55fc745db6df3661971a
start: 120

current approval status

not_reconciled

duplicate text group

dup-01800b95cc581c9859d6

extraction review status

automated_candidate_pending_source_review

generic names

SARGRAMOSTIM

ind-span-6f84627784ecd545b8c6

label id

4ad3993c-6c7f-4a33-8ead-a912636ff4a1

positive predicate support span

Source null

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

d918de6bede8f776ad4fea2bc639292f8454d9733fbbdfdd7fd4414b6200e571

source defined aliases

source span

end: 327
end exclusive: true
exact text: ( 1.1 )
label id: 4ad3993c-6c7f-4a33-8ead-a912636ff4a1
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 51c63480b2c107abc721beaeedb753b07a960e2c49fa55fc745db6df3661971a
start: 320

source url

https://api.fda.gov/drug/label.json?search=id%3A%224ad3993c-6c7f-4a33-8ead-a912636ff4a1%22

spl effective date

2024-12-06

spl set id

bb9a3820-f31a-4dd9-bef4-97094c01a398

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

unclear

Passage 3 · positive indication candidate

application numbers

BLA103362

brand names

Leukine

classification reasons

inherited_predicate_from_same_label_section_requires_review
no_tumor_directed_keyword_in_positive_statement

clinical review status

pending

content role

positive_indication_candidate

context span

end: 686
end exclusive: true
exact text: incidence of severe and life-threatening infections and infections resulting in death following induction chemotherapy in adult patients 55 years and older with acute myeloid leukemia (AML). ( 1.1 ) For the mobilization of hematopoietic progenitor cells into peripheral blood for collection by leukapheresis and autologous transplantation in adult patients. ( 1.2 ) For the acceleration of myeloid reconstitution following autologous bone marrow or peripheral blood progenitor cell transplantation in adult and pediatric patients 2 years of age and older. (
label id: 4ad3993c-6c7f-4a33-8ead-a912636ff4a1
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 51c63480b2c107abc721beaeedb753b07a960e2c49fa55fc745db6df3661971a
start: 128

current approval status

not_reconciled

duplicate text group

dup-2515059553f3ab7aac00

extraction review status

automated_candidate_pending_source_review

generic names

SARGRAMOSTIM

ind-span-27541c14da38d84e7429

label id

4ad3993c-6c7f-4a33-8ead-a912636ff4a1

positive predicate support span

end: 70
end exclusive: true
exact text: is a leukocyte growth factor indicated
label id: 4ad3993c-6c7f-4a33-8ead-a912636ff4a1
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 51c63480b2c107abc721beaeedb753b07a960e2c49fa55fc745db6df3661971a
start: 32

qualifier mentions

context exact
llection by leukapheresis and autologous transplantation in adult patients.
kind
age
polarity
not_inferred
span
end
485
end exclusive
true
exact text
adult patients
label id
4ad3993c-6c7f-4a33-8ead-a912636ff4a1
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
51c63480b2c107abc721beaeedb753b07a960e2c49fa55fc745db6df3661971a
start
471

regulatory links

schema version

0.1.0

source batch sha256

d918de6bede8f776ad4fea2bc639292f8454d9733fbbdfdd7fd4414b6200e571

source defined aliases

source span

end: 486
end exclusive: true
exact text: For the mobilization of hematopoietic progenitor cells into peripheral blood for collection by leukapheresis and autologous transplantation in adult patients.
label id: 4ad3993c-6c7f-4a33-8ead-a912636ff4a1
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 51c63480b2c107abc721beaeedb753b07a960e2c49fa55fc745db6df3661971a
start: 328

source url

https://api.fda.gov/drug/label.json?search=id%3A%224ad3993c-6c7f-4a33-8ead-a912636ff4a1%22

spl effective date

2024-12-06

spl set id

bb9a3820-f31a-4dd9-bef4-97094c01a398

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

non_oncology_or_unclear_candidate

Passage 4 · unclassified context

application numbers

BLA103362

brand names

Leukine

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

unclassified_context

context span

end: 694
end exclusive: true
exact text: th acute myeloid leukemia (AML). ( 1.1 ) For the mobilization of hematopoietic progenitor cells into peripheral blood for collection by leukapheresis and autologous transplantation in adult patients. ( 1.2 ) For the acceleration of myeloid reconstitution following autologous bone marrow or peripheral blood progenitor cell transplantation in adult and pediatric patients 2 years of age and older. ( 1.3 ) F
label id: 4ad3993c-6c7f-4a33-8ead-a912636ff4a1
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 51c63480b2c107abc721beaeedb753b07a960e2c49fa55fc745db6df3661971a
start: 287

current approval status

not_reconciled

duplicate text group

dup-621b35f4bdd5dca49581

extraction review status

automated_candidate_pending_source_review

generic names

SARGRAMOSTIM

ind-span-e240fba333758456d632

label id

4ad3993c-6c7f-4a33-8ead-a912636ff4a1

positive predicate support span

Source null

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

d918de6bede8f776ad4fea2bc639292f8454d9733fbbdfdd7fd4414b6200e571

source defined aliases

source span

end: 494
end exclusive: true
exact text: ( 1.2 )
label id: 4ad3993c-6c7f-4a33-8ead-a912636ff4a1
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 51c63480b2c107abc721beaeedb753b07a960e2c49fa55fc745db6df3661971a
start: 487

source url

https://api.fda.gov/drug/label.json?search=id%3A%224ad3993c-6c7f-4a33-8ead-a912636ff4a1%22

spl effective date

2024-12-06

spl set id

bb9a3820-f31a-4dd9-bef4-97094c01a398

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

unclear

Passage 5 · positive indication candidate

application numbers

BLA103362

brand names

Leukine

classification reasons

inherited_predicate_from_same_label_section_requires_review
no_tumor_directed_keyword_in_positive_statement

clinical review status

pending

content role

positive_indication_candidate

context span

end: 884
end exclusive: true
exact text: myeloid leukemia (AML). ( 1.1 ) For the mobilization of hematopoietic progenitor cells into peripheral blood for collection by leukapheresis and autologous transplantation in adult patients. ( 1.2 ) For the acceleration of myeloid reconstitution following autologous bone marrow or peripheral blood progenitor cell transplantation in adult and pediatric patients 2 years of age and older. ( 1.3 ) For the acceleration of myeloid reconstitution following allogeneic bone marrow transplantation in adult and pediatric patients 2 years of age and older. ( 1.4 ) For treatment of delayed neut
label id: 4ad3993c-6c7f-4a33-8ead-a912636ff4a1
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 51c63480b2c107abc721beaeedb753b07a960e2c49fa55fc745db6df3661971a
start: 295

current approval status

not_reconciled

duplicate text group

dup-0c046c331bcb2cad7726

extraction review status

automated_candidate_pending_source_review

generic names

SARGRAMOSTIM

ind-span-429b30a33494196ab7d9

label id

4ad3993c-6c7f-4a33-8ead-a912636ff4a1

positive predicate support span

end: 70
end exclusive: true
exact text: is a leukocyte growth factor indicated
label id: 4ad3993c-6c7f-4a33-8ead-a912636ff4a1
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 51c63480b2c107abc721beaeedb753b07a960e2c49fa55fc745db6df3661971a
start: 32

qualifier mentions

context exact
rrow or peripheral blood progenitor cell transplantation in adult and pediatric patients 2 years of age and older.
kind
age
polarity
not_inferred
span
end
635
end exclusive
true
exact text
adult
label id
4ad3993c-6c7f-4a33-8ead-a912636ff4a1
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
51c63480b2c107abc721beaeedb753b07a960e2c49fa55fc745db6df3661971a
start
630
context exact
ripheral blood progenitor cell transplantation in adult and pediatric patients 2 years of age and older.
kind
age
polarity
not_inferred
span
end
658
end exclusive
true
exact text
pediatric patients
label id
4ad3993c-6c7f-4a33-8ead-a912636ff4a1
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
51c63480b2c107abc721beaeedb753b07a960e2c49fa55fc745db6df3661971a
start
640
context exact
enitor cell transplantation in adult and pediatric patients 2 years of age and older.
kind
age
polarity
not_inferred
span
end
673
end exclusive
true
exact text
2 years of age
label id
4ad3993c-6c7f-4a33-8ead-a912636ff4a1
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
51c63480b2c107abc721beaeedb753b07a960e2c49fa55fc745db6df3661971a
start
659

regulatory links

schema version

0.1.0

source batch sha256

d918de6bede8f776ad4fea2bc639292f8454d9733fbbdfdd7fd4414b6200e571

source defined aliases

source span

end: 684
end exclusive: true
exact text: For the acceleration of myeloid reconstitution following autologous bone marrow or peripheral blood progenitor cell transplantation in adult and pediatric patients 2 years of age and older.
label id: 4ad3993c-6c7f-4a33-8ead-a912636ff4a1
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 51c63480b2c107abc721beaeedb753b07a960e2c49fa55fc745db6df3661971a
start: 495

source url

https://api.fda.gov/drug/label.json?search=id%3A%224ad3993c-6c7f-4a33-8ead-a912636ff4a1%22

spl effective date

2024-12-06

spl set id

bb9a3820-f31a-4dd9-bef4-97094c01a398

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

non_oncology_or_unclear_candidate

Passage 6 · unclassified context

application numbers

BLA103362

brand names

Leukine

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

unclassified_context

context span

end: 892
end exclusive: true
exact text: . ( 1.2 ) For the acceleration of myeloid reconstitution following autologous bone marrow or peripheral blood progenitor cell transplantation in adult and pediatric patients 2 years of age and older. ( 1.3 ) For the acceleration of myeloid reconstitution following allogeneic bone marrow transplantation in adult and pediatric patients 2 years of age and older. ( 1.4 ) For treatment of delayed neutrophil r
label id: 4ad3993c-6c7f-4a33-8ead-a912636ff4a1
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 51c63480b2c107abc721beaeedb753b07a960e2c49fa55fc745db6df3661971a
start: 485

current approval status

not_reconciled

duplicate text group

dup-ef892c113104cca2ddb6

extraction review status

automated_candidate_pending_source_review

generic names

SARGRAMOSTIM

ind-span-ae57f1d717aa624991e9

label id

4ad3993c-6c7f-4a33-8ead-a912636ff4a1

positive predicate support span

Source null

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

d918de6bede8f776ad4fea2bc639292f8454d9733fbbdfdd7fd4414b6200e571

source defined aliases

source span

end: 692
end exclusive: true
exact text: ( 1.3 )
label id: 4ad3993c-6c7f-4a33-8ead-a912636ff4a1
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 51c63480b2c107abc721beaeedb753b07a960e2c49fa55fc745db6df3661971a
start: 685

source url

https://api.fda.gov/drug/label.json?search=id%3A%224ad3993c-6c7f-4a33-8ead-a912636ff4a1%22

spl effective date

2024-12-06

spl set id

bb9a3820-f31a-4dd9-bef4-97094c01a398

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

unclear

Passage 7 · positive indication candidate

application numbers

BLA103362

brand names

Leukine

classification reasons

inherited_predicate_from_same_label_section_requires_review
no_tumor_directed_keyword_in_positive_statement

clinical review status

pending

content role

positive_indication_candidate

context span

end: 1046
end exclusive: true
exact text: ) For the acceleration of myeloid reconstitution following autologous bone marrow or peripheral blood progenitor cell transplantation in adult and pediatric patients 2 years of age and older. ( 1.3 ) For the acceleration of myeloid reconstitution following allogeneic bone marrow transplantation in adult and pediatric patients 2 years of age and older. ( 1.4 ) For treatment of delayed neutrophil recovery or graft failure after autologous or allogeneic bone marrow transplantation in adult and pediatric patients 2 years of age and older. ( 1.5 ) To i
label id: 4ad3993c-6c7f-4a33-8ead-a912636ff4a1
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 51c63480b2c107abc721beaeedb753b07a960e2c49fa55fc745db6df3661971a
start: 493

current approval status

not_reconciled

duplicate text group

dup-d54f4f2fc651229754da

extraction review status

automated_candidate_pending_source_review

generic names

SARGRAMOSTIM

ind-span-97ef80472feefc974713

label id

4ad3993c-6c7f-4a33-8ead-a912636ff4a1

positive predicate support span

end: 70
end exclusive: true
exact text: is a leukocyte growth factor indicated
label id: 4ad3993c-6c7f-4a33-8ead-a912636ff4a1
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 51c63480b2c107abc721beaeedb753b07a960e2c49fa55fc745db6df3661971a
start: 32

qualifier mentions

context exact
itution following allogeneic bone marrow transplantation in adult and pediatric patients 2 years of age and older.
kind
age
polarity
not_inferred
span
end
797
end exclusive
true
exact text
adult
label id
4ad3993c-6c7f-4a33-8ead-a912636ff4a1
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
51c63480b2c107abc721beaeedb753b07a960e2c49fa55fc745db6df3661971a
start
792
context exact
llowing allogeneic bone marrow transplantation in adult and pediatric patients 2 years of age and older.
kind
age
polarity
not_inferred
span
end
820
end exclusive
true
exact text
pediatric patients
label id
4ad3993c-6c7f-4a33-8ead-a912636ff4a1
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
51c63480b2c107abc721beaeedb753b07a960e2c49fa55fc745db6df3661971a
start
802
context exact
bone marrow transplantation in adult and pediatric patients 2 years of age and older.
kind
age
polarity
not_inferred
span
end
835
end exclusive
true
exact text
2 years of age
label id
4ad3993c-6c7f-4a33-8ead-a912636ff4a1
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
51c63480b2c107abc721beaeedb753b07a960e2c49fa55fc745db6df3661971a
start
821

regulatory links

schema version

0.1.0

source batch sha256

d918de6bede8f776ad4fea2bc639292f8454d9733fbbdfdd7fd4414b6200e571

source defined aliases

source span

end: 846
end exclusive: true
exact text: For the acceleration of myeloid reconstitution following allogeneic bone marrow transplantation in adult and pediatric patients 2 years of age and older.
label id: 4ad3993c-6c7f-4a33-8ead-a912636ff4a1
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 51c63480b2c107abc721beaeedb753b07a960e2c49fa55fc745db6df3661971a
start: 693

source url

https://api.fda.gov/drug/label.json?search=id%3A%224ad3993c-6c7f-4a33-8ead-a912636ff4a1%22

spl effective date

2024-12-06

spl set id

bb9a3820-f31a-4dd9-bef4-97094c01a398

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

non_oncology_or_unclear_candidate

Passage 8 · unclassified context

application numbers

BLA103362

brand names

Leukine

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

unclassified_context

context span

end: 1054
end exclusive: true
exact text: ic patients 2 years of age and older. ( 1.3 ) For the acceleration of myeloid reconstitution following allogeneic bone marrow transplantation in adult and pediatric patients 2 years of age and older. ( 1.4 ) For treatment of delayed neutrophil recovery or graft failure after autologous or allogeneic bone marrow transplantation in adult and pediatric patients 2 years of age and older. ( 1.5 ) To increase
label id: 4ad3993c-6c7f-4a33-8ead-a912636ff4a1
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 51c63480b2c107abc721beaeedb753b07a960e2c49fa55fc745db6df3661971a
start: 647

current approval status

not_reconciled

duplicate text group

dup-8a9f4af92b20f5e11d80

extraction review status

automated_candidate_pending_source_review

generic names

SARGRAMOSTIM

ind-span-d0e0e65cc6eeb50c1d7f

label id

4ad3993c-6c7f-4a33-8ead-a912636ff4a1

positive predicate support span

Source null

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

d918de6bede8f776ad4fea2bc639292f8454d9733fbbdfdd7fd4414b6200e571

source defined aliases

source span

end: 854
end exclusive: true
exact text: ( 1.4 )
label id: 4ad3993c-6c7f-4a33-8ead-a912636ff4a1
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 51c63480b2c107abc721beaeedb753b07a960e2c49fa55fc745db6df3661971a
start: 847

source url

https://api.fda.gov/drug/label.json?search=id%3A%224ad3993c-6c7f-4a33-8ead-a912636ff4a1%22

spl effective date

2024-12-06

spl set id

bb9a3820-f31a-4dd9-bef4-97094c01a398

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

unclear

Passage 9 · unclassified context

application numbers

BLA103362

brand names

Leukine

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

unclassified_context

context span

end: 1233
end exclusive: true
exact text: nts 2 years of age and older. ( 1.3 ) For the acceleration of myeloid reconstitution following allogeneic bone marrow transplantation in adult and pediatric patients 2 years of age and older. ( 1.4 ) For treatment of delayed neutrophil recovery or graft failure after autologous or allogeneic bone marrow transplantation in adult and pediatric patients 2 years of age and older. ( 1.5 ) To increase survival in adult and pediatric patients from birth to 17 years of age acutely exposed to myelosuppressive doses of radiation (Hematopoietic Syndrome of Acute Radiation Syndrome [
label id: 4ad3993c-6c7f-4a33-8ead-a912636ff4a1
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 51c63480b2c107abc721beaeedb753b07a960e2c49fa55fc745db6df3661971a
start: 655

current approval status

not_reconciled

duplicate text group

dup-15d98653189e69c9f670

extraction review status

automated_candidate_pending_source_review

generic names

SARGRAMOSTIM

ind-span-11b4e3fcc7bd2d9b1992

label id

4ad3993c-6c7f-4a33-8ead-a912636ff4a1

positive predicate support span

Source null

qualifier mentions

context exact
ter autologous or allogeneic bone marrow transplantation in adult and pediatric patients 2 years of age and older.
kind
age
polarity
not_inferred
span
end
984
end exclusive
true
exact text
adult
label id
4ad3993c-6c7f-4a33-8ead-a912636ff4a1
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
51c63480b2c107abc721beaeedb753b07a960e2c49fa55fc745db6df3661971a
start
979
context exact
gous or allogeneic bone marrow transplantation in adult and pediatric patients 2 years of age and older.
kind
age
polarity
not_inferred
span
end
1007
end exclusive
true
exact text
pediatric patients
label id
4ad3993c-6c7f-4a33-8ead-a912636ff4a1
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
51c63480b2c107abc721beaeedb753b07a960e2c49fa55fc745db6df3661971a
start
989
context exact
bone marrow transplantation in adult and pediatric patients 2 years of age and older.
kind
age
polarity
not_inferred
span
end
1022
end exclusive
true
exact text
2 years of age
label id
4ad3993c-6c7f-4a33-8ead-a912636ff4a1
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
51c63480b2c107abc721beaeedb753b07a960e2c49fa55fc745db6df3661971a
start
1008

regulatory links

schema version

0.1.0

source batch sha256

d918de6bede8f776ad4fea2bc639292f8454d9733fbbdfdd7fd4414b6200e571

source defined aliases

source span

end: 1033
end exclusive: true
exact text: For treatment of delayed neutrophil recovery or graft failure after autologous or allogeneic bone marrow transplantation in adult and pediatric patients 2 years of age and older.
label id: 4ad3993c-6c7f-4a33-8ead-a912636ff4a1
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 51c63480b2c107abc721beaeedb753b07a960e2c49fa55fc745db6df3661971a
start: 855

source url

https://api.fda.gov/drug/label.json?search=id%3A%224ad3993c-6c7f-4a33-8ead-a912636ff4a1%22

spl effective date

2024-12-06

spl set id

bb9a3820-f31a-4dd9-bef4-97094c01a398

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

unclear

Passage 10 · unclassified context

application numbers

BLA103362

brand names

Leukine

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

unclassified_context

context span

end: 1241
end exclusive: true
exact text: e and older. ( 1.4 ) For treatment of delayed neutrophil recovery or graft failure after autologous or allogeneic bone marrow transplantation in adult and pediatric patients 2 years of age and older. ( 1.5 ) To increase survival in adult and pediatric patients from birth to 17 years of age acutely exposed to myelosuppressive doses of radiation (Hematopoietic Syndrome of Acute Radiation Syndrome [H-ARS]).
label id: 4ad3993c-6c7f-4a33-8ead-a912636ff4a1
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 51c63480b2c107abc721beaeedb753b07a960e2c49fa55fc745db6df3661971a
start: 834

current approval status

not_reconciled

duplicate text group

dup-7e7eb54d4af01ca39cc4

extraction review status

automated_candidate_pending_source_review

generic names

SARGRAMOSTIM

ind-span-95b477f6c66294bfebde

label id

4ad3993c-6c7f-4a33-8ead-a912636ff4a1

positive predicate support span

Source null

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

d918de6bede8f776ad4fea2bc639292f8454d9733fbbdfdd7fd4414b6200e571

source defined aliases

source span

end: 1041
end exclusive: true
exact text: ( 1.5 )
label id: 4ad3993c-6c7f-4a33-8ead-a912636ff4a1
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 51c63480b2c107abc721beaeedb753b07a960e2c49fa55fc745db6df3661971a
start: 1034

source url

https://api.fda.gov/drug/label.json?search=id%3A%224ad3993c-6c7f-4a33-8ead-a912636ff4a1%22

spl effective date

2024-12-06

spl set id

bb9a3820-f31a-4dd9-bef4-97094c01a398

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

unclear

Passage 11 · unclassified context

application numbers

BLA103362

brand names

Leukine

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

unclassified_context

context span

end: 1441
end exclusive: true
exact text: der. ( 1.4 ) For treatment of delayed neutrophil recovery or graft failure after autologous or allogeneic bone marrow transplantation in adult and pediatric patients 2 years of age and older. ( 1.5 ) To increase survival in adult and pediatric patients from birth to 17 years of age acutely exposed to myelosuppressive doses of radiation (Hematopoietic Syndrome of Acute Radiation Syndrome [H-ARS]). ( 1.6 ) 1.1 Acute Myeloid Leukemia Following Induction Chemotherapy LEUKINE is indicated to shorten time to neutrophil recovery and to reduce the incidence of severe, life-threatening, or fatal infec
label id: 4ad3993c-6c7f-4a33-8ead-a912636ff4a1
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 51c63480b2c107abc721beaeedb753b07a960e2c49fa55fc745db6df3661971a
start: 842

current approval status

not_reconciled

duplicate text group

dup-579518c9b3ca917130a6

extraction review status

automated_candidate_pending_source_review

generic names

SARGRAMOSTIM

ind-span-6b6a43b907aa398c7daa

label id

4ad3993c-6c7f-4a33-8ead-a912636ff4a1

positive predicate support span

Source null

qualifier mentions

context exact
To increase survival in adult and pediatric patients from birth to 17 years of age acutel
kind
age
polarity
not_inferred
span
end
1071
end exclusive
true
exact text
adult
label id
4ad3993c-6c7f-4a33-8ead-a912636ff4a1
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
51c63480b2c107abc721beaeedb753b07a960e2c49fa55fc745db6df3661971a
start
1066
context exact
To increase survival in adult and pediatric patients from birth to 17 years of age acutely exposed to myelosuppr
kind
age
polarity
not_inferred
span
end
1094
end exclusive
true
exact text
pediatric patients
label id
4ad3993c-6c7f-4a33-8ead-a912636ff4a1
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
51c63480b2c107abc721beaeedb753b07a960e2c49fa55fc745db6df3661971a
start
1076
context exact
ease survival in adult and pediatric patients from birth to 17 years of age acutely exposed to myelosuppressive doses of radiation (Hem
kind
age
polarity
not_inferred
span
end
1124
end exclusive
true
exact text
17 years of age
label id
4ad3993c-6c7f-4a33-8ead-a912636ff4a1
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
51c63480b2c107abc721beaeedb753b07a960e2c49fa55fc745db6df3661971a
start
1109

regulatory links

schema version

0.1.0

source batch sha256

d918de6bede8f776ad4fea2bc639292f8454d9733fbbdfdd7fd4414b6200e571

source defined aliases

source span

end: 1241
end exclusive: true
exact text: To increase survival in adult and pediatric patients from birth to 17 years of age acutely exposed to myelosuppressive doses of radiation (Hematopoietic Syndrome of Acute Radiation Syndrome [H-ARS]).
label id: 4ad3993c-6c7f-4a33-8ead-a912636ff4a1
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 51c63480b2c107abc721beaeedb753b07a960e2c49fa55fc745db6df3661971a
start: 1042

source url

https://api.fda.gov/drug/label.json?search=id%3A%224ad3993c-6c7f-4a33-8ead-a912636ff4a1%22

spl effective date

2024-12-06

spl set id

bb9a3820-f31a-4dd9-bef4-97094c01a398

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

unclear

Passage 12 · unclassified context

application numbers

BLA103362

brand names

Leukine

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

unclassified_context

context span

end: 1449
end exclusive: true
exact text: To increase survival in adult and pediatric patients from birth to 17 years of age acutely exposed to myelosuppressive doses of radiation (Hematopoietic Syndrome of Acute Radiation Syndrome [H-ARS]). ( 1.6 ) 1.1 Acute Myeloid Leukemia Following Induction Chemotherapy LEUKINE is indicated to shorten time to neutrophil recovery and to reduce the incidence of severe, life-threatening, or fatal infections fo
label id: 4ad3993c-6c7f-4a33-8ead-a912636ff4a1
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 51c63480b2c107abc721beaeedb753b07a960e2c49fa55fc745db6df3661971a
start: 1042

current approval status

not_reconciled

duplicate text group

dup-7874920efabad974d3f9

extraction review status

automated_candidate_pending_source_review

generic names

SARGRAMOSTIM

ind-span-82521fbf169a4d911a33

label id

4ad3993c-6c7f-4a33-8ead-a912636ff4a1

positive predicate support span

Source null

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

d918de6bede8f776ad4fea2bc639292f8454d9733fbbdfdd7fd4414b6200e571

source defined aliases

source span

end: 1249
end exclusive: true
exact text: ( 1.6 )
label id: 4ad3993c-6c7f-4a33-8ead-a912636ff4a1
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 51c63480b2c107abc721beaeedb753b07a960e2c49fa55fc745db6df3661971a
start: 1242

source url

https://api.fda.gov/drug/label.json?search=id%3A%224ad3993c-6c7f-4a33-8ead-a912636ff4a1%22

spl effective date

2024-12-06

spl set id

bb9a3820-f31a-4dd9-bef4-97094c01a398

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

unclear

Passage 13 · positive indication candidate

application numbers

BLA103362

brand names

Leukine

classification reasons

explicit_positive_indication_predicate
supportive_or_complication_use_words

clinical review status

pending

content role

positive_indication_candidate

context span

end: 1751
end exclusive: true
exact text: ase survival in adult and pediatric patients from birth to 17 years of age acutely exposed to myelosuppressive doses of radiation (Hematopoietic Syndrome of Acute Radiation Syndrome [H-ARS]). ( 1.6 ) 1.1 Acute Myeloid Leukemia Following Induction Chemotherapy LEUKINE is indicated to shorten time to neutrophil recovery and to reduce the incidence of severe, life-threatening, or fatal infections following induction chemotherapy in adult patients 55 years and older with acute myeloid leukemia (AML). 1.2 Autologous Peripheral Blood Progenitor Cell Mobilization and Collection LEUKINE is indicated in adult patients with cancer undergoing autologous hematopoietic stem cell transplantation for the mo
label id: 4ad3993c-6c7f-4a33-8ead-a912636ff4a1
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 51c63480b2c107abc721beaeedb753b07a960e2c49fa55fc745db6df3661971a
start: 1050

current approval status

not_reconciled

duplicate text group

dup-b7175bfa83260f8b9727

extraction review status

automated_candidate_pending_source_review

generic names

SARGRAMOSTIM

ind-span-c8e332463bbde324f187

label id

4ad3993c-6c7f-4a33-8ead-a912636ff4a1

positive predicate support span

end: 1330
end exclusive: true
exact text: is indicated
label id: 4ad3993c-6c7f-4a33-8ead-a912636ff4a1
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 51c63480b2c107abc721beaeedb753b07a960e2c49fa55fc745db6df3661971a
start: 1318

qualifier mentions

context exact
ng, or fatal infections following induction chemotherapy in adult patients 55 years and older with acute myeloid leukemia (AML).
kind
age
polarity
not_inferred
span
end
1497
end exclusive
true
exact text
adult patients
label id
4ad3993c-6c7f-4a33-8ead-a912636ff4a1
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
51c63480b2c107abc721beaeedb753b07a960e2c49fa55fc745db6df3661971a
start
1483
context exact
fections following induction chemotherapy in adult patients 55 years and older with acute myeloid leukemia (AML).
kind
age
polarity
not_inferred
span
end
1516
end exclusive
true
exact text
55 years and older
label id
4ad3993c-6c7f-4a33-8ead-a912636ff4a1
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
51c63480b2c107abc721beaeedb753b07a960e2c49fa55fc745db6df3661971a
start
1498

regulatory links

schema version

0.1.0

source batch sha256

d918de6bede8f776ad4fea2bc639292f8454d9733fbbdfdd7fd4414b6200e571

source defined aliases

source span

end: 1551
end exclusive: true
exact text: 1.1 Acute Myeloid Leukemia Following Induction Chemotherapy LEUKINE is indicated to shorten time to neutrophil recovery and to reduce the incidence of severe, life-threatening, or fatal infections following induction chemotherapy in adult patients 55 years and older with acute myeloid leukemia (AML).
label id: 4ad3993c-6c7f-4a33-8ead-a912636ff4a1
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 51c63480b2c107abc721beaeedb753b07a960e2c49fa55fc745db6df3661971a
start: 1250

source url

https://api.fda.gov/drug/label.json?search=id%3A%224ad3993c-6c7f-4a33-8ead-a912636ff4a1%22

spl effective date

2024-12-06

spl set id

bb9a3820-f31a-4dd9-bef4-97094c01a398

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

Passage 14 · positive indication candidate

application numbers

BLA103362

brand names

Leukine

classification reasons

explicit_positive_indication_predicate
tumor_or_malignant_hematology_words_in_positive_statement

clinical review status

pending

content role

positive_indication_candidate

context span

end: 2050
end exclusive: true
exact text: utrophil recovery and to reduce the incidence of severe, life-threatening, or fatal infections following induction chemotherapy in adult patients 55 years and older with acute myeloid leukemia (AML). 1.2 Autologous Peripheral Blood Progenitor Cell Mobilization and Collection LEUKINE is indicated in adult patients with cancer undergoing autologous hematopoietic stem cell transplantation for the mobilization of hematopoietic progenitor cells into peripheral blood for collection by leukapheresis. 1.3 Autologous Peripheral Blood Progenitor Cell and Bone Marrow Transplantation LEUKINE is indicated for the acceleration of myeloid reconstitution following autologous peripheral blood progenitor ce
label id: 4ad3993c-6c7f-4a33-8ead-a912636ff4a1
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 51c63480b2c107abc721beaeedb753b07a960e2c49fa55fc745db6df3661971a
start: 1352

current approval status

not_reconciled

duplicate text group

dup-7689bd4dca8429691c58

extraction review status

automated_candidate_pending_source_review

generic names

SARGRAMOSTIM

ind-span-a761748d1a4b5bb3c535

label id

4ad3993c-6c7f-4a33-8ead-a912636ff4a1

positive predicate support span

end: 1648
end exclusive: true
exact text: is indicated
label id: 4ad3993c-6c7f-4a33-8ead-a912636ff4a1
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 51c63480b2c107abc721beaeedb753b07a960e2c49fa55fc745db6df3661971a
start: 1636

qualifier mentions

context exact
or Cell Mobilization and Collection LEUKINE is indicated in adult patients with cancer undergoing autologous hematopoietic stem cell t
kind
age
polarity
not_inferred
span
end
1666
end exclusive
true
exact text
adult patients
label id
4ad3993c-6c7f-4a33-8ead-a912636ff4a1
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
51c63480b2c107abc721beaeedb753b07a960e2c49fa55fc745db6df3661971a
start
1652

regulatory links

schema version

0.1.0

source batch sha256

d918de6bede8f776ad4fea2bc639292f8454d9733fbbdfdd7fd4414b6200e571

source defined aliases

source span

end: 1850
end exclusive: true
exact text: 1.2 Autologous Peripheral Blood Progenitor Cell Mobilization and Collection LEUKINE is indicated in adult patients with cancer undergoing autologous hematopoietic stem cell transplantation for the mobilization of hematopoietic progenitor cells into peripheral blood for collection by leukapheresis.
label id: 4ad3993c-6c7f-4a33-8ead-a912636ff4a1
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 51c63480b2c107abc721beaeedb753b07a960e2c49fa55fc745db6df3661971a
start: 1552

source url

https://api.fda.gov/drug/label.json?search=id%3A%224ad3993c-6c7f-4a33-8ead-a912636ff4a1%22

spl effective date

2024-12-06

spl set id

bb9a3820-f31a-4dd9-bef4-97094c01a398

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

tumor_directed_candidate

Passage 15 · positive indication candidate

application numbers

BLA103362

brand names

Leukine

classification reasons

explicit_positive_indication_predicate
tumor_or_malignant_hematology_words_in_positive_statement

clinical review status

pending

content role

positive_indication_candidate

context span

end: 2446
end exclusive: true
exact text: adult patients with cancer undergoing autologous hematopoietic stem cell transplantation for the mobilization of hematopoietic progenitor cells into peripheral blood for collection by leukapheresis. 1.3 Autologous Peripheral Blood Progenitor Cell and Bone Marrow Transplantation LEUKINE is indicated for the acceleration of myeloid reconstitution following autologous peripheral blood progenitor cell (PBPC) or bone marrow transplantation in adult and pediatric patients 2 years of age and older with non-Hodgkin's lymphoma (NHL), acute lymphoblastic leukemia (ALL) and Hodgkin's lymphoma (HL). 1.4 Allogeneic Bone Marrow Transplantation LEUKINE is indicated for the acceleration of myeloid reconstitution in adult and pediatric patients 2 years of age and older undergoing allogeneic bone marr
label id: 4ad3993c-6c7f-4a33-8ead-a912636ff4a1
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 51c63480b2c107abc721beaeedb753b07a960e2c49fa55fc745db6df3661971a
start: 1651

current approval status

not_reconciled

duplicate text group

dup-1c024c14e0b096f4626b

extraction review status

automated_candidate_pending_source_review

generic names

SARGRAMOSTIM

ind-span-2542fcb8a5da4262455c

label id

4ad3993c-6c7f-4a33-8ead-a912636ff4a1

positive predicate support span

end: 1951
end exclusive: true
exact text: is indicated
label id: 4ad3993c-6c7f-4a33-8ead-a912636ff4a1
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 51c63480b2c107abc721beaeedb753b07a960e2c49fa55fc745db6df3661971a
start: 1939

qualifier mentions

context exact
od progenitor cell (PBPC) or bone marrow transplantation in adult and pediatric patients 2 years of age and older with non-Ho
kind
age
polarity
not_inferred
span
end
2099
end exclusive
true
exact text
adult
label id
4ad3993c-6c7f-4a33-8ead-a912636ff4a1
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
51c63480b2c107abc721beaeedb753b07a960e2c49fa55fc745db6df3661971a
start
2094
context exact
tor cell (PBPC) or bone marrow transplantation in adult and pediatric patients 2 years of age and older with non-Hodgkin's lymphoma (NHL),
kind
age
polarity
not_inferred
span
end
2122
end exclusive
true
exact text
pediatric patients
label id
4ad3993c-6c7f-4a33-8ead-a912636ff4a1
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
51c63480b2c107abc721beaeedb753b07a960e2c49fa55fc745db6df3661971a
start
2104
context exact
bone marrow transplantation in adult and pediatric patients 2 years of age and older with non-Hodgkin's lymphoma (NHL), acute lymphobl
kind
age
polarity
not_inferred
span
end
2137
end exclusive
true
exact text
2 years of age
label id
4ad3993c-6c7f-4a33-8ead-a912636ff4a1
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
51c63480b2c107abc721beaeedb753b07a960e2c49fa55fc745db6df3661971a
start
2123

regulatory links

schema version

0.1.0

source batch sha256

d918de6bede8f776ad4fea2bc639292f8454d9733fbbdfdd7fd4414b6200e571

source defined aliases

source span

end: 2246
end exclusive: true
exact text: 1.3 Autologous Peripheral Blood Progenitor Cell and Bone Marrow Transplantation LEUKINE is indicated for the acceleration of myeloid reconstitution following autologous peripheral blood progenitor cell (PBPC) or bone marrow transplantation in adult and pediatric patients 2 years of age and older with non-Hodgkin's lymphoma (NHL), acute lymphoblastic leukemia (ALL) and Hodgkin's lymphoma (HL).
label id: 4ad3993c-6c7f-4a33-8ead-a912636ff4a1
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 51c63480b2c107abc721beaeedb753b07a960e2c49fa55fc745db6df3661971a
start: 1851

source url

https://api.fda.gov/drug/label.json?search=id%3A%224ad3993c-6c7f-4a33-8ead-a912636ff4a1%22

spl effective date

2024-12-06

spl set id

bb9a3820-f31a-4dd9-bef4-97094c01a398

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

tumor_directed_candidate

Passage 16 · positive indication candidate

application numbers

BLA103362

brand names

Leukine

classification reasons

explicit_positive_indication_predicate
no_tumor_directed_keyword_in_positive_statement

clinical review status

pending

content role

positive_indication_candidate

context span

end: 2697
end exclusive: true
exact text: cell (PBPC) or bone marrow transplantation in adult and pediatric patients 2 years of age and older with non-Hodgkin's lymphoma (NHL), acute lymphoblastic leukemia (ALL) and Hodgkin's lymphoma (HL). 1.4 Allogeneic Bone Marrow Transplantation LEUKINE is indicated for the acceleration of myeloid reconstitution in adult and pediatric patients 2 years of age and older undergoing allogeneic bone marrow transplantation from HLA-matched related donors. 1.5 Allogeneic or Autologous Bone Marrow Transplantation: Treatment of Delayed Neutrophil Recovery or Graft Failure LEUKINE is indicated for the treatment of adult and pediatric patients 2 years and
label id: 4ad3993c-6c7f-4a33-8ead-a912636ff4a1
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 51c63480b2c107abc721beaeedb753b07a960e2c49fa55fc745db6df3661971a
start: 2047

current approval status

not_reconciled

duplicate text group

dup-de5a4d797152fc69fa2d

extraction review status

automated_candidate_pending_source_review

generic names

SARGRAMOSTIM

ind-span-cd36e89978354b579fc4

label id

4ad3993c-6c7f-4a33-8ead-a912636ff4a1

positive predicate support span

end: 2310
end exclusive: true
exact text: is indicated
label id: 4ad3993c-6c7f-4a33-8ead-a912636ff4a1
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 51c63480b2c107abc721beaeedb753b07a960e2c49fa55fc745db6df3661971a
start: 2298

qualifier mentions

context exact
indicated for the acceleration of myeloid reconstitution in adult and pediatric patients 2 years of age and older undergoing
kind
age
polarity
not_inferred
span
end
2366
end exclusive
true
exact text
adult
label id
4ad3993c-6c7f-4a33-8ead-a912636ff4a1
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
51c63480b2c107abc721beaeedb753b07a960e2c49fa55fc745db6df3661971a
start
2361
context exact
for the acceleration of myeloid reconstitution in adult and pediatric patients 2 years of age and older undergoing allogeneic bone marrow
kind
age
polarity
not_inferred
span
end
2389
end exclusive
true
exact text
pediatric patients
label id
4ad3993c-6c7f-4a33-8ead-a912636ff4a1
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
51c63480b2c107abc721beaeedb753b07a960e2c49fa55fc745db6df3661971a
start
2371
context exact
n of myeloid reconstitution in adult and pediatric patients 2 years of age and older undergoing allogeneic bone marrow transplantation
kind
age
polarity
not_inferred
span
end
2404
end exclusive
true
exact text
2 years of age
label id
4ad3993c-6c7f-4a33-8ead-a912636ff4a1
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
51c63480b2c107abc721beaeedb753b07a960e2c49fa55fc745db6df3661971a
start
2390

regulatory links

schema version

0.1.0

source batch sha256

d918de6bede8f776ad4fea2bc639292f8454d9733fbbdfdd7fd4414b6200e571

source defined aliases

source span

end: 2497
end exclusive: true
exact text: 1.4 Allogeneic Bone Marrow Transplantation LEUKINE is indicated for the acceleration of myeloid reconstitution in adult and pediatric patients 2 years of age and older undergoing allogeneic bone marrow transplantation from HLA-matched related donors.
label id: 4ad3993c-6c7f-4a33-8ead-a912636ff4a1
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 51c63480b2c107abc721beaeedb753b07a960e2c49fa55fc745db6df3661971a
start: 2247

source url

https://api.fda.gov/drug/label.json?search=id%3A%224ad3993c-6c7f-4a33-8ead-a912636ff4a1%22

spl effective date

2024-12-06

spl set id

bb9a3820-f31a-4dd9-bef4-97094c01a398

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

non_oncology_or_unclear_candidate

Passage 17 · positive indication candidate

application numbers

BLA103362

brand names

Leukine

classification reasons

explicit_positive_indication_predicate
supportive_or_complication_use_words

clinical review status

pending

content role

positive_indication_candidate

context span

end: 3024
end exclusive: true
exact text: is indicated for the acceleration of myeloid reconstitution in adult and pediatric patients 2 years of age and older undergoing allogeneic bone marrow transplantation from HLA-matched related donors. 1.5 Allogeneic or Autologous Bone Marrow Transplantation: Treatment of Delayed Neutrophil Recovery or Graft Failure LEUKINE is indicated for the treatment of adult and pediatric patients 2 years and older who have undergone allogeneic or autologous bone marrow transplantation in whom neutrophil recovery is delayed or failed. 1.6 Acute Exposure to Myelosuppressive Doses of Radiation (H-ARS) LEUKINE is indicated to increase survival in adult and pediatric patients from birth to 17 years of age acutely exposed to myelosuppr
label id: 4ad3993c-6c7f-4a33-8ead-a912636ff4a1
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 51c63480b2c107abc721beaeedb753b07a960e2c49fa55fc745db6df3661971a
start: 2298

current approval status

not_reconciled

duplicate text group

dup-37bff2382bff3599d473

extraction review status

automated_candidate_pending_source_review

generic names

SARGRAMOSTIM

ind-span-45e55ddaddc8b83df6f8

label id

4ad3993c-6c7f-4a33-8ead-a912636ff4a1

positive predicate support span

end: 2634
end exclusive: true
exact text: is indicated
label id: 4ad3993c-6c7f-4a33-8ead-a912636ff4a1
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 51c63480b2c107abc721beaeedb753b07a960e2c49fa55fc745db6df3661971a
start: 2622

qualifier mentions

context exact
or Graft Failure LEUKINE is indicated for the treatment of adult and pediatric patients 2 years and older who have undergone
kind
age
polarity
not_inferred
span
end
2661
end exclusive
true
exact text
adult
label id
4ad3993c-6c7f-4a33-8ead-a912636ff4a1
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
51c63480b2c107abc721beaeedb753b07a960e2c49fa55fc745db6df3661971a
start
2656
context exact
Failure LEUKINE is indicated for the treatment of adult and pediatric patients 2 years and older who have undergone allogeneic or autologo
kind
age
polarity
not_inferred
span
end
2684
end exclusive
true
exact text
pediatric patients
label id
4ad3993c-6c7f-4a33-8ead-a912636ff4a1
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
51c63480b2c107abc721beaeedb753b07a960e2c49fa55fc745db6df3661971a
start
2666
context exact
indicated for the treatment of adult and pediatric patients 2 years and older who have undergone allogeneic or autologous bone marrow tra
kind
age
polarity
not_inferred
span
end
2702
end exclusive
true
exact text
2 years and older
label id
4ad3993c-6c7f-4a33-8ead-a912636ff4a1
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
51c63480b2c107abc721beaeedb753b07a960e2c49fa55fc745db6df3661971a
start
2685

regulatory links

schema version

0.1.0

source batch sha256

d918de6bede8f776ad4fea2bc639292f8454d9733fbbdfdd7fd4414b6200e571

source defined aliases

source span

end: 2824
end exclusive: true
exact text: 1.5 Allogeneic or Autologous Bone Marrow Transplantation: Treatment of Delayed Neutrophil Recovery or Graft Failure LEUKINE is indicated for the treatment of adult and pediatric patients 2 years and older who have undergone allogeneic or autologous bone marrow transplantation in whom neutrophil recovery is delayed or failed.
label id: 4ad3993c-6c7f-4a33-8ead-a912636ff4a1
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 51c63480b2c107abc721beaeedb753b07a960e2c49fa55fc745db6df3661971a
start: 2498

source url

https://api.fda.gov/drug/label.json?search=id%3A%224ad3993c-6c7f-4a33-8ead-a912636ff4a1%22

spl effective date

2024-12-06

spl set id

bb9a3820-f31a-4dd9-bef4-97094c01a398

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

Passage 18 · positive indication candidate

application numbers

BLA103362

brand names

Leukine

classification reasons

explicit_positive_indication_predicate
supportive_or_complication_use_words

clinical review status

pending

content role

positive_indication_candidate

context span

end: 3111
end exclusive: true
exact text: indicated for the treatment of adult and pediatric patients 2 years and older who have undergone allogeneic or autologous bone marrow transplantation in whom neutrophil recovery is delayed or failed. 1.6 Acute Exposure to Myelosuppressive Doses of Radiation (H-ARS) LEUKINE is indicated to increase survival in adult and pediatric patients from birth to 17 years of age acutely exposed to myelosuppressive doses of radiation (Hematopoietic Syndrome of Acute Radiation Syndrome [H-ARS]).
label id: 4ad3993c-6c7f-4a33-8ead-a912636ff4a1
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 51c63480b2c107abc721beaeedb753b07a960e2c49fa55fc745db6df3661971a
start: 2625

current approval status

not_reconciled

duplicate text group

dup-cf81acd35cf33f24511e

extraction review status

automated_candidate_pending_source_review

generic names

SARGRAMOSTIM

ind-span-1072f27cdea7c73d83b0

label id

4ad3993c-6c7f-4a33-8ead-a912636ff4a1

positive predicate support span

end: 2911
end exclusive: true
exact text: is indicated
label id: 4ad3993c-6c7f-4a33-8ead-a912636ff4a1
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 51c63480b2c107abc721beaeedb753b07a960e2c49fa55fc745db6df3661971a
start: 2899

qualifier mentions

context exact
iation (H-ARS) LEUKINE is indicated to increase survival in adult and pediatric patients from birth to 17 years of age acutel
kind
age
polarity
not_inferred
span
end
2941
end exclusive
true
exact text
adult
label id
4ad3993c-6c7f-4a33-8ead-a912636ff4a1
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
51c63480b2c107abc721beaeedb753b07a960e2c49fa55fc745db6df3661971a
start
2936
context exact
ARS) LEUKINE is indicated to increase survival in adult and pediatric patients from birth to 17 years of age acutely exposed to myelosuppr
kind
age
polarity
not_inferred
span
end
2964
end exclusive
true
exact text
pediatric patients
label id
4ad3993c-6c7f-4a33-8ead-a912636ff4a1
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
51c63480b2c107abc721beaeedb753b07a960e2c49fa55fc745db6df3661971a
start
2946
context exact
ease survival in adult and pediatric patients from birth to 17 years of age acutely exposed to myelosuppressive doses of radiation (Hem
kind
age
polarity
not_inferred
span
end
2994
end exclusive
true
exact text
17 years of age
label id
4ad3993c-6c7f-4a33-8ead-a912636ff4a1
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
51c63480b2c107abc721beaeedb753b07a960e2c49fa55fc745db6df3661971a
start
2979

regulatory links

schema version

0.1.0

source batch sha256

d918de6bede8f776ad4fea2bc639292f8454d9733fbbdfdd7fd4414b6200e571

source defined aliases

source span

end: 3111
end exclusive: true
exact text: 1.6 Acute Exposure to Myelosuppressive Doses of Radiation (H-ARS) LEUKINE is indicated to increase survival in adult and pediatric patients from birth to 17 years of age acutely exposed to myelosuppressive doses of radiation (Hematopoietic Syndrome of Acute Radiation Syndrome [H-ARS]).
label id: 4ad3993c-6c7f-4a33-8ead-a912636ff4a1
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 51c63480b2c107abc721beaeedb753b07a960e2c49fa55fc745db6df3661971a
start: 2825

source url

https://api.fda.gov/drug/label.json?search=id%3A%224ad3993c-6c7f-4a33-8ead-a912636ff4a1%22

spl effective date

2024-12-06

spl set id

bb9a3820-f31a-4dd9-bef4-97094c01a398

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