LABELS · 5958fefc-c45c-0cde-e063-6294a90a0887

BILDYOS

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: 2026-08-18
Captured: 2026-09-09T23:37:47.659725+00:00
Current indication reconciliation: Not reconciled

Boxed warning in this label

WARNING: SEVERE HYPOCALCEMIA IN PATIENTS WITH ADVANCED KIDNEY DISEASE Patients with advanced chronic kidney disease (eGFR < 30 mL/min/1.73 m 2 ), including dialysis dependent patients, are at greater risk of severe hypocalcemia following denosumab products administration. Severe hypocalcemia resulting in hospitalization, life-threatening events and fatal cases have been reported [see Warnings and Precautions ( 5.1 )] . The presence of chronic kidney disease-mineral bone disorder (CKD-MBD) markedly increases the risk of hypocalcemia in these patients [see Warnings and Precautions ( 5.1 )] . Prior to initiating Bildyos in patients with advanced chronic kidney disease, evaluate for the presence of CKD-MBD. Treatment with Bildyos in these patients should be supervised by a healthcare provider with expertise in the diagnosis and management of CKD-MBD [see Dosage and Administration ( 2.2 ) and Warnings and Precautions ( 5.1 )]. WARNING: SEVERE HYPOCALCEMIA IN PATIENTS WITH ADVANCED KIDNEY DISEASE See full prescribing information for complete boxed warning. Patients with advanced chronic kidney disease are at greater risk of severe hypocalcemia following denosumab products administration. Severe hypocalcemia resulting in hospitalization, life-threatening events and fatal cases have been reported. ( 5.1 ) The presence of chronic kidney disease-mineral bone disorder (CKD-MBD) markedly increases the risk of hypocalcemia. ( 5.1 ) Prior to initiating Bildyos in patients with advanced chronic kidney disease, evaluate for the presence of CKD-MBD. Treatment with Bildyos in these patients should be supervised by a healthcare provider with expertise in the diagnosis and management of CKD-MBD. ( 2.2 , 5.1 )

Indications and usage: exact source text

1 INDICATIONS AND USAGE Bildyos is a RANK ligand (RANKL) inhibitor indicated for treatment: of postmenopausal women with osteoporosis at high risk for fracture. ( 1.1 ) to increase bone mass in men with osteoporosis at high risk for fracture. ( 1.2 ) of glucocorticoid-induced osteoporosis in men and women at high risk for fracture. ( 1.3 ) to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer. ( 1.4 ) to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer. ( 1.5 ) 1.1 Treatment of Postmenopausal Women with Osteoporosis at High Risk for Fracture Bildyos is indicated for the treatment of postmenopausal women with osteoporosis at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other available osteoporosis therapy. In postmenopausal women with osteoporosis, denosumab reduces the incidence of vertebral, nonvertebral, and hip fractures [see Clinical Studies ( 14.1 )] . 1.2 Treatment to Increase Bone Mass in Men with Osteoporosis Bildyos is indicated for treatment to increase bone mass in men with osteoporosis at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other available osteoporosis therapy [see Clinical Studies ( 14.2 )] . 1.3 Treatment of Glucocorticoid-Induced Osteoporosis Bildyos is indicated for the treatment of glucocorticoid-induced osteoporosis in men and women at high risk of fracture who are either initiating or continuing systemic glucocorticoids in a daily dosage equivalent to 7.5 mg or greater of prednisone and expected to remain on glucocorticoids for at least 6 months. High risk of fracture is defined as a history of osteoporotic fracture, multiple risk factors for fracture, or patients who have failed or are intolerant to other available osteoporosis therapy [see Clinical Studies ( 14.3 )] . 1.4 Treatment of Bone Loss in Men Receiving Androgen Deprivation Therapy for Prostate Cancer Bildyos is indicated as a treatment to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy (ADT) for nonmetastatic prostate cancer. In these patients denosumab also reduced the incidence of vertebral fractures [see Clinical Studies ( 14.4 )] . 1.5 Treatment of Bone Loss in Women Receiving Adjuvant Aromatase Inhibitor Therapy for Breast Cancer Bildyos is indicated as a treatment to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer [see Clinical Studies ( 14.5 )] .

Full extracted label fields

application numbers

BLA761444

boxed warning exact

WARNING: SEVERE HYPOCALCEMIA IN PATIENTS WITH ADVANCED KIDNEY DISEASE Patients with advanced chronic kidney disease (eGFR < 30 mL/min/1.73 m 2 ), including dialysis dependent patients, are at greater risk of severe hypocalcemia following denosumab products administration. Severe hypocalcemia resulting in hospitalization, life-threatening events and fatal cases have been reported [see Warnings and Precautions ( 5.1 )] . The presence of chronic kidney disease-mineral bone disorder (CKD-MBD) markedly increases the risk of hypocalcemia in these patients [see Warnings and Precautions ( 5.1 )] . Prior to initiating Bildyos in patients with advanced chronic kidney disease, evaluate for the presence of CKD-MBD. Treatment with Bildyos in these patients should be supervised by a healthcare provider with expertise in the diagnosis and management of CKD-MBD [see Dosage and Administration ( 2.2 ) and Warnings and Precautions ( 5.1 )]. WARNING: SEVERE HYPOCALCEMIA IN PATIENTS WITH ADVANCED KIDNEY DISEASE See full prescribing information for complete boxed warning. Patients with advanced chronic kidney disease are at greater risk of severe hypocalcemia following denosumab products administration. Severe hypocalcemia resulting in hospitalization, life-threatening events and fatal cases have been reported. ( 5.1 ) The presence of chronic kidney disease-mineral bone disorder (CKD-MBD) markedly increases the risk of hypocalcemia. ( 5.1 ) Prior to initiating Bildyos in patients with advanced chronic kidney disease, evaluate for the presence of CKD-MBD. Treatment with Bildyos in these patients should be supervised by a healthcare provider with expertise in the diagnosis and management of CKD-MBD. ( 2.2 , 5.1 )

brand names

BILDYOS

current indication status

not_reconciled

dailymed set url

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b9e32bf7-d70a-4083-8577-c15751c7f769

generic names

DENOSUMAB

5958fefc-c45c-0cde-e063-6294a90a0887

indications and usage exact

1 INDICATIONS AND USAGE Bildyos is a RANK ligand (RANKL) inhibitor indicated for treatment: of postmenopausal women with osteoporosis at high risk for fracture. ( 1.1 ) to increase bone mass in men with osteoporosis at high risk for fracture. ( 1.2 ) of glucocorticoid-induced osteoporosis in men and women at high risk for fracture. ( 1.3 ) to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer. ( 1.4 ) to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer. ( 1.5 ) 1.1 Treatment of Postmenopausal Women with Osteoporosis at High Risk for Fracture Bildyos is indicated for the treatment of postmenopausal women with osteoporosis at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other available osteoporosis therapy. In postmenopausal women with osteoporosis, denosumab reduces the incidence of vertebral, nonvertebral, and hip fractures [see Clinical Studies ( 14.1 )] . 1.2 Treatment to Increase Bone Mass in Men with Osteoporosis Bildyos is indicated for treatment to increase bone mass in men with osteoporosis at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other available osteoporosis therapy [see Clinical Studies ( 14.2 )] . 1.3 Treatment of Glucocorticoid-Induced Osteoporosis Bildyos is indicated for the treatment of glucocorticoid-induced osteoporosis in men and women at high risk of fracture who are either initiating or continuing systemic glucocorticoids in a daily dosage equivalent to 7.5 mg or greater of prednisone and expected to remain on glucocorticoids for at least 6 months. High risk of fracture is defined as a history of osteoporotic fracture, multiple risk factors for fracture, or patients who have failed or are intolerant to other available osteoporosis therapy [see Clinical Studies ( 14.3 )] . 1.4 Treatment of Bone Loss in Men Receiving Androgen Deprivation Therapy for Prostate Cancer Bildyos is indicated as a treatment to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy (ADT) for nonmetastatic prostate cancer. In these patients denosumab also reduced the incidence of vertebral fractures [see Clinical Studies ( 14.4 )] . 1.5 Treatment of Bone Loss in Women Receiving Adjuvant Aromatase Inhibitor Therapy for Breast Cancer Bildyos is indicated as a treatment to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer [see Clinical Studies ( 14.5 )] .

indications and usage tables exact

is original packager

true

manufacturer names

Organon LLC

matched search terms

cancer

package ndcs

78206-193-01

product ndcs

78206-193

product types

HUMAN PRESCRIPTION DRUG

recent major changes exact

record type

complete_spl_indications_section_candidate

routes

SUBCUTANEOUS

rxcuis

2723350
2723357

source batch

file

/private/tmp/cancer-full-research/indications/raw/labels-00300.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 · indication intro context

application numbers

BLA761444

brand names

BILDYOS

classification reasons

explicit_positive_indication_predicate
no_tumor_directed_keyword_in_positive_statement
incomplete_colon_led_indication_intro

clinical review status

pending

content role

indication_intro_context

context span

end: 360
end exclusive: true
exact text: 1 INDICATIONS AND USAGE Bildyos is a RANK ligand (RANKL) inhibitor indicated for treatment: of postmenopausal women with osteoporosis at high risk for fracture. ( 1.1 ) to increase bone mass in men with osteoporosis at high risk for fracture. ( 1.2 ) of glucocorticoid-induced osteoporosis in men and women at high risk for fracture. ( 1.3 ) to increase bone m
label id: 5958fefc-c45c-0cde-e063-6294a90a0887
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 3c45dca85d83b80dd2cd45007a8f7b97fcb059038c6248c97b90893793354f4e
start: 0

current approval status

not_reconciled

duplicate text group

dup-66b4e9a4e34ada51dcbb

extraction review status

automated_candidate_pending_source_review

generic names

DENOSUMAB

ind-span-5559c0f1101eba69fb87

label id

5958fefc-c45c-0cde-e063-6294a90a0887

positive predicate support span

end: 76
end exclusive: true
exact text: is a RANK ligand (RANKL) inhibitor indicated
label id: 5958fefc-c45c-0cde-e063-6294a90a0887
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 3c45dca85d83b80dd2cd45007a8f7b97fcb059038c6248c97b90893793354f4e
start: 32

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

bbaf8e3e49a06d91fa717d034adb1798932735c99e42d8d769cf5f9eb31d345e

source defined aliases

source span

end: 160
end exclusive: true
exact text: 1 INDICATIONS AND USAGE Bildyos is a RANK ligand (RANKL) inhibitor indicated for treatment: of postmenopausal women with osteoporosis at high risk for fracture.
label id: 5958fefc-c45c-0cde-e063-6294a90a0887
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 3c45dca85d83b80dd2cd45007a8f7b97fcb059038c6248c97b90893793354f4e
start: 0

source url

https://api.fda.gov/drug/label.json?search=id%3A%225958fefc-c45c-0cde-e063-6294a90a0887%22

spl effective date

2026-08-18

spl set id

b9e32bf7-d70a-4083-8577-c15751c7f769

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

not_applicable

Passage 2 · unclassified context

application numbers

BLA761444

brand names

BILDYOS

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

unclassified_context

context span

end: 368
end exclusive: true
exact text: 1 INDICATIONS AND USAGE Bildyos is a RANK ligand (RANKL) inhibitor indicated for treatment: of postmenopausal women with osteoporosis at high risk for fracture. ( 1.1 ) to increase bone mass in men with osteoporosis at high risk for fracture. ( 1.2 ) of glucocorticoid-induced osteoporosis in men and women at high risk for fracture. ( 1.3 ) to increase bone mass in m
label id: 5958fefc-c45c-0cde-e063-6294a90a0887
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 3c45dca85d83b80dd2cd45007a8f7b97fcb059038c6248c97b90893793354f4e
start: 0

current approval status

not_reconciled

duplicate text group

dup-2e84afac73ce60f8d7be

extraction review status

automated_candidate_pending_source_review

generic names

DENOSUMAB

ind-span-8cfafcb3546b9957397f

label id

5958fefc-c45c-0cde-e063-6294a90a0887

positive predicate support span

Source null

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

bbaf8e3e49a06d91fa717d034adb1798932735c99e42d8d769cf5f9eb31d345e

source defined aliases

source span

end: 168
end exclusive: true
exact text: ( 1.1 )
label id: 5958fefc-c45c-0cde-e063-6294a90a0887
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 3c45dca85d83b80dd2cd45007a8f7b97fcb059038c6248c97b90893793354f4e
start: 161

source url

https://api.fda.gov/drug/label.json?search=id%3A%225958fefc-c45c-0cde-e063-6294a90a0887%22

spl effective date

2026-08-18

spl set id

b9e32bf7-d70a-4083-8577-c15751c7f769

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

BLA761444

brand names

BILDYOS

classification reasons

inherited_predicate_from_same_label_section_requires_review
supportive_or_complication_use_words

clinical review status

pending

content role

positive_indication_candidate

context span

end: 442
end exclusive: true
exact text: 1 INDICATIONS AND USAGE Bildyos is a RANK ligand (RANKL) inhibitor indicated for treatment: of postmenopausal women with osteoporosis at high risk for fracture. ( 1.1 ) to increase bone mass in men with osteoporosis at high risk for fracture. ( 1.2 ) of glucocorticoid-induced osteoporosis in men and women at high risk for fracture. ( 1.3 ) to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for no
label id: 5958fefc-c45c-0cde-e063-6294a90a0887
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 3c45dca85d83b80dd2cd45007a8f7b97fcb059038c6248c97b90893793354f4e
start: 0

current approval status

not_reconciled

duplicate text group

dup-fd349a8811162ea2c87c

extraction review status

automated_candidate_pending_source_review

generic names

DENOSUMAB

ind-span-1fbf51d2ec10ad0ebf02

label id

5958fefc-c45c-0cde-e063-6294a90a0887

positive predicate support span

end: 76
end exclusive: true
exact text: is a RANK ligand (RANKL) inhibitor indicated
label id: 5958fefc-c45c-0cde-e063-6294a90a0887
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 3c45dca85d83b80dd2cd45007a8f7b97fcb059038c6248c97b90893793354f4e
start: 32

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

bbaf8e3e49a06d91fa717d034adb1798932735c99e42d8d769cf5f9eb31d345e

source defined aliases

source span

end: 242
end exclusive: true
exact text: to increase bone mass in men with osteoporosis at high risk for fracture.
label id: 5958fefc-c45c-0cde-e063-6294a90a0887
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 3c45dca85d83b80dd2cd45007a8f7b97fcb059038c6248c97b90893793354f4e
start: 169

source url

https://api.fda.gov/drug/label.json?search=id%3A%225958fefc-c45c-0cde-e063-6294a90a0887%22

spl effective date

2026-08-18

spl set id

b9e32bf7-d70a-4083-8577-c15751c7f769

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 4 · unclassified context

application numbers

BLA761444

brand names

BILDYOS

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

unclassified_context

context span

end: 450
end exclusive: true
exact text: igand (RANKL) inhibitor indicated for treatment: of postmenopausal women with osteoporosis at high risk for fracture. ( 1.1 ) to increase bone mass in men with osteoporosis at high risk for fracture. ( 1.2 ) of glucocorticoid-induced osteoporosis in men and women at high risk for fracture. ( 1.3 ) to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetasta
label id: 5958fefc-c45c-0cde-e063-6294a90a0887
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 3c45dca85d83b80dd2cd45007a8f7b97fcb059038c6248c97b90893793354f4e
start: 43

current approval status

not_reconciled

duplicate text group

dup-c13a5510d20fae241d2f

extraction review status

automated_candidate_pending_source_review

generic names

DENOSUMAB

ind-span-ae48c04496a18f85da27

label id

5958fefc-c45c-0cde-e063-6294a90a0887

positive predicate support span

Source null

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

bbaf8e3e49a06d91fa717d034adb1798932735c99e42d8d769cf5f9eb31d345e

source defined aliases

source span

end: 250
end exclusive: true
exact text: ( 1.2 )
label id: 5958fefc-c45c-0cde-e063-6294a90a0887
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 3c45dca85d83b80dd2cd45007a8f7b97fcb059038c6248c97b90893793354f4e
start: 243

source url

https://api.fda.gov/drug/label.json?search=id%3A%225958fefc-c45c-0cde-e063-6294a90a0887%22

spl effective date

2026-08-18

spl set id

b9e32bf7-d70a-4083-8577-c15751c7f769

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 · unclassified context

application numbers

BLA761444

brand names

BILDYOS

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

unclassified_context

context span

end: 533
end exclusive: true
exact text: ANKL) inhibitor indicated for treatment: of postmenopausal women with osteoporosis at high risk for fracture. ( 1.1 ) to increase bone mass in men with osteoporosis at high risk for fracture. ( 1.2 ) of glucocorticoid-induced osteoporosis in men and women at high risk for fracture. ( 1.3 ) to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer. ( 1.4 ) to increase bone mass in women at high risk for fractu
label id: 5958fefc-c45c-0cde-e063-6294a90a0887
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 3c45dca85d83b80dd2cd45007a8f7b97fcb059038c6248c97b90893793354f4e
start: 51

current approval status

not_reconciled

duplicate text group

dup-0ee4146e0268fc40c1c7

extraction review status

automated_candidate_pending_source_review

generic names

DENOSUMAB

ind-span-9379ec16a82c989897a9

label id

5958fefc-c45c-0cde-e063-6294a90a0887

positive predicate support span

Source null

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

bbaf8e3e49a06d91fa717d034adb1798932735c99e42d8d769cf5f9eb31d345e

source defined aliases

source span

end: 333
end exclusive: true
exact text: of glucocorticoid-induced osteoporosis in men and women at high risk for fracture.
label id: 5958fefc-c45c-0cde-e063-6294a90a0887
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 3c45dca85d83b80dd2cd45007a8f7b97fcb059038c6248c97b90893793354f4e
start: 251

source url

https://api.fda.gov/drug/label.json?search=id%3A%225958fefc-c45c-0cde-e063-6294a90a0887%22

spl effective date

2026-08-18

spl set id

b9e32bf7-d70a-4083-8577-c15751c7f769

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 6 · unclassified context

application numbers

BLA761444

brand names

BILDYOS

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

unclassified_context

context span

end: 541
end exclusive: true
exact text: at high risk for fracture. ( 1.1 ) to increase bone mass in men with osteoporosis at high risk for fracture. ( 1.2 ) of glucocorticoid-induced osteoporosis in men and women at high risk for fracture. ( 1.3 ) to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer. ( 1.4 ) to increase bone mass in women at high risk for fracture recei
label id: 5958fefc-c45c-0cde-e063-6294a90a0887
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 3c45dca85d83b80dd2cd45007a8f7b97fcb059038c6248c97b90893793354f4e
start: 134

current approval status

not_reconciled

duplicate text group

dup-946963bcbb6bf2d7ce9b

extraction review status

automated_candidate_pending_source_review

generic names

DENOSUMAB

ind-span-9eb5f2828da2cd203f4b

label id

5958fefc-c45c-0cde-e063-6294a90a0887

positive predicate support span

Source null

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

bbaf8e3e49a06d91fa717d034adb1798932735c99e42d8d769cf5f9eb31d345e

source defined aliases

source span

end: 341
end exclusive: true
exact text: ( 1.3 )
label id: 5958fefc-c45c-0cde-e063-6294a90a0887
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 3c45dca85d83b80dd2cd45007a8f7b97fcb059038c6248c97b90893793354f4e
start: 334

source url

https://api.fda.gov/drug/label.json?search=id%3A%225958fefc-c45c-0cde-e063-6294a90a0887%22

spl effective date

2026-08-18

spl set id

b9e32bf7-d70a-4083-8577-c15751c7f769

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

BLA761444

brand names

BILDYOS

classification reasons

inherited_predicate_from_same_label_section_requires_review
supportive_or_complication_use_words

clinical review status

pending

content role

positive_indication_candidate

context span

end: 670
end exclusive: true
exact text: risk for fracture. ( 1.1 ) to increase bone mass in men with osteoporosis at high risk for fracture. ( 1.2 ) of glucocorticoid-induced osteoporosis in men and women at high risk for fracture. ( 1.3 ) to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer. ( 1.4 ) to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer. ( 1.5 ) 1.1 Treatment of Postmenopausal Women with Osteoporosis at H
label id: 5958fefc-c45c-0cde-e063-6294a90a0887
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 3c45dca85d83b80dd2cd45007a8f7b97fcb059038c6248c97b90893793354f4e
start: 142

current approval status

not_reconciled

duplicate text group

dup-8fcf8f3335771f1d4501

extraction review status

automated_candidate_pending_source_review

generic names

DENOSUMAB

ind-span-5fa03ef8d02386bc8ba3

label id

5958fefc-c45c-0cde-e063-6294a90a0887

positive predicate support span

end: 76
end exclusive: true
exact text: is a RANK ligand (RANKL) inhibitor indicated
label id: 5958fefc-c45c-0cde-e063-6294a90a0887
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 3c45dca85d83b80dd2cd45007a8f7b97fcb059038c6248c97b90893793354f4e
start: 32

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

bbaf8e3e49a06d91fa717d034adb1798932735c99e42d8d769cf5f9eb31d345e

source defined aliases

source span

end: 470
end exclusive: true
exact text: to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer.
label id: 5958fefc-c45c-0cde-e063-6294a90a0887
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 3c45dca85d83b80dd2cd45007a8f7b97fcb059038c6248c97b90893793354f4e
start: 342

source url

https://api.fda.gov/drug/label.json?search=id%3A%225958fefc-c45c-0cde-e063-6294a90a0887%22

spl effective date

2026-08-18

spl set id

b9e32bf7-d70a-4083-8577-c15751c7f769

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 8 · unclassified context

application numbers

BLA761444

brand names

BILDYOS

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

unclassified_context

context span

end: 678
end exclusive: true
exact text: duced osteoporosis in men and women at high risk for fracture. ( 1.3 ) to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer. ( 1.4 ) to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer. ( 1.5 ) 1.1 Treatment of Postmenopausal Women with Osteoporosis at High Risk
label id: 5958fefc-c45c-0cde-e063-6294a90a0887
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 3c45dca85d83b80dd2cd45007a8f7b97fcb059038c6248c97b90893793354f4e
start: 271

current approval status

not_reconciled

duplicate text group

dup-6f760543bdc625eede7a

extraction review status

automated_candidate_pending_source_review

generic names

DENOSUMAB

ind-span-2b2445dd28d376dd8624

label id

5958fefc-c45c-0cde-e063-6294a90a0887

positive predicate support span

Source null

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

bbaf8e3e49a06d91fa717d034adb1798932735c99e42d8d769cf5f9eb31d345e

source defined aliases

source span

end: 478
end exclusive: true
exact text: ( 1.4 )
label id: 5958fefc-c45c-0cde-e063-6294a90a0887
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 3c45dca85d83b80dd2cd45007a8f7b97fcb059038c6248c97b90893793354f4e
start: 471

source url

https://api.fda.gov/drug/label.json?search=id%3A%225958fefc-c45c-0cde-e063-6294a90a0887%22

spl effective date

2026-08-18

spl set id

b9e32bf7-d70a-4083-8577-c15751c7f769

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 · positive indication candidate

application numbers

BLA761444

brand names

BILDYOS

classification reasons

inherited_predicate_from_same_label_section_requires_review
supportive_or_complication_use_words

clinical review status

pending

content role

positive_indication_candidate

context span

end: 801
end exclusive: true
exact text: teoporosis in men and women at high risk for fracture. ( 1.3 ) to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer. ( 1.4 ) to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer. ( 1.5 ) 1.1 Treatment of Postmenopausal Women with Osteoporosis at High Risk for Fracture Bildyos is indicated for the treatment of postmenopausal women with osteoporosis at high risk for fracture, d
label id: 5958fefc-c45c-0cde-e063-6294a90a0887
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 3c45dca85d83b80dd2cd45007a8f7b97fcb059038c6248c97b90893793354f4e
start: 279

current approval status

not_reconciled

duplicate text group

dup-7b22eefdea3599082c89

extraction review status

automated_candidate_pending_source_review

generic names

DENOSUMAB

ind-span-058dd8b05509f74f8945

label id

5958fefc-c45c-0cde-e063-6294a90a0887

positive predicate support span

end: 76
end exclusive: true
exact text: is a RANK ligand (RANKL) inhibitor indicated
label id: 5958fefc-c45c-0cde-e063-6294a90a0887
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 3c45dca85d83b80dd2cd45007a8f7b97fcb059038c6248c97b90893793354f4e
start: 32

qualifier mentions

context exact
ease bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer.
kind
stage_or_setting
polarity
not_inferred
span
end
589
end exclusive
true
exact text
adjuvant aromatase inhibitor therapy for br
label id
5958fefc-c45c-0cde-e063-6294a90a0887
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
3c45dca85d83b80dd2cd45007a8f7b97fcb059038c6248c97b90893793354f4e
start
546

regulatory links

schema version

0.1.0

source batch sha256

bbaf8e3e49a06d91fa717d034adb1798932735c99e42d8d769cf5f9eb31d345e

source defined aliases

source span

end: 601
end exclusive: true
exact text: to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer.
label id: 5958fefc-c45c-0cde-e063-6294a90a0887
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 3c45dca85d83b80dd2cd45007a8f7b97fcb059038c6248c97b90893793354f4e
start: 479

source url

https://api.fda.gov/drug/label.json?search=id%3A%225958fefc-c45c-0cde-e063-6294a90a0887%22

spl effective date

2026-08-18

spl set id

b9e32bf7-d70a-4083-8577-c15751c7f769

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 10 · unclassified context

application numbers

BLA761444

brand names

BILDYOS

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

unclassified_context

context span

end: 809
end exclusive: true
exact text: ving androgen deprivation therapy for nonmetastatic prostate cancer. ( 1.4 ) to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer. ( 1.5 ) 1.1 Treatment of Postmenopausal Women with Osteoporosis at High Risk for Fracture Bildyos is indicated for the treatment of postmenopausal women with osteoporosis at high risk for fracture, defined a
label id: 5958fefc-c45c-0cde-e063-6294a90a0887
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 3c45dca85d83b80dd2cd45007a8f7b97fcb059038c6248c97b90893793354f4e
start: 402

current approval status

not_reconciled

duplicate text group

dup-0a56f7b01eec1c8ccc4c

extraction review status

automated_candidate_pending_source_review

generic names

DENOSUMAB

ind-span-b7a0177e3449c50dd09f

label id

5958fefc-c45c-0cde-e063-6294a90a0887

positive predicate support span

Source null

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

bbaf8e3e49a06d91fa717d034adb1798932735c99e42d8d769cf5f9eb31d345e

source defined aliases

source span

end: 609
end exclusive: true
exact text: ( 1.5 )
label id: 5958fefc-c45c-0cde-e063-6294a90a0887
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 3c45dca85d83b80dd2cd45007a8f7b97fcb059038c6248c97b90893793354f4e
start: 602

source url

https://api.fda.gov/drug/label.json?search=id%3A%225958fefc-c45c-0cde-e063-6294a90a0887%22

spl effective date

2026-08-18

spl set id

b9e32bf7-d70a-4083-8577-c15751c7f769

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 · positive indication candidate

application numbers

BLA761444

brand names

BILDYOS

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: 1172
end exclusive: true
exact text: rogen deprivation therapy for nonmetastatic prostate cancer. ( 1.4 ) to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer. ( 1.5 ) 1.1 Treatment of Postmenopausal Women with Osteoporosis at High Risk for Fracture Bildyos is indicated for the treatment of postmenopausal women with osteoporosis at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other available osteoporosis therapy. In postmenopausal women with osteoporosis, denosumab reduces the incidence of vertebral, nonvertebral, and hip fractures [see Clinical Studies ( 14.1 )] . 1.2 Treatment to Increase Bone Mass in Men w
label id: 5958fefc-c45c-0cde-e063-6294a90a0887
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 3c45dca85d83b80dd2cd45007a8f7b97fcb059038c6248c97b90893793354f4e
start: 410

current approval status

not_reconciled

duplicate text group

dup-c1b3a325ea0d5f0f68db

extraction review status

automated_candidate_pending_source_review

generic names

DENOSUMAB

ind-span-9e6d7bc1e489277ff77d

label id

5958fefc-c45c-0cde-e063-6294a90a0887

positive predicate support span

end: 712
end exclusive: true
exact text: is indicated
label id: 5958fefc-c45c-0cde-e063-6294a90a0887
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 3c45dca85d83b80dd2cd45007a8f7b97fcb059038c6248c97b90893793354f4e
start: 700

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

bbaf8e3e49a06d91fa717d034adb1798932735c99e42d8d769cf5f9eb31d345e

source defined aliases

source span

end: 972
end exclusive: true
exact text: 1.1 Treatment of Postmenopausal Women with Osteoporosis at High Risk for Fracture Bildyos is indicated for the treatment of postmenopausal women with osteoporosis at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other available osteoporosis therapy.
label id: 5958fefc-c45c-0cde-e063-6294a90a0887
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 3c45dca85d83b80dd2cd45007a8f7b97fcb059038c6248c97b90893793354f4e
start: 610

source url

https://api.fda.gov/drug/label.json?search=id%3A%225958fefc-c45c-0cde-e063-6294a90a0887%22

spl effective date

2026-08-18

spl set id

b9e32bf7-d70a-4083-8577-c15751c7f769

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 12 · unclassified context

application numbers

BLA761444

brand names

BILDYOS

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

unclassified_context

context span

end: 1327
end exclusive: true
exact text: at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other available osteoporosis therapy. In postmenopausal women with osteoporosis, denosumab reduces the incidence of vertebral, nonvertebral, and hip fractures [see Clinical Studies ( 14.1 )] . 1.2 Treatment to Increase Bone Mass in Men with Osteoporosis Bildyos is indicated for treatment to increase bone mass in men with osteoporosis at high risk for fracture, defined as a history of osteo
label id: 5958fefc-c45c-0cde-e063-6294a90a0887
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 3c45dca85d83b80dd2cd45007a8f7b97fcb059038c6248c97b90893793354f4e
start: 773

current approval status

not_reconciled

duplicate text group

dup-89b3ebbcc7c68e883905

extraction review status

automated_candidate_pending_source_review

generic names

DENOSUMAB

ind-span-14e9b575d8ec17f53c8f

label id

5958fefc-c45c-0cde-e063-6294a90a0887

positive predicate support span

Source null

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

bbaf8e3e49a06d91fa717d034adb1798932735c99e42d8d769cf5f9eb31d345e

source defined aliases

source span

end: 1127
end exclusive: true
exact text: In postmenopausal women with osteoporosis, denosumab reduces the incidence of vertebral, nonvertebral, and hip fractures [see Clinical Studies ( 14.1 )] .
label id: 5958fefc-c45c-0cde-e063-6294a90a0887
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 3c45dca85d83b80dd2cd45007a8f7b97fcb059038c6248c97b90893793354f4e
start: 973

source url

https://api.fda.gov/drug/label.json?search=id%3A%225958fefc-c45c-0cde-e063-6294a90a0887%22

spl effective date

2026-08-18

spl set id

b9e32bf7-d70a-4083-8577-c15751c7f769

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

BLA761444

brand names

BILDYOS

classification reasons

explicit_positive_indication_predicate
supportive_or_complication_use_words

clinical review status

pending

content role

positive_indication_candidate

context span

end: 1703
end exclusive: true
exact text: ant to other available osteoporosis therapy. In postmenopausal women with osteoporosis, denosumab reduces the incidence of vertebral, nonvertebral, and hip fractures [see Clinical Studies ( 14.1 )] . 1.2 Treatment to Increase Bone Mass in Men with Osteoporosis Bildyos is indicated for treatment to increase bone mass in men with osteoporosis at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other available osteoporosis therapy [see Clinical Studies ( 14.2 )] . 1.3 Treatment of Glucocorticoid-Induced Osteoporosis Bildyos is indicated for the treatment of glucocorticoid-induced osteoporosis in men and women at high risk of fracture who are either initiating
label id: 5958fefc-c45c-0cde-e063-6294a90a0887
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 3c45dca85d83b80dd2cd45007a8f7b97fcb059038c6248c97b90893793354f4e
start: 928

current approval status

not_reconciled

duplicate text group

dup-fd0dcb925212a42882ba

extraction review status

automated_candidate_pending_source_review

generic names

DENOSUMAB

ind-span-7e58a10d216517a0f2a9

label id

5958fefc-c45c-0cde-e063-6294a90a0887

positive predicate support span

end: 1209
end exclusive: true
exact text: is indicated
label id: 5958fefc-c45c-0cde-e063-6294a90a0887
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 3c45dca85d83b80dd2cd45007a8f7b97fcb059038c6248c97b90893793354f4e
start: 1197

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

bbaf8e3e49a06d91fa717d034adb1798932735c99e42d8d769cf5f9eb31d345e

source defined aliases

source span

end: 1503
end exclusive: true
exact text: 1.2 Treatment to Increase Bone Mass in Men with Osteoporosis Bildyos is indicated for treatment to increase bone mass in men with osteoporosis at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other available osteoporosis therapy [see Clinical Studies ( 14.2 )] .
label id: 5958fefc-c45c-0cde-e063-6294a90a0887
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 3c45dca85d83b80dd2cd45007a8f7b97fcb059038c6248c97b90893793354f4e
start: 1128

source url

https://api.fda.gov/drug/label.json?search=id%3A%225958fefc-c45c-0cde-e063-6294a90a0887%22

spl effective date

2026-08-18

spl set id

b9e32bf7-d70a-4083-8577-c15751c7f769

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

BLA761444

brand names

BILDYOS

classification reasons

explicit_positive_indication_predicate
no_tumor_directed_keyword_in_positive_statement
positive_statement_also_contains_qualification_review_required

clinical review status

pending

content role

positive_indication_candidate

context span

end: 2070
end exclusive: true
exact text: d as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other available osteoporosis therapy [see Clinical Studies ( 14.2 )] . 1.3 Treatment of Glucocorticoid-Induced Osteoporosis Bildyos is indicated for the treatment of glucocorticoid-induced osteoporosis in men and women at high risk of fracture who are either initiating or continuing systemic glucocorticoids in a daily dosage equivalent to 7.5 mg or greater of prednisone and expected to remain on glucocorticoids for at least 6 months. High risk of fracture is defined as a history of osteoporotic fracture, multiple risk factors for fracture, or patients who have failed or are intolerant to other available osteoporosis therapy [see
label id: 5958fefc-c45c-0cde-e063-6294a90a0887
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 3c45dca85d83b80dd2cd45007a8f7b97fcb059038c6248c97b90893793354f4e
start: 1304

current approval status

not_reconciled

duplicate text group

dup-94b5b268908f315696e8

extraction review status

automated_candidate_pending_source_review

generic names

DENOSUMAB

ind-span-0505206ae764e38e5d1e

label id

5958fefc-c45c-0cde-e063-6294a90a0887

positive predicate support span

end: 1577
end exclusive: true
exact text: is indicated
label id: 5958fefc-c45c-0cde-e063-6294a90a0887
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 3c45dca85d83b80dd2cd45007a8f7b97fcb059038c6248c97b90893793354f4e
start: 1565

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

bbaf8e3e49a06d91fa717d034adb1798932735c99e42d8d769cf5f9eb31d345e

source defined aliases

source span

end: 1870
end exclusive: true
exact text: 1.3 Treatment of Glucocorticoid-Induced Osteoporosis Bildyos is indicated for the treatment of glucocorticoid-induced osteoporosis in men and women at high risk of fracture who are either initiating or continuing systemic glucocorticoids in a daily dosage equivalent to 7.5 mg or greater of prednisone and expected to remain on glucocorticoids for at least 6 months.
label id: 5958fefc-c45c-0cde-e063-6294a90a0887
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 3c45dca85d83b80dd2cd45007a8f7b97fcb059038c6248c97b90893793354f4e
start: 1504

source url

https://api.fda.gov/drug/label.json?search=id%3A%225958fefc-c45c-0cde-e063-6294a90a0887%22

spl effective date

2026-08-18

spl set id

b9e32bf7-d70a-4083-8577-c15751c7f769

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 15 · risk or warning

application numbers

BLA761444

brand names

BILDYOS

classification reasons

risk_or_warning_words_without_positive_predicate

clinical review status

pending

content role

risk_or_warning

context span

end: 2298
end exclusive: true
exact text: cture who are either initiating or continuing systemic glucocorticoids in a daily dosage equivalent to 7.5 mg or greater of prednisone and expected to remain on glucocorticoids for at least 6 months. High risk of fracture is defined as a history of osteoporotic fracture, multiple risk factors for fracture, or patients who have failed or are intolerant to other available osteoporosis therapy [see Clinical Studies ( 14.3 )] . 1.4 Treatment of Bone Loss in Men Receiving Androgen Deprivation Therapy for Prostate Cancer Bildyos is indicated as a treatment to increase bone mass in men at high risk for fracture receiving andro
label id: 5958fefc-c45c-0cde-e063-6294a90a0887
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 3c45dca85d83b80dd2cd45007a8f7b97fcb059038c6248c97b90893793354f4e
start: 1671

current approval status

not_reconciled

duplicate text group

dup-24355eb5b8009a25366a

extraction review status

automated_candidate_pending_source_review

generic names

DENOSUMAB

ind-span-84c52646ae378f7babde

label id

5958fefc-c45c-0cde-e063-6294a90a0887

positive predicate support span

Source null

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

bbaf8e3e49a06d91fa717d034adb1798932735c99e42d8d769cf5f9eb31d345e

source defined aliases

source span

end: 2098
end exclusive: true
exact text: High risk of fracture is defined as a history of osteoporotic fracture, multiple risk factors for fracture, or patients who have failed or are intolerant to other available osteoporosis therapy [see Clinical Studies ( 14.3 )] .
label id: 5958fefc-c45c-0cde-e063-6294a90a0887
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 3c45dca85d83b80dd2cd45007a8f7b97fcb059038c6248c97b90893793354f4e
start: 1871

source url

https://api.fda.gov/drug/label.json?search=id%3A%225958fefc-c45c-0cde-e063-6294a90a0887%22

spl effective date

2026-08-18

spl set id

b9e32bf7-d70a-4083-8577-c15751c7f769

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

not_applicable

Passage 16 · positive indication candidate

application numbers

BLA761444

brand names

BILDYOS

classification reasons

explicit_positive_indication_predicate
supportive_or_complication_use_words

clinical review status

pending

content role

positive_indication_candidate

context span

end: 2562
end exclusive: true
exact text: ined as a history of osteoporotic fracture, multiple risk factors for fracture, or patients who have failed or are intolerant to other available osteoporosis therapy [see Clinical Studies ( 14.3 )] . 1.4 Treatment of Bone Loss in Men Receiving Androgen Deprivation Therapy for Prostate Cancer Bildyos is indicated as a treatment to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy (ADT) for nonmetastatic prostate cancer. In these patients denosumab also reduced the incidence of vertebral fractures [see Clinical Studies ( 14.4 )] . 1.5 Treatment of Bone Loss in Women Receiving Adjuvant Aromatase Inhibitor Therapy for
label id: 5958fefc-c45c-0cde-e063-6294a90a0887
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 3c45dca85d83b80dd2cd45007a8f7b97fcb059038c6248c97b90893793354f4e
start: 1899

current approval status

not_reconciled

duplicate text group

dup-b76040520cead852a9c6

extraction review status

automated_candidate_pending_source_review

generic names

DENOSUMAB

ind-span-f2f5947176c6f75e4ed4

label id

5958fefc-c45c-0cde-e063-6294a90a0887

positive predicate support span

end: 2212
end exclusive: true
exact text: is indicated
label id: 5958fefc-c45c-0cde-e063-6294a90a0887
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 3c45dca85d83b80dd2cd45007a8f7b97fcb059038c6248c97b90893793354f4e
start: 2200

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

bbaf8e3e49a06d91fa717d034adb1798932735c99e42d8d769cf5f9eb31d345e

source defined aliases

source span

end: 2362
end exclusive: true
exact text: 1.4 Treatment of Bone Loss in Men Receiving Androgen Deprivation Therapy for Prostate Cancer Bildyos is indicated as a treatment to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy (ADT) for nonmetastatic prostate cancer.
label id: 5958fefc-c45c-0cde-e063-6294a90a0887
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 3c45dca85d83b80dd2cd45007a8f7b97fcb059038c6248c97b90893793354f4e
start: 2099

source url

https://api.fda.gov/drug/label.json?search=id%3A%225958fefc-c45c-0cde-e063-6294a90a0887%22

spl effective date

2026-08-18

spl set id

b9e32bf7-d70a-4083-8577-c15751c7f769

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 17 · unclassified context

application numbers

BLA761444

brand names

BILDYOS

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

unclassified_context

context span

end: 2674
end exclusive: true
exact text: Therapy for Prostate Cancer Bildyos is indicated as a treatment to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy (ADT) for nonmetastatic prostate cancer. In these patients denosumab also reduced the incidence of vertebral fractures [see Clinical Studies ( 14.4 )] . 1.5 Treatment of Bone Loss in Women Receiving Adjuvant Aromatase Inhibitor Therapy for Breast Cancer Bildyos is indicated as a treatment to increase bone mass in women at high risk for fracture recei
label id: 5958fefc-c45c-0cde-e063-6294a90a0887
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 3c45dca85d83b80dd2cd45007a8f7b97fcb059038c6248c97b90893793354f4e
start: 2163

current approval status

not_reconciled

duplicate text group

dup-cb8eb419d88078b95a95

extraction review status

automated_candidate_pending_source_review

generic names

DENOSUMAB

ind-span-aca04a3aae74ea2c0332

label id

5958fefc-c45c-0cde-e063-6294a90a0887

positive predicate support span

Source null

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

bbaf8e3e49a06d91fa717d034adb1798932735c99e42d8d769cf5f9eb31d345e

source defined aliases

source span

end: 2474
end exclusive: true
exact text: In these patients denosumab also reduced the incidence of vertebral fractures [see Clinical Studies ( 14.4 )] .
label id: 5958fefc-c45c-0cde-e063-6294a90a0887
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 3c45dca85d83b80dd2cd45007a8f7b97fcb059038c6248c97b90893793354f4e
start: 2363

source url

https://api.fda.gov/drug/label.json?search=id%3A%225958fefc-c45c-0cde-e063-6294a90a0887%22

spl effective date

2026-08-18

spl set id

b9e32bf7-d70a-4083-8577-c15751c7f769

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 18 · positive indication candidate

application numbers

BLA761444

brand names

BILDYOS

classification reasons

explicit_positive_indication_predicate
supportive_or_complication_use_words

clinical review status

pending

content role

positive_indication_candidate

context span

end: 2767
end exclusive: true
exact text: racture receiving androgen deprivation therapy (ADT) for nonmetastatic prostate cancer. In these patients denosumab also reduced the incidence of vertebral fractures [see Clinical Studies ( 14.4 )] . 1.5 Treatment of Bone Loss in Women Receiving Adjuvant Aromatase Inhibitor Therapy for Breast Cancer Bildyos is indicated as a treatment to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer [see Clinical Studies ( 14.5 )] .
label id: 5958fefc-c45c-0cde-e063-6294a90a0887
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 3c45dca85d83b80dd2cd45007a8f7b97fcb059038c6248c97b90893793354f4e
start: 2275

current approval status

not_reconciled

duplicate text group

dup-78112f6ce351ea13ecbe

extraction review status

automated_candidate_pending_source_review

generic names

DENOSUMAB

ind-span-9ac8ece8e5729c6d2b1c

label id

5958fefc-c45c-0cde-e063-6294a90a0887

positive predicate support span

end: 2596
end exclusive: true
exact text: is indicated
label id: 5958fefc-c45c-0cde-e063-6294a90a0887
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 3c45dca85d83b80dd2cd45007a8f7b97fcb059038c6248c97b90893793354f4e
start: 2584

qualifier mentions

context exact
1.5 Treatment of Bone Loss in Women Receiving Adjuvant Aromatase Inhibitor Therapy for Breast Cancer Bildyos is indicated as a treatment to increase
kind
stage_or_setting
polarity
not_inferred
span
end
2564
end exclusive
true
exact text
Adjuvant Aromatase Inhibitor Therapy for Br
label id
5958fefc-c45c-0cde-e063-6294a90a0887
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
3c45dca85d83b80dd2cd45007a8f7b97fcb059038c6248c97b90893793354f4e
start
2521
context exact
ease bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer [see Clinical Studies ( 14.5 )] .
kind
stage_or_setting
polarity
not_inferred
span
end
2722
end exclusive
true
exact text
adjuvant aromatase inhibitor therapy for br
label id
5958fefc-c45c-0cde-e063-6294a90a0887
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
3c45dca85d83b80dd2cd45007a8f7b97fcb059038c6248c97b90893793354f4e
start
2679

regulatory links

schema version

0.1.0

source batch sha256

bbaf8e3e49a06d91fa717d034adb1798932735c99e42d8d769cf5f9eb31d345e

source defined aliases

source span

end: 2767
end exclusive: true
exact text: 1.5 Treatment of Bone Loss in Women Receiving Adjuvant Aromatase Inhibitor Therapy for Breast Cancer Bildyos is indicated as a treatment to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer [see Clinical Studies ( 14.5 )] .
label id: 5958fefc-c45c-0cde-e063-6294a90a0887
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 3c45dca85d83b80dd2cd45007a8f7b97fcb059038c6248c97b90893793354f4e
start: 2475

source url

https://api.fda.gov/drug/label.json?search=id%3A%225958fefc-c45c-0cde-e063-6294a90a0887%22

spl effective date

2026-08-18

spl set id

b9e32bf7-d70a-4083-8577-c15751c7f769

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