LABELS · c0ae96a3-47b7-4b70-98a2-e88074ff6f10

WYOST

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: 2026-02-20
Captured: 2026-09-09T23:37:58.719708+00:00
Current indication reconciliation: Not reconciled

Indications and usage: exact source text

1 INDICATIONS AND USAGE Wyost is a RANK ligand (RANKL) inhibitor indicated for: • Prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors. ( 1.1 ) • Treatment of adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity. ( 1.2 , 14.3 ) • Treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy. ( 1.3 ) 1.1 Multiple Myeloma and Bone Metastasis from Solid Tumors Wyost is indicated for the prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors. 1.2 Giant Cell Tumor of Bone Wyost is indicated for the treatment of adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity [see Clinical Trials ( 14.2 )]. 1.3 Hypercalcemia of Malignancy Wyost is indicated for the treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy.

Full extracted label fields

application numbers

BLA761362

boxed warning exact

brand names

WYOST

current indication status

not_reconciled

dailymed set url

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=69e4890d-5dd9-42a5-aa41-ce50635eaed7

generic names

DENOSUMAB

c0ae96a3-47b7-4b70-98a2-e88074ff6f10

indications and usage exact

1 INDICATIONS AND USAGE Wyost is a RANK ligand (RANKL) inhibitor indicated for: • Prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors. ( 1.1 ) • Treatment of adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity. ( 1.2 , 14.3 ) • Treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy. ( 1.3 ) 1.1 Multiple Myeloma and Bone Metastasis from Solid Tumors Wyost is indicated for the prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors. 1.2 Giant Cell Tumor of Bone Wyost is indicated for the treatment of adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity [see Clinical Trials ( 14.2 )]. 1.3 Hypercalcemia of Malignancy Wyost is indicated for the treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy.

indications and usage tables exact

is original packager

true

manufacturer names

Sandoz Inc

matched search terms

myeloma
tumor
tumors
malignancy

package ndcs

61314-228-94

product ndcs

61314-228

product types

HUMAN PRESCRIPTION DRUG

recent major changes exact

Dosage and Administration ( 2.1 ) 10/2025 Warnings and Precautions ( 5.1 ) 10/2025

record type

complete_spl_indications_section_candidate

routes

SUBCUTANEOUS

rxcuis

2715386
2715393

source batch

file

/private/tmp/cancer-full-research/indications/raw/labels-00600.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

BLA761362

brand names

WYOST

classification reasons

explicit_positive_indication_predicate
no_tumor_directed_keyword_in_positive_statement
incomplete_colon_led_indication_intro

clinical review status

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content role

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end: 279
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exact text: 1 INDICATIONS AND USAGE Wyost is a RANK ligand (RANKL) inhibitor indicated for: • Prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors. ( 1.1 ) • Treatment of adults and skeletally mature adolescents with
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qualifier mentions

regulatory links

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exact text: 1 INDICATIONS AND USAGE Wyost is a RANK ligand (RANKL) inhibitor indicated for:
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source url

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spl effective date

2026-02-20

spl set id

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spl version

structured fields status

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structured indication

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

use intent

not_applicable

Passage 2 · positive indication candidate

application numbers

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brand names

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classification reasons

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supportive_or_complication_use_words

clinical review status

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context span

end: 409
end exclusive: true
exact text: 1 INDICATIONS AND USAGE Wyost is a RANK ligand (RANKL) inhibitor indicated for: • Prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors. ( 1.1 ) • Treatment of adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity. ( 1.2 , 14.3 )
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exact text: is a RANK ligand (RANKL) inhibitor indicated
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qualifier mentions

context exact
in patients with multiple myeloma and in patients with bone metastases from solid tumors.
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exact text: • Prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors.
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source url

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spl effective date

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spl set id

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spl version

structured fields status

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structured indication

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

use intent

supportive_care_candidate

Passage 3 · unclassified context

application numbers

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brand names

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classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

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context span

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exact text: ONS AND USAGE Wyost is a RANK ligand (RANKL) inhibitor indicated for: • Prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors. ( 1.1 ) • Treatment of adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity. ( 1.2 , 14.3 ) • Treatm
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exact text: ( 1.1 )
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source url

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spl effective date

2026-02-20

spl set id

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spl version

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structured indication

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

use intent

unclear

Passage 4 · positive indication candidate

application numbers

BLA761362

brand names

WYOST

classification reasons

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tumor_or_malignant_hematology_words_in_positive_statement

clinical review status

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context span

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exact text: USAGE Wyost is a RANK ligand (RANKL) inhibitor indicated for: • Prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors. ( 1.1 ) • Treatment of adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity. ( 1.2 , 14.3 ) • Treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy. ( 1.3 ) 1.1 Multiple Myeloma and Bone Metastasis from Solid Tumors Wyost is indicated for the preventio
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DENOSUMAB

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label id

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positive predicate support span

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qualifier mentions

context exact
• Treatment of adults and skeletally mature adolescents with giant cell tumor of
kind
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polarity
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end
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exact text
adults
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context exact
ly mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity.
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regulatory links

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exact text: • Treatment of adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity.
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source url

https://api.fda.gov/drug/label.json?search=id%3A%22c0ae96a3-47b7-4b70-98a2-e88074ff6f10%22

spl effective date

2026-02-20

spl set id

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structured indication

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

use intent

tumor_directed_candidate

Passage 5 · unclassified context

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brand names

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exact text: m solid tumors. ( 1.1 ) • Treatment of adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity. ( 1.2 , 14.3 ) • Treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy. ( 1.3 ) 1.1 Multiple Myeloma and Bone Metastasis from Solid Tumors Wyost is indicated for the prevention of skeletal-r
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source url

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use intent

unclear

Passage 6 · unclassified context

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exact text: ( 1.1 ) • Treatment of adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity. ( 1.2 , 14.3 ) • Treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy. ( 1.3 ) 1.1 Multiple Myeloma and Bone Metastasis from Solid Tumors Wyost is indicated for the prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metasta
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source url

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use intent

unclear

Passage 7 · unclassified context

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exact text: tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity. ( 1.2 , 14.3 ) • Treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy. ( 1.3 ) 1.1 Multiple Myeloma and Bone Metastasis from Solid Tumors Wyost is indicated for the prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metastases from
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exact text: ( 1.3 )
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source url

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spl effective date

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line: Source null
prior therapy: Source null
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use intent

unclear

Passage 8 · positive indication candidate

application numbers

BLA761362

brand names

WYOST

classification reasons

explicit_positive_indication_predicate
supportive_or_complication_use_words

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