LABELS · 3f864a08-c693-4fdf-8158-c9e0d956fcad

JUBBONTI

Open original source → · Download preserved record

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

Label effective date: 2025-10-30
Captured: 2026-09-09T23:37:44.904352+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 Jubbonti in patients with advanced chronic kidney disease, evaluate for the presence of CKD-MBD. Treatment with Jubbonti 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 Jubbonti in patients with advanced chronic kidney disease, evaluate for the presence of CKD-MBD. Treatment with Jubbonti 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 Jubbonti 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 Jubbonti 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 Jubbonti 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 Jubbonti 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 Jubbonti 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 Jubbonti 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

BLA761362

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 Jubbonti in patients with advanced chronic kidney disease, evaluate for the presence of CKD-MBD. Treatment with Jubbonti 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 Jubbonti in patients with advanced chronic kidney disease, evaluate for the presence of CKD-MBD. Treatment with Jubbonti 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

JUBBONTI

current indication status

not_reconciled

dailymed set url

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=4bf239bb-c467-4add-b7cf-ea666e4fc693

generic names

DENOSUMAB

3f864a08-c693-4fdf-8158-c9e0d956fcad

indications and usage exact

1 INDICATIONS AND USAGE Jubbonti 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 Jubbonti 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 Jubbonti 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 Jubbonti 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 Jubbonti 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 Jubbonti 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

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Sandoz Inc

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cancer

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HUMAN PRESCRIPTION DRUG

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Warnings and Precautions ( 5.2 ) 10/2025

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Source passages and status connections

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

Passage 1 · indication intro context

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exact text: 1 INDICATIONS AND USAGE Jubbonti 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 osteopor
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Passage 2 · unclassified context

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exact text: 1 INDICATIONS AND USAGE Jubbonti 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
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Passage 3 · unclassified context

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exact text: 1 INDICATIONS AND USAGE Jubbonti 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 mas
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exact text: 1 INDICATIONS AND USAGE Jubbonti 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 fo
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Passage 5 · unclassified context

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exact text: d (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 nonmet
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Passage 6 · unclassified context

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exact text: ) 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 fr
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Passage 7 · unclassified context

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exact text: igh 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 r
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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 Jubbonti 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
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Passage 19 · positive indication candidate

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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 Jubbonti 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 )] .
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Preserved source evidence · Not medical advice