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JUBBONTI (DENOSUMAB-BBDZ)
JUBBONTI (generic name: DENOSUMAB-BBDZ) is a RANK Ligand Inhibitor [EPC] drug developed by SANDOZ INC. It is currently FDA-approved.
At a glance
| Generic name | DENOSUMAB-BBDZ |
|---|---|
| Sponsor | SANDOZ INC |
| Drug class | RANK Ligand Inhibitor [EPC] |
| Therapeutic area | Other |
| Phase | FDA-approved |
Approved indications
Boxed warnings
- 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 ) .
Common side effects
- Back pain
- Pain in extremity
- Musculoskeletal pain
- Hypercholesterolemia
- Cystitis
- Arthralgia
- Nasopharyngitis
- Hypertension
- Bronchitis
- Headache
- Constipation
- Pharyngitis
Serious adverse events
- Hypocalcemia
- Nonfatal serious adverse events
- All-cause mortality
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- JUBBONTI CI brief — competitive landscape report
- JUBBONTI updates RSS · CI watch RSS
- SANDOZ INC portfolio CI
Frequently asked questions about JUBBONTI
What is JUBBONTI?
JUBBONTI (DENOSUMAB-BBDZ) is a RANK Ligand Inhibitor [EPC] drug developed by SANDOZ INC.
Who makes JUBBONTI?
JUBBONTI is developed and marketed by SANDOZ INC (see full SANDOZ INC pipeline at /company/sandoz).
What is the generic name of JUBBONTI?
DENOSUMAB-BBDZ is the generic (nonproprietary) name of JUBBONTI.
What drug class is JUBBONTI in?
JUBBONTI belongs to the RANK Ligand Inhibitor [EPC] class. See all RANK Ligand Inhibitor [EPC] drugs at /class/rank-ligand-inhibitor-epc.
What development phase is JUBBONTI in?
JUBBONTI is FDA-approved (marketed).
What are the side effects of JUBBONTI?
Common side effects of JUBBONTI include Back pain, Pain in extremity, Musculoskeletal pain, Hypercholesterolemia, Cystitis, Arthralgia. Serious adverse events: Hypocalcemia, Nonfatal serious adverse events, All-cause mortality.
Related
- Drug class: All RANK Ligand Inhibitor [EPC] drugs
- Manufacturer: SANDOZ INC — full pipeline
- Therapeutic area: All drugs in Other
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing