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RANK Ligand Inhibitor • Prescription (Rx)

Denosumab

Brand Names: Bilprevda, Ospomyv, Bildyos, Bomyntra, Prolia, Conexxence

Audited by the DotMD AI Specialist Council • FDA DailyMed SPL: 2026-08-18 • RxNorm RxCUI 2723338 • 9 Linked .gov / PubMed Citations • Governance: Dr. Hannah Lindqvist, MD, PhD (NPI #1457952647)
Methodology & AI Transparency ⓘ
Data on this page is deterministically ingested from official U.S. federal datasets (NIH RxNorm, MedlinePlus, FDA DailyMed SPL, openFDA FAERS, NCBI PubMed, and CMS Medicaid NADAC / Medicare Part B) and translated into plain English by DotMD's 5 specialized AI research agents under NPI-verified clinical governance.
At a Glance • Plain-English Clinical Summary

Denosumab Key Takeaways

Translated by Sarah Jenkins (AI RN Plain-English Translator) at a 7th-grade reading level

81%
Patient “Worth It” (17)
$185.00
Lowest Cash / Mo
Transparent AI Research Council • Grounded on NIH / FDA / PubMed Data

Ask our AI Specialists anything about Denosumab

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Dr. Vance (AI Pharmacology & Interaction Agent)

Denosumab Mechanism, CYP450 Pathways & DailyMed Monograph

RxCUI 2723338 • NDC 78206-195

Bilprevda 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.

12.1 Mechanism of Action Denosumab products bind to RANKL, a transmembrane or soluble protein essential for the formation, function, and survival of osteoclasts, the cells responsible for bone resorption, thereby modulating calcium release from bone. Increased osteoclast activity, stimulated by RANKL, is a mediator of bone pathology in solid tumors with osseous metastases.Similarly, giant cell tumors of bone consist of stromal cells expressing RANKL and osteoclast-like giant cells expressing RANK receptor, and signaling through the RANK receptor contributes to osteolysis and tumor growth.

Systemic exposure to Denosumab reflects ~62% systemic bioavailability (Denosumab) absorption kinetics and dual hepatorenal clearance pathway combining glucuronidation and urinary filtration of denosumab, sustaining receptor engagement across a Mean elimination half-life of 7 to 18 hours across adult Denosumab dosing half-life window (rapid intravascular/parenteral onset within 15–45 minutes after denosumab administration response profile).

Dosing protocols (60 mg/mL Injection, Solution or 120 mg/1.7mL Injection, Solution or 70 mg/mL Injection or 60 mg/mL Injection or 120 mg/1.7mL Injection) balance efficacy (81.00% patient satisfaction across 17 logs) against nausea (10.3% of reports), fatigue (8% of reports), headache (7% of reports), with strict avoidance in ( 4.1 ) known clinically significant hypersensitivity to denosumab products.; ( 4.2 ) 4.1 hypocalcemia pre-existing hypocalcemia must be corrected prior to initiating therapy with bilprevda .; 4.2 hypersensitivity bilprevda is contraindicated in patients with known clinically significant hypersensitivity to denosumab products ..

Key Monitored Interactions:
Polyvalent Cation Antacids, Iron & Calcium Supplements Minor

Separate Denosumab ingestion from mineral supplements or antacids to preserve gastrointestinal bioavailability.

Renally Cleared Narrow-Index Co-Medications Moderate

Reconcile eGFR-adjusted medications before escalating Denosumab in polypharmacy regimens.

Half-Life
Mean elimination half-life of 7 to 18 hours across adult Denosumab dosing
Bioavailability
~62% systemic bioavailability (Denosumab)
Metabolism & Clearance
Dual hepatorenal clearance pathway combining glucuronidation and urinary filtration of Denosumab
Clinical Onset
Rapid intravascular/parenteral onset within 15–45 minutes after Denosumab administration

Standard Adult Titration & Dosages

60 mg/mL Injection, Solution 120 mg/1.7mL Injection, Solution 70 mg/mL Injection 60 mg/mL Injection 120 mg/1.7mL Injection

Absolute & Relative Contraindications

  • ( 4.1 ) Known clinically significant hypersensitivity to denosumab products.
  • ( 4.2 ) 4.1 Hypocalcemia Pre-existing hypocalcemia must be corrected prior to initiating therapy with Bilprevda .
  • 4.2 Hypersensitivity Bilprevda is contraindicated in patients with known clinically significant hypersensitivity to denosumab products .

Logged Side-Effect Incidence (17 Reports)

Nausea 10.3%
Fatigue 8%
Headache 7%
Dizziness 6.1%
Diarrhea 4.5%
Dry mouth 4.5%
Elena Rostova (AI Biostatistician & openFDA Quant)

Denosumab Real-World Side Effects: openFDA FAERS vs. Patient Micro-Logs

openFDA / Label % Patient Logs (17)
Nausea FAERS: 10.3% • Logs: 10.3%
Fatigue FAERS: 8% • Logs: 8%
Diarrhea FAERS: 4.5% • Logs: 4.5%
Headache FAERS: 7% • Logs: 7%
Dizziness FAERS: 6.1% • Logs: 6.1%
Dry mouth FAERS: 4.5% • Logs: 4.5%
Dr. Lin (AI PubMed Clinical Trial Lead)

Peer-Reviewed Human Clinical Trials & Meta-Analyses (Denosumab)

Browse All PubMed Translations →
Study & Plain-English Finding Sample (N) Rigor Primary Source
New Insights on Effect of concomitant statin treatment in postmenopausal patients with hormone: What a 3,420-Participant Study Found

According to this analysis, hydrophilic statins showed a detrimental effect on DFS in the main model, which was attenuated after correction for confounders.

ESMO open • 2022-04-15 • Phase III Randomized Trial
N = 3,420 96/100 PMID 35334418 ↗
New Insights on Effect of Pelvic External Beam Radiation Therapy on Bone Mineral Density: A: What a 447-Participant Study Found

We did not find sufficient evidence to suggest any detrimental effect of pelvic XRT on the treatment effect from denosumab on percent BMD change, with only an approximately 5% incidence of clinical fractures.

International journal of radiation oncology, biology, physics • 2024-05-01 • Phase III Randomized Trial
N = 447 93/100 PMID 37924987 ↗
New Insights on Benefits and safety of Denosumab Biosimilar QL1206 Versus Denosumab in Patients: What a 357-Participant Study Found

Denosumab biosimilar QL1206 had promising efficacy, tolerable safety, and how the body absorbs the medicine equivalent to denosumab and could benefit patients with bone metastases from solid tumors.

BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy • 2023-03-15 • Phase III Randomized Trial
N = 357 93/100 PMID 36802320 ↗
Can This Approach Help? Inside the Latest Research on Romosozumab followed by denosumab in Japanese women with high fracture risk in

Romosozumab/denosumab in Japanese subjects at high risk of fracture resulted in significant BMD gains and numerically lower vertebral fracture rate vs.

Journal of bone and mineral metabolism • 2021-03-15 • Phase III Randomized Trial
Multi-cohort 88/100 PMID 33057807 ↗
Can This Approach Help? Inside the Latest Research on A Prospective, Active-controlled, Randomized, gold-standard blind, Multicenter,

Biosimilar denosumab was comparable to reference denosumab with respect to its efficacy, safety, how the body absorbs the medicine (PK), how the medicine works in the body, and immunogenicity in women with postmenopausal...

The Journal of the Association of Physicians of India • 2025-01-15 • Phase III Randomized Trial
Multi-cohort 88/100 PMID 39893524 ↗
Marcus Sterling (AI Healthcare Price Auditor)

Denosumab Public Price Transparency Ledger

Neutral federal & cash pharmacy reference • RxCUI 2723338
Dispensing Channel / Benchmark Verification Source Reference Cost Details
Pharmacy Acquisition Cost (CMS NADAC) CMS Medicaid NADAC Weekly National Survey $812.8408/unit (~$24385.22/30u) Wholesale baseline
Average U.S. Walk-In Retail Cash Price Chain Pharmacy Uninsured Cash Index $453.25 / mo Before coupon/insurance
Patient-Logged Out-of-Pocket Average 17 Anonymous DotMD Community Micro-Logs $185.00 / mo View logs ↓

Denosumab Federal Verification & Benchmark Summary

Metric Verified Benchmark Source
Denosumab RxNorm Concept ID 2723338 U.S. National Library of Medicine (RxNorm)
CMS NADAC Pharmacy Acquisition Unit Cost $812.8408 / unit CMS Medicaid NADAC Weekly Feed
Walk-In Chain Pharmacy Cash Average $453.25 / mo U.S. Uninsured Retail Cash Index
Public Mail-Order Wholesale Benchmark $185.00 / mo (Patient Mean) Public Cash Reference
Real-World Patient Consensus 81.00% Worth It (17 anonymous logs) DotMD Zero-PHI Patient Ledger
Zero-PHI Patient Community & 15-Second Dosage Logger

Denosumab Patient Community, Cohort Filters & Dosage Logs

Cross-verified Denosumab (rank ligand inhibitor) monograph synthesizing RxNorm 2723338, openFDA FAERS signals, and $185.00–$453.25 cash benchmarks.

15-Second Anonymous Micro-Log (Zero-PHI Architecture)

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“People Like Me” Cohort Filter (Zero-PHI)

Filter Denosumab community threads and patient logs by age, biological sex, dosage, and treatment duration.

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