Prescription medicine
Denosumab Brand names: Bomyntra, Denosumab-Bmwo, Osenvelt, Jubereq, Ospomyv; first approved as Prolia
Denosumab (Prolia) is a prescription medicine with an FDA approval on record since 2010. No generic is listed; pharmacies paid $1,862.74 per mL (Prolia 60 mg/mL syringe) in the October 7, 2026 NADAC survey.
- No generic listed
Check it at the source: the denosumab FDA label on DailyMed (effective June 23, 2026, Amgen, Inc); the BLA 125320 record on Drugs@FDA; every denosumab label on DailyMed.
Highlights of the record
FDA label of June 23, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageXgeva 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.
Forms and strengths
- 60 mg/ml
- 70 mg/ml
- 120 mg/1.7ml
Injection; injection (solution).
On the market
- Earliest approval on file
- June 1, 2010 Prolia, Amgen; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 10 of which 0 under generic applications, 10 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $1,862.74 per mL Prolia 60 mg/mL syringe
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 2 since 2013 0 Class I among all firms' recalls; latest April 21, 2025
- FAERS reports
- 201,378 through July 30, 2026
What is denosumab used for?
From the label: indications and usageXgeva 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. […]
Conditions named in the indications of denosumab's FDA labels, with every medicine labeled for each:
From other denosumab labelsOsteoporosis: • of postmenopausal women with osteoporosis at high risk for fracture.
FDA pharmacologic class: RANK Ligand Inhibitor.
Source: FDA drug label (XGEVA), Amgen, Inc, effective June 23, 2026 (SPL set 628f0998-1206-4001-aeee-18133aa9f3bf), via openFDA; the full label on DailyMed
What does the patient leaflet for denosumab say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about Prolia?If you receive Prolia, you should not receive other denosumab products at the same time. Prolia can cause serious side effects including: Increased risk of severe low calcium levels in your blood (hypocalcemia). Prolia may lower the calcium levels in your blood. If you have low blood calcium before you start receiving Prolia, it may get worse during treatment. Your low blood calcium must be treated before you receive Prolia. Talk to your doctor before starting Prolia. Your doctor may prescribe calcium and vitamin D to help prevent low calcium levels in your blood while you take Prolia. Take calcium and vitamin D as your doctor tells you to. If you have advanced chronic kidney disease (may or may not be on kidney dialysis), Prolia may increase your risk for severe low calcium levels in your blood, which could result in hospitalization, life-threatening events and death. A mineral and bone disorder associated with kidney disease called chronic kidney disease-mineral bone disorder (CKD-MBD) may increase your risk for severe low calcium levels in blood. Before you start Prolia and during treatment, your doctor may need to do certain blood tests to check for CKD-MBD. Most people with low blood calcium levels do not have symptoms, but some people may have symptoms. Call your doctor right away if you have symptoms of low blood calcium such as: spasms, twitches, or cramps in your muscles numbness or tingling in your fingers, toes, or around your mouth Serious allergic reactions. Serious allergic reactions have happened in people who take Prolia. Call your doctor or go to your nearest emergency room right away if you have any symptoms of a serious allergic reaction. […]
From the patient leaflet: How should I store Prolia if I need to pick it up from a pharmacy?Keep Prolia in a refrigerator at 36°F to 46°F (2°C to 8°C) in the original carton. Do not freeze Prolia. When you remove Prolia from the refrigerator, Prolia must be kept at room temperature [up to 77°F (25°C)] in the original carton and must be used within 30 days. Do not keep Prolia at temperatures above 77°F (25°C). Warm temperatures will affect how Prolia works. Do not shake Prolia. Keep Prolia in the original carton to protect from light. Keep Prolia and all medicines out of the reach of children.
Source: FDA drug label (Prolia), Amgen, Inc, effective June 26, 2026 (SPL set 49e5afe9-a0c7-40c4-af9f-f287a80c5c88), via openFDA; the full label on DailyMed
Is there a generic for denosumab (Prolia)?
No generic denosumab is approved (Drugs@FDA, October 8, 2026).
- 2010 earliest approval on file
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for denosumab (Prolia)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $1,862.74 per mL (Prolia 60 mg/mL syringe), up 3% from $1,809.19 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Prolia 60 mg/mL syringe (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Bildyos 60 mg/mL syringe | Brand | $814.13 per mL | n/a | n/a |
| Conexxence 60 mg/mL syringe | Brand | $1,740.45 per mL | n/a | n/a |
| Jubbonti 60 mg/mL syringe | Brand | $1,536.91 per mL | n/a | +1% |
| Prolia 60 mg/mL syringe | Brand | $1,862.74 per mL | n/a | +3% |
| Stoboclo 60 mg/mL syringe | Brand | $1,582.15 per mL | n/a | n/a |
| Xgeva 120 mg/1.7 mL vial | Brand | $2,001.52 per mL | $3,402.58 per vial | +3% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has denosumab been recalled?
The FDA's Enforcement Report lists 2 recalls naming denosumab since 2013: 0 Class I (the most serious), 2 Class II, 0 Class III; 1 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| April 21, 2025 | Class II | Mckesson Medical-Surgical Inc. Corporate Office | CGMP Deviations; potential temperature excursions due to transit delays |
| September 17, 2013 | Class II | Amgen, Inc. | Presence of Particulate Matter: Visible cellulose fibers were observed in a small number of prefilled syringes during a routine quality examination. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the denosumab label say about other medicines?
The denosumab label names 1 other medicine in its interaction, contraindication or warning sections. The labels of 3 other medicines name denosumab. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Prednisone | warnings and precautions | A number of reports note that patients were also receiving treatment with glucocorticoids (e.g., prednisone) at the time of fracture. |
Other labels that name denosumab
Source: FDA drug label (XGEVA), Amgen, Inc, effective June 23, 2026 (SPL set 628f0998-1206-4001-aeee-18133aa9f3bf), via openFDA; the full label on DailyMed
What do FAERS reports show for denosumab?
The FDA Adverse Event Reporting System holds 201,378 reports that list denosumab among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 25,734 are coded as a death and 31,434 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Reports rose sharply in 2017 (33,838, against a median of 10,399 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as denosumab?
2 other medicines are given the same way (subcutaneous) and in the same FDA class as denosumab or labeled mainly for the same use (osteoporosis), the same class first. Osteoporosis lists all 16 medicines labeled for it, by any route. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (subcutaneous) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Teriparatide | Osteoporosis | 4 labelers | $479.95 per mL 560 mcg/2.24 mL pen | No current entry |
| Abaloparatide | Osteoporosis | none listed | n/a | No current entry |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does denosumab compare with medicines for the same use?
1 side-by-side page set denosumab beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Denosumab side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other