Denosumab Injection
Denosumab Injection is a bone-protecting medicine (a RANK ligand inhibitor) used to treat osteoporosis and to build bone mass in people at high risk of fracture, including those losing bone from prostate cancer or breast cancer treatment.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 9 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
Denosumab is a twice-yearly injection that blocks RANKL, a protein that switches on bone-dissolving cells, to treat osteoporosis and bone loss from prostate or breast cancer treatment; on the market since about 2010 and made by several companies, it is a common choice when fracture risk is high. Most people tolerate it well, and the usual complaints are back pain and muscle or joint aches. Watch for low calcium, the focus of its boxed warning in advanced kidney disease and dialysis, so take calcium and vitamin D daily and report cramps, numbness or tingling right away. Never stop without a plan, because fracture risk climbs after it wears off.
Clinical pearls
- Get a dental check-up before starting, and tell your dentist about denosumab before any tooth extraction, since jaw bone damage can occur.
- If a dose is late, get it as soon as you can, then count each next six-month dose from that date.
- New thigh, hip or groin pain deserves a prompt call, as it can signal an unusual thigh bone fracture.
- Women who could become pregnant need effective birth control during treatment and for at least 5 months after the last dose.
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾
People with advanced kidney disease (including those on dialysis) are at much higher risk of severe low calcium after denosumab. This has led to hospitalization, life-threatening events, and deaths.
Having chronic kidney disease-mineral bone disorder (a kidney-related bone and mineral problem) raises the risk even more. Before starting Jubbonti, your doctor should check for it. Treatment should be overseen by a provider experienced in managing it. Watch for muscle cramps, spasms, numbness or tingling, and tell your care team right away.
Patient information guide A plain-language walkthrough of Denosumab Injection, written from its FDA label.
What Denosumab Injection is used for
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Denosumab Injection is used to protect bones in several situations. Jubbonti is indicated for the following:
- Treating postmenopausal women with osteoporosis at high risk for fracture
- Increasing bone mass in men with osteoporosis at high risk for fracture
- Treating glucocorticoid-induced osteoporosis in men and women at high risk for fracture
- Increasing bone mass in men at high risk for fracture who receive androgen deprivation therapy for nonmetastatic prostate cancer
- Increasing bone mass in women at high risk for fracture who receive adjuvant aromatase inhibitor therapy for breast cancer
How Denosumab Injection works
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Denosumab binds to RANKL, a protein needed for osteoclasts to form, work, and survive. Osteoclasts are the cells that break down bone.
By keeping RANKL from activating its receptor (RANK), denosumab reduces bone breakdown and increases bone mass and strength.
Denosumab Injection dosage
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Denosumab Injection is given under the skin (subcutaneous), usually once every 6 months. Prolia is given by a healthcare provider.
- Common sites are the upper arm, upper thigh, or abdomen.
- Take calcium and vitamin D daily as directed.
- If you miss a dose, get it as soon as you can, then continue every 6 months from that date.
Follow your prescriber and the product label.
Dosing details from the FDA-approved label
From the Denosumab Injection prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.
- Recommended dosage (all patients)
- 60 mg administered as a single subcutaneous injection once every 6 months, in the upper arm, the upper thigh, or the abdomen
- To be administered by a healthcare provider
- All patients should receive calcium 1000 mg daily and at least 400 IU vitamin D daily; if a dose is missed, administer as soon as the patient is available, then schedule injections every 6 months from the date of the last injection
- Advanced chronic kidney disease [eGFR < 30 mL/min/1.73 m2], including dialysis-dependent patients
- 60 mg administered as a single subcutaneous injection once every 6 months
- Before treatment, evaluate for CKD-MBD with iPTH, serum calcium, 25(OH) vitamin D, and 1,25(OH)2 vitamin D
Read the label’s full dosing text
2 DOSAGE AND ADMINISTRATION Pregnancy must be ruled out prior to administration of Prolia. ( 2.1 ) Before initiating Prolia in patients with advanced chronic kidney disease, including dialysis patients, evaluate for the presence of chronic kidney disease mineral and bone disorder with intact parathyroid hormone, serum calcium, 25(OH) vitamin D, and 1,25(OH) 2 vitamin D. ( 2.2 , 5.1 , 8.6 ) Prolia should be administered by a healthcare provider. ( 2.3 ) Administer 60 mg every 6 months as a subcutaneous injection in the upper arm, upper thigh, or abdomen. ( 2.3 ) Instruct patients to take calcium 1000 mg daily and at least 400 IU vitamin D daily. ( 2.3 ) 2.1 Pregnancy Testing Prior to Initiation of Prolia Pregnancy must be ruled out prior to administration of Prolia. Perform pregnancy testing in all females of reproductive potential prior to administration of Prolia. Based on findings in animals, Prolia can cause fetal harm when administered to pregnant women [see Use in Specific Populations (8.1 , 8.3) ] . 2.2 Laboratory Testing in Patients with Advanced Chronic Kidney Disease Prior to Initiation of Prolia In patients with advanced chronic kidney disease [i.e., estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m 2 ], including dialysis-dependent patients, evaluate for the presence of chronic kidney disease mineral and bone disorder (CKD-MBD) with intact parathyroid hormone (iPTH), serum calcium, 25(OH) vitamin D, and 1,25 (OH) 2 vitamin D prior to decisions regarding Prolia treatment. Consider also assessing bone turnover status (serum markers of bone turnover or bone biopsy) to evaluate the underlying bone disease that may be present [see Warnings and Precautions (5.1) ] . 2.3 Recommended Dosage Prolia should be administered by a healthcare provider. The recommended dose of Prolia is 60 mg administered as a single subcutaneous injection once every 6 months. Administer Prolia via subcutaneous injection in the upper arm, the upper thigh, or the abdomen. All patients should receive calcium 1000 mg daily and at least 400 IU vitamin D daily [see Warnings and Precautions (5.1) ] . If a dose of Prolia is missed, administer the injection as soon as the patient is available. Thereafter, schedule injections every 6 months from the date of the last injection.
Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →
Denosumab Injection side effects
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Common side effects depend on the condition treated:
Common side effects
- Back pain
- Pain in arms or legs
- Muscle and bone pain
- Joint pain
- High cholesterol
- Bladder infection (cystitis)
- Cold-like symptoms (nasopharyngitis)
- Headache
- Cold-like symptoms, bronchitis, or headache
When to get medical help
- Muscle cramps, spasms, numbness or tingling, which can signal low calcium
- Signs of an allergic reaction, such as swelling of the face or throat, trouble breathing, hives or low blood pressure
- Signs of infection, such as red, warm, swollen or painful skin (cellulitis), or other signs of a serious infection
- Jaw pain, loose teeth, or a mouth sore that will not heal
- New or unusual thigh, hip, or groin pain
- Severe bone, joint, or muscle pain
- Severe rash, dermatitis, or eczema
- Back pain or new fractures after stopping treatment
Denosumab Injection warnings and precautions
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- Severe low calcium: can be fatal, especially in advanced kidney disease. Low calcium must be corrected before starting.
- Serious infections: including skin infections that led to hospitalization.
- Allergic reactions: including anaphylaxis. Treatment is stopped permanently if a significant reaction occurs.
- Jaw bone damage: keep up good oral hygiene and report jaw problems.
- Unusual thigh bone fractures: report new thigh, hip, or groin pain.
- Stopping treatment: fracture risk rises, including multiple spine fractures, so a switch to another bone-protecting medicine is advised.
- Bone turnover suppression: long-term effects are unknown.
Denosumab Injection interactions
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A few things can change the risks of denosumab:
- Other denosumab products: should not be used at the same time.
- Calcimimetic drugs: may worsen low calcium.
- Steroids, chemotherapy, angiogenesis inhibitors: may raise jaw bone problem risk.
- Immunosuppressants: may raise infection risk.
Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.
Before taking Denosumab Injection
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- Do not use with low calcium, pregnancy, or a past serious allergic reaction to denosumab.
- Women who could become pregnant need a pregnancy test and effective birth control during treatment and for at least 5 months after the last dose of Jubbonti.
- Breastfeeding: there is no information on denosumab in human milk.
- Not approved for children.
- Kidney disease: no dose change is needed, but advanced kidney disease raises the risk of severe low calcium.
- Older adults: no overall differences, though some may be more sensitive.
- Male partners: condoms are not needed to protect a partner, as seminal fluid levels are very low.
Denosumab Injection overdose
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There is no experience with overdosage of denosumab products.
What Denosumab Injection does in the body
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Denosumab lowers a blood marker of bone breakdown (CTX) by about 85% within 3 days, with the largest drop by 1 month. Bone formation markers fall later, starting around 1 month. The effect fades as the drug level falls. After stopping, bone breakdown markers rise 40% to 60% above starting levels and return to baseline within 12 months.
How your body processes Denosumab Injection
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After a subcutaneous injection, denosumab peaks in the blood at a median of about 10 days. Its half-life is about 25 days, and levels decline over 4 to 5 months. It does not build up with repeat dosing every 6 months. Kidney function did not change its levels, so no dose adjustment is needed. It did not affect a drug processed by CYP3A4.
How to store Denosumab Injection
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Store Ospomyv refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light. Do not freeze. refrigerator, Ospomyv may be stored at room temperature for a single period of up to 60 days, but not exceeding the original expiry date.
Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
Supplements & herbs that interact with Denosumab Injection
55 supplements and herbal products have documented interactions with Denosumab Injection in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Moderate · 53
- Minor · 2
Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.
Denosumab Injection: pharmacist answers to common questions
Quick, plain-English answers to the questions patients ask most about Denosumab Injection — the kind of thing our pharmacy team would talk through with you at the counter.
What is denosumab for?
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How often will I get the shot?
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What side effects should I expect?
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Is it safe if I have kidney disease?
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What happens if I stop denosumab?
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Can I use it if I could become pregnant?
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Is Denosumab Injection available over the counter?
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When was Denosumab Injection first available?
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Who makes Denosumab Injection?
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Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
More about Denosumab Injection on HelloPharmacist
Denosumab Injection forms and strengths (how it comes)
Denosumab Injection is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Injection
How this form is used
- Jubbonti is used to treat osteoporosis in postmenopausal women and men at high risk for fracture.
- Jubbonti is used for glucocorticoid-induced osteoporosis.
- Jubbonti is used to increase bone mass in men on androgen deprivation therapy for nonmetastatic prostate cancer and in women on adjuvant aromatase inhibitor therapy for breast cancer.
- Prolia is given by a healthcare provider as a subcutaneous injection every 6 months in the upper arm, upper thigh, or abdomen.
- Prolia is given with daily calcium and vitamin D.
- Conexxence should not be used together with other denosumab products.
Denosumab Injection on the U.S. market: products, makers and brands
How Denosumab Injection appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
5 companies list 10 Denosumab Injection product records with the FDA, mostly as injection; the earliest marketing or approval year on record is 2010. Brand names on the directory include Prolia, Xgeva, Wyost and 13 more; the rest are generics.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
How widely Denosumab Injection is used (Medicaid data)
A general measure of how commonly Denosumab Injection is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Denosumab Injection is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Denosumab Injection prescribed? Of the 1,601 medications we measure, Denosumab Injection ranks #559 by Medicaid prescriptions — more than 65% of them.
Utilization by Denosumab Injection product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
1 ML denosumab 60 MG/ML Prefilled Syringe Most dispensed
Summed across the 2 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 993452
1.7 ML denosumab-bbdz 70 MG/ML Injection
Summed across the 1 of 1 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2715386
1 ML denosumab-bbdz 60 MG/ML Prefilled Syringe
Summed across the 1 of 1 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2715513
1.7 ML denosumab-bmwo 70 MG/ML Injection
Summed across the 1 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2717866
Other Denosumab Injection products — combination packs and listings not yet matched to a specific clinical product (kept visible so every prescription is accounted for)
Summed across the 1 of 11 listed NDC products with Medicaid activity.
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Denosumab Injection, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 6 of 17 listed Denosumab Injection NDCs with Medicaid activity.
Compare Denosumab Injection products
A representative set of FDA-listed product records for Denosumab Injection — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Injection | ||||
| 60 mg/mL | Subcutaneous | Amgen, Inc | BLA | View NDC → |
| 120 mg/1.7 mL | Subcutaneous | Amgen, Inc | BLA | View NDC → |
| 60 mg/mL | Subcutaneous | Cordavis Limited | BLA | View NDC → |
| 60 mg/mL | Subcutaneous | Fresenius Kabi USA, LLC | BLA | View NDC → |
| 70 mg/mL | Subcutaneous | Fresenius Kabi USA, LLC × 2 listings | BLA | View NDC → |
| 60 mg/mL | Subcutaneous | Organon LLC | BLA | View NDC → |
| 120 mg/1.7 mL | Subcutaneous | Organon LLC | BLA | View NDC → |
| 60 mg/mL | Subcutaneous | Sandoz Inc | BLA | View NDC → |
| 120 mg/1.7 mL | Subcutaneous | Sandoz Inc | BLA | View NDC → |
Showing 10 of 10 products — FDA National Drug Code Directory. See every product, package size and price: browse all 10 Denosumab Injection NDCs →
Denosumab Injection side effects reported to the FDA (FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Denosumab Injection — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Denosumab Injection in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
Denosumab Injection FDA approval history
How Denosumab Injection went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
Denosumab Injection recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
The FDA’s enforcement reports list one Denosumab recall since July 2021. It is still ongoing. A recall names specific lots from one company, so check the lot number on your own bottle rather than assuming every product is affected; your pharmacist can check whether your supply came from an affected lot.
- PROLIA (denosumab), injection, 60mg/mL, For Subcutaneous Use Only, Rx Only, Manufactured by: Amgen Inc., Thousand Oaks, CA 91320, NDC 55513-710-21 Lots: Lot: 1180924, Expiration date: 6/30/2027. FDA record D-0538-2025 →
Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 993449 3 dose forms · 23 strengths
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Dose form (SCDF) Injectable Solution RxCUI 993457In current FDA listingsClinical drug / strength (SCD) 60 MG/MLRxCUI 993458 -
Dose form (SCDF) Injection RxCUI 1655915In current FDA listingsClinical drug / strength (SCD) 1 ML denosumab-nxxp 60 MG/MLRxCUI 27259051.7 ML denosumab 70 MG/MLRxCUI 10463981.7 ML denosumab-bbdz 70 MG/MLRxCUI 27153861.7 ML denosumab-bmwo 70 MG/MLRxCUI 27178661.7 ML denosumab-bnht 70 MG/MLRxCUI 27175421.7 ML denosumab-desu 70 MG/MLRxCUI 27472551.7 ML denosumab-dssb 70 MG/MLRxCUI 27260341.7 ML denosumab-kyqq 70 MG/MLRxCUI 27259391.7 ML denosumab-mobz 70 MG/MLRxCUI 27293231.7 ML denosumab-nxxp 70 MG/MLRxCUI 27233381.7 ML denosumab-qbde 70 MG/MLRxCUI 2725590 -
Dose form (SCDF) Prefilled Syringe RxCUI 993451No current FDA listingClinical drug / strength (SCD) 1 ML denosumab 60 MG/MLRxCUI 9934521 ML denosumab-bbdz 60 MG/MLRxCUI 27155131 ML denosumab-bmwo 60 MG/MLRxCUI 27178551 ML denosumab-bnht 60 MG/MLRxCUI 27175311 ML denosumab-desu 60 MG/MLRxCUI 27468711 ML denosumab-dssb 60 MG/MLRxCUI 27255021 ML denosumab-kyqq 60 MG/MLRxCUI 27259281 ML denosumab-mobz 60 MG/MLRxCUI 27293121 ML denosumab-nxxp 60 MG/MLRxCUI 27233501 ML denosumab-qbde 60 MG/MLRxCUI 27255661.7 ML denosumab-bnht 70 MG/MLRxCUI 2717551
Look up RxCUI 993449 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
Denosumab Injection supply and shortage status
Whether Denosumab Injection is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
💵 What Denosumab Injection costs pharmacies (NADAC benchmark)
The national average invoice price pharmacies pay for the drug itself, from CMS's NADAC survey (data as of Sep 30, 2026). This is a supply-cost benchmark — not a retail price and not what you'd pay at the counter.
| Form | Strength | Pharmacy acquisition benchmark | |
|---|---|---|---|
| Injection · Subcutaneous | 60 mg/mL | $1,862.74 per mL | NDC details & price history |
| Injection · Subcutaneous | 120 mg/1.7 mL | $2,001.52 per mL | NDC details & price history |
| Injection, Solution · Subcutaneous | 60 mg/mL | $814.13 per mL | NDC details & price history |
Source: CMS National Average Drug Acquisition Cost (NADAC), a survey of retail pharmacy invoice prices. Benchmarks shown are the range across package sizes of a representative product for each form and strength — other manufacturers' products may differ.
Denosumab Injection brand names
Denosumab Injection is sold under 16 brand names in the FDA directory — Prolia, Xgeva, Wyost, Jubbonti and others. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.
Who makes Denosumab Injection: manufacturers and labelers
5 companies list Denosumab Injection products with the FDA. By number of product records, the largest are Fresenius Kabi USA, LLC, Amgen, Inc, Organon LLC. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.
Denosumab Injection drug class (RxNorm)
Denosumab Injection belongs to the RANK Ligand Inhibitor class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
Sources for this Denosumab Injection page
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How this page is built
HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Sandoz Inc is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →