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Prolia denosumab 60 mg/mL Injection, 1 syringe — NDC 55513-0710-01 package photo

Prolia denosumab 60 mg/mL Injection, 1 syringe

by Amgen, Inc · 1 SYRINGE in 1 CARTON (55513-710-01) / 1 mL in 1 SYRINGE
NDC 55513-0710-01
🏷️ FDA NDC (as labeled) 55513-710-01 billing pads the product segment with a zero
This package
Contains1 syringe Cost per mL$1,863.72 NADAC Per package$1,863.72 / 1 ml Pack sizes2 compare ↓
Also priced by: Medicaid pays $1,224.98/unit · Part D plans $1,843.56/unit — full pricing hub ↓
Also comes in: 1 mL 55513-0710-21
Rx only Brand On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

🚨
Active recall for this product.
Class II · Apr 21, 2025 — CGMP Deviations; potential temperature excursions due to transit delays (Mckesson Medical-Surgical Inc. Corporate Office) · FDA recall D-0538-2025
Check your lot/expiration against the official notice — look up the recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 55513-710-01
Product NDC 55513-710
11-digit billing NDC 55513071001
NCPDP billing unit ML — per mL (volume)
RxCUI 993452, 993456
UNII 4EQZ6YO2HI
Application # BLA125320
SPL Set ID 49e5afe9-a0c7-40c4-af9f-f287a80c5c88
Established class (EPC) RANK Ligand Inhibitor
Mechanism of action RANK Ligand Blocking Activity
DEA schedule Non-controlled
Marketing category BLA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2010-06-05
Route SUBCUTANEOUS
Dosage form INJECTION
Substance DENOSUMAB
GPI-14 3004453000E520
GCN Seq No 066396
GCN 28656
HICL code 037012
Ingredient (HICL) Denosumab
HIC1 code P
Therapeutic class — broad (HIC1) Endocrine System
HIC2 code P4
Therapeutic class — intermediate (HIC2) Parathyroid/Bone Resorption Drugs
HIC3 code P4L
Therapeutic class — specific (HIC3) Bone Resorption Inhibitors
AHFS code 90:16.00.00
AHFS class Bone-Modifying Agents
FDB label name PROLIA 60 MG/ML SYRINGE
FDB brand name Prolia
Legend status F — Federal legend — prescription drug or device
Biologic (Purple Book) 351(a)
Why two NDCs? The FDA registers this code as 55513-710-01 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 55513-0710-01. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the RANK Ligand Inhibitor class.

Pharmacologic class RANK Ligand Inhibitor
Drug family (ATC) Other drugs affecting bone structure and mineralization
How it works RANK Ligand Blocking Activity
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerAmgen, Inc
FDA applicationBLA125320 (BLA)
Labeler code55513
First marketedJun 2010
Product typeHuman Prescription Drug
Portfolio81 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name PROLIA 60 MG/ML SYRINGE Ingredient Denosumab
📖 What it is MedlinePlus · NLM

Denosumab injection is used to treat certain cases of osteoporosis (a condition in which the bones become thin and weak and break easily) to treat bone loss in individuals with prostate cancer or breast cancer who are being treated with certain medications that cause bone loss to reduce the risk of fractures caused by multiple myeloma (cancer that begins in the bone marrows and causes bone damage) or other types of cancer that has spread to the bones to treat a certain type of giant cell tumor of bone (GCTB; a type of bone tumor) to treat high calcium levels caused by cancer in peopl...

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Denosumab works by blocking a protein in your body that signals bone-dissolving cells to break down bone. By slowing that process, it helps your bones stay denser and stronger — wh...
  • What exactly does this injection do, and why do I need it?
  • You only need the injection once every 6 months — so just two visits a year. Between those visits, the most important thing you can do is take your calcium and vitamin D every sing...
  • How often do I have to come in for the shot, and what do I need to do between visits?
📖 Read our full Denosumab Injection guide →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • 0.1 mg / 1 mL UNII 7T1F30V5YH
    A synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together and keeps them from separating in liquid formulations.
  • 1 mg / 1 mL UNII 4550K0SC9B
    Sodium acetate is a salt derived from acetic acid. It acts as a buffer to help maintain the medicine's pH stability and may serve as a preservative or solubilizer in liquid formulations.
  • UNII 55X04QC32I
    A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
  • 47 mg / 1 mL UNII 506T60A25R
    Sorbitol is a natural sugar alcohol derived from glucose. It serves as a sweetener, humectant, and bulking agent in medications to improve taste and help maintain moisture in the product.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

5 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer mLPer package
Retail pharmacies payNADAC · weekly $1,863.720 $1,863.72 / 1 ml
Medicaid paysCMS SDUD · 12 mo $1,224.98 $1,224.98 / 1 ml
Medicare drug plans payPart D · Q2 2026 $1,843.56 $1,843.56 / 1 ml
Medicare Part B allowsASP · J0897 $30.101 / J0897 unit —
NADAC price history (per mL) — tap or hover for the price & month
Nov 2021 Jun 2023 Jan 2026 Aug 2026 $1,865.270 $1,309.550
▲ Up 42% over the last 11 months.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🧾 Billing & reimbursement

FDA NDC (as labeled)55513-710-01
11-digit billing NDC55513-0710-01
Format5-3-2 as registered → padded to 5-4-2 for billing (zero added to the product segment)
HCPCS J-codeJ0897
DescriptorINJECTION, DENOSUMAB, 1 MG
Billing units / pkg60 units
Crosswalk sourcePDAC NDC-HCPCS crosswalk (DME MAC / DMEPOS)
Where does this data come from?
The HCPCS J-code crosswalk comes from the CMS ASP NDC-HCPCS crosswalk and the DMEPDAC (DME MAC) NDC-HCPCS crosswalk — free public CMS data. Billing units are derived from the code’s descriptor and the package amount.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Bildyos 60 mg/mL 78206-0193-01 Organon 1 syringe $812.841 — Availability likely save 56%
Jubbonti 60 mg/mL 61314-0240-63 Sandoz 1 syringe $1,537.250 — Availability likely save 18%
Conexxence 60 mg/mL 65219-0668-01 Fresenius 1 syringe $1,740.450 — Availability likely save 7%
Prolia 60 mg/mLthis 55513-0710-01 Amgen, 1 syringe $1,863.720 — Availability likely —
Ospomyv 60 mg/mL 83457-0012-10 Cordavis 1 syringe — — FDA listed —
About this product: this is a biologic. Biologics don't have small-molecule generics — competition comes from FDA-licensed biosimilars (shown above), not generics.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & biosimilar status

🏛️
2010
First FDA approval
Jun 2010
📍
2026
Currently FDA-listed
16 years listed
🔓
2026
Biosimilars listed
18 FDA-licensed
🧬FDA-licensed biosimilars listed

18 interchangeables are FDA-licensed for this reference biologic — see the list below. (Biologics have no small-molecule generics.)

🛡️ Latest patent/protection date listed: Biosimilars are already FDA-licensed for this product — the last listed patent runs to Sep 2040.
📅 FDA approved Jun 1, 2010

Why the date isn’t exact: Biosimilar timing can change because patents may be challenged, settled, licensed, added or removed, and litigation can move the real date earlier or later.

FDA Purple Book — biosimilars & interchangeables ⓘ
Reference product
Proliadenosumab Xgevadenosumab
Interchangeable 18
Aukelsodenosumab-kyqq Bildyosdenosumab-nxxp Bilprevdadenosumab-nxxp Bomyntradenosumab-bnht Boncresadenosumab-mobz Bosayadenosumab-kyqq Conexxencedenosumab-bnht Enobydenosumab-qbde Jubbontidenosumab-bbdz Jubereqdenosumab-desu Osenveltdenosumab-bmwo Ospomyvdenosumab-dssb Osvyrtidenosumab-desu Oziltusdenosumab-mobz Stoboclodenosumab-bmwo Wyostdenosumab-bbdz Xbrykdenosumab-dssb Xtrenbodenosumab-qbde
Source: FDA Purple Book (purplebooksearch.fda.gov), matched on the reference product’s active ingredient.
Patents & exclusivity — FDA Purple Book
US 10,583,397 — biologic patent
US 10,227,627 — biologic patent
US 10,822,630 — biologic patent
US 10,894,972 — biologic patent
US 11,077,404 — biologic patent
US 11,098,079 — biologic patent
US 11,130,980 — biologic patent
US 11,254,963 — biologic patent
US 11,299,760 — biologic patent
US 11,434,514 — biologic patent
US 8,053,236 — biologic patent
US 8,460,896 — biologic patent
US 8,680,248 — biologic patent
US 10,106,829 — biologic patent
US 10,513,723 — biologic patent
US 10,167,492 — biologic patent
US 9,481,901 — biologic patent
US 9,388,447 — biologic patent
US 9,359,435 — biologic patent
US 9,328,134 — biologic patent
US 9,320,816 — biologic patent
US 9,228,168 — biologic patent
US 9,133,493 — biologic patent
US 9,012,178 — biologic patent
US 8,058,418 — biologic patent
US 7,928,205 — biologic patent
US 7,427,659 — biologic patent
US 7,364,736 — biologic patent
US 11,685,772 — biologic patent
US 11,319,568 — biologic patent
US 11,275,090 — biologic patent
US 9,371,554 — biologic patent
US 12,025,618 — biologic patent
US 9,881,367 — biologic patent
US 9,803,166 — biologic patent
US 12,059,555 — biologic patent
US 11,492,372 — biologic patent
US 11,293,930 — biologic patent
US 11,192,919 — biologic patent
US 8,217,153 — biologic patent
US 12,084,686 — biologic patent
US 11,786,866 — biologic patent
US 11,744,950 — biologic patent
US 11,634,476 — biologic patent
US 7,662,930 — biologic patent
US 11,427,848 — biologic patent
US 11,459,595 — biologic patent
US 11,486,883 — biologic patent
US 11,946,085 — biologic patent
US 11,952,605 — biologic patent
US 7,888,101 — biologic patent
US 8,247,210 — biologic patent
US 10,421,987 — biologic patent
US 10,655,156 — biologic patent
US 10,907,186 — biologic patent
US 11,292,829 — biologic patent
US 11,384,378 — biologic patent
Exclusivity RefProduct
2010 2012 2014 2016 2018 2020 2022 2024 2026 2028 2030 2032 2034 2036 2038 2040
Today
LOE
Biologic patent Exclusivity
🏛️Reference-product exclusivity
A flat 12 years of FDA market protection from first licensure. No biosimilar can be licensed before it ends — regardless of patents.
🧪Listed biologic patents
Patents the reference maker lists covering the molecule, formulation, or manufacturing. A biosimilar generally can’t launch until these resolve.
🔁Interchangeability
An interchangeable biosimilar may be substituted at the pharmacy (state laws vary). The first one can earn its own exclusivity period.
🛈 What do these terms mean?
Biologic patent
A patent the reference product’s maker has publicly listed. A biosimilar generally can’t launch until these expire — unless they’re invalidated or resolved in a settlement.
Reference-product exclusivity
A flat 12 years of FDA market protection from the biologic’s first licensure (the BPCIA). No biosimilar can be licensed before it ends, regardless of patents.
Interchangeable exclusivity
The first interchangeable biosimilar can earn a period as the only interchangeable version (pharmacists can substitute it without the prescriber).
Earliest biosimilar (LOE)
The latest of all the dates above — the soonest a biosimilar can realistically reach the market. Litigation and settlements can move it earlier.

Biologics have no small-molecule “generics” — competition comes from FDA-licensed biosimilars, tracked in the FDA Purple Book.

Listed patents (57)
PatentTypeUse codeExpires
US 10,583,397 ↗ Biologic patent — Jul 28, 2035
US 10,227,627 ↗ Biologic patent — Dec 11, 2034
US 10,822,630 ↗ Biologic patent — Dec 1, 2035
US 10,894,972 ↗ Biologic patent — May 29, 2034
US 11,077,404 ↗ Biologic patent — May 13, 2035
US 11,098,079 ↗ Biologic patent — Jul 21, 2037
US 11,130,980 ↗ Biologic patent — Apr 5, 2035
US 11,254,963 ↗ Biologic patent — Dec 9, 2034
US 11,299,760 ↗ Biologic patent — Oct 30, 2034
US 11,434,514 ↗ Biologic patent — May 29, 2034
US 8,053,236 ↗ Biologic patent — Jan 19, 2030
US 8,460,896 ↗ Biologic patent — Dec 6, 2026
US 8,680,248 ↗ Biologic patent — Dec 6, 2026
US 10,106,829 ↗ Biologic patent — Dec 11, 2034
US 10,513,723 ↗ Biologic patent — Dec 9, 2034
US 10,167,492 ↗ Biologic patent — Dec 1, 2035
US 9,481,901 ↗ Biologic patent — May 29, 2034
US 9,388,447 ↗ Biologic patent — Apr 20, 2032
US 9,359,435 ↗ Biologic patent — May 22, 2027
US 9,328,134 ↗ Biologic patent — Feb 20, 2034
US 9,320,816 ↗ Biologic patent — Nov 14, 2030
US 9,228,168 ↗ Biologic patent — Jan 19, 2030
US 9,133,493 ↗ Biologic patent — Apr 20, 2032
US 9,012,178 ↗ Biologic patent — Aug 5, 2031
US 8,058,418 ↗ Biologic patent — Nov 30, 2023
US 7,928,205 ↗ Biologic patent — Feb 12, 2027
US 7,427,659 ↗ Biologic patent — Mar 15, 2025
US 7,364,736 ↗ Biologic patent — Feb 19, 2025
US 11,685,772 ↗ Biologic patent — Jun 29, 2032
US 11,319,568 ↗ Biologic patent — Mar 10, 2034
US 11,275,090 ↗ Biologic patent — Jul 2, 2037
US 9,371,554 ↗ Biologic patent — Dec 14, 2032
US 12,025,618 ↗ Biologic patent — Aug 26, 2039
US 9,881,367 ↗ Biologic patent — Aug 9, 2037
US 9,803,166 ↗ Biologic patent — Sep 29, 2034
US 12,059,555 ↗ Biologic patent — Sep 2, 2040
US 11,492,372 ↗ Biologic patent — Mar 11, 2034
US 11,293,930 ↗ Biologic patent — Mar 26, 2033
US 11,192,919 ↗ Biologic patent — Nov 13, 2035
US 8,217,153 ↗ Biologic patent — Jan 5, 2027
US 12,084,686 ↗ Biologic patent — Mar 10, 2034
US 11,786,866 ↗ Biologic patent — Oct 21, 2035
US 11,744,950 ↗ Biologic patent — Nov 21, 2039
US 11,634,476 ↗ Biologic patent — Jun 29, 2032
US 7,662,930 ↗ Biologic patent — Apr 24, 2027
US 11,427,848 ↗ Biologic patent — Jun 4, 2035
US 11,459,595 ↗ Biologic patent — Mar 10, 2034
US 11,486,883 ↗ Biologic patent — Mar 26, 2033
US 11,946,085 ↗ Biologic patent — May 29, 2034
US 11,952,605 ↗ Biologic patent — Mar 10, 2034
US 7,888,101 ↗ Biologic patent — Apr 6, 2027
US 8,247,210 ↗ Biologic patent — Dec 6, 2026
US 10,421,987 ↗ Biologic patent — May 29, 2034
US 10,655,156 ↗ Biologic patent — Dec 11, 2034
US 10,907,186 ↗ Biologic patent — Dec 11, 2034
US 11,292,829 ↗ Biologic patent — Jun 29, 2032
US 11,384,378 ↗ Biologic patent — Jun 4, 2035
FDA exclusivity
CodeWhat it grantsExpires
RefProductReference-product exclusivity (12-year, BPCIA) — no biosimilar can be licensed before this dateJun 1, 2022
Common questions
Is there a biosimilar for PROLIA 60 MG/ML SYRINGE?
Yes — at least one FDA-licensed biosimilar is listed for this biologic. See the Purple Book family above for the available products.
Why do different websites show different biosimilar dates?
Biosimilar availability isn’t based on one single date. Some sources use the reference-product exclusivity, some use the last listed patent, and patent litigation, settlements, and licenses can all change the real-world launch date. This page shows the underlying Purple Book dates so you can see why estimates differ.
Can a biosimilar launch before the last patent expires?
Sometimes. A biosimilar maker may settle with the reference manufacturer or receive a license to launch earlier. In other cases, the last listed protection delays competition.
What does “current Purple Book estimate” mean?
It means we’re using the latest patent and exclusivity dates currently listed in the FDA Purple Book. It is not a guaranteed launch date.
What does “FDA listed” mean?
It means the product appears in the FDA’s official directory. That’s a good sign a product exists for the U.S. market, but on its own it does not confirm a pharmacy can get it today. Where we have recent retail pricing data, we label it “Availability likely” instead.
What does a patent or protection date mean here?
It’s the latest date currently listed in the FDA Purple Book for a patent or exclusivity on the reference biologic. It can affect when a biosimilar becomes widely available — but it is not a guaranteed launch date. Settlements and licenses can move the real date earlier or later.
Built from the FDA Purple Book Patent List (patents the reference-product sponsor has publicly listed under the BPCIA) plus reference-product exclusivity. Biosimilars cannot launch until these clear; patent litigation and settlements can shift the real date. Biologics have no small-molecule generics — competition comes from FDA-licensed biosimilars, not the Orange Book.
Where does this data come from?
Patents and exclusivity from the FDA Purple Book (biologics), refreshed from public FDA data. Biosimilar launch timing is an estimate, not a guarantee.

🗺️ Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 55513-0710-01, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q4 2025 · 4 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
17.2K
Units reimbursed last 4 qtrs
16.6K
Gross reimbursed last 4 qtrs
$20.34M
Avg / prescription
$1,182.73
Avg / unit
$1,224.98
Latest quarter Q4 2025
2.3KRx
Medicaid pays / mL
$1,224.98
gross reimbursed
vs
NADAC / mL
$1,863.72
acquisition cost
=
Spread
−$638.74
-34% vs cost
What Medicaid paid per mL (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
59% FFS 41% MCO
Fee-for-service · 10,182 Rx Managed care · 7,012 Rx
State Medicaid map
Alaska: 71 units · 9.7 per 100k residents AK Maine: 58 units · 4.2 per 100k residents ME Washington: 221 units · 2.8 per 100k residents WA Idaho: 79 units · 4.0 per 100k residents ID Montana: 117 units · 10.3 per 100k residents MT North Dakota: 55 units · 7.0 per 100k residents ND Minnesota: 230 units · 4.0 per 100k residents MN Wisconsin: 311 units · 5.3 per 100k residents WI Michigan: 432 units · 4.3 per 100k residents MI New York: 1,410 units · 7.2 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: 186 units · 4.4 per 100k residents OR Nevada: 41 units · 1.3 per 100k residents NV Wyoming: 190 units · 32.5 per 100k residents WY South Dakota: 303 units · 33.0 per 100k residents SD Iowa: 52 units · 1.6 per 100k residents IA Illinois: 1,062 units · 8.5 per 100k residents IL Indiana: 730 units · 10.6 per 100k residents IN Ohio: 610 units · 5.2 per 100k residents OH Pennsylvania: 376 units · 2.9 per 100k residents PA New Jersey: 367 units · 4.0 per 100k residents NJ Massachusetts: 561 units · 8.0 per 100k residents MA California: 1,963 units · 5.0 per 100k residents CA Utah: 6 units · 0.2 per 100k residents UT Colorado: 230 units · 3.9 per 100k residents CO Nebraska: 339 units · 17.1 per 100k residents NE Missouri: 329 units · 5.3 per 100k residents MO Kentucky: 184 units · 4.1 per 100k residents KY West Virginia: 165 units · 9.3 per 100k residents WV Virginia: 634 units · 7.3 per 100k residents VA Maryland: 139 units · 2.2 per 100k residents MD Connecticut: 876 units · 24.2 per 100k residents CT Rhode Island: no data reported RI Arizona: 438 units · 5.9 per 100k residents AZ New Mexico: 219 units · 10.4 per 100k residents NM Kansas: 203 units · 6.9 per 100k residents KS Arkansas: 234 units · 7.6 per 100k residents AR Tennessee: 25 units · 0.4 per 100k residents TN North Carolina: 329 units · 3.0 per 100k residents NC South Carolina: 283 units · 5.3 per 100k residents SC Delaware: 38 units · 3.7 per 100k residents DE Oklahoma: 206 units · 5.1 per 100k residents OK Louisiana: 24 units · 0.5 per 100k residents LA Mississippi: 239 units · 8.1 per 100k residents MS Alabama: 203 units · 4.0 per 100k residents AL Georgia: 654 units · 5.9 per 100k residents GA D.C.: no data reported DC Hawaii: 56 units · 3.9 per 100k residents HI Texas: 300 units · 1.0 per 100k residents TX Florida: 801 units · 3.5 per 100k residents FL
Units reimbursed · per 100k residents
0.233.0
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 South Dakota 33.0 /100k
2 Wyoming 32.5 /100k
3 Connecticut 24.2 /100k
4 Nebraska 17.1 /100k
5 Indiana 10.6 /100k
6 New Mexico 10.4 /100k
7 Montana 10.3 /100k
8 Alaska 9.7 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

💊 Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
1 syringe55513-0710-21 31,058 Rx · $43,745,662
1 syringe this page55513-0710-01 17,194 Rx · $20,335,883
Drug total (last 4 qtrs): 48,252 Rx · 48,805 units · $64,081,545 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Prolia — the program that covers self-administered drugs. 1 manufacturer.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Prolia. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$138.24M
Claims incl. refills
74.1K
Beneficiaries
73.8K
Spend / beneficiary
$1,874.28
Spend / claim
$1,865.91
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Denosumab — the ingredient across all brands.

Top reported reactions

Death20,353
Arthralgia8,910
Osteonecrosis Of Jaw8,645
Fatigue7,746
Pain In Extremity7,032
Pain6,958
Back Pain6,929

Age at onset

Neonate17
Infant9
Child134
Adolescent157
Adult25,247
Elderly74,113

Reporter sex

201,365 reports
Male · 16%
Female · 84%
Unknown · 0%

Serious outcomes

Hospitalization31,434
Disabling3,268
Life-threatening2,543
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 11,455 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startStatus
55513-0710-01 You're viewing this 1 SYRINGE in 1 CARTON (55513-710-01) / 1 mL in 1 SYRINGE $1,863.72 / mL $1,863.72 2010-06-05 Active
55513-0710-21 1 SYRINGE in 1 CARTON (55513-710-21) / 1 mL in 1 SYRINGE $1,863.72 / mL $1,863.72 2024-03-05 Active

This pack has the lowest per-mL cost of the 2 priced pack sizes ($1,863.72 NADAC).

This pack accounts for about 36% of this product's recent Medicaid fills; most go to a different pack size. See all packs ↓

Pack size FAQ

What quantity is in NDC 55513-0710-01?
NDC 55513-0710-01 contains 1 syringe — 1 syringe in 1 carton / 1 ml in 1 syringe.
What is the difference between NDC 55513-0710-01 and NDC 55513-0710-21?
Both are Prolia denosumab 60 mg/mL Injection — the drug itself is identical. NDC 55513-0710-01 is the 1 syringe package, while NDC 55513-0710-21 is the 1 syringe package.
What NDC number is used to bill for this package of Prolia denosumab 60 mg/mL Injection?
Bill NDC 55513-0710-01 — the 11-digit billing format is 55513071001. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🚨 Boxed Warning 🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients 💬 Medication Guide
🚨 Boxed Warning ~1 min read ▾

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 Prolia 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 Prolia in patients with advanced chronic kidney disease, evaluate for the presence of CKD-MBD. Treatment with Prolia 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 Prolia 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 Prolia in patients with advanced chronic kidney disease, evaluate for the presence of CKD-MBD. Treatment with Prolia 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 ~2 min read ▾

1 INDICATIONS AND USAGE Prolia 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 )

1.1Treatment of Postmenopausal Women with Osteoporosis at High Risk for Fracture Prolia 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, Prolia reduces the incidence of vertebral, nonvertebral, and hip fractures [see Clinical Studies (14.1) ] .

1.2Treatment to Increase Bone Mass in Men with Osteoporosis Prolia 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) ] .

1.3Treatment of Glucocorticoid-Induced Osteoporosis Prolia 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) ] .

1.4Treatment of Bone Loss in Men Receiving Androgen Deprivation Therapy for Prostate Cancer Prolia 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 Prolia also reduced the incidence of vertebral fractures [see Clinical Studies (14.4) ] .

1.5Treatment of Bone Loss in Women Receiving Adjuvant Aromatase Inhibitor Therapy for Breast Cancer Prolia 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) ] .

⏱️ Dosage and Administration ~3 min read ▾

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 )

2.1Pregnancy 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) ] .

2.2Laboratory 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) ] .

2.3Recommended 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.

2.4Preparation and Administration Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Prolia is a clear, colorless to pale yellow solution that may contain trace amounts of translucent to white proteinaceous particles. Do not use if the solution is discolored or cloudy or if the solution contains many particles or foreign particulate matter.

Prior to administration, Prolia may be removed from the refrigerator and brought to room temperature up to 25°C (77°F) by standing in the original container. This generally takes 15 to 30 minutes. Do not warm Prolia in any other way [see How Supplied/Storage and Handling (16) ] .

Instructions for Administration of Prolia Prefilled Syringe with Needle Safety Guard IMPORTANT: In order to minimize accidental needlesticks, the Prolia single-dose prefilled syringe will have a green safety guard; manually activate the safety guard after the injection is given. DO NOT slide the green safety guard forward over the needle before administering the injection; it will lock in place and prevent injection. Activate the green safety guard (slide over the needle) after the injection.

Step 1: Remove Gray Needle Cap Remove needle cap. Step 2: Administer Subcutaneous Injection Choose an injection site. The recommended injection sites for Prolia include: the upper arm OR the upper thigh OR the abdomen.

Insert needle and inject all the liquid subcutaneously. Do not administer into muscle or blood vessel. DO NOT put gray needle cap back on needle.

Step 3: Immediately Slide Green Safety Guard Over Needle With the needle pointing away from you. Hold th…

💊 Dosage Forms and Strengths 31 words ▾

3 DOSAGE FORMS AND STRENGTHS Injection: 60 mg/mL clear, colorless to pale yellow solution in a single-dose prefilled syringe. Injection: 60 mg/mL solution in a single-dose prefilled syringe ( 3 )

⛔ Contraindications 126 words ▾

4 CONTRAINDICATIONS Prolia is contraindicated in: Patients with hypocalcemia: Pre-existing hypocalcemia must be corrected prior to initiating therapy with Prolia [see Warnings and Precautions (5.1) ] . Pregnant women: Prolia may cause fetal harm when administered to a pregnant woman. In women of reproductive potential, pregnancy testing should be performed prior to initiating treatment with Prolia [see Use in Specific Populations (8.1) ] .

Patients with hypersensitivity to Prolia: Prolia is contraindicated in patients with a history of systemic hypersensitivity to any component of the product. Reactions have included anaphylaxis, facial swelling, and urticaria [see Warnings and Precautions (5.3) and Adverse Reactions (6.2) ] . Hypocalcemia ( 4 , 5.1 ) Pregnancy ( 4 , 8.1 ) Known hypersensitivity to Prolia ( 4 , 5.3 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Hypocalcemia: Pre-existing hypocalcemia must be corrected before initiating Prolia. May worsen, especially in patients with renal impairment. Adequately supplement all patients with calcium and vitamin D.

Concomitant use of calcimimetic drugs may also worsen hypocalcemia risk. Evaluate for presence of chronic kidney disease mineral-bone disorder. Monitor serum calcium.

( 5.1 ) Same Active Ingredient: Patients receiving Prolia should not receive other denosumab products concomitantly. ( 5.2 ) Hypersensitivity including anaphylactic reactions may occur. Discontinue permanently if a clinically significant reaction occurs.

( 5.3 ) Osteonecrosis of the jaw: Has been reported with Prolia. Monitor for symptoms. ( 5.4 ) Atypical femoral fractures: Have been reported.

Evaluate patients with thigh or groin pain to rule out a femoral fracture. ( 5.5 ) Multiple vertebral fractures have been reported following Prolia discontinuation. Patients should be transitioned to another antiresorptive agent if Prolia is discontinued.

( 5.6 ) Serious infections including skin infections: May occur, including those leading to hospitalization. Advise patients to seek prompt medical attention if they develop signs or symptoms of infection, including cellulitis. ( 5.7 ) Dermatologic reactions: Dermatitis, rashes, and eczema have been reported.

Consider discontinuing Prolia if severe symptoms develop. ( 5.8 ) Severe bone, joint, muscle pain may occur. Discontinue use if severe symptoms develop.

( 5.9 ) Suppression of bone turnover: Significant suppression has been demonstrated. Monitor for consequences of bone over-suppression. ( 5.10 )

5.1Severe Hypocalcemia and Mineral Metabolism Changes Prolia can cause severe hypocalcemia and fatal cases have been reported. Pre-existing hypocalcemia must be corrected prior to initiating therapy with Prolia. Adequately supplement all patients with calcium and vitamin D [see Dosage and Administration (2.1) , Contraindications (4) , and Adverse Reactions (6.1) ] .

In patients without advanced chronic kidney disease who are predisposed to hypocalcemia and disturbances of mineral metabolism (e.g. history of hypoparathyroidism, thyroid surgery, parathyroid surgery, malabsorption syndromes, excision of small intestine, treatment with other calcium-lowering drugs), assess serum calcium and mineral levels (phosphorus and magnesium) 10 to14 days after Prolia injection. In some postmarketing cases, hypocalcemia persisted for weeks or months and required frequent monitoring and intravenous and/or oral calcium replacement, with or without vitamin D.

Patients with Advanced Chronic Kidney Disease Patients with advanced chronic kidney disease [i.e., eGFR < 30 mL/min/1.73 m 2 ] including dialysis-dependent patients are at greater risk for severe hypocalcemia following Prolia administration. Severe hypocalcemia resulting in hospitalization, life-threatening events and fatal cases have been reported. The presence of underlying chronic kidney disease-mineral bone disorder (CKD-MBD, renal osteodystrophy) markedly increases the risk of hypocalcemia.

Concomitant use of calcimimetic drugs may also worsen hypocalcemia risk. To minimize the risk of hypocalcemia in patients with advanced chronic kidney disease, evaluate for the presence of chronic kidney disease-mineral and bone disorder 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.

Monitor serum calcium weekly for the first month after Prolia administration and monthly thereafter. Instruct all patients with advanced chronic kidney disease, including those who are dialysis-dependent, about the symptoms of hypocalcemia and the importance of maintaining serum calcium levels with adequate calcium and activated vitamin D su…

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following serious adverse reactions are discussed below and also elsewhere in the labeling: Severe Hypocalcemia and Mineral Metabolism Changes [see Warnings and Precautions (5.1) ] Hypersensitivity [see Warnings and Precautions (5.3) ] Osteonecrosis of the Jaw [see Warnings and Precautions (5.4) ] Atypical Subtrochanteric and Diaphyseal Femoral Fractures [see Warnings and Precautions (5.5) ] Multiple Vertebral Fractures (MVF) Following Discontinuation of Prolia Treatment [see Warnings and Precautions (5.6) ] Serious Infections [see Warnings and Precautions (5.7) ] Dermatologic Adverse Reactions [see Warnings and Precautions (5.8) ] The most common adverse reactions reported with Prolia in patients with postmenopausal osteoporosis are back pain, pain in extremity, musculoskeletal pain, hypercholesterolemia, and cystitis.

The most common adverse reactions reported with Prolia in men with osteoporosis are back pain, arthralgia, and nasopharyngitis. The most common adverse reactions reported with Prolia in patients with glucocorticoid-induced osteoporosis are back pain, hypertension, bronchitis, and headache. The most common (per patient incidence ≥ 10%) adverse reactions reported with Prolia in patients with bone loss receiving androgen deprivation therapy for prostate cancer or adjuvant aromatase inhibitor therapy for breast cancer are arthralgia and back pain.

Pain in extremity and musculoskeletal pain have also been reported in clinical trials. The most common adverse reactions leading to discontinuation of Prolia in patients with postmenopausal osteoporosis are back pain and constipation. Postmenopausal osteoporosis: Most common adverse reactions (> 5% and more common than placebo) were: back pain, pain in extremity, hypercholesterolemia, musculoskeletal pain, and cystitis.

Pancreatitis has been reported in clinical trials. ( 6.1 ) Male osteoporosis: Most common adverse reactions (> 5% and more common than placebo) were: back pain, arthralgia, and nasopharyngitis. ( 6.1 ) Glucocorticoid-induced osteoporosis: Most common adverse reactions (> 3% and more common than active-control group) were: back pain, hypertension, bronchitis, and headache.

( 6.1 ) Bone loss due to hormone ablation for cancer: Most common adverse reactions (≥ 10% and more common than placebo) were: arthralgia and back pain. Pain in extremity and musculoskeletal pain have also been reported in clinical trials. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Amgen Inc. at 1-800-77-AMGEN (1-800-772-6436) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

6.1Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in clinical practice. Treatment of Postmenopausal Women with Osteoporosis The safety of Prolia in the treatment of postmenopausal osteoporosis was assessed in a 3-year, randomized, double-blind, placebo-controlled, multinational study of 7808 postmenopausal women aged 60 to 91 years.

A total of 3876 women were exposed to placebo and 3886 women were exposed to Prolia administered subcutaneously once every 6 months as a single 60 mg dose. All women were instructed to take at least 1000 mg of calcium and 400 IU of vitamin D supplementation per day. The incidence of all-cause mortality was 2.3% (n = 90) in the placebo group and 1.8% (n = 70) in the Prolia group.

The incidence of nonfatal serious adverse events was 24.2% in the placebo group and 25.0% in the Prolia group. The percentage of patients who withdrew from the study due to adverse events was 2.1% and 2.4% for the placebo and Prolia groups, respectively. The most common adverse reactions reported with Prolia in patients with postmenopausal osteoporosis are back pain, pain in extremity, musculoskeletal pain, hypercholesterolemia, and cystitis.

Adve…

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Pregnant women and females of reproductive potential: Prolia may cause fetal harm when administered to pregnant women. Advise females of reproductive potential to use effective contraception during therapy, and for at least 5 months after the last dose of Prolia. ( 8.1 , 8.3 ) Pediatric patients: Prolia is not approved for use in pediatric patients.

( 8.4 ) Renal impairment: No dose adjustment is necessary in patients with renal impairment. 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. The presence of underlying chronic kidney disease-mineral bone disorder markedly increases the risk of hypocalcemia.

( 5.1 , 8.6 )

8.1Pregnancy Risk Summary Prolia is contraindicated for use in pregnant women because it may cause harm to a fetus. There are insufficient data with denosumab use in pregnant women to inform any drug-associated risks for adverse developmental outcomes. In utero denosumab exposure from cynomolgus monkeys dosed monthly with denosumab throughout pregnancy at a dose 50-fold higher than the recommended human dose based on body weight resulted in increased fetal loss, stillbirths, and postnatal mortality, and absent lymph nodes, abnormal bone growth, and decreased neonatal growth [see Data ] .

Data Animal Data The effects of denosumab on prenatal development have been studied in both cynomolgus monkeys and genetically engineered mice in which RANK ligand (RANKL) expression was turned off by gene removal (a "knockout mouse"). In cynomolgus monkeys dosed subcutaneously with denosumab throughout pregnancy starting at gestational day 20 and at a pharmacologically active dose 50-fold higher than the recommended human dose based on body weight, there was increased fetal loss during gestation, stillbirths, and postnatal mortality.

Other findings in offspring included absence of axillary, inguinal, mandibular, and mesenteric lymph nodes; abnormal bone growth, reduced bone strength, reduced hematopoiesis, dental dysplasia, and tooth malalignment; and decreased neonatal growth. At birth out to 1 month of age, infants had measurable blood levels of denosumab (22-621% of maternal levels). Following a recovery period from birth out to 6 months of age, the effects on bone quality and strength returned to normal; there were no adverse effects on tooth eruption, though dental dysplasia was still apparent; axillary and inguinal lymph nodes remained absent, while mandibular and mesenteric lymph nodes were present, though small; and minimal to moderate mineralization in multiple tissues was seen in one recovery animal.

There was no evidence of maternal harm prior to labor; adverse maternal effects occurred infrequently during labor. Maternal mammary gland development was normal. There was no fetal NOAEL (no observable adverse effect level) established for this study because only one dose of 50 mg/kg was evaluated.

Mammary gland histopathology at 6 months of age was normal in female offspring exposed to denosumab in utero ; however, development and lactation have not been fully evaluated. In RANKL knockout mice, absence of RANKL (the target of denosumab) also caused fetal lymph node agenesis and led to postnatal impairment of dentition and bone growth. Pregnant RANKL knockout mice showed altered maturation of the maternal mammary gland, leading to impaired lactation [see Use in Specific Populations (8.2) and Nonclinical Toxicology (13.2) ] .

The no effect dose for denosumab-induced teratogenicity is unknown. However, a C max of 22.9 ng/mL was identified in cynomolgus monkeys as a level in which no biologic effects (NOEL) of denosumab were observed (no inhibition of RANKL) [see Clinical Pharmacology (12.3) ] .

8.2Lactation Risk Summary There is no information regarding the presence of denosumab in human milk, the effects on the breastfed infant, or the effects on milk production. Denosumab was detecte…

🤰 Pregnancy ~2 min read ▾

8.1Pregnancy Risk Summary Prolia is contraindicated for use in pregnant women because it may cause harm to a fetus. There are insufficient data with denosumab use in pregnant women to inform any drug-associated risks for adverse developmental outcomes. In utero denosumab exposure from cynomolgus monkeys dosed monthly with denosumab throughout pregnancy at a dose 50-fold higher than the recommended human dose based on body weight resulted in increased fetal loss, stillbirths, and postnatal mortality, and absent lymph nodes, abnormal bone growth, and decreased neonatal growth [see Data ] .

Data Animal Data The effects of denosumab on prenatal development have been studied in both cynomolgus monkeys and genetically engineered mice in which RANK ligand (RANKL) expression was turned off by gene removal (a "knockout mouse"). In cynomolgus monkeys dosed subcutaneously with denosumab throughout pregnancy starting at gestational day 20 and at a pharmacologically active dose 50-fold higher than the recommended human dose based on body weight, there was increased fetal loss during gestation, stillbirths, and postnatal mortality.

Other findings in offspring included absence of axillary, inguinal, mandibular, and mesenteric lymph nodes; abnormal bone growth, reduced bone strength, reduced hematopoiesis, dental dysplasia, and tooth malalignment; and decreased neonatal growth. At birth out to 1 month of age, infants had measurable blood levels of denosumab (22-621% of maternal levels). Following a recovery period from birth out to 6 months of age, the effects on bone quality and strength returned to normal; there were no adverse effects on tooth eruption, though dental dysplasia was still apparent; axillary and inguinal lymph nodes remained absent, while mandibular and mesenteric lymph nodes were present, though small; and minimal to moderate mineralization in multiple tissues was seen in one recovery animal.

There was no evidence of maternal harm prior to labor; adverse maternal effects occurred infrequently during labor. Maternal mammary gland development was normal. There was no fetal NOAEL (no observable adverse effect level) established for this study because only one dose of 50 mg/kg was evaluated.

Mammary gland histopathology at 6 months of age was normal in female offspring exposed to denosumab in utero ; however, development and lactation have not been fully evaluated. In RANKL knockout mice, absence of RANKL (the target of denosumab) also caused fetal lymph node agenesis and led to postnatal impairment of dentition and bone growth. Pregnant RANKL knockout mice showed altered maturation of the maternal mammary gland, leading to impaired lactation [see Use in Specific Populations (8.2) and Nonclinical Toxicology (13.2) ] .

The no effect dose for denosumab-induced teratogenicity is unknown. However, a C max of 22.9 ng/mL was identified in cynomolgus monkeys as a level in which no biologic effects (NOEL) of denosumab were observed (no inhibition of RANKL) [see Clinical Pharmacology (12.3) ] .

🧒 Pediatric Use ~2 min read ▾

8.4Pediatric Use The safety and effectiveness of Prolia have not been established in pediatric patients. In one multicenter, open-label study conducted in 153 pediatric patients with osteogenesis imperfecta, aged 2 to 17 years, evaluating fracture risk reduction, efficacy was not demonstrated. Hypercalcemia has been reported in pediatric patients with osteogenesis imperfecta treated with denosumab products, including Prolia.

Some cases required hospitalization and were complicated by acute renal injury [see Warnings and Precautions (5.11) ]. Clinical studies in pediatric patients with osteogenesis imperfecta were terminated early due to the occurrence of life-threatening events and hospitalizations due to hypercalcemia. Safety and effectiveness were not demonstrated for the treatment of glucocorticoid-induced osteoporosis in one multicenter, randomized, double-blind, placebo-controlled, parallel-group study conducted in 24 pediatric patients with glucocorticoid-induced osteoporosis, aged 5 to 17 years, evaluating change from baseline in lumbar spine BMD Z-score.

Based on results from animal studies, Prolia may negatively affect long-bone growth and dentition in pediatric patients below the age of 4 years. Juvenile Animal Toxicity Data Treatment with Prolia may impair long-bone growth in children with open growth plates and may inhibit eruption of dentition. In neonatal rats, inhibition of RANKL (the target of Prolia therapy) with a construct of osteoprotegerin bound to Fc (OPG-Fc) at doses ≤ 10 mg/kg was associated with inhibition of bone growth and tooth eruption.

Adolescent primates treated with denosumab at doses 10 and 50 times (10 and 50 mg/kg dose) higher than the recommended human dose of 60 mg administered every 6 months, based on body weight (mg/kg), had abnormal growth plates, considered to be consistent with the pharmacological activity of denosumab [see Nonclinical Toxicology (13.2) ]. Cynomolgus monkeys exposed in utero to denosumab exhibited bone abnormalities, an absence of axillary, inguinal, mandibular, and mesenteric lymph nodes, reduced hematopoiesis, tooth malalignment, and decreased neonatal growth.

Some bone abnormalities recovered once exposure was ceased following birth; however, axillary, and inguinal lymph nodes remained absent 6 months post-birth [see Use in Specific Populations (8.1) ] .

🧓 Geriatric Use 124 words ▾

8.5Geriatric Use Of the total number of patients in clinical studies of Prolia, 9943 patients (76%) were ≥ 65 years old, while 3576 (27%) were ≥ 75 years old. Of the patients in the osteoporosis study in men, 133 patients (55%) were ≥ 65 years old, while 39 patients (16%) were ≥ 75 years old. Of the patients in the glucocorticoid-induced osteoporosis study, 355 patients (47%) were ≥ 65 years old, while 132 patients (17%) were ≥ 75 years old.

No overall differences in safety or efficacy were observed between these patients and younger patients, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Prolia binds to RANKL, a transmembrane or soluble protein essential for the formation, function, and survival of osteoclasts, the cells responsible for bone resorption. Prolia prevents RANKL from activating its receptor, RANK, on the surface of osteoclasts and their precursors. Prevention of the RANKL/RANK interaction inhibits osteoclast formation, function, and survival, thereby decreasing bone resorption and increasing bone mass and strength in both cortical and trabecular bone.

12.2Pharmacodynamics In clinical studies, treatment with 60 mg of Prolia resulted in reduction in the bone resorption marker serum type 1 C-telopeptide (CTX) by approximately 85% by 3 days, with maximal reductions occurring by 1 month. CTX levels were below the limit of assay quantitation (0.049 ng/mL) in 39% to 68% of patients 1 to 3 months after dosing of Prolia. At the end of each dosing interval, CTX reductions were partially attenuated from a maximal reduction of ≥ 87% to ≥ 45% (range: 45% to 80%), as serum denosumab levels diminished, reflecting the reversibility of the effects of Prolia on bone remodeling.

These effects were sustained with continued treatment. Upon reinitiation, the degree of inhibition of CTX by Prolia was similar to that observed in patients initiating Prolia treatment. Consistent with the physiological coupling of bone formation and resorption in skeletal remodeling, subsequent reductions in bone formation markers (i.e., osteocalcin and procollagen type 1 N-terminal peptide [P1NP]) were observed starting 1 month after the first dose of Prolia.

After discontinuation of Prolia therapy, markers of bone resorption increased to levels 40% to 60% above pretreatment values but returned to baseline levels within 12 months.

12.3Pharmacokinetics In a study conducted in healthy male and female volunteers (n = 73, age range: 18 to 64 years) following a single subcutaneously administered Prolia dose of 60 mg, the mean area-under-the-concentration-time curve up to 16 weeks (AUC 0-16 weeks ) of denosumab was 316 mcg ∙ day/mL (SD = 101 mcg ∙ day/mL). The mean maximum denosumab concentration (C max ) was 6.75 mcg/mL (SD = 1.89 mcg/mL). No accumulation or change in denosumab pharmacokinetics with time is observed with multiple dosing of 60 mg subcutaneously administered once every 6 months.

Absorption Following subcutaneous administration, the median time to maximum denosumab concentration (T max ) was 10 days (range: 3 to 21 days). Distribution The mean volume of distribution for denosumab was

5.2 L (SD =

1.7L). Elimination Serum denosumab concentrations declined over a period of 4 to 5 months with a mean half-life of 25.4 days (SD = 8.5 days; n = 46). A population pharmacokinetic analysis was performed to evaluate the effects of demographic characteristics.

This analysis showed no notable differences in pharmacokinetics with age (in postmenopausal women), race, or body weight (36 to 140 kg). Seminal Fluid Pharmacokinetic Study Serum and seminal fluid concentrations of denosumab were measured in 12 healthy male volunteers (age range: 43 to 65 years). After a single 60 mg subcutaneous administration of denosumab, the mean (± SD) C max values in the serum and seminal fluid samples were 6170 (± 2070) and 100 (± 81.9) ng/mL, respectively, resulting in a maximum seminal fluid concentration of approximately 2% of serum levels.

The median (range) T max values in the serum and seminal fluid samples were 8.0 (7.9 to 21) and 21 (8.0 to 49) days, respectively. Among the subjects, the highest denosumab concentration in seminal fluid was 301 ng/mL at 22 days post-dose. On the first day of measurement (10 days post-dose), nine of eleven subjects had quantifiable concentrations in semen.

On the last day of measurement (106 days post-dose), five subjects still had quantifiable concentrations of denosumab in seminal fluid, with a mean (± SD) seminal fluid concentration of 21.1 (± 36.5) ng/mL across all su…

🧬 Mechanism of Action 71 words ▾

12.1Mechanism of Action Prolia binds to RANKL, a transmembrane or soluble protein essential for the formation, function, and survival of osteoclasts, the cells responsible for bone resorption. Prolia prevents RANKL from activating its receptor, RANK, on the surface of osteoclasts and their precursors. Prevention of the RANKL/RANK interaction inhibits osteoclast formation, function, and survival, thereby decreasing bone resorption and increasing bone mass and strength in both cortical and trabecular bone.

📦 How Supplied / Storage and Handling 150 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied Prolia (denosumab) injection is a clear, colorless to pale yellow solution supplied in a single-dose prefilled syringe with a safety guard. The prefilled syringe is not made with natural rubber latex. 60 mg/mL in a single-dose prefilled syringe 1 per carton NDC 55513-710-01 NDC 55513-710-21 Storage and Handling Store Prolia refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light.

Do not freeze. Prior to administration, Prolia may be allowed to reach room temperature up to 25°C (77°F) in the original container. Once removed from the refrigerator, Prolia must not be exposed to temperatures above 25°C (77°F) and must be used within 30 days.

Discard Prolia if not used within the 30 days. Do not use Prolia after the expiry date printed on the label. Protect Prolia from direct light and heat.

Avoid vigorous shaking of Prolia.

📦 Storage and Handling 98 words ▾

Storage and Handling Store Prolia refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light. Do not freeze. Prior to administration, Prolia may be allowed to reach room temperature up to 25°C (77°F) in the original container.

Once removed from the refrigerator, Prolia must not be exposed to temperatures above 25°C (77°F) and must be used within 30 days. Discard Prolia if not used within the 30 days. Do not use Prolia after the expiry date printed on the label.

Protect Prolia from direct light and heat. Avoid vigorous shaking of Prolia.

📋 Description 96 words ▾

11 DESCRIPTION Denosumab is a human IgG2 monoclonal antibody with affinity and specificity for human RANKL (receptor activator of nuclear factor kappa-B ligand). Denosumab has an approximate molecular weight of 147 kDa and is produced in genetically engineered mammalian (Chinese hamster ovary) cells. Prolia (denosumab) injection is a sterile, preservative-free, clear, colorless to pale yellow solution for subcutaneous use.

Each single-dose prefilled syringe contains 1 mL solution of 60 mg denosumab, glacial acetic acid (1 mg), polysorbate 20 (0.1 mg), sorbitol (47 mg), Water for Injection (USP), and sodium hydroxide to adjust the pH to 5.2.

💬 Information for Patients ~2 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Medication Guide). Hypocalcemia Advise the patient to adequately supplement with calcium and vitamin D and instruct them on the importance of maintaining serum calcium levels while receiving Prolia [see Warnings and Precautions (5.1) and Use in Specific Populations (8.6) ] . Advise patients to seek prompt medical attention if they develop signs or symptoms of hypocalcemia.

Severe Hypocalcemia in Patients with Advanced Chronic Kidney Disease Advise patients with advanced chronic kidney disease, including those who are dialysis-dependent, about the symptoms of hypocalcemia and the importance of maintaining serum calcium levels with adequate calcium and activated vitamin D supplementation. Advise these patients to have their serum calcium measured weekly for the first month after Prolia administration and monthly thereafter [see Dosage and Administration (2.2) , Warnings and Precautions (5.1) and Use in Specific Populations (8.6) ] .

Drug Products with Same Active Ingredient Advise patients that if they receive Prolia, they should not receive other denosumab products concomitantly [see Warnings and Precautions (5.2) ] . Hypersensitivity Advise patients to seek prompt medical attention if signs or symptoms of hypersensitivity reactions occur. Advise patients who have had signs or symptoms of systemic hypersensitivity reactions that they should not receive denosumab products [see Warnings and Precautions (5.3) and Contraindications (4) ] .

Osteonecrosis of the Jaw Advise patients to maintain good oral hygiene during treatment with Prolia and to inform their dentist prior to dental procedures that they are receiving Prolia. Patients should inform their physician or dentist if they experience persistent pain and/or slow healing of the mouth or jaw after dental surgery [see Warnings and Precautions (5.4) ] . Atypical Subtrochanteric and Diaphyseal Femoral Fractures Advise patients to report new or unusual thigh, hip, or groin pain [see Warnings and Precautions (5.5) ] .

Multiple Vertebral Fractures (MVF) Following Discontinuation of Prolia Treatment Advise patients not to interrupt Prolia therapy without talking to their physician [see Warnings and Precautions (5.6) ] . Serious Infections Advise patients to seek prompt medical attention if they develop signs or symptoms of infections, including cellulitis [see Warnings and Precautions (5.7) ] . Dermatologic Adverse Reactions Advise patients to seek prompt medical attention if they develop signs or symptoms of dermatological reactions (such as dermatitis, rashes, and eczema) [see Warnings and Precautions (5.8) ] .

Musculoskeletal Pain Inform patients that severe bone, joint, and/or muscle pain have been reported in patients taking Prolia. Patients should report severe symptoms if they develop [see Warnings and Precautions (5.9) ] . Pregnancy/Nursing Counsel females of reproductive potential to use effective contraceptive measure to prevent pregnancy during treatment and for at least 5 months after the last dose of Prolia.

Advise the patient to contact their physician immediately if pregnancy does occur during these times. Advise patients not to take Prolia while pregnant or breastfeeding. If a patient wishes to start breastfeeding after treatment, advise her to discuss the appropriate timing with her physician [see Contraindications (4) and Use in Specific Populations (8.1) ] .

Schedule of Administration Advise patients that if a dose of Prolia is missed, the injection should be administered as soon as convenient. Thereafter, schedule injections every 6 months from the date of the last injection.

💬 Medication Guide ~3 min read ▾

This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised: 05/2025 Medication Guide Prolia ® (PRÓ-lee-a) (denosumab) Injection, for subcutaneous use 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.

Symptoms of a serious allergic reaction may include: low blood pressure (hypotension) trouble breathing throat tightness swelling of your face, lips, or tongue rash itching hives Severe jaw bone problems (osteonecrosis). Severe jaw bone problems may happen when you take Prolia. Your doctor should examine your mouth before you start Prolia.

Your doctor may tell you to see your dentist before you start Prolia. It is important for you to practice good mouth care during treatment with Prolia. Ask your doctor or dentist about good mouth care if you have any questions.

Unusual thigh bone fractures. Some people have developed unusual fractures in their thigh bone. Symptoms of a fracture include new or unusual pain in your hip, groin, or thigh.

Increased risk of broken bones, including broken bones in the spine, after stopping, skipping or delaying Prolia. Talk with your doctor before starting Prolia treatment. After your treatment with Prolia is stopped, or if you skip or delay taking a dose, your risk for breaking bones, including bones in your spine, is increased.

Your risk for having more than 1 broken bone in your spine is increased if you have already had a broken bone in your spine. Do not stop, skip or delay taking Prolia without first talking with your doctor. If your Prolia treatment is stopped, talk to your doctor about other medicine that you can take.

Serious infections. Serious infections in your skin, lower stomach area (abdomen), bladder, or ear may happen if you take Prolia. Inflammation of the inner lining of the heart (endocarditis) due to an infection also may happen more often in people who take Prolia.

You may need to go to the hospital for treatment if you develop an infection. Prolia is a medicine that may affect the ability of your body to fight infections. People who have a weakened immune system or take medicines that affect the immune system may have an increased risk for developing serious infections.

Call your doctor right away if you have any of the following symptoms of infection: fever or chills skin that…

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
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For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.