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Stoboclo denosumab-bmwo 60 mg/mL Injection, 1 syringe — NDC 72606-037-01 (Billing 72606-0037-01)

by CELLTRION USA, Inc. · 1 SYRINGE in 1 CARTON / 1 mL in 1 SYRINGE

This is a package of 1 syringe of Stoboclo denosumab-bmwo 60 mg/mL Injection from CELLTRION USA, Inc., marketed since Jul 2025 and currently FDA-listed; retail pharmacies pay about $1,582.15 per mL (NADAC). It is this product's only package size.

NDC 72606-0037-01
🏷️ FDA NDC (as labeled) 72606-037-01 billing pads the product segment with a zero
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed 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

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 72606-037-01
Product NDC 72606-037
11-digit billing NDC 72606003701
NCPDP billing unit ML — per mL (volume)
RxCUI 2717855, 2717862
UNII 4EQZ6YO2HI
UPC 0372606037019
Application # BLA761404
SPL Set ID 10b9eea3-bf70-4ff3-a0b9-54248cbfd156
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 2025-07-02
Route SUBCUTANEOUS
Dosage form INJECTION
Substance DENOSUMAB
Biologic (Purple Book) 351(k) Interchangeable · interchangeable biosimilar
Reference product denosumab

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 3004453022E520
GCN Seq No 087324
GCN 57209
HICL code 050310
Ingredient (HICL) Denosumab-Bmwo
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 STOBOCLO 60 MG/ML SYRINGE
FDB brand name Stoboclo
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 087324
  • GCN: 57209
  • GPI-14 (Medi-Span): 3004453022E520
  • HICL (First Databank): 050310
  • AHFS class code: 90:16.00.00
  • RxCUI (RxNorm): 2717855
Why two NDCs? The FDA registers this code as 72606-037-01 — 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 → 72606-0037-01. 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.

Clinical

Label name STOBOCLO 60 MG/ML SYRINGE Ingredient Denosumab-Bmwo
📗 Our plain-language guide HelloPharmacist
  • It treats osteoporosis in people at high risk for fracture, including postmenopausal women, men, and people on long-term steroids. It also helps build bone in men on prostate cance...
  • Usually once every 6 months, given under the skin by a healthcare provider. If you miss one, get it as soon as you can and your 6-month schedule restarts from then. Take your calci...
  • Back pain, limb pain, and muscle or joint aches are most common. Some people notice bladder infections, cold symptoms, or headaches. Call your doctor for muscle cramps or tingling,...
  • No dose change is needed, but advanced kidney disease or dialysis raises the risk of severe low calcium, which can be life-threatening. Your doctor should check your calcium and mi...
📖 Read our full Denosumab Injection guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
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.

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 $1,582.150 $1,582.15 / 1 ml
Medicaid paysCMS SDUD · 12 mo $983.28 $983.28 / 1 ml
Medicare drug plans payPart D · Q2 2026 $1,809.83 $1,809.83 / 1 ml
Medicare Part B allowsASP · Q5157 $25.979 / Q5157 unit —
NADAC price history (per mL) — tap or hover for the price & month
Jul 2026 Aug 2026 Sep 2026 $1,584.710 $1,578.180
Flat over the last 3 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)72606-037-01
11-digit billing NDC72606-0037-01
Format5-3-2 as registered → padded to 5-4-2 for billing (zero added to the product segment)
HCPCS J-codeQ5157
Descriptor1 MG
Billing units / pkg60 units
How the units are derivedThis package is 1; the HCPCS unit is 1 MG, so one package = 60 billing units.
Medicare Part B spend (2026 (Q1))$45,188,899 · 19,782 claims · $2,284.34 per claim (all NDCs under Q5157)
Crosswalk sourceCMS ASP NDC-HCPCS Crosswalk
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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
72606-0037-01 You're viewing this Main listing 1 SYRINGE in 1 CARTON / 1 mL in 1 SYRINGE 2025-07-02 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Stoboclo 60 mg/mLthis 72606-0037-01 CELLTRION 1 syringe $1,582.150 — Availability likely —
Denosumab-BMWO 60 mg/mL 72606-0058-01 CELLTRION 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

🏛️
2025
First FDA approval
Feb 2025
📍
2026
Currently FDA-listed
1 year 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 Feb 2037.
📅 FDA approved Feb 28, 2025

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
Exclusivity RefProduct
2025 2027 2029 2031 2033 2035 2037
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.

FDA exclusivity
CodeWhat it grantsExpires
RefProductReference-product exclusivity (12-year, BPCIA) — no biosimilar can be licensed before this dateFeb 28, 2037
Common questions
Is there a biosimilar for STOBOCLO 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.

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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

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.

Manufacturer & labeler

LabelerCELLTRION USA, Inc.
FDA applicationBLA761404 (BLA)
Labeler code72606
First marketedJul 2025
Product typeHuman Prescription Drug
Portfolio30 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.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). 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 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Package Label / Principal Display Panel
🚨 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 denosumab products administration. Severe hypocalcemia resulting in hospitalization, life-threatening events and fatal cases have been reported [see Warnings and Precautions (5.1) ] . The presence of chronic kidney disease-mineral bone disorder (CKD-MBD) markedly increases the risk of hypocalcemia in these patients [see Warnings and Precautions (5.1) ] .

Prior to initiating Stoboclo in patients with advanced chronic kidney disease, evaluate for the presence of CKD-MBD. Treatment with Stoboclo in these patients should be supervised by a healthcare provider with expertise in the diagnosis and management of CKD-MBD [see Dosage and Administration (2.2) and Warnings and Precautions (5.1) ] WARNING: SEVERE HYPOCALCEMIA IN PATIENTS WITH ADVANCED KIDNEY DISEASE See full prescribing information for complete boxed warning. Patients with advanced chronic kidney disease are at greater risk of severe hypocalcemia following denosumab products administration.

Severe hypocalcemia resulting in hospitalization, life-threatening events and fatal cases have been reported. ( 5.1 ) The presence of chronic kidney disease-mineral bone disorder (CKD-MBD) markedly increases the risk of hypocalcemia. ( 5.1 ) Prior to initiating Stoboclo in patients with advanced chronic kidney disease, evaluate for the presence of CKD-MBD.

Treatment with Stoboclo 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 Stoboclo 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 Stoboclo 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, denosumab reduces the incidence of vertebral, nonvertebral, and hip fractures [see Clinical Studies (14.1) ] .

1.2Treatment to Increase Bone Mass in Men with Osteoporosis Stoboclo 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 Stoboclo 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 Stoboclo 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 denosumab 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 Stoboclo 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 Stoboclo. ( 2.1 ) Before initiating Stoboclo 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 ) Stoboclo 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 Stoboclo Pregnancy must be ruled out prior to administration of Stoboclo. Perform pregnancy testing in all females of reproductive potential prior to administration of Stoboclo. Based on findings in animals, denosumab products 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 Stoboclo 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 Stoboclo 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 Stoboclo should be administered by a healthcare provider. The recommended dose of Stoboclo is 60 mg administered as a single subcutaneous injection once every 6 months. Administer Stoboclo 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 Stoboclo 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. Stoboclo is a clear, colorless to pale yellow solution. Do not use if the solution is discolored or cloudy or if the solution contains particles or foreign particulate matter.

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

Instructions for Administration of Prefilled Syringe with Safety Guard IMPORTANT: To reduce the risk of accidental needle stick injury, each prefilled syringe has a safety guard that is automatically activated to cover the needle after you have given the injection. Do not pull back on the plunger rod at any time. Step 1: Remove the Needle Cap Dispose of the needle cap right away in the nearest sharps disposal container.

DO NOT re-cap the prefilled syringe. Image Image Step 2: Administer Subcutaneous Injection Choose an appropriate injection site. The recommended injection sites for Stoboclo include: the outer area of the upper arms OR the upper legs (thighs) OR around the stomach area (abdomen).

Inject all of the liquid by using your thumb to push the plunger rod all the way down. If the plunger rod is not fully pressed, the safety guard will not extend to cover the needle when it is removed. Image Image Step 3: Remove the prefilled syringe from the injection site After the prefilled syringe is em… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 32 words ▾

3 DOSAGE FORMS AND STRENGTHS Injection: 60 mg/mL of 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 129 words ▾

4 CONTRAINDICATIONS Stoboclo is contraindicated in: Patients with hypocalcemia: Pre-existing hypocalcemia must be corrected prior to initiating therapy with Stoboclo [see Warnings and Precautions (5.1) ] . Pregnant women: Denosumab products 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 Stoboclo [see Use in Specific Populations (8.1) ] .

Patients with hypersensitivity to denosumab products: Stoboclo 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) , Adverse Reactions (6.2) ] . Hypocalcemia ( 4 , 5.1 ) Pregnancy ( 4 , 8.1 ) Known hypersensitivity to denosumab products ( 4 , 5.3 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Hypocalcemia: Pre-existing hypocalcemia must be corrected before initiating Stoboclo. 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 Stoboclo 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 denosumab products. 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 treatment discontinuation. Patients should be transitioned to another antiresorptive agent if Stoboclo 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 Stoboclo 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 Denosumab products can cause severe hypocalcemia and fatal cases have been reported. Pre-existing hypocalcemia must be corrected prior to initiating therapy with Stoboclo. 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 to 14 days after Stoboclo 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 denosumab products 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 Stoboclo 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 Stoboclo 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… [Excerpted — this section continues on DailyMed.]

🤒 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 Treatment Discontinuation [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 denosumab products in patients with postmenopausal osteoporosis are back pain, pain in extremity, musculoskeletal pain, hypercholesterolemia, and cystitis.

The most common adverse reactions reported with denosumab products in men with osteoporosis are back pain, arthralgia, and nasopharyngitis. The most common adverse reactions reported with denosumab products in patients with glucocorticoid-induced osteoporosis are back pain, hypertension, bronchitis, and headache. The most common (per patient incidence ≥ 10%) adverse reactions reported with denosumab products 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 denosumab products 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 CELLTRION USA, Inc. at 1-800-560-9414 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 denosumab 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 denosumab 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 denosumab group.

The incidence of nonfatal serious adverse events was 24.2% in the placebo group and 25.0% in the denosumab group. The percentage of patients who withdrew from the study due to adverse events was 2.1% and 2.4% for the placebo and denosumab groups, respectively. The most common adverse reactions reported with denosumab in patients with postmenopausal osteoporosis are back pain, pain in extremity, mu… [Excerpted — this section continues on DailyMed.]

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Pregnant women and females of reproductive potential: Denosumab products 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 Stoboclo. ( 8.1 , 8 3 ) Pediatric patients: Stoboclo 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 Stoboclo is contraindicated for use in pregnant women because it may cause harm to a fetus. There are insufficient data with denosumab products 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) , Nonclinical Toxicology (13.2) ] .

The no effect dose for denosumab product-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 products in human milk, the effects on the breastfed infant, or the effects… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~2 min read ▾

8.1Pregnancy Risk Summary Stoboclo is contraindicated for use in pregnant women because it may cause harm to a fetus. There are insufficient data with denosumab products 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) , Nonclinical Toxicology (13.2) ] .

The no effect dose for denosumab product-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 Stoboclo have not been established in pediatric patients. In one multicenter, open-label study with denosumab 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.

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, denosumab may negatively affect long-bone growth and dentition in pediatric patients below the age of 4 years. Juvenile Animal Toxicity Data Treatment with denosumab products 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 denosumab 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 denosumab, 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 Denosumab products bind to RANKL, a transmembrane or soluble protein essential for the formation, function, and survival of osteoclasts, the cells responsible for bone resorption. Denosumab products prevent 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 denosumab 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 denosumab. 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 denosumab on bone remodeling.

These effects were sustained with continued treatment. Upon reinitiation, the degree of inhibition of CTX by denosumab was similar to that observed in patients initiating denosumab 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 denosumab.

After discontinuation of denosumab 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 denosumab 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 (Tmax) 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: 43-65 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… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 73 words ▾

12.1Mechanism of Action Denosumab products bind to RANKL, a transmembrane or soluble protein essential for the formation, function, and survival of osteoclasts, the cells responsible for bone resorption. Denosumab products prevent 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 191 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied Stoboclo (denosumab-bmwo) 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 72606-037-01 Storage and Handling Store Stoboclo 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, Stoboclo may be allowed to reach room temperature up to 25°C (77°F) in the original carton. Stoboclo may be stored at temperatures up to a maximum 25°C (77°F) for a single period of up to 63 days but not exceeding the original expiry date.

If necessary, the product may be returned to the refrigerator once within 63 days and provided this does not exceed the original expiry date. It must be used after subsequent removal from refrigeration. Discard Stoboclo if not used or returned to refrigerator within the 63 days.

Do not use Stoboclo after the expiry date printed on the label. Protect Stoboclo from direct light and heat. Avoid vigorous shaking of Stoboclo.

📦 Storage and Handling 141 words ▾

Storage and Handling Store Stoboclo 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, Stoboclo may be allowed to reach room temperature up to 25°C (77°F) in the original carton.

Stoboclo may be stored at temperatures up to a maximum 25°C (77°F) for a single period of up to 63 days but not exceeding the original expiry date. If necessary, the product may be returned to the refrigerator once within 63 days and provided this does not exceed the original expiry date. It must be used after subsequent removal from refrigeration.

Discard Stoboclo if not used or returned to refrigerator within the 63 days. Do not use Stoboclo after the expiry date printed on the label. Protect Stoboclo from direct light and heat.

Avoid vigorous shaking of Stoboclo.

📋 Description 92 words ▾

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

Each single-dose prefilled syringe of Stoboclo contains 60 mg denosumab-bmwo, 0.26 mg acetic acid, 0.1 mg polysorbate 20, 1.05 mg sodium acetate, 47 mg sorbitol, and Water for Injection. The pH is 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 Stoboclo [see Warnings and Precautions (5.1) , 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 Stoboclo administration and monthly thereafter [see Dosage and Administration (2.2) , Warnings and Precautions (5.1) , Use in Specific Populations (8.6) ].

Drug Products with Same Active Ingredient Advise patients that if they receive Stoboclo, 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) , Contraindications (4) ] .

Osteonecrosis of the Jaw Advise patients to maintain good oral hygiene during treatment with Stoboclo and to inform their dentist prior to dental procedures that they are receiving Stoboclo. 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 Treatment Discontinuation Advise patients not to interrupt Stoboclo 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 denosumab products. 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 Stoboclo.

Advise the patient to contact their physician immediately if pregnancy does occur during these times. Advise patients not to take Stoboclo 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) , Use in Specific Populations (8.1) ].

Schedule of Administration Advise patients that if a dose of Stoboclo 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: 10/2025 Medication Guide Stoboclo ® (stoe bok' loe) (denosumab-bmwo) Injection, for subcutaneous use What is the most important information I should know about Stoboclo?

If you receive Stoboclo, you should not receive other denosumab products at the same time. Stoboclo can cause serious side effects including: Increased risk of severe low calcium levels in your blood (hypocalcemia). Stoboclo may lower the calcium levels in your blood.

If you have low blood calcium before you start receiving Stoboclo, it may get worse during treatment. Your low blood calcium must be treated before you receive Stoboclo. Talk to your doctor before starting Stoboclo.

Your doctor may prescribe calcium and vitamin D to help prevent low calcium levels in your blood while you take Stoboclo. 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), Stoboclo 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 Stoboclo 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 denosumab products. 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 Stoboclo. Your doctor should examine your mouth before you start Stoboclo.

Your doctor may tell you to see your dentist before you start Stoboclo. It is important for you to practice good mouth care during treatment with Stoboclo. 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 Stoboclo . Talk with your doctor before starting Stoboclo treatment. After your treatment with Stoboclo 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 Stoboclo without first talking with your doctor. If your Stoboclo 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 Stoboclo. Inflammation of the inner lining of the heart (endocarditis) due to an infection also may happen more often in people who take Stoboclo.

You may need to go to the hospital for treatment if you develop an infection. Stoboclo 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 an… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacokinetics ~3 min read ▾

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 denosumab 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 (Tmax) 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: 43-65 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 subjects (n = 12). Drug Interactions In a study of 19 postmenopausal women with low BMD and rheumatoid arthritis treated with etanercept (50 mg subcutaneous injection once weekly), a single-dose of denosumab (60 mg subcutaneous injection) was administered 7 days after the previous dose of etanercept. No clinically significant changes in the pharmacokinetics of etanercept were observed.

Cytochrome P450 substrates In a study of 17 postmenopausal women with osteoporosis, midazolam (2 mg oral) was administered 2 weeks after a single-dose of denosumab (60 mg subcutaneous injection), which approximates the T max of denosumab. Denosumab did not affect the pharmacokinetics of midazolam, which is metabolized by cytochrome P450 3A4 (CYP3A4). This indicates that denosumab products should not alter the pharmacokinetics of drugs metabolized by CYP3A4 in postmenopausal women with osteoporosis.

Specific Populations Gender: Mean serum denosumab concentration-time profiles observed in a study conducted in healthy men ≥ 50 years were similar to those observed in a study conducted in postmenopausal women using the same dose regimen. Age: The pharmacokinetics of denosumab were not affected by age across all populations studied whose ages ranged from 28 to 87 years. Race: The pharmacokinetics of denosumab were not affected by race.

Renal Impairment: In a study of 55 patients with varying degrees of renal function, including patients on dialysis, the degree of renal impairment had no effect on the pharmacokinetics of denosumab; thus, dose adjustment for renal impairment is not necessary. Hepatic Impairment: No clinical studies have been conducted to evaluate the effect of hepatic impairment on the pharmacokinetics of denosumab products.

🧬 Pharmacodynamics 196 words ▾

12.2Pharmacodynamics In clinical studies, treatment with 60 mg of denosumab 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 denosumab. 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 denosumab on bone remodeling.

These effects were sustained with continued treatment. Upon reinitiation, the degree of inhibition of CTX by denosumab was similar to that observed in patients initiating denosumab 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 denosumab.

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

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES

14.1Treatment of Postmenopausal Women with Osteoporosis The efficacy and safety of denosumab in the treatment of postmenopausal osteoporosis was demonstrated in a 3-year, randomized, double-blind, placebo-controlled trial. Enrolled women had a baseline BMD T-score between -2.5 and -4.0 at either the lumbar spine or total hip. Women with other diseases (such as rheumatoid arthritis, osteogenesis imperfecta, and Paget's disease) or on therapies that affect bone were excluded from this study.

The 7808 enrolled women were aged 60 to 91 years with a mean age of 72 years. Overall, the mean baseline lumbar spine BMD T-score was -2.8, and 23% of women had a vertebral fracture at baseline. Women were randomized to receive subcutaneous injections of either placebo (N = 3906) or denosumab 60 mg (N = 3902) once every 6 months.

All women received at least 1000 mg calcium and 400 IU vitamin D supplementation daily. The primary efficacy variable was the incidence of new morphometric (radiologically-diagnosed) vertebral fractures at 3 years. Vertebral fractures were diagnosed based on lateral spine radiographs (T4-L4) using a semiquantitative scoring method.

Secondary efficacy variables included the incidence of hip fracture and nonvertebral fracture, assessed at 3 years. Effect on Vertebral Fractures Denosumab significantly reduced the incidence of new morphometric vertebral fractures at 1, 2, and 3 years (p < 0.0001), as shown in Table 3. The incidence of new vertebral fractures at year 3 was 7.2% in the placebo-treated women compared to 2.3% for the denosumab-treated women.

The absolute risk reduction was 4.8% and relative risk reduction was 68% for new morphometric vertebral fractures at year 3. Table 3. The Effect of Denosumab on the Incidence of New Vertebral Fractures in Postmenopausal Women Proportion of Women with Fracture (%) Event rates based on crude rates in each interval.

Absolute Risk Reduction (%) Absolute risk reduction and relative risk reduction based on Mantel-Haenszel method adjusting for age group variable. (95% CI) Relative Risk Reduction (%) (95% CI) Placebo N = 3691 (%) Denosumab N = 3702 (%) 0-1 Year 2.2 0.9 1.4 (0.8, 1.9) 61 (42, 74) 0-2 Years 5.0 1.4 3.5 (2.7, 4.3) 71 (61, 79) 0-3 Years 7.2 2.3 4.8 (3.9, 5.8) 68 (59, 74) Denosumab was effective in reducing the risk for new morphometric vertebral fractures regardless of age, baseline rate of bone turnover, baseline BMD, baseline history of fracture, or prior use of a drug for osteoporosis.

Effect on Hip Fractures The incidence of hip fracture was 1.2% for placebo-treated women compared to 0.7% for denosumab-treated women at year 3. The age-adjusted absolute risk reduction of hip fractures was 0.3% with a relative risk reduction of 40% at 3 years (p = 0.04) (see Figure 1). Figure 1.

Cumulative Incidence of Hip Fractures Over 3 Years N = number of subjects randomized Chemical Structure Effect on Nonvertebral Fractures Treatment with denosumab resulted in a significant reduction in the incidence of nonvertebral fractures (see Table 4). Table 4. The Effect of Denosumab on the Incidence of Nonvertebral Fractures at Year 3 Proportion of Women with Fracture (%) Event rates based on Kaplan-Meier estimates at 3 years.

Absolute Risk Reduction (%) (95% CI) Relative Risk Reduction (%) (95% CI) Placebo N = 3906 (%) Denosumab N = 3902 (%) Nonvertebral fracture Excluding those of the vertebrae (cervical, thoracic, and lumbar), skull, facial, mandible, metacarpus, and finger and toe phalanges. 8.0 6.5 1.5 (0.3, 2.7) 20 (5, 33) p-value = 0.01. Effect on Bone Mineral Density (BMD) Treatment with denosumab significantly increased BMD at all anatomic sites measured at 3 years.

The treatment differences in BMD at 3 years were 8.8% at the lumbar spine, 6.4% at the total hip, and 5.2% at the femoral neck. Consistent effects on BMD were observed at the lumbar spine, regardless of baseline age, race, weight/body mass index (BMI), baseline BMD, and level of bone turnover… [Excerpted — this section continues on DailyMed.]

🧪 Nonclinical Toxicology ~1 min read ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenicity The carcinogenic potential of denosumab products has not been evaluated in long-term animal studies. Mutagenicity The genotoxic potential of denosumab products has not been evaluated. Impairment of Fertility Denosumab had no effect on female fertility or male reproductive organs in monkeys at doses that were 13- to 50-fold higher than the recommended human dose of 60 mg subcutaneously administered once every 6 months, based on body weight (mg/kg).

13.2Animal Toxicology and/or Pharmacology Denosumab products are inhibitors of osteoclastic bone resorption via inhibition of RANKL. In ovariectomized monkeys, once-monthly treatment with denosumab suppressed bone turnover and increased BMD and strength of cancellous and cortical bone at doses 50-fold higher than the recommended human dose of 60 mg administered once every 6 months, based on body weight (mg/kg). Bone tissue was normal with no evidence of mineralization defects, accumulation of osteoid, or woven bone.

Because the biological activity of denosumab in animals is specific to nonhuman primates, evaluation of genetically engineered ("knockout") mice or use of other biological inhibitors of the RANK/RANKL pathway, namely OPG-Fc, provided additional information on the pharmacodynamic properties of denosumab products. RANK/RANKL knockout mice exhibited absence of lymph node formation, as well as an absence of lactation due to inhibition of mammary gland maturation (lobulo-alveolar gland development during pregnancy) . Neonatal RANK/RANKL knockout mice exhibited reduced bone growth and lack of tooth eruption.

A corroborative study in 2-week-old rats given the RANKL inhibitor OPG-Fc also showed reduced bone growth, altered growth plates, and impaired tooth eruption. These changes were partially reversible in this model when dosing with the RANKL inhibitors was discontinued.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 75 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenicity The carcinogenic potential of denosumab products has not been evaluated in long-term animal studies. Mutagenicity The genotoxic potential of denosumab products has not been evaluated. Impairment of Fertility Denosumab had no effect on female fertility or male reproductive organs in monkeys at doses that were 13- to 50-fold higher than the recommended human dose of 60 mg subcutaneously administered once every 6 months, based on body weight (mg/kg).

📄 Package Label / Principal Display Panel 80 words ▾

PRINCIPAL DISPLAY PANEL - 60 mg/mL Syringe Carton Stoboclo ® (denosumab-bmwo) Injection 60 mg/mL FOR SUBCUTANEOUS USE ONLY Stoboclo should be administered by a healthcare provider ATTENTION: Dispense the enclosed Medication Guide to each patient NDC 72606-037-01 Rx only Each carton contains one Single-dose Prefilled Syringe with safety guard x 1 See Prescribing Information for Full Prescribing and Manufacturing Information. Stoboclo 60 mg/mL is administered once every 6 months. CELLTRION USA CELLTRION PRINCIPAL DISPLAY PANEL - 60 mg/mL Syringe Carton

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

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 this package alone, 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.
📅 Q3 2025 – Q1 2026 · 3 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
25
Units reimbursed last 4 qtrs
26
Gross reimbursed last 4 qtrs
$25.6K
Avg / prescription
$1,022.61
Avg / unit
$982.37
Latest quarter Q1 2026
25Rx
Medicaid pays / mL
$982.37
gross reimbursed
vs
NADAC / mL
$1,582.15
acquisition cost
=
Spread
−$599.78
-38% 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 ⓘ
100% MCO
Fee-for-service · 0 Rx Managed care · 25 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: no data reported MI New York: no data reported NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: no data reported IN Ohio: no data reported OH Pennsylvania: no data reported PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: 14 units · 0.0 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: no data reported TX Florida: 12 units · 0.1 per 100k residents FL
Units reimbursed · per 100k residents
0.00.1
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 Florida 0.1 /100k
2 California 0.0 /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.

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

Medicare Part D (outpatient prescription) spending for Stoboclo — 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 Stoboclo. 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
$3.79M
Claims incl. refills
2.3K
Beneficiaries
2.3K
Spend / beneficiary
$1,680.64
Spend / claim
$1,673.22
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 Stoboclo (this brand).

Top reported reactions

Back Pain2
Dizziness2
Headache2
Pain2
Rheumatoid Arthritis2
Vomiting2
Abdominal Pain Upper1

Reporter sex

10 reports
Reports over time (by year) — tap or hover for the count & year
2025 2026 9 1
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.
← 72606-0036-01 · CELLTRION 72606-0038-01 · CELLTRION →
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.