What this pack is
Prolia is the brand name in this record; denosumab is the generic name. Read both together with the dosage form (injectable product).
PACK CHECK · MARKET FIRST
ProliaGeneric namedenosumab
How this medicine works
The DailyMed PROLIA label says denosumab binds RANKL and prevents activation of RANK on osteoclasts and their precursors; this inhibits osteoclast formation, function and survival and reduces bone resorption. It explains a bone-remodelling pathway, not whether an individual needs injection, when to inject, how to use calcium or vitamin D, whether to stop, or how to sequence another bone medicine.
Read source: United States ↗reviewed 2026-08-20More about its action and precautions →Check the market, names, dosage form and route together
A medicine may use different brand names across markets. Keep the market, brand, generic name, dosage form and route together; one matching field does not prove that two packs are the same or interchangeable.
Open the complete product-identity record
Use these fields when the pack, market name or package image needs closer checking. They are evidence boundaries, not substitution instructions.
- International brand name
- Prolia
- Generic name
- denosumab
- Dosage-form class
- Subcutaneous injection(60 mg/mL single-doseprefilled syringe; as listed in the 2025 FDA label)
- Route
- Subcutaneous injection
- Package-image status
- A source-linked public label image is available below
No source-verifiable mainland-China trade-name cue has been established for this record. This does not establish whether the medicine exists, is approved or is available in mainland China. Check pack text and current CDE/NMPA records item by item.
FOR EVERYDAY QUESTIONS
After the leaflet, continue with the question you still need to check
What this page can show
This is a source-traceable public record. It helps you read the product identity and its listed source documents; each market still needs its own current record check.
What to bring to the next conversation
Bring the actual pack, the label or prescription, and a complete medicine list when you speak with a pharmacist or clinician.
NEXT SAFE STEP
Choose the next safe check
A question about changing, combining or splitting?Put the exact packs on one list before a pharmacist or prescriber checks the full context.Open the family medicine list →A question about cost, reimbursement or availability?First lock the market, exact presentation and date. Use local official reimbursement, hospital or pharmacy channels for a current answer rather than a web estimate.Open regulator and market-record entry points →Unsure about a pack or a cross-border product?Photo reading can return possible record matches only. Check the actual product against the current regulator record for its market.Identify pack text locally →Saw a recall, approval or procurement headline?Open the original publisher, then match its product, market and date. Do not make a stop or switch decision from a headline.Read primary-source news →
PRODUCT PRESENTATION IDENTITY
Strength, pack and device identity
A vial concentration, unit-per-mL value or device marking identifies the exact labelled product. It does not calculate an individual's amount, timing, administration, missed-use action, combination or switch.
1 source-backed strength, pack or device records — open the full list
First match the market, dosage form and labelled amount on the pack in hand. The number of tablets, sachets or devices in a pack is not a personal dose or schedule.
United States label · DailyMed SPL v186; label effective 26 Jun 2026
60 mg/1 mL (60 mg/mL); one single-dose prefilled-syringe carton
- Product code
- NDC 55513-710-21
- Form and route
- denosumab injection; single-dose prefilled syringe · subcutaneous (labelled route; this page does not determine an individual's administration)
- Labelled concentration
- 60 mg/mL (labelled concentration; not an individual injection amount)Product identity, not an individual dose
- Container
- single-dose prefilled syringe with safety guard · 1 mL
- Delivery device
- safety guard
- Listing review
- Current label display and NDC Directory listing reviewed 2026-08-25; actual marketing, stock and availability are not established.
- denosumab
- 60 mg60 mg/mL labelled concentration; not an individual's injection amount or conversion instruction
- denosumab
- 60 mglabelled amount in one 1 mL single-dose prefilled syringe; not an individual administration instruction
- Package
- 1 single-dose prefilled syringe per carton
PUBLIC LABEL IMAGE
Appearance and package-text clues
This current public-label package panel helps check the brand, generic name, strength and dosage-form clues only. It does not authenticate a product in hand or establish originator status, availability, sale eligibility, another package or another market.
Open the public label source ↗LABEL READING · NOT A PRESCRIPTION
PROLIA label reading: 60 mg/mL is product strength, not an answer for self-scheduling an injection
Reading level: drug-specific label reading. This record has been expanded around its dosage form or a higher-risk reading question; the current target-market label and professional review still apply.
This module uses the 2025 U.S. FDA label as a reading entry point. It helps read a PROLIA prefilled syringe's generic name, strength and route; it does not create an individual injection, calcium/vitamin D, delay or stopping plan.
- The label's “60 mg/mL single-dose prefilled syringe” describes strength, concentration and package form together. It does not determine when any individual should be injected, whether it can be advanced or delayed, or whether another injectable can replace it.
- The label identifies hypocalcaemia, kidney-related risk and assessment before initiation as important matters. Especially with advanced chronic kidney disease, recent test changes or multiple medicines, do not independently start, delay, stop or add products from a webpage, package or past routine alone.
- The label states that people receiving PROLIA should not also receive another denosumab product. This is a safety check requiring the complete medicine list and exact product, not a basis for self-deciding whether another medicine is “the same ingredient” or for self-switching or stopping.
- Photos, syringe colour and package wording only help locate a source. Markets, label versions and packages can differ; an image cannot authenticate a product, confirm current approval or replace prompt medical assessment for symptoms such as spasms, tingling or severe illness.
PHARMACOVIGILANCE · OFFICIAL ROUTES
Check safety information in the right market
Start with the public label or product record linked to this dossier, then use the official safety routes below for the market that applies to the medicine in hand.
Match five details before using a safety record
- Brand and generic nameBoth must match the medicine named by the record.
- Dosage form and strengthTablet, capsule, injection, inhaler, patch and eye drop are not interchangeable.
- Market and notice dateA record applies only to the country or region and date it names.
- Lot, pack and manufacturerRecord these only when the official notice specifically names them.
- Current product informationA historical record may have been superseded by the current label.
This checklist only helps organise the right question. It does not create a personal conclusion about stopping, switching, dose, combination or suitability.
This dossier’s product-level source checkFDA · United States · Regulatory product record or label archive · 2026-08-20
This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk.
Markets actually represented by the reviewed product documents
- United States · 2
This is a document-coverage summary, not a claim that the medicine is authorised, supplied, interchangeable or actively monitored in every listed market today.
This record’s label or product-record routeFDA: PROLIA 2025-05 U.S. label (BLA 125320) ↗reviewed 2026-08-20
Other official market or version documents for this record
These are separately reviewed product documents for the same dossier. Their market, date, dosage form and document status must stay attached to each link; they do not establish interchangeability between products, strengths, packs, indications or countries.
- U.S. National Library of Medicine DailyMed · United States · Public medicine label · 2026-08-20DailyMed (NLM): PROLIA public label (2026-06 updated) ↗reviewed 2026-08-20
Reviewed official safety records
A dated record is not automatically a current alert. Read the named product, form, batch, market, date and source type before treating it as relevant.
- FDA Drug Safety Communication: Boxed Warning for severe hypocalcemia with Prolia (denosumab) in advanced chronic kidney disease2024-01-19 · On 2024-01-19, after completing its review, FDA added a Boxed Warning to U.S. Prolia (denosumab) prescribing information about severe hypocalcemia risk in patients with advanced chronic kidney disease; the communication specifically discusses dialysis patients and people with CKD-mineral and bone disorder. This is U.S. regulatory information for a named product and population. It cannot determine whether any person is in that population, needs testing or monitoring, or should start, defer, stop or change a product. Check the current target-market label, actual product and responsible care team.Primary-source record (open linked document) ↗reviewed 2026-08-22
Global official safety gateways
- NMPA Centre for Drug Reevaluation · Mainland ChinaPrimary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item.Drug-vigilance bulletins and safety notices ↗reviewed 2026-08-22
- FDA · United StatesPrimary FDA pages for important new safety issues, labelling changes and risk communications.Drug Safety Communications ↗reviewed 2026-08-22
- FDA MedWatch · United StatesU.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality.Safety information and serious-problem reporting ↗reviewed 2026-08-22
- EMA · European Union / European Economic AreaOfficial EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment.Pharmacovigilance overview and EudraVigilance ↗reviewed 2026-08-22
- MHRA · United KingdomPrimary UK MHRA medicine-safety updates for professionals and the public.Drug Safety Update ↗reviewed 2026-08-22
- PMDA · JapanPMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents.Medicine safety information ↗reviewed 2026-08-22
- MFDS · Republic of KoreaMFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case.Medicine safety letters ↗reviewed 2026-08-22
- HSA · SingaporeHSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information.Adverse-event reporting and medicine-safety information ↗reviewed 2026-08-22
- Health Canada · CanadaHealth Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item.MedEffect Canada: advisories, warnings and recalls ↗reviewed 2026-08-22
- TGA · AustraliaPrimary Australian TGA safety alerts, advisories and monitoring information for therapeutic products.Medicine safety alerts ↗reviewed 2026-08-22
- Swissmedic · SwitzerlandOfficial Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality.Pharmacovigilance and suspected adverse-reaction reporting ↗reviewed 2026-08-22
- Medsafe · New ZealandNew Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information.Medicine safety communications ↗reviewed 2026-08-22
- SAHPRA · South AfricaSAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information.Medicine safety information, alerts and pharmacovigilance ↗reviewed 2026-08-22
- WHO · GlobalWHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market.Medicine and vaccine safety-alert archive ↗reviewed 2026-08-22
- Anvisa · BrazilAnvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item.Pharmacovigilance, alerts and VigiMed ↗reviewed 2026-08-22
This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline.
For severe or rapidly worsening symptoms, suspected overdose, a severe allergic reaction, loss of consciousness or another emergency, use local emergency services. Do not wait for an online alert search or change a medicine from this page.
PRIVATE FAMILY LIST
Bring this record into a local medicine list
Only the brand, generic name, dosage form and route are added, and they stay in this browser. Copy strength, label directions, start/stop history and any concern from the actual pack; this tool does not calculate a dose or decide combination, switching or stopping.
Add to the family medicine list →PACK · LABEL · MEDICINE LIST
Six checks for this medicine pack
Use this card to organise questions about Prolia (denosumab). Keep the exact pack, its current label and the full medicine list together.
Identify the exact product
Prolia is the brand in this record and denosumab is the active-ingredient name. Check both with the dosage form (Subcutaneous injection(60 mg/mL single-doseprefilled syringe; as listed in the 2025 FDA label)) and the market on the actual pack.
Read the labelled strength in context
mg/mL, mg per vial or a total volume describes the labelled concentration or pack identity of an injectable product. It is not an individual infusion amount, preparation instruction or schedule.
Check the exact injection presentation
For an injectable or infusion presentation, verify the route, concentration, container and device in the exact current label. Do not transfer, share, prepare or substitute it from this page.
Put every product on one list
Include prescriptions, over-the-counter products, eye drops, creams, vitamins, minerals, herbs and supplements. A pharmacist or prescriber needs the whole list before any combination, alternation, switch or stop is considered.
Ask a specific pharmacogenetics question
Ask which medicine, which gene and what clinical decision a result could change. A gene–drug association does not mean broad genetic testing is needed for everyone and must not be used to change treatment without professional review.
Know when to seek urgent help
For a severe reaction, fainting, difficulty breathing or sudden worsening symptoms around an injection or infusion, use the local treatment team or emergency service now. Do not wait for a website reply or alter preparation, infusion or another medicine yourself.
This card does not calculate a dose, decide whether medicines can be combined, or replace a clinician or pharmacist. Market-specific current labels and the person's full context still need review.
MARKET DOCUMENTS · READ SEPARATELY
Enlarged market leaflets and regulator documents
Each link retains its own market, date, dosage form and document status. These documents support larger-print reading and item-by-item checking; they do not make products, strengths, packs, indications or use between countries or regions interchangeable.
- FDA: PROLIA 2025-05 U.S. label (BLA 125320) ↗reviewed 2026-08-20
- DailyMed (NLM): PROLIA public label (2026-06 updated) ↗reviewed 2026-08-20
HOW IT WORKS · NOT A TREATMENT PLAN
How denosumab works: it blocks the RANKL-RANK interaction
- “Affects osteoclasts” cannot decide whether an individual should start, delay, redose after a missed treatment or stop PROLIA, and cannot replace assessment of fracture risk, kidney function, calcium/vitamin-D status, dental issues, prior treatment and the complete medicine list.
- Acting on bone, or having a name that suggests antiresorption, does not make PROLIA self-combinable, alternatable or substitutable with a bisphosphonate, another denosumab product, calcium or vitamin preparation. Every product, route, timing plan and laboratory check requires professional confirmation.
- The label gives a particular warning about hypocalcaemia risk related to advanced kidney disease. With seizure, marked muscle spasm/twitching, numbness or tingling, mental-status change or another acute severe concern, use timely local emergency support; do not self-supplement calcium, change medicine or skip evaluation from a mechanism page.
SOURCE EVIDENCE REGISTER
Source evidence map
Every public link is labelled with its market, document status and document type. A historical public record is not a current label, and an official lookup entry is not a product-specific record.
- FDA: PROLIA 2025-05 U.S. label (BLA 125320) ↗reviewed 2026-08-20
- DailyMed (NLM): PROLIA public label (2026-06 updated) ↗reviewed 2026-08-20
- FDA Drugs@FDA official search entry ↗Official lookup entry · reviewed 2026-08-20
SOURCE-TRACEABLE ARCHIVE
Proliadenosumab
This page includes an exact current U.S. public-label package panel for Prolia, alongside documentary primary-source material. It helps check product identity, but does not itself establish originator status, product quality, availability or sale eligibility.
DOCUMENT TIMELINE
Document timeline
Initial U.S. approval year listed in the FDA label
The FDA label archive linked here lists Initial U.S. Approval: 2010. This historical locator is not a conclusion about current approval, availability, holder or another market.
FDA: PROLIA prescribing information ↗FDA label archive version
This page links the 2025-05 FDA label archive as a traceable reading entry point. Current labeling, strength, indication and safety information require separate verification against the target market’s current document.
FDA: PROLIA prescribing information ↗
MARKET SCOPE
Market-record boundary
United States
Public label archive linkedOnly the FDA document listed on this page is linked.
Mainland China, EU, Japan
Market record not establishedNo local approval, holder, strength, supply or sale-eligibility conclusion is inferred from the U.S. label archive.
How to read this record
Read each document in its stated market, date and dosage-form context. A historical record is not a current label and does not support individual medical, substitution or purchasing conclusions.
Keep international and mainland China records separate
This page has a U.S. public history/regulatory archive but no mainland China record for this specific product. That does not establish whether the medicine exists, is approved or is available in mainland China. Verify product identity, dosage form, strength, holder and the current label item by item.
RECORD FAQ
Record questions
Does a label archive represent current product information?
Not automatically. The archive locates a source; each point needs verification against the target market’s current official label.
Why are price and originator/generic conclusions not shown?
Those conclusions require separately complete and human-reviewed product, dosage-form, strength, pack, market, date and primary-record fields; one label file is insufficient.
READ NEXT
Related reading
Evidence status
The listed links are public sources selected for traceability. They must be rechecked against the current target-market record before any use beyond reading and research.