GlobalRPh Renal Dosing Masterv6.6
Evidence addition

Denosumab - PROLIA subcutaneous injection

Local official-label summaryBase record retrieved 2026-09-09See the evidence for this drug4 sources available - open source summaries, references and comparisons

PROLIA / Denosumab

READ THE SOURCE-SPECIFIC ANSWER

Renal guidance at a glance

Cautions / source differences (2)
Review first - source-specific qualification

No renal dose adjustment does not remove advanced-CKD safeguards

Selected mirror and June 2026 label paragraphs agree. Advanced-CKD calcium surveillance differs from the nonadvanced-CKD 10-14-day instruction.

Before applying: Review CKD-MBD and the advanced-CKD monitoring plan before using the no-adjustment statement.

Evidence for this qualification

Selected-source qualification; independent clinician review pending.

Confirm the product, indication and renal measure. The selected summary is not a complete prescribing monograph.

Choose a source to read (4)

Display order is not a clinical ranking. Date of retrieval is not the label revision date. Sources are never merged into one regimen. Other sources and conflicts remain below.

1 additional source qualifications - review before use
PROLIA: no adjustment does not mean routine-risk treatment

Both retrieved sources contain advanced-CKD hypocalcemia precautions. This is not a disagreement or a missing-warning claim. Dose unchanged and CKD-MBD safety assessment are different questions.

Before applying: Complete the advanced-CKD assessment and monitoring plan with appropriate expertise; do not substitute the nonadvanced-CKD monitoring interval.

Also check: PROLIA: no adjustment does not mean routine-risk treatment

Official source

Denosumab - PROLIA subcutaneous injection

Product / population
PROLIA for its labeled bone indications; not an XGEVA or biosimilar dosing substitution.
Renal measure
Indexed eGFR <30 mL/min/1.73 m2; dialysis/CKD-MBD population retained
Before using this finding

Use the advanced-CKD monitoring schedule, not the separate nonadvanced-CKD 10-14-day instruction.

Selected named sections only; not a complete monograph or independent clinical approval.

Selected exact-product labeling sections read. Original-source bytes and complete revision histories were not retained or reconciled; retrieval does not establish current product availability.

Renal dosing, restrictions and evidence limits

In advanced CKD (eGFR <30 mL/min/1.73 m2), including dialysis, evaluate CKD-MBD before treatment using iPTH, calcium, 25-hydroxyvitamin D and 1,25-dihydroxyvitamin D; consider bone-turnover assessment. Correct pre-existing hypocalcemia. Monitor calcium weekly for the first month after a dose and monthly thereafter, with adequate calcium and activated vitamin D and CKD-MBD-experienced supervision. Calcimimetics can add risk. The separate 10-14-day monitoring advice for predisposed patients without advanced CKD is not this advanced-CKD schedule. No renal dose adjustment does not remove these safeguards.

Source revision: 6/2026 | Retrieved: 2026-09-10. Retrieval date is not the revision date.

Source: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=49e5afe9-a0c7-40c4-af9f-f287a80c5c88

Scope: Selected source text imported locally; independent clinical review pending. Not a complete prescribing monograph. GlobalRPh v6.6.

Full source card / provenance

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Source-specific interpretation

What the dialysis evidence actually supports

Removal information alone does not define a maintenance dose, supplemental dose or dialysis schedule. A reported regimen still requires its product, indication, renal measure and dialysis assumptions to match the patient.

Denosumab - PROLIA subcutaneous injection

Authored v6.0; retrieved 2026-09-10 - retained source, not freshly reviewed in this release

No dialysis regimen established in selected content

Read the source and its limits

GlobalRPh RX List - PROLIA

Authored v6.0; retrieved 2026-09-10 - retained source, not freshly reviewed in this release

No dialysis regimen established in selected content

Read the source and its limits

These manual classifications apply only to the identified selected sections, not every retained source or the entire prescribing information. They are not dosing clearance.

Source-first renal review

Evidence sources and renal implications

Choose a source to jump directly to its locally stored result. Qualitative precautions and evidence gaps remain visible even when no numerical clearance schedule is supplied.

Read 2 source difference / applicability notes

Official product label

PROLIA - official advanced-CKD safety check

Monitoring or renal-toxicity guidance. This finding concerns risk or surveillance; it may not establish a dose adjustment.

PROLIA - official advanced-CKD safety check; selected renal passages, not a complete prescribing monograph.

Renal method: eGFR, mL/min/1.73 m2; retain body-surface-area indexing.
Retrieved: 2026-09-09

Read local renal resultOpen original reference
Official product label

Denosumab - PROLIA subcutaneous injection

Qualified no-adjustment statement. Apply only to the population, product and renal range described in this source.
Before using this finding

Use the advanced-CKD monitoring schedule, not the separate nonadvanced-CKD 10-14-day instruction.

Dialysis evidence: No dialysis regimen established in selected content

PROLIA for its labeled bone indications; not an XGEVA or biosimilar dosing substitution.

Renal method: Indexed eGFR <30 mL/min/1.73 m2; dialysis/CKD-MBD population retained
Retrieved: 2026-09-10

Read local renal resultOpen original reference
GlobalRPh RX List

GlobalRPh RX List - PROLIA

No adjustment within stated limits. This does not establish dosing outside the studied renal range or population.

Denosumab - PROLIA subcutaneous injection; selected renal passages, not a complete prescribing monograph.

Renal method: eGFR, mL/min/1.73 m2; retain body-surface-area indexing.
Retrieved: 2026-09-09

Read local renal resultOpen original reference
GlobalRPh RX List

GlobalRPh RX List - PROLIA

Qualified no-adjustment statement. Apply only to the population, product and renal range described in this source.
Before using this finding

No renal dose adjustment is not clearance of hypocalcemia or CKD-MBD risk.

Dialysis evidence: No dialysis regimen established in selected content

PROLIA for its labeled bone indications; not an XGEVA or biosimilar dosing substitution.

Renal method: Advanced CKD: indexed eGFR <30 mL/min/1.73 m2
Retrieved: 2026-09-10

Read local renal resultOpen original reference

Source presence is not independent validation. A label mirror is not a second independent source; review the original reference and exact formulation.

Product / population check

Confirm the exact formulation before using a renal source

These links compare product identities, not interchangeable doses. A selected summary is not a complete prescribing monograph.

Source-specific review points

PROLIA: no adjustment does not mean routine-risk treatmentNo renal dose adjustment does not remove advanced-CKD safeguards

Read the attributed comparison notes and source cards below. No conflict has been silently adjudicated.

Source-quality holds
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Search the stored clinical text

Locate a word or phrase within this drug's source summaries. Choose all sources or one source to focus the search. The selection never hides warnings or source text, changes a dose, or proves that a renal finding is absent.

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All source summaries, original wording and provenance
Before applying a renal protocol

Check the setting. Compare whole sources.

No patient-specific dose is calculated. Context choices only display reminders; they do not validate, hide or change any regimen.

Share a reproducible source review

Choose sources below, then open a print-ready comparison with product scope, renal method, dates and cautions. Links can pin the exact local cards; they never contain patient values or choose a dose.

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Jump to renal guidanceRead 2 difference / caution notesClinician guide

Select two distinct source versions. The complete stored summaries will appear below.

Build a source-review outline for documentation

This creates a blank decision outline with the source identities you select, not a dose recommendation or completed clinical assessment. No patient fields are collected, saved or sent. Complete the clinical decisions in your approved documentation system.

Choose one or two sources above or use the source checkboxes below.

Renal-context checklist: population, kidney trend and dialysis

These prompts are a reading aid, not a prescription checklist or proof that all requirements have been met. No selections are stored or sent to a server.

Read the exact source scope, renal metric and date before selecting a row. No applicability assessment has been performed.

See source-specific renal methods and the clinical interpretation guide for the supporting context.

Read before choosing a regimen

Source differences and product cautions

Search differences across all drugs

These are specific issues found during source review, not an automated judgment that one source is universally correct. A label mirror and its original label are not independent evidence.

monitoring scope

PROLIA: no adjustment does not mean routine-risk treatment

Both retrieved sources contain advanced-CKD hypocalcemia precautions. This is not a disagreement or a missing-warning claim. Dose unchanged and CKD-MBD safety assessment are different questions.

How to use this: Complete the advanced-CKD assessment and monitoring plan with appropriate expertise; do not substitute the nonadvanced-CKD monitoring interval.

GlobalRPh RX List - PROLIAPROLIA - official advanced-CKD safety check

Source-specific interpretation; independent clinician adjudication pending.

qualified no adjustment and monitoring

No renal dose adjustment does not remove advanced-CKD safeguards

Selected mirror and June 2026 label paragraphs agree. Advanced-CKD calcium surveillance differs from the nonadvanced-CKD 10-14-day instruction.

How to use this: Review CKD-MBD and the advanced-CKD monitoring plan before using the no-adjustment statement.

GlobalRPh RX List - PROLIADenosumab - PROLIA subcutaneous injection

Source-specific interpretation; independent clinician adjudication pending.

Go directly to the relevant source section

Renal dosing and precautions

Choose a source, then jump to its renal or dialysis section. These links locate stored text; they do not merge regimens or certify that sources agree.

New source summary - independent clinical review pending. Summaries of the identified label sections are included locally. Source import and numeric transcription checks are not independent two-reference validation. Do not treat this card as an approved institutional dosing protocol.

No dialysis or renal heading shown? Read the complete source summary. Absence of a heading is not evidence that dose adjustment is unnecessary.

Compare or copy source versions

All content below is stored locally. Read a whole source version; do not combine its dose with another source's interval, renal metric or dialysis assumptions.

Original content / product scopePROLIA - official advanced-CKD safety checkDenosumab - PROLIA subcutaneous injectionGlobalRPh RX List - PROLIAGlobalRPh RX List - PROLIA
Choose two source checkboxes below.
Exact product and population matter. This added page contains locally stored, source-specific clinical summaries. Historical handbook information, when present, is identified separately and may conflict with U.S. labeling. Confirm indication, population, kidney-function method, monitoring and the full prescribing information before applying a regimen.
Locally stored source content

Exact product and population

Product identity selected for the separately displayed source protocols below. Reference: https://globalrph.com/rx-list/prolia-drug/

Exact product and population

Denosumab - PROLIA subcutaneous injection; selected renal passages, not a complete prescribing monograph.

RDM50-SCOPE-denosumab-prolia · Source section: Selected source product scopeRenal section finder
Separate U.S. product-label layer

FDA / DailyMed dosing and renal information

Official

PROLIA - official advanced-CKD safety check

Open original reference

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DailyMed / Amgen, Inc · PROLIA - official advanced-CKD safety check; selected renal passages, not a complete prescribing monograph.

Renal method: eGFR, mL/min/1.73 m2; retain body-surface-area indexing.
Source date: Prescribing information revised June 2026.
Retrieved: 2026-09-09

Monitoring or renal-toxicity guidance. This finding concerns risk or surveillance; it may not establish a dose adjustment.

Selected source text imported locally; independent clinical review pending. Not a complete prescribing monograph.

Renal dosing, restrictions and evidence limits

The June 2026 label retains no renal adjustment alongside a boxed warning for severe hypocalcemia in advanced CKD, including dialysis. The eGFR threshold is <30 mL/min/1.73 m2. Before treatment decisions, evaluate CKD-MBD using iPTH, calcium, 25(OH) vitamin D and 1,25(OH)2 vitamin D. Calcium monitoring is weekly for the first month and monthly thereafter. Provide appropriate calcium and activated vitamin D under CKD-MBD expertise. Correct pre-existing hypocalcemia. This is a safety and monitoring requirement, not a rationale for an invented smaller dose.

RDM50-official-denosumab-prolia-027fc85709-C1 · Source locator: Boxed warning; sections 2.2 and 5.1, lines 366-367 and 428-432; section 8.6.

Source-specific limits

Identity check: DailyMed labeler Amgen, Inc. Current archive version 186 published 2026-07-07. This archive date is separate from the prescribing-information revision and does not itself prove that renal instructions changed. Raw SPL XML was not independently downloaded or hashed.

Source identity and provenance
Source family
product_label
Source
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=49e5afe9-a0c7-40c4-af9f-f287a80c5c88
Retrieved
2026-09-09
Exact label title
PROLIA- denosumab injection
DailyMed Set ID
49e5afe9-a0c7-40c4-af9f-f287a80c5c88
Labeler
Amgen, Inc
Label revision
Prescribing information revised June 2026.
Archive publication date
2026-07-07
SPL version
186
FDA application
BLA125320
Renal-function method
eGFR, mL/min/1.73 m2; retain body-surface-area indexing.
Source date/version
Prescribing information revised June 2026.
Hash meaning
SHA-256 of local authored summary only; not original HTML, PDF or SPL bytes.
Local summary SHA-256
42b465a555c152065f473e862b280089e888da77baa14f5d6b5e4cf3ddcc1d6c
Official

Denosumab - PROLIA subcutaneous injection

Open original reference

Open / share this exact local source

DailyMed / Amgen Inc. · PROLIA for its labeled bone indications; not an XGEVA or biosimilar dosing substitution.

Renal method: Indexed eGFR <30 mL/min/1.73 m2; dialysis/CKD-MBD population retained
Source date: 6/2026
Retrieved: 2026-09-10

Qualified no-adjustment statement. Apply only to the population, product and renal range described in this source.
Before using this finding

Use the advanced-CKD monitoring schedule, not the separate nonadvanced-CKD 10-14-day instruction.

Dialysis evidence: No dialysis regimen established in selected content

Selected source text imported locally; independent clinical review pending. Not a complete prescribing monograph.

Renal dosing, restrictions and evidence limits

In advanced CKD (eGFR <30 mL/min/1.73 m2), including dialysis, evaluate CKD-MBD before treatment using iPTH, calcium, 25-hydroxyvitamin D and 1,25-dihydroxyvitamin D; consider bone-turnover assessment. Correct pre-existing hypocalcemia. Monitor calcium weekly for the first month after a dose and monthly thereafter, with adequate calcium and activated vitamin D and CKD-MBD-experienced supervision. Calcimimetics can add risk. The separate 10-14-day monitoring advice for predisposed patients without advanced CKD is not this advanced-CKD schedule. No renal dose adjustment does not remove these safeguards.

RDM60-official-denosumab-prolia-027fc85709-C1 · Source locator: 2.2; 5.1; 8.6

Source-specific limits

Selected named sections only; not a complete monograph or independent clinical approval.

Selected exact-product labeling sections read. Original-source bytes and complete revision histories were not retained or reconciled; retrieval does not establish current product availability.

Source identity and provenance
Source family
product_label
Source
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=49e5afe9-a0c7-40c4-af9f-f287a80c5c88
Retrieved
2026-09-10
Exact label title
Denosumab - PROLIA subcutaneous injection
DailyMed Set ID
49e5afe9-a0c7-40c4-af9f-f287a80c5c88
Labeler
Amgen Inc.
DailyMed page updated
2026-06-26
Label revision
6/2026
Renal-function method
Indexed eGFR <30 mL/min/1.73 m2; dialysis/CKD-MBD population retained
Source date/version
6/2026
Hash meaning
SHA-256 of local authored summary only; not original HTML, PDF or SPL bytes.
Local summary SHA-256
11f7cf7806d6a7911f6603bff59eae09a6767cf95b6c26e0e1dd8179c79314c5
Locally imported selected renal sections

GlobalRPh RX List renal information

Rxlist

GlobalRPh RX List - PROLIA

Open original reference

Open / share this exact local source

GlobalRPh-hosted RX List · Denosumab - PROLIA subcutaneous injection; selected renal passages, not a complete prescribing monograph.

Renal method: eGFR, mL/min/1.73 m2; retain body-surface-area indexing.
Source date: Source revision date not established in selected retrieval.
Retrieved: 2026-09-09

Label mirror, not independent corroboration. This is selected locally stored RX List content. Full monograph import and current official-label review are not implied.
No adjustment within stated limits. This does not establish dosing outside the studied renal range or population.

Selected source text imported locally; independent clinical review pending. Not a complete prescribing monograph.

Renal dosing, restrictions and evidence limits

No renal dosage adjustment is required, but advanced CKD (eGFR <30 mL/min/1.73 m2), including dialysis, increases severe hypocalcemia risk. CKD-mineral and bone disorder increases that risk further. Correct hypocalcemia before treatment. Evaluate calcium, intact PTH, 25(OH) vitamin D and 1,25(OH)2 vitamin D before a treatment decision; consider bone-turnover assessment. For advanced CKD, measure calcium weekly during the first month after administration and monthly thereafter, with appropriate calcium/activated vitamin D and CKD-MBD expertise. The separate 10-14-day check for predisposed patients without advanced CKD is not this monitoring schedule. Scope is PROLIA, not an oncology denosumab regimen.

RDM50-rxlist-denosumab-prolia-dc32313496-C1 · Source locator: Renal statement, lines 453-455; hypocalcemia/CKD-MBD warning, lines 292-301.

Source identity and provenance
Source family
product_label_mirror
Source
https://globalrph.com/rx-list/prolia-drug/
Retrieved
2026-09-09
Renal-function method
eGFR, mL/min/1.73 m2; retain body-surface-area indexing.
Source date/version
Source revision date not established in selected retrieval.
Hash meaning
SHA-256 of local authored summary only; not original HTML, PDF or SPL bytes.
Local summary SHA-256
a6b3d2bb4468073c1016e9feb9f5498c66c666abfe654b10e7d2879682d81d92
Rxlist

GlobalRPh RX List - PROLIA

Open original reference

Open / share this exact local source

GlobalRPh-hosted RX List · PROLIA for its labeled bone indications; not an XGEVA or biosimilar dosing substitution.

Renal method: Advanced CKD: indexed eGFR <30 mL/min/1.73 m2
Source date: Source revision date not established in selected retrieval.
Retrieved: 2026-09-10

Label mirror, not independent corroboration. This is selected locally stored RX List content. Full monograph import and current official-label review are not implied.
Qualified no-adjustment statement. Apply only to the population, product and renal range described in this source.
Before using this finding

No renal dose adjustment is not clearance of hypocalcemia or CKD-MBD risk.

Dialysis evidence: No dialysis regimen established in selected content

Selected source text imported locally; independent clinical review pending. Not a complete prescribing monograph.

Renal dosing, restrictions and evidence limits

The mirror retains no renal dose adjustment but identifies severe hypocalcemia risk in advanced CKD, including dialysis, especially with CKD-mineral and bone disorder. It calls for assessment of calcium, iPTH, 25-hydroxyvitamin D and 1,25-dihydroxyvitamin D, with consideration of bone-turnover assessment. The advanced-CKD paragraph specifies calcium checks weekly in the first month and monthly thereafter. Dose adjustment and the decision whether treatment can be safely supervised are separate questions.

RDM60-rxlist-denosumab-prolia-dc32313496-C1 · Source locator: Dosage: advanced CKD; warnings: severe hypocalcemia; renal impairment

Source-specific limits

Selected named sections only; not a complete monograph or independent clinical approval.

A label mirror is not independent corroboration of its underlying label. See the separately attributed official source; concordance is limited to selected sections.

Source identity and provenance
Source family
product_label_mirror
Source
https://globalrph.com/rx-list/prolia-drug/
Retrieved
2026-09-10
Renal-function method
Advanced CKD: indexed eGFR <30 mL/min/1.73 m2
Source date/version
Source revision date not established in selected retrieval.
Hash meaning
SHA-256 of local authored summary only; not original HTML, PDF or SPL bytes.
Local summary SHA-256
61bbed3fba5412df58538bb04a0a07b8da2188c024af5998233fffb325e67655

Provenance and preservation

Additional summaries stored on this page: 2 official-label, 2 RX List, 0 professional, 0 handbook. Empty additional-source groups are not shown. A missing layer is not a no-adjustment recommendation.

Original source
https://globalrph.com/rx-list/prolia-drug/
Source retrieval
2026-09-09. This is not the source publication or label revision date.
Original source type
rxlist summary
Local text SHA-256
b8c40369c45969379cd6656f2f7a0de9857a8fe83de79145437489b6d4fc5230
Import versus clinical validation
Source-section locators identify where retained content came from. A source-section identifier does not assert that every numeric statement has been independently corroborated. The local text hash is not a hash of original HTML, an FDA PDF or SPL XML.

This page is an additional exact-product entry, not a recovered GlobalRPh monograph. Its primary scope text and separately attributed clinical summaries are locally included.

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