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1 local source card selected. Local card fingerprints checked where supplied. This is not an original-document hash, source-currency guarantee or clinical approval. Record-level cautions below are the current library's cautions, not a frozen prior version.
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Clinical context remains essential
Independent clinical review is pending. Confirm indication, exact formulation/route, population, renal measure and units, kidney-function stability, dialysis prescription, interacting drugs, monitoring and source revision. An RX mirror and its original label are not independent corroboration. Missing disagreement notes do not certify agreement.
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PROLIA - official advanced-CKD safety check
Product / population
PROLIA - official advanced-CKD safety check; selected renal passages, not a complete prescribing monograph.
Selected source text imported locally; independent clinical review pending. Not a complete prescribing monograph.
Documented differences and cautions on this drug
All record notes are retained here, including notes about sources not selected in this review.
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.
What to reconcile: Complete the advanced-CKD assessment and monitoring plan with appropriate expertise; do not substitute the nonadvanced-CKD monitoring interval.
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.
This reference does not select a regimen. Complete the indication, measured/estimated renal function and trend, dialysis setting, source rationale, monitoring and reassessment plan in your institution's approved documentation system. Confirm the complete current source before adopting its regimen.
GlobalRPh v6.6 | RDM66-DIRECT-PHP-20260911 | Local library date 2026-09-11. Selected-card identity does not imply clinical verification.