GlobalRPh Renal Dosing Masterv6.6
Source review / handoff

Mitomycin pyelocalyceal solution (JELMYTO)

One or two intact local summaries. No averaged regimen, patient-specific dose or automatic source preference.

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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.

Record caution: RX rendering incomplete: renal guidance here was recovered from the separately identified DailyMed label, not from the truncated RX page.

Check source scope before reading a dose

Mitomycin pyelocalyceal solution (JELMYTO)

Product / population
Adult JELMYTO, pyelocalyceal instillation only; exact UroGen label.
Renal method
GFR in mL/min as printed; no estimator specified in section 8.6
Source revision
June 2025
Retrieved
2026-09-07
Local review status
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.

DailyMed recovered renal guidance; the RX page remains incomplete

The fetched RX rendering stopped before usable renal instructions. A separate exact JELMYTO DailyMed summary now supplies the renal restriction and obstruction precautions.

What to reconcile: Use the labeled pyelocalyceal formulation, not IV mitomycin or another urinary formulation. An alternative-label import does not convert the truncated RX page into a successful RX renal review.

Source-specific interpretation; independent clinician adjudication pending.

Open this note and its source references
Official

Mitomycin pyelocalyceal solution (JELMYTO)

Open original reference

DailyMed / UroGen Pharma, Inc. · Adult JELMYTO, pyelocalyceal instillation only; exact UroGen label.

Renal method: GFR in mL/min as printed; no estimator specified in section 8.6
Source date: June 2025
Retrieved: 2026-09-07

Dose or interval guidance. Use only the product, indication, renal metric and population described in this source.

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

Renal dosing, restrictions and evidence limits

Avoid JELMYTO when GFR is below 30 mL/min; severe renal impairment lacks data. This is the pyelocalyceal product, not IV mitomycin or a bladder formulation. For adult low-grade upper-tract urothelial cancer, the label uses 4 mg/mL with volume determined by pyelography, up to 15 mL (60 mg), weekly for six weeks. This is not a renal-reduced regimen. Monitor kidney function and symptoms of ureteric obstruction; severity may require holding or permanently stopping treatment. Preparation, alkalinization and administration instructions must also be followed. The truncated RX page is not counted as a successful renal import; this separate DailyMed summary supplies the missing guidance.

RDM36-official-mitomycin-jelmyto-cc88ae9486-C1 · Source locator: Sections 2.1-2.2, 5.1 and 8.6; highlights revision.

Source-specific limits

DailyMed page updated July 9, 2025. Page update differs from label revision. SPL XML and full original label not archived.

Source identity and provenance
Source family
product_label
Source
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3d3d5053-5427-4a68-a40b-edb60699521e
Retrieved
2026-09-07
Exact label title
Mitomycin pyelocalyceal solution (JELMYTO)
DailyMed Set ID
3d3d5053-5427-4a68-a40b-edb60699521e
Labeler
UroGen Pharma, Inc.
DailyMed page updated
2025-07-09
Label revision
June 2025
Renal-function method
GFR in mL/min as printed; no estimator specified in section 8.6
Source date/version
June 2025
Hash meaning
SHA-256 of local authored summary only; not original HTML, PDF or SPL bytes.
Local summary SHA-256
a5ad698f2f29171339a92bc7303cd6c5166e19bd206673964c677c2044a92fbc

Document the clinical decision separately

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.

Pinned reference: https://globalrph.com/blogCalcs/renal-dosing-master/compare.php?id=mitomycin-jelmyto&s1=RDM36-official-mitomycin-jelmyto-cc88ae9486&h1=164db4d31d6e141dc1aa708c28558a154cb5d6ee7b1fe465fe8ed3557060e911