Mitomycin pyelocalyceal solution (JELMYTO)

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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.

Before applying: 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.

Also check: DailyMed recovered renal guidance; the RX page remains incomplete

Official source

Product / population: Adult JELMYTO, pyelocalyceal instillation only; exact UroGen label.
Renal measure: GFR in mL/min as printed; no estimator specified in section 8.6

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

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.

Source revision: June 2025 | Retrieved: 2026-09-07. Retrieval date is not the revision date.

Source: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3d3d5053-5427-4a68-a40b-edb60699521e

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Official product label

Mitomycin pyelocalyceal solution (JELMYTO)

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

Adult JELMYTO, pyelocalyceal instillation only; exact UroGen label.

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

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Important product / source limitation: RX rendering incomplete: renal guidance here was recovered from the separately identified DailyMed label, not from the truncated RX page.

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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.

How to use this: 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.

Mitomycin pyelocalyceal solution (JELMYTO)

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Official source

Mitomycin pyelocalyceal solution (JELMYTO)

Adult JELMYTO, pyelocalyceal instillation only; exact UroGen label.

Method: GFR in mL/min as printed; no estimator specified in section 8.6

Renal dosing, restrictions and evidence limits Read this complete source summary

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Original content / product scope Mitomycin pyelocalyceal solution (JELMYTO)

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Product identity selected for the separately displayed source protocols below. Reference: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3d3d5053-5427-4a68-a40b-edb60699521e

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Adult JELMYTO, pyelocalyceal instillation only; exact UroGen label.

RDM36-SCOPE-mitomycin-jelmyto · Source section: Selected source product scopeRenal section finder

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Mitomycin pyelocalyceal solution (JELMYTO)

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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

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

Provenance and preservation

Additional summaries stored on this page: 1 official-label, 0 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://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3d3d5053-5427-4a68-a40b-edb60699521e
Source retrieval: 2026-09-07. This is not the source publication or label revision date.
Original source type: source summary
Local text SHA-256: 8f24aa54204e31d1088dc246b1f8c886f7b741c810e5c3430b0b17c5cf8c5df2
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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