Miglustat - OPFOLDA with POMBILITI | GlobalRPh Renal Dosing Master

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OPFOLDA: paired therapy and every-other-week renal dosing

The OPFOLDA instruction belongs to a weight-based regimen paired with POMBILITI, not a daily Gaucher-disease miglustat schedule.

Before applying: Confirm paired therapy, body weight, renal method and infusion timing. Do not transfer a ZAVESCA regimen.

Also check: OPFOLDA: paired therapy and every-other-week renal dosing

Rxlist source

GlobalRPh RX List - OPFOLDA

Product / population: Miglustat - OPFOLDA with POMBILITI; selected renal source sections only, not a complete prescribing monograph.
Renal measure: Cockcroft-Gault creatinine clearance (CrCl), mL/min.

RX mirror: this is not independent corroboration of its underlying label. Check dated-label and formulation limitations.

Renal dosing, restrictions and evidence limits

For adults weighing at least 40 kg with late-onset Pompe disease not improving on current enzyme replacement, OPFOLDA is used with POMBILITI. At Cockcroft-Gault CrCl 15-59 mL/min, the renal dose is 195 mg for weight >=50 kg or 130 mg for 40 to <50 kg, every other week approximately one hour before POMBILITI. Mild impairment (60-89) needs no reduction. ESRD has not been studied. Preserve the combination, fasting and missed-dose instructions; this is not the ZAVESCA regimen.

Source revision: RX page prints July 2024. | Retrieved: 2026-09-08. Retrieval date is not the revision date.

Source: https://globalrph.com/rx-list/opfolda-drug/

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

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GlobalRPh RX List

GlobalRPh RX List - OPFOLDA

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

Miglustat - OPFOLDA with POMBILITI; selected renal source sections only, not a complete prescribing monograph.

Renal method: Cockcroft-Gault creatinine clearance (CrCl), mL/min.
Retrieved: 2026-09-08

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Source-specific review points

OPFOLDA: paired therapy and every-other-week renal dosing

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Source differences and product cautions

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formulation scope

OPFOLDA: paired therapy and every-other-week renal dosing

The OPFOLDA instruction belongs to a weight-based regimen paired with POMBILITI, not a daily Gaucher-disease miglustat schedule.

How to use this: Confirm paired therapy, body weight, renal method and infusion timing. Do not transfer a ZAVESCA regimen.

GlobalRPh RX List - OPFOLDA Miglustat (ZAVESCA)

Source-specific interpretation; independent clinician adjudication pending.

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Renal dosing and precautions

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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.

Rxlist source

GlobalRPh RX List - OPFOLDA

Miglustat - OPFOLDA with POMBILITI; selected renal source sections only, not a complete prescribing monograph.

Method: Cockcroft-Gault creatinine clearance (CrCl), mL/min.

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

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

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Original content / product scope GlobalRPh RX List - OPFOLDA

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/opfolda-drug/

Exact product and population

Miglustat - OPFOLDA with POMBILITI; selected renal source sections only, not a complete prescribing monograph.

RDM47-SCOPE-miglustat-opfolda · Source section: Selected source product scopeRenal section finder

Locally imported selected renal sections

GlobalRPh RX List renal information

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GlobalRPh RX List - OPFOLDA

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GlobalRPh-hosted RX List · Miglustat - OPFOLDA with POMBILITI; selected renal source sections only, not a complete prescribing monograph.

Renal method: Cockcroft-Gault creatinine clearance (CrCl), mL/min.
Source date: RX page prints July 2024.
Retrieved: 2026-09-08

Label mirror, not independent corroboration. This is selected locally stored RX List content. Full monograph import and current official-label review are not implied.

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

RDM47-rxlist-miglustat-opfolda-e88d407a01-C1 · Source locator: Dosage and renal Table 1, lines 28-62; Use in Specific Populations.

Source identity and provenance

Source family: product_label_mirror
Source: https://globalrph.com/rx-list/opfolda-drug/
Retrieved: 2026-09-08
Renal-function method: Cockcroft-Gault creatinine clearance (CrCl), mL/min.
Source date/version: RX page prints July 2024.
Hash meaning: SHA-256 of local authored summary only; not original HTML, PDF or SPL bytes.
Local summary SHA-256: d56d6677db7bbdd79f50713f6063f8dc332870f6add1c2caac9aaceab417977d

Provenance and preservation

Additional summaries stored on this page: 0 official-label, 1 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/opfolda-drug/
Source retrieval: 2026-09-08. This is not the source publication or label revision date.
Original source type: rxlist summary
Local text SHA-256: 90ff617d40925956891ab2bbda211382e4303b68c77ae252d700054e17cfc0e4
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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