GlobalRPh Renal Dosing Masterv6.8
Product-specific reference

Migalastat oral capsules (Galafold)

Local official-label summarySource retrieved 2026-10-02See the evidence for this drug2 sources available - open source summaries, references and comparisons

migalastat / Galafold

READ THE SOURCE-SPECIFIC ANSWER

Renal guidance at a glance

Cautions / source differences (1)
Review first - source-specific qualification

Before use: Migalastat oral capsules (Galafold)

Use indexed eGFR and the qualifying genetic indication; this is not a daily or pediatric regimen.

Before applying: Confirm exact indication, indexed renal estimate and alternate-day schedule; use the newer primary label for full prescribing context.

Evidence for this qualification

Selected source reconciliation only; independent clinician adjudication pending.

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

Choose a source to read (2)

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.

Official source

Migalastat oral capsules (Galafold) - selected label sections

Product / population
US GALAFOLD 123 mg oral capsules for adults with Fabry disease and a qualifying amenable GLA variant; do not extrapolate to pediatric patients.
Renal measure
Indexed eGFR, mL/min/1.73 m2; do not substitute unindexed CrCl.
Source revision
03/2025
Retrieved
2026-10-02 (not the revision date)

The official product label and its RX mirror are one underlying evidence family, not two independent clinical validations. Confirm the current exact product label before prescribing.

Renal guidance and important limits

Limits that apply to these rows

Confirm the qualifying amenable GLA variant. Avoid food and caffeine for 2 hours before and 2 hours after the dose; swallow the capsule whole.

The RX mirror shows 06/2024 while this primary label shows 03/2025. Only the named renal sections were reconciled, not the complete monographs.

Migalastat oral capsules (Galafold) - selected renal instructions
Renal settingSource-specific action and limits
Mild/moderate renal impairment: eGFR >=30 mL/min/1.73 m2No renal dose adjustment. Labeled regimen: 123 mg orally every other day, not on consecutive days.
eGFR <30 mL/min/1.73 m2 or end-stage renal disease requiring dialysisNot recommended; severe renal impairment has not been studied.
Read the retained text before reformatting
Renal settingSource-specific action and limits
Mild/moderate renal impairment: eGFR >=30 mL/min/1.73 m2No renal dose adjustment. Labeled regimen: 123 mg orally every other day, not on consecutive days.
eGFR <30 mL/min/1.73 m2 or end-stage renal disease requiring dialysisNot recommended; severe renal impairment has not been studied.

Confirm the qualifying amenable GLA variant. Avoid food and caffeine for 2 hours before and 2 hours after the dose; swallow the capsule whole.

The RX mirror shows 06/2024 while this primary label shows 03/2025. Only the named renal sections were reconciled, not the complete monographs.

Source revision: 03/2025 | Retrieved: 2026-10-02. Retrieval date is not the revision date.

Source: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=66dbd928-0f1c-48b1-a832-54e4abd9f1db

Scope: Selected renal sections summarized locally. Not a complete monograph or independent clinical approval. GlobalRPh v6.8.

Full source card / provenance

All sources, comparison tools and evidence navigation
Added / rechecked in v6.8

Read source findings

Read source-specific summaries and their qualifications. Retrieval date is not label revision date. Recent review does not imply clinical approval.

Official

Migalastat oral capsules (Galafold) - selected label sections

Before using this finding

Confirm exact indication, indexed renal estimate and alternate-day schedule; use the newer primary label for full prescribing context.

Dialysis evidence: Use is not recommended / excluded in the named dialysis population; not a dialysis dose

Retrieved: 2026-10-02
Source revision: 03/2025

Renal measure: Indexed eGFR, mL/min/1.73 m2; do not substitute unindexed CrCl.

Read this dated source finding
Rxlist

Migalastat oral capsules (Galafold) - RX mirror renal summary

Before using this finding

Confirm exact indication, indexed renal estimate and alternate-day schedule; use the newer primary label for full prescribing context.

Dialysis evidence: Use is not recommended / excluded in the named dialysis population; not a dialysis dose

Retrieved: 2026-10-02
Source revision: 06/2024

Renal measure: Indexed eGFR, mL/min/1.73 m2; do not substitute unindexed CrCl.

Read this dated source finding
See all retained evidence sources
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.

Migalastat oral capsules (Galafold) - selected label sections

Source retrieved 2026-10-02

Use is not recommended / excluded in the named dialysis population; not a dialysis dose

Read the source and its limits

Migalastat oral capsules (Galafold) - RX mirror renal summary

Source retrieved 2026-10-02

Use is not recommended / excluded in the named dialysis population; not a dialysis dose

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 1 source difference / applicability notes

Official product label

Migalastat oral capsules (Galafold) - selected label sections

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

Confirm exact indication, indexed renal estimate and alternate-day schedule; use the newer primary label for full prescribing context.

Dialysis evidence: Use is not recommended / excluded in the named dialysis population; not a dialysis dose

US GALAFOLD 123 mg oral capsules for adults with Fabry disease and a qualifying amenable GLA variant; do not extrapolate to pediatric patients.

Renal method: Indexed eGFR, mL/min/1.73 m2; do not substitute unindexed CrCl.
Retrieved: 2026-10-02

Read local renal resultOpen original reference
GlobalRPh RX List

Migalastat oral capsules (Galafold) - RX mirror renal summary

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

Confirm exact indication, indexed renal estimate and alternate-day schedule; use the newer primary label for full prescribing context.

Dialysis evidence: Use is not recommended / excluded in the named dialysis population; not a dialysis dose

US GALAFOLD 123 mg oral capsules for adults with Fabry disease and a qualifying amenable GLA variant; do not extrapolate to pediatric patients.

Renal method: Indexed eGFR, mL/min/1.73 m2; do not substitute unindexed CrCl.
Retrieved: 2026-10-02

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.

Find text within this drug
Find a term without leaving this drug

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.

Find:

Enter at least two characters. This in-page search is processed in your browser. Do not enter patient identifiers; advertising scripts also run on this page.

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.

Open / share selected sources
Jump to renal guidanceRead 1 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.

source scope and renal guidance

Before use: Migalastat oral capsules (Galafold)

Use indexed eGFR and the qualifying genetic indication; this is not a daily or pediatric regimen.

How to use this: Confirm exact indication, indexed renal estimate and alternate-day schedule; use the newer primary label for full prescribing context.

Migalastat oral capsules (Galafold) - selected label sectionsMigalastat oral capsules (Galafold) - RX mirror renal summary

Selected source reconciliation only; 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.

Independent clinical review is pending. These selected summaries are not an approved institutional dosing protocol. Confirm the exact product, the complete current source and local policy before use.
Official source

Migalastat oral capsules (Galafold) - selected label sections

US GALAFOLD 123 mg oral capsules for adults with Fabry disease and a qualifying amenable GLA variant; do not extrapolate to pediatric patients.

Method: Indexed eGFR, mL/min/1.73 m2; do not substitute unindexed CrCl.

Renal guidance and important limitsRead this complete source summary
Rxlist source

Migalastat oral capsules (Galafold) - RX mirror renal summary

US GALAFOLD 123 mg oral capsules for adults with Fabry disease and a qualifying amenable GLA variant; do not extrapolate to pediatric patients.

Method: Indexed eGFR, mL/min/1.73 m2; do not substitute unindexed CrCl.

Renal guidance and important limitsRead 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.

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 scopeMigalastat oral capsules (Galafold) - selected label sectionsMigalastat oral capsules (Galafold) - RX mirror renal summary
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.

Important source distinctions

The official product label and its RX mirror are one underlying evidence family, not two independent clinical validations. Confirm the current exact product label before prescribing.

Locally stored source content

Exact product and population

Product identity selected for the separately displayed source protocols below. Reference: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=66dbd928-0f1c-48b1-a832-54e4abd9f1db

Exact product and population

US GALAFOLD 123 mg oral capsules for adults with Fabry disease and a qualifying amenable GLA variant; do not extrapolate to pediatric patients.

RDM68-migalastat-galafold-360867cf49 · Source section: Selected primary product label: indications / formulationRenal section finder
Separate U.S. product-label layer

FDA / DailyMed dosing and renal information

Official

Migalastat oral capsules (Galafold) - selected label sections

Open original reference

Open / share this exact local source

DailyMed / GALAFOLD US labeling · US GALAFOLD 123 mg oral capsules for adults with Fabry disease and a qualifying amenable GLA variant; do not extrapolate to pediatric patients.

Renal method: Indexed eGFR, mL/min/1.73 m2; do not substitute unindexed CrCl.
Source date: 03/2025
Retrieved: 2026-10-02

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

Confirm exact indication, indexed renal estimate and alternate-day schedule; use the newer primary label for full prescribing context.

Dialysis evidence: Use is not recommended / excluded in the named dialysis population; not a dialysis dose

Selected renal sections summarized locally. Not a complete monograph or independent clinical approval.

Renal guidance and important limits

Limits that apply to these rows

Confirm the qualifying amenable GLA variant. Avoid food and caffeine for 2 hours before and 2 hours after the dose; swallow the capsule whole.

The RX mirror shows 06/2024 while this primary label shows 03/2025. Only the named renal sections were reconciled, not the complete monographs.

Migalastat oral capsules (Galafold) - selected renal instructions
Renal settingSource-specific action and limits
Mild/moderate renal impairment: eGFR >=30 mL/min/1.73 m2No renal dose adjustment. Labeled regimen: 123 mg orally every other day, not on consecutive days.
eGFR <30 mL/min/1.73 m2 or end-stage renal disease requiring dialysisNot recommended; severe renal impairment has not been studied.
Read the retained text before reformatting
Renal settingSource-specific action and limits
Mild/moderate renal impairment: eGFR >=30 mL/min/1.73 m2No renal dose adjustment. Labeled regimen: 123 mg orally every other day, not on consecutive days.
eGFR <30 mL/min/1.73 m2 or end-stage renal disease requiring dialysisNot recommended; severe renal impairment has not been studied.

Confirm the qualifying amenable GLA variant. Avoid food and caffeine for 2 hours before and 2 hours after the dose; swallow the capsule whole.

The RX mirror shows 06/2024 while this primary label shows 03/2025. Only the named renal sections were reconciled, not the complete monographs.

RDM68-migalastat-galafold-207a6d9781 · Source locator: Sections 1, 2.1, 2.2 and 8.6

Source-specific limits

The official product label and its RX mirror are one underlying evidence family, not two independent clinical validations. Confirm the current exact product label before prescribing.

Source identity and provenance
Source family
product_label
Source
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=66dbd928-0f1c-48b1-a832-54e4abd9f1db
Retrieved
2026-10-02
DailyMed Set ID
66dbd928-0f1c-48b1-a832-54e4abd9f1db
Renal-function method
Indexed eGFR, mL/min/1.73 m2; do not substitute unindexed CrCl.
Source date/version
03/2025
Hash meaning
Local authored summary; not source HTML/XML/PDF bytes
Local summary SHA-256
207a6d9781e8cad5c992d992b0a7164bdaabb9602b01805f69ebdd26d593c3e8
Locally imported selected renal sections

GlobalRPh RX List renal information

Rxlist

Migalastat oral capsules (Galafold) - RX mirror renal summary

Open original reference

Open / share this exact local source

GlobalRPh RX List / product-label mirror · US GALAFOLD 123 mg oral capsules for adults with Fabry disease and a qualifying amenable GLA variant; do not extrapolate to pediatric patients.

Renal method: Indexed eGFR, mL/min/1.73 m2; do not substitute unindexed CrCl.
Source date: 06/2024
Retrieved: 2026-10-02

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.
Before using this finding

Confirm exact indication, indexed renal estimate and alternate-day schedule; use the newer primary label for full prescribing context.

Dialysis evidence: Use is not recommended / excluded in the named dialysis population; not a dialysis dose

Selected renal sections summarized locally. Not a complete monograph or independent clinical approval.

Renal guidance and important limits

The June 2024 mirror gives no adjustment for eGFR at least 30 mL/min/1.73 m2, and does not recommend use below 30 or for end-stage renal disease requiring dialysis. Adult amenable-variant eligibility and every-other-day administration remain important. The mirror predates the March 2025 primary label.

RDM68-migalastat-galafold-5ad3adb3e5 · Source locator: Named RX renal impairment, dosage and renal-warning sections

Source-specific limits

The official product label and its RX mirror are one underlying evidence family, not two independent clinical validations. Confirm the current exact product label before prescribing.

Source identity and provenance
Source family
product_label
Source
https://globalrph.com/rx-list/galafold-drug/
Retrieved
2026-10-02
Renal-function method
Indexed eGFR, mL/min/1.73 m2; do not substitute unindexed CrCl.
Source date/version
06/2024
Hash meaning
Local authored summary; not source HTML/XML/PDF bytes
Local summary SHA-256
5ad3adb3e5eae98041d202c04bdf499de19fde7ddc3e6710c4a109f73b4f55e0

Provenance and preservation

Additional summaries stored on this page: 1 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://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=66dbd928-0f1c-48b1-a832-54e4abd9f1db
Source retrieval
2026-10-02. This is not the source publication or label revision date.
Original source type
multisource addition
Local text SHA-256
360867cf49245ac9fbdb5f67ab462038fe86b8d4de98d29cd6902bcd90e570c4
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.

Read the full coverage report