Prescribing guide
Galafold (migalastat)Amenability, every-other-day dosing, renal limits and prior authorization criteria for Fabry diseaseFor prescribers and their offices treating fabry disease: what the pharmacy needs before it ships, what the prior authorization wants documented, the titration and the monitoring the label requires.
Dispensing gate
No REMS; Galafold Referral Form (also a prescription in some states) with patient consent to Amicus Assist by fax 1-833-264-2873 or email assist@amicusrx.com; specialty pharmacy ships after any prior authorization.
Example PA threshold
Cigna example: age 18 or older, documented pathogenic or likely pathogenic amenable GLA variant per in vitro assay, geneticist, nephrologist or Fabry specialist, no concurrent Fabrazyme or Elfabrio.
Monitoring
No scheduled monitoring in the label; not recommended at eGFR below 30 or on dialysis; caffeine within 2 hours of a dose lowers exposure.
Support line
Amicus Assist, 1-833-264-2872 (1-833-AMICUS-A), Monday to Friday 8 AM to 8 PM ET; Case Manager contacts office and patient within 1 business day; copay as little as $0 for commercial plans; Amicus Patient Assistance Program.
Give your patient their plan
A one-page handout for starting Galafold, in plain language: what the first fill waits on, the first dates, who will call and the symptoms to report, with blank lines for the start date and your office's number. The link opens the patient's full first 90 days page, where their dates become calendar entries.
trialfriend.com/p/galafoldBefore the first fill: REMS, labs and enrollment
The steps that the pharmacy, the REMS or the drugmaker's program will wait on, in the order they usually need to happen. A first fill of a specialty drug most often stalls on one of these rather than on the plan.
| Step | What it requires | Source |
|---|---|---|
| REMS | None. Galafold does not appear on the FDA's list of approved REMS, and the label and approval letters name none. | FDA REMS list |
| Confirm amenability | Match the patient's GLA variant to label Table 2 (DNA or protein change). Multiple variants must appear as that exact combination and be on a single chromosome; consult a clinical genetics professional for females with multiple variants. Unlisted variants are non-amenable or untested; Amicus Medical Information, 1-877-4AMICUS. | FDA label |
| Search tool | Amicus's US HCP search accepts a DNA or protein change, or up to 3 variants on the same chromosome, and reports whether the variant is listed in the prescribing information. | Amenability search |
| Confirm the variant is disease-causing | The label says the prescriber, with a clinical genetics professional if needed, decides before initiation whether the amenable variant causes Fabry disease. Note c.937G>T (p.D313Y) is listed as considered benign. | FDA label |
| Check renal function | Not recommended at eGFR below 30 mL/min/1.73m2 or with dialysis; not studied in Fabry patients below 30. | FDA label |
| Submit the Referral Form | Pages 1 to 3: patient and insurance details with copies of all insurance cards, the prescription (NDC 71904-100-01, 14-capsule wallet, ICD-10 E75.21, 123mg PO every other day, quantity and refills), prescriber signature (no stamps) and the Statement of Medical Necessity with the amenable variant. Fax 1-833-264-2873 or email assist@amicusrx.com. | Referral Form |
| Patient consent | The patient signs the privacy authorization and Amicus Assist enrollment on page 2, plus a separate copay program attestation. Declining does not block therapy but limits support services. | Referral Form |
| After submission | A Case Manager contacts the office and patient within 1 business day and states whether PA is required and the steps. The specialty pharmacy coordinates delivery once PA is confirmed, and the Case Manager supports refills and reauthorizations. | Amicus Assist HCP |
Prior authorization criteria and what to document
One public policy as the example: Cigna, February 15, 2026. Approval a year at a time. This policy took effect on February 15, 2026 and cites the March 2025 label, whose prescribing text matches the current DailyMed version. Other plans set their own rules, and the Blue Cross Blue Shield Federal Employee Program is one example. It asks for an amenable variant without the pathogenic wording and allows 42 capsules per 84 days. It is here as an example of what a plan asks for, not as a rule.
| Element | What the policy asks | In the chart | Source |
|---|---|---|---|
| Age | 18 or older | Date of birth on the request | Cigna policy |
| Variant | Pathogenic or likely pathogenic amenable GLA variant based on in vitro assay data [documentation required] | Genetic test report naming the variant and its classification | Cigna policy |
| VUS | The February 15, 2026 revision removed the prior path for a VUS with a qualifying Fabry sign or symptom | If the report says VUS, a genetics interpretation in the chart | Cigna policy |
| Prescriber | Prescribed by or in consultation with a geneticist, nephrologist or physician who specializes in Fabry disease | Specialty on the request, or the consult note | Cigna policy |
| Monotherapy | Concurrent Fabrazyme or Elfabrio is not medically necessary | Current medication list; ERT stop date if switching | Cigna policy |
| Quantity | FEP example: 42 capsules per 84 days, 12-month approvals | Prescription written in 14-capsule wallets | FEP Blue policy |
Galafold dosing and titration
| When | Label | Source |
|---|---|---|
| Day 1 onward | 123mg orally once every other day at the same time of day; not on consecutive days; swallow whole, do not cut, crush or chew. No titration and no other strength. | FDA label |
| Fasting | No food or caffeine at least 2 hours before and 2 hours after each dose (minimum 4-hour fast). Water (plain, flavored or sweetened), pulp-free fruit juice and caffeine-free carbonated drinks are allowed. | FDA label |
| Missed dose | Take within 12 hours of the scheduled time; after 12 hours, resume at the next planned every-other-day dose. | FDA label |
| Supply | Wallet pack of 14 capsules in two 7-count blister strips (NDC 71904-100-01), a 28-day supply. Store 20 to 25°C, excursions 15 to 30°C, in original packaging to protect from moisture. | FDA label |
| Adherence | The Galafold MyDay app sends every-other-day reminders, fasting start and end reminders and refill reminders, per Amicus. | Galafold HCP support |
| Renal impairment | No adjustment at eGFR 30 or higher; not recommended below 30 or with dialysis. | FDA label |
| Pediatrics and older adults | Not established under 18; too few patients 65 or older to judge differences. | FDA label |
Monitoring the Galafold label requires
| When | What | What the label says to do with it | Source |
|---|---|---|---|
| Before starting | eGFR | Not recommended below 30 mL/min/1.73m2 or on dialysis; AUC 4.3 times higher in severe impairment | FDA label |
| Any time | Common adverse reactions | Headache 35% against 21%, nasopharyngitis 18% against 6%, UTI 15% against 0, nausea 12% against 6%, pyrexia 12% against 3% in the 6-month placebo phase | FDA label |
| Any time | Angioedema | Postmarketing report, added in March 2025; frequency not estimable | FDA letter S-009 |
| Pharmacodynamics | Plasma lyso-Gb3 | Median change at month 6 -2.37 nmol/L on Galafold against 0.53 on placebo (Study 1); the label sets no target or schedule | FDA label |
| Pregnancy or lactation | Registry enrollment | Pregnancy Coordinating Center 1-888-239-0758, fabrypregnancy@ubc.com; participation voluntary | FDA label |
| Renewal | Clinical status | The Cigna policy approves 1 year at a time and lists no separate renewal criteria | Cigna policy |
Galafold drug interactions and contraindications
| Label category | Agents and what the label says | Source |
|---|---|---|
| Avoid | Caffeine within 2 hours before and 2 hours after dosing; 190mg caffeine lowered migalastat AUC 55% and Cmax 60% | FDA label |
| Food | A meal 1 hour before or after dosing lowered AUC 37% to 42% and Cmax 15% to 39% | FDA label |
| No meaningful effect | Sucrose, aspartame and acesulfame potassium | FDA label |
| CYP and transporters | Not an inhibitor or inducer of CYP450; not a substrate of P-gp, BCRP, OAT1, OAT3 or OCT2; minor UGT elimination | FDA label |
| Enzyme replacement | The label does not address concurrent ERT; the Cigna policy treats concurrent Fabrazyme or Elfabrio as not medically necessary | Cigna policy |
| Pharmacokinetics | Bioavailability about 75%, tmax about 3 hours, half-life about 4 hours, no accumulation every other day; 77% of a dose recovered in urine | FDA label |
Why a first fill stalls, and the fix
- Prior authorization pending or deniedCigna's policy wants a pathogenic or likely pathogenic amenable variant, documented, and a geneticist, nephrologist or Fabry specialist. The Amicus Assist Case Manager tells the office whether prior authorization is needed and what the steps are.
- The variant is of uncertain significanceCigna's February 2026 update removed an earlier path that accepted a variant of uncertain significance with Fabry symptoms. The label strongly recommends a clinical genetics professional review such variants before treatment.
- The variant is not in the label's tableThe label says an unlisted variant is either not amenable or has not been tested. It points doctors to Amicus Medical Information at 1-877-4AMICUS for more information.
- You also receive enzyme replacement infusionsCigna does not cover Galafold used together with Fabrazyme or Elfabrio. Cigna notes Galafold is not FDA approved for use with enzyme replacement, and the prescriber decides which treatment continues.
- A refill asked for too earlySome plans cap how many capsules can be dispensed at one time. The Blue Cross Blue Shield Federal Employee Program allows 42 capsules per 84 days, which equals 3 wallet packs.
- A copay you cannot payWith commercial insurance, the copay program offers as little as $0 a month, subject to program maximums. People with Medicare, Medicaid, TRICARE, VA, DOD or other government coverage are excluded. The Amicus Patient Assistance Program gives free drug to uninsured or underinsured people who qualify.
Amicus Assist
- A Case Manager who verifies and explains coverage, helps with prior authorization questions, and coordinates prescription deliveries and refills
- A Patient Education Liaison who answers questions about Fabry disease and Galafold and helps set a routine, without giving medical advice
- Copay help for commercial insurance, as little as $0 a month subject to program maximums, not valid with Medicare, Medicaid, TRICARE, VA, DOD or state drug programs
- The Amicus Patient Assistance Program, free product for eligible uninsured or underinsured patients
- Help finding independent charitable foundations, which set their own rules
- Spanish-speaking Case Managers
Questions prescribers' offices ask about Galafold
What is the Galafold dose?
The label effective August 28, 2025 gives 123mg orally once every other day at the same time of day, never on consecutive days, swallowed whole. Patients fast from food and caffeine at least 2 hours before and 2 hours after each dose; there is one strength and no titration.
How is GLA variant amenability confirmed?
Table 2 of the label effective August 28, 2025 lists the variants amenable in the HEK-293 in vitro assay, defined as a relative increase of at least 20% and an absolute increase of at least 3% of wild-type alpha-Gal A activity. A clinical genetics professional should interpret the variant as pathogenic or likely pathogenic; consultation is strongly recommended for a VUS or possibly benign variant. Amicus offers a US HCP search tool that mirrors the label table.
Can Galafold be used in renal impairment?
The label effective August 28, 2025 needs no adjustment at eGFR 30 mL/min/1.73m2 or higher and does not recommend Galafold below 30 or on dialysis. Single-dose AUC rose 1.2, 1.8 and 4.3 times in mild, moderate and severe impairment, with Cmax unchanged.
Does Galafold have a REMS or required monitoring?
No REMS appears on the FDA's REMS list, and the label effective August 28, 2025 has no boxed warning, no contraindications and no Warnings and Precautions section. It sets no laboratory monitoring schedule.
What do insurers ask for to approve Galafold?
The Cigna policy on this page, effective February 15, 2026, asks for age 18 or older and a documented pathogenic or likely pathogenic amenable GLA variant based on in vitro assay data. It requires a geneticist, nephrologist or Fabry specialist, approves 1 year at a time, and excludes concurrent Fabrazyme or Elfabrio.
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Sources
- DailyMed - GALAFOLD- migalastat hydrochloride capsule (prescribing information, Patient Information and Instructions for Use, SPL version 18), Amicus Therapeutics US, via DailyMed, 2025-08-28.
- GALAFOLD prescribing information, revised 3/2025 (Drugs@FDA file 208623s009lbl.pdf), FDA, Drugs@FDA, 2025-03-19.
- Approved Risk Evaluation and Mitigation Strategies (REMS), FDA, 2026-11-07.
- NDA 208623 replacement approval letter, Galafold (migalastat) capsules, 123 mg, effective August 10, 2018, FDA, 2018-08-10.
- NDA 208623/S-005 supplement approval letter, Galafold (migalastat) capsules, FDA, 2021-12-10.
- NDA 208623/S-006 and S-007 supplement approval letter, Galafold (migalastat) capsules, FDA, 2023-06-20.
- NDA 208623/S-008 supplement approval letter, Galafold (migalastat) capsules, FDA, 2024-06-05.
- NDA 208623/S-009 supplement approval letter, Galafold (migalastat) capsules, FDA, 2025-03-19.
- Amicus Assist | Galafold (migalastat) | Official Patient Site, Amicus Therapeutics, 2026-11-07.
- Fabry Support - Amicus Assist Patient, Amicus Therapeutics, 2026-11-07.
- Patient Support - Fabry Support (hcp-fabry-support) - Amicus Assist HCP, Amicus Therapeutics, 2026-11-07.
- Galafold (migalastat) Referral Form, Amicus Therapeutics, 2026-11-07.
- Taking Galafold | Galafold (migalastat) | Official Patient Site, Amicus Therapeutics, 2026-11-07.
- Testing | Galafold (migalastat) | Official Patient Site, Amicus Therapeutics, 2026-11-07.
- Galafold® (migalastat) Amenability | Search Amenable GLA Variants, Amicus Therapeutics, 2026-11-07.
- Support for Galafold® (migalastat) Patients with AMICUS ASSIST®, Amicus Therapeutics, 2026-11-07.
- Fabry Disease – Galafold, Drug Coverage Policy IP0400, Cigna, 2026-02-15.
- Pharmacy Policy 5.30.057, Galafold, Blue Cross Blue Shield Federal Employee Program, 2026-04-01.
A reference drawn from the August 28, 2025 label, the drugmaker's published program and one public insurer policy shown as an example, checked on November 7, 2026. Labels and policies change; the label on DailyMed and the plan's current policy govern. Trial Friend is not a medical provider. It reports what these documents say and does not judge whether a drug is safe or right for any patient; that is the prescriber's decision. Not a substitute for the prescribing information.