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Rx Item-GALAFOLD- migalastat hydrochloride capsule 123MG 14 CAPSULES BY AMICUS T

RX71904-100-01 Visit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop

Rx Item-GALAFOLD- migalastat hydrochloride capsule 123MG 14 CAPSULES BY AMICUS T

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NDC No.71904-0100-01 71904-100-01 71904010001 7190410001 UPC/GTIN No.3-71336-10001-7 371336-100017 371336100017 MPN No. 010001 Only Lic.-Physician, Pharmacy, Dentist, Drug Mfg, Dist., Gov, Hospital, Lic.Lab, Naturalist, Naturopath, NP, Optometrist, & Pharmacist, PA, Physical Therapist, Podiatrist, Research Co., Uni., VA, Vet & Wholesalers In Scope Of their Practice Can Order Rx Item.

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For: Fabry Disease

Galafold (migalastat) is an alpha-galactosidase A (alpha-Gal A) pharmacological chaperone indicated for the treatment of adults with a confirmed diagnosis of Fabry disease and an amenable galactosidase alpha gene variant.GALAFOLD capsules are supplied as 123 mg migalastat, size �2" capsules with opaque blue cap and opaque white body filled with white to pale brown powder and imprinted with �A1001" in black ink.

GALAFOLD capsules are packaged as two 7-count capsules blister strips with aluminum foil lidding encased in cardboard blister cards providing 14 capsules per wallet pack that supplies the drug product for 4 weeks (28 days).

Wallet pack containing 14 GALAFOLD capsules NDC 71904-100-01.

Store at USP Controlled Room Temperature of 20� to 25�C (68� to 77�F) with excursions permitted between 15� and 30�C (59� and 86�F). These highlights do not include all the information needed to use GALAFOLD safely and effectively. See full prescribing information for GALAFOLD.

GALAFOLD� (migalastat) capsules, for oral use
Initial U.S. Approval: 2018

INDICATIONS AND USAGE

GALAFOLD is an alpha-galactosidase A (alpha-Gal A) pharmacological chaperone indicated for the treatment of adults with a confirmed diagnosis of Fabry disease and an amenable galactosidase alpha gene (GLA) variant based on in vitro assay data. (1, 12.1)

This indication is approved under accelerated approval based on reduction in kidney interstitial capillary cell globotriaosylceramide (KIC GL-3) substrate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. (1)

DOSAGE AND ADMINISTRATION

Select adults with confirmed Fabry disease who have an amenable GLA variant for treatment with GALAFOLD.
Treatment is indicated for patients with an amenable GLA variant that is interpreted by a clinical genetics professional as causing Fabry disease (pathogenic, likely pathogenic) in the clinical context of the patient. Consultation with a clinical genetics professional is strongly recommended in cases where the amenable GLA variant is of uncertain clinical significance (VUS, variant of uncertain significance) or may be benign (not causing Fabry disease). (2, 12.1)
The recommended dosage regimen of GALAFOLD is 123 mg orally once every other day at the same time of day. (2)
Take on an empty stomach. Do not consume food at least 2 hours before and 2 hours after taking GALAFOLD to give a minimum 4 hours fast. (2)
Do not take GALAFOLD on 2 consecutive days. (2)
If a dose is missed entirely for the day, take the missed dose only if it is within 12 hours of the normal time that the dose should have been taken. If more than 12 hours have passed, resume taking GALAFOLD at the next planned dosing day and time and according to the every-other-day dosing schedule. (2)
Swallow capsules whole; do not cut, crush, or chew. (2)

DOSAGE FORMS AND STRENGTHS

Capsules: 123 mg migalastat. (3)

CONTRAINDICATIONS

None. (4)

ADVERSE REACTIONS

Most common adverse drug reactions ? 10% are: headache, nasopharyngitis, urinary tract infection, nausea, and pyrexia. (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Amicus Therapeutics at 1-877-4AMICUS or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.

Revised: 6/2019

RX71904-100-01
Rx Item-GALAFOLD- migalastat hydrochlori
RX71904-100-01

Visit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.
Rx Item-GALAFOLD- migalastat hydrochlori
Visit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.

Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop
AmericanPharmaWholesale.com
Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop