Inborn errors of metabolism:

Indications for: GALAFOLD

Treatment of adults with confirmed Fabry disease and an amenable GLA variant based on in vitro assay data.

Adult Dosage:

Swallow whole. Take on empty stomach. Avoid food or caffeine ≥2hrs before and 2hrs after dose. 123mg once every other day; do not take on 2 consecutive days.

Children Dosage:

Not established.

GALAFOLD Warnings/Precautions:

Severe renal impairment or ESRD on dialysis: not recommended. Pregnancy. Nursing mothers.

GALAFOLD Classification:

Alpha-galactosidase A pharmacological chaperone.

GALAFOLD Interactions:

May be antagonized by caffeine; separate by at least 2hrs before and 2hrs after Galafold administration.

Adverse Reactions:

Headache, nasopharyngitis, urinary tract infection, nausea, pyrexia, abdominal pain, back pain, cough, diarrhea, epistaxis.

Drug Elimination:

Renal (~77%), fecal (20%). Half-life: ~4 hours.

Generic Drug Availability:

NO

How Supplied:

Caps—14